Your Cells. Their Research. Your Permission?

Dec 30, 2015 · 291 comments
Mary (Atlanta, GA)
Has society become so warped as to refuse cells for research without some kind of payoff? The example given is bogus - one's cell phone includes all kinds of identifiable personal information. Not so with cells used for research.

Do those here wanting to be compensated realize their cells are worthless until hours of time and money have been spent to analyze and determine whether they even might be of use?

Then we have the question of how many and of what societal segment will grant thr use of their cells for research without compensation.

No.
Miriam (Raleigh)
Many years ago, I was diagnosed with a serious chronic disease. I chose to seek care at an institution that in my younger years I had been affliatied rather than the one I was currented affliated, for privacy - we providers are a nosy bunch. At the treating facility I was invited to join a research trial and in that I had been very active in reasearch, I consented. Later when many vials of blood were being drawn, I noted that some were prepped for transport, and in that I had been informed on the consent all research on samples was in house, I queried why? It was being sent to an ourside, collaborating center which just so happened where I practiced. In that I was the Chair at that time of the IRB of that facility where the samples were being sent , hilarity did not ensue. For anybody. So yes consent is the gold standard.
Katayoun Chamany (New York)
These proposed changes need to be viewed within the context of existing inequities in society. The proposed change to require reconsent for downstream research, may present formidable challenges for those researchers with limited funding and infrastructure. Thus, rather than broaden research participation and research scope, these proposals may bias research directions towards those that are seen to have large financial payoffs and that include the participation of a privileged class that has not endured the injustices of past biomedical studies. Furthermore, many community voices informed the development of these revised guidelines as can be viewed in the freely available video clips of iNIH Workshop to Explore the Ethical, Legal, and Social Implications (ELSI) of Citizen Science. The Privacy and Trust Principles that accompany the PMI attempt to address these community groups' concerns and people should review these as well. A thorough address of this perspective can be seen at the Biopolitical Times in a blog post I authored."New Rules Proposed to Address Privacy and Trust in the Precision Medicine Initiative." (http://www.biopoliticaltimes.org/article.php?id=8990) I echo Skloot's call to action- everyone deserves to be heard.
hyp3rcrav3 (Seattle)
I have given permission for my liver cells to be used. However, if the organization involved makes a profit, I should get a high percentage of the gross.
JS (CT)
I’ve worked in biomedical research for the last 35 years developing methods of diagnosis using DNA from biopsy tissues. My entire career has been in academia and I’ve never personally profited from these tests. I think I’m not unusual among my peers in that my only goal has been to move forward medical care. In my long experience in this field, I’m unaware of a single instance anywhere in which analysis of an individual's DNA has adversely affect that person's welfare due to inappropriate use or disclosure of confidential genetic or disease-related information. To the contrary, I see patients every day whose care has benefited enormously because of knowledge obtained from their DNA and the DNA of others.

The profit motive has complicated and distorted the central mission of medicine in this country, but that is a separate and much larger issue that needs to be addressed comprehensively at a societal and political level. In the meantime, private enterprise is the way that health care advances are delivered to patients in this country.

It will be a great misfortune if an over-reaction to imagined dangers and resentment of greedy profiteers in the biomedical industry leads to a clamp down on research using patient-derived tissues and DNA. There is a tipping point phenomenon that operates in research when the difficulties, time, and costs of meeting regulatory requirements make researchers decide that certain promising avenues of investigation are not worth pursuing.
sad taxpayer (NY, NY)
Should the analogy at the article beginning be to offering someone your cell phone AFTER all identifying information has been removed? The third paragraph clearly states that is the case with tissue studies! Who wouldn't donate their cell phone with no personal information on it to charity? Why not donate anonymous cell tissue for medical research as well!
Robert Iovino (Southampton, NY)
Consider framing our ethical responsibilities, when conducting such gene based research, by prioritizing the less cumbersome but equally important principle of respect for human dignity, instead of the bioethical principle of respect for patient autonomy/informed consent. What unites us as humans is encoded in our DNA.
Scott (Iowa)
The medicine proposed by our gene pool suggests that many people may not be allowed to have a say. For instance, those in prison have their DNA taken without consent. Who will say what is to be done with these samples? Can families of felons have a say in the distribution of family DNA? Who is the ultimate arbiter over second class ex-felons and, not forgetting the transient illegal immigrant, those who have no legal status comparable to first class American citizens?
jenmoran (east hollywood)
Permission, yes. Profit, no. I would want to know that no creepy profiteer could make money from the use of my cells. All benefits should be free to people who might have their health improved.
also MD (Zurich)
Nice try, but that's not how stuff works. Why would investor (including your pension fund) put money into medical research (rather than casinos, real estate, etc.) if there is no gain to be made?
Kathryn Tominey (Benton City, Wa)
Samples or specimens used are not actually "unidentified or unidentifiable". The conclusions reached in published papers and as based for patents must be teaceable to sources so if issues arise thry can get back to original sources as it were. Samples are identified by code number in some way.

Yes, large freezers full of samples - they will get used to it.
Ken Weiss (Pennsylvania)
The problem is not that the samples can be used, without knowing the personal ID of the donor, which provides all the required scientific information for research. It's that irrelevant personal information can be found, directly or indirectly, from such data. All sorts of prying eyes, recreational or political, or economic could avail themselves of the data. That is why new restrictions, if they are serious, are important.

It should be recognized that most people, even savvy ones but especially those not involved in science and so on, have very little ability to understand these issues and of course the scientists and their support staff can obtain permission as if it were 'informed'. And if you're a patient, with a frightening illness, your'e likely to agree to anything abstract or innocent-sounding like this that your doctor suggests. Even the staff may have no idea what downstream uses might arise. How many are truly 'informed', even among the investigators (if all risks and benefits were known, for example, why would the research be being done?).

Intrusive technology is a problem for our age, in many areas besides this one. It is not as if there has been no history, even in living memory, about what authorities can (will?) do with personal data, and genetics isn't particularly new or unique in this respect. So serious restrictions, if even possible, are in order.
c smith (PA)
What is the issue with totally anonymous tissue samples used for research?
angbob (Hollis, NH)
My tissue is my property. If you wish to use it, pay me.
W.A. Spitzer (Faywood)
angbob.....If you wish to withhold your discarded cells/tissues from medical research thereby retarding medical advances, than why is it not fair for medical research to with hold medical advances from your treatment?
Miriam (Raleigh)
WA - what you are purposing is no where near a "fair trade" Angbob or his\her insurance company will pay for that advance when treatment is offered. You do understand that alll this research is not exactly for charity - there is an expectation of return on that investment - again the patient will pay for that new and wonderful treatment and , as pharma tells us, part of that huge price tag is the R&D.
Godlessly Honest (Not Here)
Why is NYT promoting this farce? Why are you, NYT executive editors helping the right wing distract attention from our government's responsibility to rein in monopolization and limitless profit margins with those who produce life-or-death medicines? Shame on you for playing this card for them, and helping the right wing in its campaign to bring all beneficial medical research to a grinding halt!

BOOOOOOOO, NYT!!!
Martin (NYC)
I am not enthused about having Shkreli Insurance decide that my pre-existing condition of some possible genetic defect makes me uninsurable since I have a slightly increased risk of eventually developing some disease, which Mr Shkreli will charge $100,000. per dose for "curing" and he knows who I am and where to find me. If they have enough tissue samples, they can de-anonymize all of them.
KC (NJ)
Thanks for writing this. I will be interested to see the full set of changes that are being proposed to the Common Rule. I am glad that the government is soliciting public comments, and I'm glad that the author is has alerted us to this.

A comment on "non-identifiable" samples: The quotation marks seem appropriate. Speculating that research on biospecimens might often occur at the same institution where the specimens were acquired, it seems that the people scrutinizing these tissues may be the same individuals who were part of the patient's care team, if they are involved in both clinical and research roles. So in that case the identity may be remembered by the investigators, even if any ID labels are gone. Whether or not this should be a concern, I don't know. It just seems that de-identification is an ideal that is often only partially attained.
Patricia Riveroll (Ottawa, Canada)
I quote from your article "That form would disclose any potential for commercial profit and whether donors would be compensated".

Why are we always thinking about "compensation". Life is to share and be lived. I profundly think that getting medical information is a gift to improve and evolve as human beings.
angbob (Hollis, NH)
That's nice, but why should anyone profit from using your tissue without paying you?
Francis (Thunder Bay)
But wait a minute, am I qualified to provide consent for the use of these cells. After all, don't these cells really belong to my parents?
Jennifer (United States)
How would revising the Common Rule impact Institutional Review Board (human subject research) protocols for each institution? If scientists are already following federal and institution protocol for 'discarded' samples, then how would adding an extra layer of paperwork help protect the public and assist in the evolution of medical science? Adding further layers of consent and paperwork for unidentifiable samples isn't needed. Teaching and practicing ethical scientific behaviors is.

For example: scientists shouldn't be allowed to identify the samples (as explained in the article). If their research study takes a new direction, and identification of the participants in needed at that point, then an addendum to the IRB can be submitted. If the researchers' new direction is found to be sound (both scientifically and ethically) then the corresponding IRB will make that decision. That's why we have the IRB process for any research involving human subjects.
amrcitizen16 (AZ)
One question that pops to mind is how tissues may be used to cloning humans. It is illegal at the present in the U.S. but not in other countries. If a scientist realizes that the genetic imprint of the tissue is "perfect" can the donor stop it from being cloned? Even with the new Common Rule, it will not allow the donor to designate how the tissue is being used. It only allows consent. Storing tissues for future use in the interest of medicine means that your future generations will have to deal with the aftermath of any problems arising from any genetic testing. We should be given options not to allow genetic testing other than for the disease being studied, any genetic information should never be allowed out of the scientists hands this would include any government entities inside and outside the country. This would not prevent testing of samples but would greatly enable more control of how one's tissue or blood products are used. An option on storage length should be part of the form as well. If the disease is in the early stages of investigation, storage can be lengthened to 30 years but not more. It is incredible to me to realize that storage has been going on without the consent of the donor. Advances in medical technology have increased 100 times fold within ten years and cannot keep up with the many questions driven by a society that is overwhelmed by these advances.
georgiadem (Atlanta)
One just has to read "The Immortal Life of Henrietta Lacks" to understand the relationship between research, researchers and a patient's right to consent their tissues verses the pursuit of knowledge and financial reward. You cannot rely on someones ethics winning out over their gain. As someone who has participated in medical research in the past I feel ethics should be first and foremost in the pursuit of medical science advancements.
W.A. Spitzer (Faywood)
"One just has to read "The Immortal Life of Henrietta Lacks" to understand the relationship between research, researchers and a patient's right to consent".....You forgot to mention the interest of the author in selling the book; which, without the artificially fabricated ethical controversy, would not have had nearly the same exposure and resulting profit.
Richard (Manhattan)
You have a right to your opinion about whether what happened to Lacks and her family represents an ethical controversy or not. Stating as fact that the book "artificially fabricated" an ethical controversy is a different matter, and a very serious accusation - what is your evidence for that claim?
MJR (Stony Brook, NY)
I believe the substative issues here really concern control and compensation as opposed to privacy which is nullified by de-identifying the specimens. True some incredible hacks may be able to trace the DNA profile back to you if they have identified comparable profiles of your relatives - but come on - for what nefarious purpose? The control and compensation issues are at least valid - but can be minimized by institutional/investigator agreements with patients and volunteers that: the donor's genomic DNA cannot be used to propagate an immortalized cell line, or to create a chimeric animal or another human being; and no compensation is owed. Patient samples - even if they are de-identified - should not be made available for research without the patient's signature on such an agreement. As to compensation for minute amounts of tissues and cells - that is taking individualism and greed to absurd limits. Just because sociopathic capitalists might exploit you does not mean we should all go down the same dark path. Sure - you are free to divorce yourself from humanity and go live in the wilderness, but if you hope for a civilization that can effectively treat human diseases, some of us must demonstrate the very human trait of altruism - and too much regulation would likely crush.
lcr999 (ny)
I am surprised this loophole even exists. Restrictions exists for all other types of human subjects research, some of them very silly. I would think that consent and protocol review for use of my DNA would be much more important than consent and protocol review for my opinion on some issue.
George W. Hayduke (Hite's Crossing, UT)
My Cells. My Time. My Money. My Discretion.
I profoundly don't understand why I cannot have complete discretion over my body and its parts. I can choose which charities, churches or community efforts I donate my time or money to, and steer clear of those whose goals or ideals do not match mine. Why should my cells, whether I "need them" or not, be allowed to go somewhere and support something I may not believe in or want to support? I have revoked my organ donor approval for exactly this reason.
W.A. Spitzer (Faywood)
"I profoundly don't understand why I cannot have complete discretion over my body and its parts."....You should, but as far as I am concerned you relinquish that right when you voluntarily ask for a medical procedure to be performed.
MNice (Minneapolis MN)
My main concern is not so much consent but commercialization. The example of Henrietta Lacks punctuates the problem. Her cells have generated millions for academic and commercial entities and yet her estate has not seen a direct benefit from that and many family members do not even have the means to afford healthcare. If researchers can patent and profit from my tissues then I should be able to own them and get a cut of the profit, particularly because the benefits of that research are not in fact socialized as soem researchers here argue. It is quite possible that the person whose cells made a breakthrough cannot afford the treatment based upon those cells. I appreciate Ted Slavin's approach.
W.A. Spitzer (Faywood)
" If researchers can patent and profit from my tissues then I should be able to own them and get a cut of the profit"....Researchers can't patent naturally occurring genetic material. By using their knowledge and hard work they might learn some things by studying your genetic material, and after hundreds of thousands of man hours of research what they learn, discover, and develop might someday lead to a useful product. If your personal knowledge, hard work, study, discovery, and development isn't involved in process, there is no way you are entitled to claim a portion of any profit that might result. Talk about being greedy....
Syd (Michigan)
Henrietta Lacks' story was the first thing I thought of when I saw this headline. The scientific community has a long history of abusing the bodies of minorities, especially black women, and using them for research without their consent, and the fact that so many scientists don't seem to be at all empathetic to those concerns just makes me mistrust them even more. Making informed consent a necessity would be a good first step in healing the wounds of the past.

Henrietta Lacks' family is dirt poor while pharmaceutical companies make billions off their mother's tragic death. They were never given a say, never warned. No one finds that deplorable?
W.A. Spitzer (Faywood)
Pharmaceutical companies have never made a nickel from HeLa cells. It is true that they are a widely used cell line in medical research, but that is entirely do to the foresight, discovery, and work of the scientists involved. Henrietta Lack and her family contributed nothing; and if her specific cell line had not been developed for its present use, another cell line from someone else would have been.
angbob (Hollis, NH)
Henrietta Lacks contributed tissue from her body. That counts.
TS (Memphis, TN)
I am much more alarmed by the huge number of current diagnoses and medical procedures that have no sound scientific basis than I am about whether someone might want to use a new technique to study that skin biopsy I had done last year. Ignorance is only measurable in retrospect, and the longer we put off the reckoning the higher the price will have been.
A Goldstein (Portland)
It is probably safe to assume that decades or even years from now, the understanding of how and why our cells do the good and bad things they do, will be unfathomably greater than it is now. There are those who would gladly give carte blanche for further investigations of their cells with the hope that responsible and talented researchers will find cures to diseases faster. For those who object to that option, they should be assured that their wishes are granted. To do that, we need clear informed consent forms. I hope most people will allow their cells to be re-examined as new insights into biology develop.
Lawrence (Palo Alto)
I recommend that readers of this article also read Ms Skloot's outstanding book about the Lacks family and the use of Henrietta Lacks's cells without her knowledge or permission. As a graduate of the Johns Hopkins School of Medicine, I was appalled to learn the details of that story.
Jim (New Orleans)
Patient concern over the use of de-identified biological materials in research is understandable. In reality, however, instances where current practice has harmed anyone are extremely rare. In contrast, there is no doubt that ready access to biological samples is absolutely essential for the rapid advancement of medical research. As a researcher for many years, I've seen the bureaucracy of research oversight take an increasing large bite out of my work time. And there is no doubt that compliance with federal guidelines and regulations have increased the cost of doing research. In fact, the rules regulating human and animal research that have accumulated in the Federal Register are now so extensive that a new workforce has developed just to interpret the rules to researchers and assure compliance. Institutional Review Boards and Institutional Animal Care and Use Committees are increasing asked to provide more and more detailed oversight of human and animal research. And research institutions, not the federal government, are required to foot the bill. I don't know what the answer is but I do think it's wrong to ask the general public to decide how broad consent to use biological materials should be unless the general public takes the time to better inform themselves on the issues and long-term ramifications.
Historic Home Plans (Oregon)
Reading these comments I find it surprising, almost shocking, to see how many people are so ready to hand over their personal power to for-profit institutions, to the point where they happily relinquish even the right to retain consent in the process.
David (California)
Do you feel the same way about companies that harvest personal information from your cell phone?
Dsiple (Los Angeles)
As a man living with HIV/AIDS for 35 years, in an ongoing research study on the effects of HIV on the brain, I have given my consent to donate my brain and any other parts of my corpse they desire for ongoing research. I have benefitted for years on research done on others, and myself to develop drugs and treatments that likely have helped keep me alive. Though it's an anonymous study with me being "patient so-and-so", I would gladly have done it with my name attached. I have not been able to donate blood, but would do so monthly if I were able. This is my way of giving back. If something were discovered that would have value in creating a drug, or a treatment or just new knowledge, I would be glad to have been a source for that, and wouldn't mind in any way, if my name were attached to it. If profits were to be made by the university that is doing the study benefitted financially from any of my DNA, tissue, blood, etc., then I'd be grateful that I'd left an endowment to them.

Medical science can't continue without the use of cadavers, or tissue, blood and other specimens. I'm glad that I'm able to consent to donate my flesh. I'm more concerned for the chimpanzees and other animals who don't get to consent.
lcr999 (ny)
Well, how would you feel, if using your DNA, and while you are still living, they discover a real cure, but want to charge you and everyone else $1M for it.
Ryan Bingham (Up there)
Makes me wonder why I'm an organ donor, when if I needed one it would set me back tens of thousands and hospitals would make huge profits off me.
Fourteen (Boston)
This is article highlights a ridiculous subject. How can "involving donors" in the research process give scientists more useful information, as Dr. Francis Collins believes? What possible input will the donor/partner provide the molecular biologist? Will we be working side-by-side, or maybe we'll just get in the way?

We lose millions of cells every day. Should we start tagging them with a tracker. Like, who cares?

And why does the Federal Policy for Protection of Human Subjects govern research on tissues and genetic material in addition to Humans? Humans need protection, but tissues and genetic material are completely different.
I've never heard a tissue calling out for Federal protection. Will they next get voting rights? Let the scientists have all the effluvia they can use.

As for re-identifying anonymous samples, this is not easy and would only be done to locate and help someone for a special public health reason - like they have Ebola and don't know it.

Give the scientists their data. If they misuse it, then take it away and censure them. Ethical failures, as with Mrs. Lacks, would fall under the protection for Humans; no need for tissue protection. If I am missing something, then a simple opt-out is adequate. We need to fast-forward personalized medicine.

Have to wonder if this is another insidious Republican initiative, designed to eventually make embryos human.
Richard (Manhattan)
"How can "involving donors" in the research process give scientists more useful information, as Dr. Francis Collins believes?"

Have you heard of epigenetics?
John (Kentfield, ca)
First, let's get something straight. Medicine is not a science; it's a practice and it's considered an art. Anonymity and proprietary issues pale next to the invasion of privacy we will experience, if we link our identity to our DNA. That kind of invasion privacy will allow industries like health insurance and large healthcare institutes to deny or allow us vital treatments based on prior knowledge. No practiced art there, unless we're talking about underhandedness as an art. It will give some industries vast power so they can determine whether you deserve to live or die based on that prior knowledge alone. I don't care if anyone uses my DNA to create a cure or if they make a profit on that cure. I can about your future and mine. Healthcare is a civil right in every developed nation but America. Giving pernicious insurance monopolies access to our DNA and our identity is a violation of our rights and will end up limiting our access to healthcare, when we need it the most. Let's wake up out there and stop worrying whether someone can make a profit and look at the broader picture. Information capture has become big business and invading our privacy has become routine. Let's keep our DNA anonymous and let science use it for the common good.
W.A. Spitzer (Faywood)
"That kind of invasion privacy will allow industries like health insurance and large healthcare institutes to deny or allow us vital treatments based on prior knowledge."....Maybe you didn't notice, but ACA requires insurance companies to provide insurance to people without regard to preexisting conditions. Further it is hard to understand how they could get the information as the cells/tissues are anonymous.
Martel Hauser (Southern California)
Years ago, I participated in a national (US) health study. Following the conclusion of the study, received a birthday card annually for another half dozen years or so. Initially I thought it was a sweet gesture; however when the cards continued coming it suddenly occurred to me that the purpose of the greeting was to ascertain if I was still alive, assuming if I'd died the card would be returned. That's kind of like receiving natal day wishes from Charles Addams!
Obviously I've outlived the study...I wonder if my drawn samples have too.
Ruth (New Mexico)
If a name or anything that can be traced back to the persons identity it is associated with the sample then consent should be mandatory. IF it's an anonymous sample that can't be traced I don't think this is an issue.
Historic Home Plans (Oregon)
As the article points out, with the continual advances in DNA sequencing and the ever growing databases, it becomes harder and harder to guarantee that anonymity.
Juvenal (Bronx, NY)
This is a manufactured crisis. It carries the veneer of legitimacy because it occurs at the intersection of privacy, bioethics, autonomy, compensation and scientific progress.

Ask yourself: has anyone actually been victimized by the way we have been doing medical research until now? Did Henrietta Lacks or her family suffer injury because of the research done with HeLa cells? Has anyone had their identity inappropriately exposed because of genetic information extracted from research specimens (aside from "re-identification" stunts like the one mentioned in the article, which are done for demonstration purposes)?

I have yet to see convincing evidence. But that doesn't stop people from feeling wronged when companies profit from a discovery made using their tissue. I believe credit should be awarded for work done. It is clear to me that the tissue is valuable only because of the researchers' intellectual efforts, not because of any work done by the patient. Still, perhaps patients should be given a fee for supplying material. If such fees were required, however, many projects would never be done, since research is expensive already, and failure is much more likely than success.

Regardless, the endpoint of this discussion is merely another informed consent form, printed in 9 point font, that patients will be asked to sign when they are in the hospital. And more book sales for Ms. Skloot.
W.A. Spitzer (Faywood)
Requesting a medical treatment should be regarded as implied consent. After all, anyone requesting medical treatment will be receiving the benefit of previous medical research.
David Kronemyer (Beverly Hills, CA USA)
You're missing the famous California decision of Moore v. Regents (see Wikipedia article re same), which held that a patient did not have property rights in discarded body parts, thus the investigator was free to use them to pursue a patent. I represented Dr. David Golde, one of the defendants in that case.
Patisotagomi (Virginia)
According to my reading, comments at regulations.gov were closed on Dec. 15. Too bad. I would have commented that I am in favor, as always, of informed consent. Any argument that this would be onerous is spurious in this day of terabits of information stored, analyzed, and shared. Of course, I am in favor of relevant research and development of processes to relieve suffering, but I think that consent, if at all possible, is preferable. In fact, I am in favor of requiring consent for each level of use of human biological material.
David Carter (New York)
That was the original deadline -- the comment period was extended and is open until Jan 6th via the link provided at the bottom of this article.
Artemus (Cambridge)
"The Common Rule doesn’t require consent for “non-identifiable” samples, but scientists have proven it’s possible to “re-identify” anonymous samples using DNA and publicly available information."

I'm confused. If previously non-identifiable samples are now identifiable, doesn't the Common Rule already apply to any future use of them?
M Peirce (Boulder, CO)
Interesting questions! But the reasons for and against requiring consent are very muddled.

Far too many people leap deep into reasons based on assuming that we "own" either (a) the individual cells we leave behind or which are taken from us, or (b) our DNA (not the individual molecules themselves, but rather our "code"). Once ownership is assumed, the requirement of consent readily follows. But the rub is that we need to justify these ownership claims - we don't get ownership rights just by wanting them, or by loosely describing our cells and our DNA as "ours" (unless correct use of possessive tense is all it takes to ground a claim of ownership).

And privacy isn't an issue unless, well… there is warrant to conclude that the kind of research being done makes it an issue. If researchers start looking into the DNA left behind by a person in a way that has a significant chance of being used against that person as an individual, then issues of privacy are pertinent, and requiring consent will be a just requirement (one that is not counterbalanced by the annoyance and work it requires of researchers). So, we cannot say in any blanket way that privacy issues are overblown, nor that the people whose DNA is being used have nothing to fear. Because it depends on the nature of the research, a blanket consent requirement would be heavy-handed overkill.

The focus of the question, instead, needs to change: What *kinds* of DNA research should require consent, and what shouldn't?
Historic Home Plans (Oregon)
I'm no legal expert and I'm probably over-simplifying somewhat. But it's my understanding that when people remove something from my garbage can without my consent it's theft. When they sift through my garbage to find personal information it's an invasion of privacy.
But they're free to take pieces of my body without my consent or knowledge, and use them for whatever medical purpose they wish, including using them for profit?
That just simply doesn't seem right.
Give me the chance to consent. I will say yes 99% of the time. I will be happy to know that it is being put to uses that benefit humanity.
But it's MY BODY. Give me back the right to what happens to it.
ACW (New Jersey)
'But it's my understanding that when people remove something from my garbage can without my consent it's theft. When they sift through my garbage to find personal information it's an invasion of privacy.'

Your understanding is incomplete. I just checked this. I'm sure a lawyer will correct me if I've misconstrued, but:
Once you put out your trash on the curb for pickup, it's abandoned property, fair game. In the house, and probably in your yard, you do still have control over it. But if it goes to the curb, and/or into a common receptacle, forget it, even if it's still identifiable as yours. If a dumpster diver finds your phone bill or a credit card you didn't shred and uses them, that is indeed a crime, and he may also have trespassed with regard to whomever owns the dumpster - but he hasn't stolen anything from you.
W.A. Spitzer (Faywood)
"But they're free to take pieces of my body without my consent or knowledge.....Did you request medical treatment? Than how is it possible for them to take pieces of your body without your consent? Since the cells/tissues might be used for future medical research, how is it that you are justified in using treatment developed from past medical research?
Historic Home Plans (Oregon)
I believe that in most communities, if recycling materials are at the curb they belong to the company contracted to collect the material and to take them is considered theft. I believe the same often applies to garbage as well.
But I believe laws on this subject do vary by community.
I'm guessing you probably got my greater point though. We seem to have more legal protection over what happens to our garbage than we do over what happens to our bodies.
Bryan (NYC)
Inform, but do not ask for consent. Everyone benefits from medical research at some point in their life, so it is only fair that everyone be required to bear the risks.
Paul Wallfisch (Dortmund, Germany)
It's at best frivolous and at worst profoundly irresponsible for Rebecca Skloot to pretend to raise awareness of a problem that simply doesn't exist. There are so many areas where government and commercial interests can and do infringe on infringe on our right to privacy band discretion. Attempting to fan the flames of some imagined paranoia about--for heaven's sake--research on anonymous cells, strikes me as nothing less than obscene. The same "concern" that drives the fanatic "pro-life" crowd. (Pro-fetus, anti-life). Making the analogy between data on our smart phones and research enabled by access to random cells is so blatantly specious, I simply can't understand how the editors at the Times allowed this in print. My feeling is that, besides knee-jerk paranoiacs, (of which there are, sadly, many millions), people will only object to research without their consent, because of misplaced greed that they'll somehow be cut-out of profits from medical developments based on "their" genetic material. This article is simply the worst news of the day!
Scott Smith (SLC, Utah)
OK, so you go to the hospital for surgery, they give you several pages of paperwork to sign, one of which contains the sentences about consent for biospecimen banking. The whole bioethical debate which is quite interesting and compelling on both sides is really reduced to the pragmatics of the paperwork, which frankly, most people will sign without reading, or reading without understanding, and the way medicine works now, most likely if you refused to sign that paragraph (you tried to cross it out), they wouldn't be able to treat you because the doctor/hospital doesn't have some alternate pathway for de-identified blood/tissue that are recovered from the surgery.
Heidi (NY)
It is the time to look at this protection and it must be an opt in consent. The future is here. Doing the right thing may be burdensome and yes research funding will need to spend more on the administrative costs.
Andrew Hart (Massachusetts)
Before beginning my PhD, I worked as a research assistant at two well-known teaching hospitals in NYC. Part of my responsibilities involved working with the "local"/hospital-based Institutional Review Board (IRB). While IRB staff were, by and large, lovely and wonderful to work with, the human subjects protection system they enforced proved, time and again, to be unnecessarily onerous, almost always impractical, and ultimately bad for human well-being.

I recall one instance of a patient who came in coughing up blood as a result of stage ivb liver cancer. Her physician - a very humane doctor, a brilliant researcher, and a lovely person - wanted to try an experimental immunotherapy under the "compassionate use" mechanism. We submitted the paperwork, but knew the approval timeline ultimately meant the patient would derive zero (potential) benefit from treatment. And we were right: she died before we heard back.

Whenever I think of human subjects "protection," I recall the scene in 'Patch Adams' where a mother is in an ER, desperate to see her family - husband and son dead, and daughter quickly deteriorating, all after being hit by a drunk driver - but can't because she hasn't completed the "necessary" paperwork.

If protection is the goal, let's not lose sight of it in a litany of regulations.
W.A. Spitzer (Faywood)
If you are unwilling to freely consent to the use of your cells/tissue for future medical research, why should you expect to receive the benefit of treatment that has accrued from past medical research? In fact your request for medical treatment should viewed in itself as an implied consent to use your cells/tissues.
Brown Dog (California)
The egregious offense shown in this article is not just about violating of anonymity, but instead it is the SELECTIVE violation of anonymity. The Henrietta Lacks story and research on her descendants reveals several offenses that clearly violated existing international agreements in the boundaries of human subjects research. The shame lies in the fact that those individuals, institutions, agencies and corporations that committed the violations should have had their federal funding, which was very likely NIH and/or NSF money, suspended. But where is any evidence that any of these violations were ever punished?

Dare I say that had the family been named Bush, Rockefeller, Kennedy, Trump, Clinton, Icahn, or Koch rather than Lacks, this violation would no more have happened to them than would a police shooting of one of their children on the streets? We do not need new rules that would curb beneficial research. Just enforcement of existing human subjects research can only be demonstrated by the punishment of those who published the personally identifiable information of subjects. The fact that the violations have been selectively ignored shows that they will continue to be ignored. "New laws" are no more than a cosmetic attempt to divert attention from the fact that existing law of all kinds are selectively applied.
Jaque (Champaign, Illinois)
I am happy to give my cells and my medical history to anyone who would advance knowledge about human biology and medical science.
Stop making this a big deal - if you took a poll what percent of adult population would not willingly give their cells for advancement of science? I guess it would be low teens.
Historic Home Plans (Oregon)
I would very happily give consent.
But I want to retain the right to choose... not just for myself... but because I don't think it is right that we should take it away from the small percentage who might wish to make a different choice.
RHE (NJ)
The writer is discussing cells and fluids.
Puss.
Not people.
There are absolutely no ethical issues at stake.
IJ (Milwaukee)
This is so much hand-wringing and conflation of two situations, anonymous and non-anonymous. None of this is in the fine print either.

In the situation of NON-ANONYMITY--i.e., the patient can be contacted again--consent forms generally include a statement that indicates that the patient will have *no* economic rights to anything gleaned from her sample. If a patient's uncomfortable with this, then a patient doesn't give consent and the sample isn't used. Period.

Similarly, if a patient consents to NON-ANONYMOUS research, the consequences are spelled out right up front. Again, uncomfortable? Say no.

In ANONYMOUS consent, a patient can say no. Then the sample isn't used. Period.

Obviously, if there's economic gain from an ANONYMOUS sample, that individual can't receive economic compensation because the sample is ANONYMOUS. In other words, the scientists don't know who this person is; there is no way of contacting him or her. Period.

As the rules are currently written, establishing anonymity from the get-go should prevent anyone from ever finding out research results. I would also suspect that the instances where this has broken down are very, very few.
A patient who gave anonymous consent should NEVER, EVER find out.

But the parameters are already there, folks. Go read some consent forms.
Skut (Bethesda)
Ms. Skloot has an enormous and dangerous financial incentive to inflame this issue. Asking for broad consent for biospecimens will require that documentation of that consent follows the specimen. If that consent is lost or not filled out properly, the sample becomes useless. Should the Lacks family have received some of the profit made from their mothers' cells - probably, but that is not the issue here. Was Ms. Lacks or her family damaged by the use of her cells for scientific research? The only "damage" I can envision is the loss of privacy, which is not an issue for the hundreds of other cancer cell lines that live on and whose origin has been better protected.
Mor (California)
This is completely unnecessary and a huge burden on biomedical research, both applied and theoretical. Optics of this are as bad as the actual inconvenience to the researchers. The idea that there is something "sacred" or special about leftover tissue and scraps of dead bodies feeds into the ignorance and techno-phobia of the uneducated and the gullible. It might even encourage the personhood nonsense of the forced-birth crowd. My DNA is just a complicated chemical. I did not invent it, I don't control it, and I have no patent on it. If my cell is like a cell-phone, it is a cell-phone, straight from the factory and with no input from me. In the future, hopefully, people will be able to take control of their bodies and edit their (or their children's) DNA at will, creating a new area of regulatory law. Then indeed, the content of my DNA may be the product of my individual creativity and will need to be protected like any other intellectual property. But in order to get there, we must not put unnecessary obstacles in the path of science.
Fanny Ennever (Olympia WA)
If research using biospecimens will only be allowed when the patient has given broad consent, then the patient’s name must always remain attached to each such biospecimen – otherwise, there would be no way to prove that consent had been given. This crucial aspect of the proposed rule was not discussed at all either in the official document or in this op-ed piece. Comments from Anne-Marie Hislop and Jackie Lee do touch on how problematic it is to retain identifiers, with significant privacy risks compared to the current system where biospecimens can be stripped of all identifiers when they are no longer needed for that patient’s healthcare, but are stored because they still might contribute to future research. The broad consent would have to include something like: “Your name will remain attached to your samples,” and this is likely to further reduce the proportion of people who give consent, making even more potential samples off limits to future research. It is important for everyone interested in this proposal to make official comments, because the government is required to take all comments into account in making the final rule: http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2015-0008
Concerned Citizen (Boston)
Sine the proposed rule change apparently consists only of adding an extremely vague and universal consent form to a medical visit, it appears to only add paperwork and associated costs.

Privacy protections should be strengthened - such as prohibitions on re-identifying anonymous samples - but simply adding an extra layer of bureaucracy will only make research more onerous without adding protection for individual patients.

Strengthening research ethics at the front end - e.g. opening up discussions of Institutional Review Board practices, prohibiting for-profit IRBs, and conversations on better management of conflicts of interest inherent in clinicians performing research on their patients - would be much more effective in preventing abuses than placing bureaucratic barriers into the way of research on anonymous samples.

The proposed rule change will do more harm than good. Let's start the conversation over.
Shannon (Boston, MA)
The fact is, this policy would devastate medical research.

Going back to get consent on tissue from rare tumors and diseases is often impossible; suddenly our ability to study these diseases is destroyed. As other comments have noted, what patient wants to get dozens of calls for specific consent for research that hadn't been thought of previously? That's right, you can't have a broad consent under this policy. Where is the funding, and infrastructure, to get specific consent from every patient going to come from? These are not small expenditures as this author seems to think.

Its a policy designed by people who have no idea how medical science works, with sentimental notions about "people's souls in their shed cells." Really? Are we to expect that such patient's would even understand the research we're talking about if someone sat down with them to explain it? Even our most educated medical and PhD students have difficulty understanding the concepts involved.

Meanwhile, numerous patients will die from their cancers in the future because of these policies. Has noone thought of this cost?

Medical researchers aren't using tissue to nefarious ends, and they are heavily regulated by institutional review boards already to ensure ethical practices. They are, often selflessly and for much less compensation than they could be getting, trying to improve the human condition and cure diseases. How about we let them do it as they have for hundreds of years?
Laura (Florida)
"Going back to get consent on tissue from rare tumors and diseases is often impossible; suddenly our ability to study these diseases is destroyed. "

It's my understanding from the article that consent will only be required from tissue obtained henceforth. There won't be "going back".
Richard (Manhattan)
Your patronizing comments about people's inability to understand research are ironic given that what you have written makes it clear that you did not even read the article properly.

You talk of "going back to get consent on tissue" when the article makes it clear this would not be required:

"Much concern centers on time, funding and how to track samples and consent. But some stems from misunderstanding. For example: Numerous comments from scientists say things like, “I CANNOT imagine needing to do this every time I request a sample from the blood bank.” But nothing would change for that scientist — existing anonymous samples wouldn’t require consent, and new ones would have been banked with consent. Many biobanks already use similar systems voluntarily."

You then say "That's right, you can't have a broad consent under this policy."

Which, at least according to the article, is not right but flat-out wrong:

"it can’t be less than 'broad consent.'"

Not: it can't be broad consent. It can't be *less than* broad consent.
Yves (Belgium)
As a researcher involved in managing data from genetic samples, I can say that broad consent is fine, but researchers have gotten nuts from the paperwork involved with re-consenting samples. It is a tremendous barrier for research. If it is too complicated to get consent, researchers will simply abandon the research question and move to another project. Important areas of research might die, and people as well as a result. Informed consent is essential for clinical trials, but not for tissue samples. How to protect privacy is a much more complex, but essentially separate matter.
Historic Home Plans (Oregon)
Until privacy protection issues are resolved the only protection we have is the ability to consent to entering into the process.
Yves (Belgium)
I do not deny that and as I said "broad consent" as described in the article is fine. It is just that informed consent has turned the field into a bureaucratic swamp where nothing is happening. Informed consent requires asking permission from the person from whom the sample was taken to reuse it for another purpose and explaining what this new purpose will be. It is impossible to do when projects involve tens, hundreds, or thousands of samples. Privacy is especially tricky because indeed the genome of each person is unique. It is therefore impossible to totally anonymize it. Many researchers are currently developing systems that try to provide good privacy protection while making powerful analyses possible. But there is a trade-off. Absolute privacy protection can only come at the cost of stopping research. Patients are waiting and they demand the best possible research.
Bryce (Syracuse)
The main fear seems to be that information derived from tissue will somehow be used to the donor’s disadvantage. In some very unlikely scenario I suppose something like this might happen, but it’s not high on my list of things to worry about.

The other concern (judging from Comments) is that somebody might benefit financially without giving me part of the pie. But if such benefit allows a product to become available to help large numbers of people (or even a few), how laudible is that resentment?

No, if I discard something (be it a diseased kidney or a recyclable metal object cluttering my attic) I delight if it can be useful to someone else! (Of course, I could opt to keep the clutter or the kidney.)

Likewise, you have the option of never donating blood because the life it saves probably won’t be yours and the providers who eventually use that donation will surely receive payment.
lcr999 (ny)
Pharmaceutical companies have no morals. To expect me to be altruistic on their behalf is ridiculous.
Dennis (Grafton, MA)
My lineage can be traced back to the very first life form created in the slurry of star dust soup on plant earth. I relinquish all patent rights of my genes to the "big bang".
Norman (NYC)
These proposed rules would do a lot of harm, with no clear benefit.

I research the medical literature.

Several years ago, there was a controversy over PSA tests used for prostate cancer.

Some doctors thought that if you had a high PSA, and certain signs on a biopsy, that meant you had prostate cancer and should have your prostate surgically removed (which resulted in sexual impotence and urinary incontinence about half the time).

Some doctors thought that a high PSA and positive biopsy gave too many false positives, and many of these men were getting this devastating surgery unnecessarily.

A group of Swedish doctors had done a study of cholesterol and heart disease 20 years earlier, and saved the blood samples. They were able to test the 20-year-old samples, then check the medical records to see how many of these untreated subjects got prostate cancer. Their results made the PSA test more accurate, and helped doctors and patients decide whether to have surgery for prostate cancer.

At the time the blood samples were collected, nobody could have forseen this study. If subjects had been required to give specific permission to use those blood samples, the study couldn't have been done.

These proposed rules would have made the Swedish research, and much of today's medical research, impossible.

Today's patients are benefitting from earlier research. They should contribute to that research. The use of their anonymized data is an insignificant price for them to pay.
jb (ok)
I'm all for cell study, although I think research results should then be used for our good, and not for profiteers who will gouge us later. Here's what I don't get. Why should my identity be "shared" with these unnamed and unknown researchers? And when I hear "with privacy protections in place", I can't avoid the grim chuckle of a person living in the NSA/corporate just-trust-us age. And another question: will we be forced to sign the form in order to get treatment or surgery? That's certainly the case with the long, tiny-print "agreements" we have to sign to get corporate (or other) services now.
SBR (Boston)
The benefits of any scientific breakthroughs generated by research on tissue samples will not be withheld from those who refuse to allow their samples to be used in research. So this becomes a free-riding problem--if for whatever selfish reason I do not consent to use of my DNA, I can still benefit from research based on others' more generous contributions. Perhaps allowing one's cells to be used for research should simply be regarded as an obligation of being a member of society?
poslug (cambridge, ma)
I have already given permission and a blood sample specific to my hospital's research efforts. What was offered that made it very intriguing is that if they find a serious condition I will be called and told. This gives me the option to do something with the information. So, Alzheimers, they tell me. This is the best trade off. So many people signed up that the time to evaluate the blood is several years.

The hospital already knows my medical conditions, one of which is supposed to be genetic (and very probably is given my family history). The hospital knows what medication I take. The medication works but no one knows exactly how nor do they know yet of long term undiscovered negative side effects. Ultimately, the potential benefit is high for me as well as others.

What is unclear is how my physicians will be updated if they find non disease genetic but pertinent data. A friend has a genetic marker for excessive bleeding making surgery a challenge. She found that out the hard way on the operating table. Will they report such hidden risks? That is what I would like to see added.

Unmentioned in the article is the benefit of a "normal" reference population. If I were in research, I would find that valuable in calculating the statistically meaningful study parameters.

How will they keep it private? If we had single payer like Sweden or Germany, it would be a non issue. I am beyond being denied now (GOP will probably take that away). Allow class action litigation.
Stephen (Grosse Pointe)
Why is the use of patient's biological material a problem? Firstly, people are justifiably worried that information obtained from them may very well be used for their personal detriment. Lost jobs, unobtainable insurance and social stigma are consequences of sloppy handling that have occurred in the past. Secondly, drug companies, heath institutions make obscene profits off of the outcome of research that is partially funded by the willingness of individuals supply data to them for free. Most people are OK with contributing to a worthy cause. But further enriching the hugely over compensated medical industry is infuriating. Finally, the utter arrogance that patients experience in their everyday dealings the medical establishment makes them think twice before giving up anything of value to it.
Eugene Patrick Devany (Massapequa Park, NY)
Anything that can be destroyed without my consent should be available for use without my consent. It is a bit like putting the garbage out to the curb. I can shread what I don't want others to see and it should be my burden to restrict use of excess tissue. Of course medical providers must protect the privacy and misuse of patient records but this does not restrict acces by insurance companies and others with a legitimate purpose. Where there is little danger of a violation of individual privacy science should not be restricted.
The remote danger of having one's DNA analysed from a sample is something that will always be available to a determined ferenzic investigator. You just can't keep your DNA out of the garbage.
njglea (Seattle)
Very recently a bio tech company tried to patent women's breast cancer tissue and claim it for their own - for profit. We need to be aware of the most sinister things that can happen because that is how the wealthiest keep their deep pockets overflowing. It's sick but true. All medically related patents should be burned and no more allowed. OUR health is not a profit center.
Marina Sebesta (Weston, FL)
How many unneeded biopsies are currently performed with the only purpose of using the samples for statistical studies or research?
Do labs sell the samples they collect?
Leslie (California)
If I am lucky (?) unlucky (?) and have cells or tissues vital to research, how do I know, how does my doctor know, when specialists begin to harvest more tissue than necessary for my routine surgery or procedure? How do I know if anything is routine care, or additional procedures or surgery with the primary purpose of access-to/procurement-of my tissues?

That happens now, without explicit consent or knowledge by patients.

But, am I to be burdened with yet another set of disclosures, opt-outs, pages of legalese'd information and signature requirements before I can see a doctor, get into a hospital, or undergo surgery? These things often get presented to me when I am not feeling well enough to even understand or decide.

Medicine and healthcare are becoming much more a business-like transaction. As costs continue to rise disproportionately, so do the risks in number, severity and type.

I feel like I am signing "treaties" now, every time I see someone.
Watchful Eye (FL)
The person and/or institution removing my name from my specimen is violating my privacy. There is no difference from taking any other part of my medical records and using it without my consent.

That said, I believe HIPAA, or the medical privacy initiative, is a colossal farce on a par with alleged voter fraud. Does it protect my medical information from government and their big business pals? I don't believe in fairy tales. More paperwork and hoops to jump through for practitioners. A reasonable effort to keep both paper and electronic records private is what I'm hoping for.

Want to use what belongs to me, what came from my body? I would love to say "go ahead, it's for the greater good ". It's a real shame anyone has to worry about becoming the next HeLa. Privacy? Hmm.
MBR (Boston)
Every time I go to a new doctor or hospital (and often on repeat visits) they ask me to sign a form acknowledging receipt of privacy practices. Usually they do not even give me the notice of privacy practices and act like I'm a fruitcake when I ask for it. Recently my visit to an ophthalmologist was delayed for 20 min because no one in the office could find a copy of their privacy practices !!

This will end up being another form people sign without understanding when they go to a medical office. And if they refuse some low-level person will refuse to draw their blood unless they wait until they get special permission from someone higher up the food chain.

Frankly, I don't care if they use my blood or tissue for medical research.

BUT I do worry about the places that say they will use your medical info for *National Security*. I can't imagine a legitimate need for my medical info that is not already covered by public health laws. And NO, I do NOT want to Secret Service or anyone else to know if my kidneys and liver are compatible with those of any president or cabinet members, much less visiting heads of state.

Seriously, read the privacy practices the next time you visit a doctor or hospital, and see what you are already signing away.
John (Suffern, NY)
The current practice of using human tissue without consent is no different from the grave robbing performed on behalf of medical schools in the early 1800s (as recorded in Dickens's A Tale of Two Cities). Many if not most of us believe a corpse is a lifeless soulless husk, so why not just take them and carve them up to advance science? Our bodies are our own, and medical professionals must not use them without a detailed informed consent process.
Bay Area HipHop (San Francisco, CA)
The opening anecdote of this article demonstrates that the author (and the professor) doesn't understand the Common Rule and the proposed changes. If you give someone your cell phone, it not only has your data, but also your identity. The biospecimens being used are completely deidentified and the data used are aggregated from multiple (frequently 1000's) of people. Furthermore, these biospecimens would otherwise be destined for the trash bin. The innovation and intellectual property creation comes from using the data from the biospecimen, not the specimen itself. It's as if someone took a part from a broken toaster in a trash dump and used it to create a new machine. The person who threw out the toaster would not be expected to be compensated. As Ms Skloot herself admits, HeLa cells were an anomaly. While it may be theoretically possible to re-identify samples, what scientist is really going to spend the time and effort on that when it has no bearing on the research? If you want, go ahead and prohibit it. It's the equivalent of making jumping of airplanes w/o a parachute illegal.
Historic Home Plans (Oregon)
Yes, the cell phone story is a very faulty "comparison".
But the fact is, there ARE valid arguments as to why MY BODY should remain under my control even if pieces of it are removed.
It's too bad the article had such a poor start.
Swamp Ophelia (New Orleans, LA)
If the cells from my breast cancer could be used in ANY way to help treat or prevent that disease, I would be delighted, and I would not need to know, be compensated, or give permission.
B. (Brooklyn)
My feelings precisely.
Historic Home Plans (Oregon)
What about those people who hold a different opinion from you and who have no legal way to protect themselves.
Consent means that you are free to do whatever you wish... AND ... those who wish to do differently are free to also.
PQuincy (California)
In a world where corporations (in particular) have been rushing to turn any resource they might ever need into 'property', growing public resistance to the current lack of rules about medical specimens is understandable.

Look at what happened to patents and copyrights -- Constitutionally protected temporary monopolies created to encourage the public good. Now, copyrights and patents have been retitled "intellectual property" (whatever that means), and can last for generations.

Is it any surprise that I'm suspicious when my medical samples are taken without my knowledge and consent and treated as the 'property' of companies that want to make billions off them?
Abbey Meyers (Connecticut)
Having served on government committees reviewing research projects I found that the greatest problems of Informed Consent documents for university research was that they were not written by scientists, but by university lawyers. The documents were more concerned with protecting the university from liability, than they were concerned about informing patients about risks and benefits of the research. I was the consumer representative on those government committees and too often, when I criticized the proposed consent documents, researchers would tell me that university lawyers would refuse to change sentences or paragraphs. So research doctors are protected, research universities are protected, but who is protecting patients who consent to participate, or have their tissues participate, in biomedical research? Changes to the Common Rule are long overdue.
Michael James (San Francisco)
We should stop all DNA research on tissue samples from our dead ancestors because it is a violation of their privacy and the privacy of their descendants.

How dare those scientists sequence the DNA of our ancestors without the consent of our ancestors !

On second thought, perhaps we should sequence the DNA of the bureaucrats and of Rebecca Skloot in a search for mutations that motivate people to promote legislation that "protects" us against inconsequential threats to our privacy and the privacy of our relatives.
ACW (New Jersey)
Actually there is an interesting case, which was covered in the NYT. Surprised this op-ed didn't cite to it.
http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all
Basically, the genetic samples contributed by the Havasupai Tribe to Arizona State University researchers were used for DNA research beyond the diabetes study for which they'd given permission.
One of their complaints that struck me was that the DNA findings produced data that 'contradicted their traditional origin stories'. Their argument is no different from Christian creationists - 'if science disproves our religion, science has to go'. And if you read the entire article, to the end, you find yourself saddened that ultimately the tribe were the losers - shutting down research that might have improved their general health and that of fellow Native Americans, not to mention some social and economic programs ... and even if you refuse to acknowledge it, that pesky DNA still says you're from Asia, 'e pur se muove'.
Leon (Manalapan, NJ)
As I recall from the original story of Henrietta Lacks, part of the controversey had to deal with the amount of money that was profited from the sale of her stored DNA. It's one thing to be able to use it for research but it's another thing to profit from it without including the original donor.
ACW (New Jersey)
The cells were derived from the cancerous tumour that killed her. They were not any kind of possession she wanted to keep, nor were they any kind of deliberate creative work on her part. Nor, when they were removed, was there the anticipation that they would be 'immortal' and as important as they have become.
The case of Henrietta Lacks is atypical, indeed extraordinary, because her name became public, and because her cells were unique to her as an individual. Most people's tissue would be valuable, if at all, not as an individual but as part of an aggregation. e.g., one of a sample of 2,500 or 10,000 men with prostate cancer between ages 65 and 80, controlled for variables. Small fish, big pond. Moreover, much research leads nowhere and some even loses money; imagine receiving a bill rather than a royalty cheque, or a letter infoming you after a class action settlement that, as you'd share in the profits of a drug developed with your tissue, you now share the liability for any side effects.
John Smith (Cherry Hill NJ)
MY BODY & MY CELLS I have directed that after my death, my body will be donated to science. This includes my cells and DNA. My wife has chosen to do the same. However, if during or after my lifetime, researchers use my cells for profit, I want part of the right to those profits to go to my heirs. In fact, I believe that the scientists doing the research should be required to offer part of the profits to the owner of the cells, alive or dead. It is my opinion that corporations, with their unbounded sense of entitlement and greed, exist solely for the quarterly profits of those who own their stocks. Historically, corporations were required in their charters, to describe, as part of the process of incorporation, the benefits to the community of their services. Reagan struck out that language in his quest toward the institutionalization of greed, according to the great late physicist, Carl Sagan. If I wish to be remembered for my acts of generosity, I certainly do not wish them to be grabbed by the greedy corporations, since their monomaniacal quest for profits must not be permitted to overrule the generosity of cell donors. Last week I was requested to give blanket permission to persons reviewing my dermatological files without my knowledge to include me in research studies, which I view as yet another example of the sense of entitlement and greed of corporations. I require prior notification each time corporations wish access to my confidential medical data!
Jane (Durham NC)
Once again, science races ahead of the law, and it's only when unforeseen problems arise that we realize the genie is out of the bottle. If you believe research into your DNA should be freely available without your permission, tell that to the Havasupi http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all In small enough populations, DNA is inherently identifiable.
manfred marcus (Bolivia)
Sound words on a touchy subject, our DNA exposed for all to see, possibly harmful if used indiscriminately, especially if some privacy ought to be preserved, for our individual well-being. On the other hand, to enjoy the wonders that today's information technology offers, much of it for 'free' (a misnomer perhaps, given that that is the price we pay so the 'goodies' offered gives the license to use our personal information for mutual benefit), we have already, and willingly, given up much of our precious little privacy. That any information derived from our tissues for the benefit of humankind is welcome, goes without saying. Asking for our permission after the fact (already made public) is the issue. Welcome to this 'brave new world', unstoppable, trusting those in the 'know' will do the right thing.
W.A. Spitzer (Faywood)
"harmful if used indiscriminately, especially if some privacy ought to be preserved, for our individual well-being."....Maybe you should explain how that could ever possibly be. Give us the best theoretical example you can make up (if you can). Then explain how that works if the cell/tissue sample is donated anonymously.
jb (ok)
WA, there's no guarantee that the DNA and other info would be anonymous. There's no such guarantee now, and even the consent form suggested in the article makes clear that such identification is possible. The story of Mrs. Lacks is a case in point. Insurance companies would be happy indeed to get information on customers' genetic odds of disease, and would certainly tailor their claim denials to match those if that were allowed. Not a theoretical example, just one very practical and indeed likely offshoot of such information's being available to profit-seeking entities.
manfred marcus (Bolivia)
Although not entirely sure a theoretical example can be constructed, in practical terms we do know that, if for example health insurance companies could get hold of a family's increased risk for a given disease, it may cancel your policy and/or deny coverage. If you had a condition harmless to anyone else, you may want to keep it to yourself, avoid the publicity if you appreciate your privacy (if, indeed, it could ever be possible).
Jack (Boston)
1. Has even one person had his/her identity stolen as a result of tissue/blood donation? If identity theft, or health insurance denial were true motivations, it would have happened already, since as the author points out we have had this capability for many years now.
2. Haven't healthy donors been reimbursed already for their donations?
3. Patients in clinical trials obtain free care and access to treatments that would otherwise not be available. Even placebo patients are usually offered active drug.
JL (Washington, DC)
As someone who works in both the medical and research fields, I understand the ethics of consent and the desire to be in control of what research is performed on your cells. Practically, I wonder if another "broad consent" paragraph in the long list of consents we have patients sign will gum up the system or make no difference - I lean toward the latter.

However, I take issue with the issue of compensation - here, we have taken the concept of "ownership" too far. While the cells may originally be from your body, by the time they are in the lab, extensive work has already been performed to make them viable even before experimentation. Countless thousands of hours more are invested before anything clinically applicable emerges. While I have my own concerns about the actual pricing and division of profits in the pharmaceutical industry, this proposed model seems to me like the lumber provider showing up and asking for his share of the profits from the boat - we would scoff at this, because he did not put in the work.

Of course, this brings up the question of compensation at the outset, which given the volume of clinically-collected samples, would bankrupt our system. In the end, I think people who protest giving away their samples "for free" don't realize how much medical research benefits society as a whole, and by extension, them, every time they walk into a doctor's office.
Leslie (California)
Your boat analogy lacks a basic question: I am not interest in where you sail or what you use your boat for, or any profits or failures you realize. I too pay for your university labs, basic research, training and education. I am not about to "donate" raw materials without knowledge or consent.

If an automaker, road engineer, or salvage yard wants my totaled car to investigate and improve vehicles, fine. I sign and release my property to them, with or without compensation. My (separate) insurance policy works out repair or replacement. Is healthcare insurance working the same way now?

Bon voyage!
jb (ok)
Lumber providers are actually paid for the lumber used to make the boat. They don't just sign it away for the good of the navy.
David (California)
I am way more concerned about Google and the likes freely harvesting personal information from my cell phone than about biological research. When is the government going to regulate that? Please don't pretend that my fictional consent authorizes this.
Big Ten Grad (Ann Arbor)
The idea that scientists per se are noble individuals working purely for the good of all is self-congratulating nonsense. You've mixed up those who take the Hippocratic Oath seriously with PhDs whose purpose is to sustain their careers and who by nature are inveterate snoops into other people's business. The researcher who gave up medicine to make millions appropriating medical data from thousands of patients at the University of Michigan is a fairly well known story in Ann Arbor. It is naive to assume self interest plays no role in science.
W.A. Spitzer (Faywood)
How many Ph.D. research scientists do you personally know? To the assumption that everyone is driven primarily by the love of money I say - don't judge everyone by yourself.
RC (MN)
The taxpayer dollars that would be used to support a bureaucracy devoted to anonymous tissue samples would be completely wasted. The net effect would be to hinder medical research. (And also would provide another example of why people object to raising taxes.)
also MD (Zurich)
I am the director of a research unit in Switzerland. At a recent bioethics refresher, the instructor (one of the persons charged with approving human research protocols) told us that "there are very few instances in which the requirement for informed consent can be waived, and death of the patient is NOT one of them". I mean, seriously??? This nonsense is what happens when lawyers and philosophers have the power to decide on issues which might be better left to physicians, who are not only more competent but mostly very conscious of their responsibilities.
PQuincy (California)
No one challenges the sense of responsibility that most physicians constantly demonstrate. But the corporations that employ them, or that may gain possession of the samples we're talking about here, are a different matter: they have consistently shown themselves not only perfectly willing to take advantage of "free" material like clinical samples, which they turn into their property and then deny others access too. More, they have shown themselves, as in the HeLa case, perfectly willing to deny, block, obfuscate, and if necessary lie about what they have done in order to protect their 'property'.

Lawyers and philosophers should not be the only voice, here; but the record suggests that they need to be included, on behalf of citizens more broadly, to make sure that the imbalance between individuals (denied property in their own body) and corporations (happy to proprietize anything at all) does not get even worse.
also MD (Zurich)
PQincy: all reasonable points, and of course I agree on the need of checks and balances. What worries me is the pendulum swinging totally to the other side. We need a bioethical vote ($2'500) to study paraffin-embedded tissues from patients who died 20 years ago, and things are getting stricter and more bureaucratic every year. Research (which is mostly academic and money-losing: corporations come in much later, when there is money to be made) is being slowed down and therapies/diagnostics may not be discovered at all, or may take much longer. We empower individuals, and this is great - but there is a stiff price that we pay as a society.
also MD (Zurich)
A colleague from the Institute of Evolutionary Medicine at my University was planned to study the DNA of Pharaoh Tutankhamun. The question was whether the Pharaoh might have been suffering from Marfan's syndrome. Well, as it turns out, in my country you cannot do that. You cannot do a genetic study on a non-anonymized sample without informed consent, and the Pharaoh has not given consent. Aren't things getting a bit out hand?
bern (La La Land)
A simple fix would be to pay anyone who has had their biomaterial used in a breakthrough medical advance. And, allow these individuals to license the discoveries made to pharmaceutical companies and medical researchers. Save the world and make a few bucks.
NJG (New Jersey)
When I was in graduate school studying biochemistry we learned about HeLa cells, which were from an anonymous donor who was called Helen Lane, when we asked about the origin of the name. The person who violated Henrietta Lack's privacy was the author of this article, who essentially created the controversy about donated tissues herself. She insists that no permission was asked from Lacks before the cell line was developed. At the time the initially studies were done, formal permissions were usually not asked for. A doctor might ask a patient is it OK for me to use your cells for research, and the patient would probably say yes and not give it another thought. At one time I isolated enzymes from human livers. The livers were given by relatives of deceased patients for research purposes. I knew nothing about the patients at all but was grateful that the tissue was donated. The studies help lead to basic understanding about how alcohol is metabolized in humans. What is evil in the medical sciences today is the price gouging currently going on for drugs developed with new technologies that were made possible by federal research grants, such as monoclonal antibodies, and by unscrupulous new owners of drug companies jacking up the prices of old legacy drugs that cost next to nothing to manufacture.
W.A. Spitzer (Faywood)
I agree with most of your sentiments, but you have obviously have never been involved in applied research directed toward finding a medical useful new drug. It is every bit as hard or harder than basic research, and more so because the only positive outcome is a drug that actually works, where as in basic research any thing that is new and interesting is a positive. Yes, the pharmaceutical companies depend on government funded basic research, but converting that information to the discovery and development of a useful drug goes far far beyond the ability of those engaged in the basic research. So thank you, but don't trash the people who bust their hump to make something useful out of your basic information.
jb (ok)
Lacks' identity was publicly known by the early '70s, and Skloot had nothing to do with that.
eac (Toronto)
The longer term question and issue is always "into whose hands will this information possibly fall in the future?" I recall a "study" being done by a company called Medco, where we were asked to submit a cheek swab for DNA testing for drug sensitivity- I watch my co-workers, caught up in the glow of possible future breakthroughs, send their swabs although the test was more than likely not relevant to them for years to come, if ever. I declined on the basis that I could not be sure where the data, and its use, might appear. Sure enough, not long afterwards, Medco was acquired by another healthcare company. Nothing I saw in the original materials suggested that ownership of all of that DNA data couldn't go along with the sale of customer Rx info and insurance details. Not comfortable at all - even when the original acquiring group is under the cover of an academic institution.
Sam I Am (Windsor, CT)
It could be that Ms. Skloot knows many out there feel strongly about this, because only those who feel strongly take the trouble to reach out to her.

The idea that I have the same privacy interests in my fingernail clippings as I do in the contents of my cell phone, which reflects the product of my consciousness, is startling (at least to me).

As Neil deGrasse Tyson told us in 'Cosmos', we, and everything in and on the earth, are all made of star stuff. If science can make use of a person's biological waste to improve medicine, then the only immoral act is to waste it.
bruce quinn (los angeles)
It can raise questions of what is "research" and anonymous research has always been in a special category. For example, if HIV infections are up 50% in three months in NYC, is that a public health issue, or a "research" issue, and does it "use private personal lab data" without permission? If Medicare patients are twice as likely to be readmitted to hospital if they are black and female, is discovering that "research" on the personal private hospital records of the patients that should be illegal? These are examples of the historical use of "anonymous" data without "consent."
Richard (Glen Arm, Maryland)
If my tissue or other biologic samples are used in biological research, with or without my permission, I would be happy for any small contribution that research makes to the future welfare of the human race.

Every time I go to a physician, I am asked to sign several pages concerning my privacy rights. Every time I do, I am contributing to the useless waste of natural resources.

In either case, my 'privacy rights' are or would be driving up the costs of medical care and medical research for the meaningless comfort of knowing that I have, once again, signed a useless piece of paper.
Rlanni (Princeton NJ)
There already is a model document for the issues raised in the opinion. The Open Source Initiative, and Open Source Foundation. An author can publish (give consent) to any user for free. That user must in turn not charge for any software derived from the original author. Just replace author with donor.
Judith (Chicago)
The cell phone is not an apt analogy for cells. This seems like a great way to prevent research from being done.
Marty (Chicago)
Every time I visit a Dr. for the first time, I'm given several forms to complete and sign. One of these forms gives "permission" to the Dr. for all sorts of things. I don't know what, because I don't have the time or interest to really read it.

This new regulation will just require the addition of a new sentence to the permission form.
Lisa Wesel (Maine)
Three years ago, my daughter had her first seizure. We took her to Boston Children's Hospital, and while the neurologists prepped her for an EEG, they asked if I would be interested in genetic testing to look for a cause. I was, but I could not afford the $3,000 cost and could not get confirmation about whether insurance would cover it. The doctor said they could freeze her blood for up to six months, giving me time to get the approval I needed.

When I mentioned this exchange to my step-sister, she said, "You know, they're going to test it anyway." I assured her that they could not do that without my consent. I was wrong. They did test my daughter's blood, and found the genetic defect that explained all of the odd disabilities that had stymied her doctors for years. Good news, right? Not quite. They didn’t do it for our benefit, they did it for their own research. They had no intention of telling me the results. I discovered it months later, only because they were foolish enough to bill my insurance company. When I saw the test on the "Explanation of Benefits" -- It was NOT covered, by the way -- I immediately called the doctor and I dared her to send me a bill. There was a good deal of hemming and hawing, followed by an apology and the offer of free genetic counseling.

I’m happy to have this information, though it does not inform my daughter’s treatment. But I now know that any medical testing you have done could just as easily be for the doctor as it is for you.
jgm (North Carolina)
I urge you to consider reporting this issue to the Chairman of the hospital's Institutional Research Board who is, by law, charged with overseeing all aspects of human research. It is quite possible that this was a rather serious breach of approved protocol and those responsible should be dealt with accordingly. Signed - a former IRB member (though not at this institution).
EB (<br/>)
I hope someone sues the pants off this institution for violating their oaths and obligations by withholding information that could affect their patients' health outcomes. Specifically proceeding while consent is in limbo is unconscionable.
Eric (Sacramento, CA)
The potential benefit to humankind is what is at stake here. I believe the current system is sufficient to maintain privacy while enhancing the ability to perform research. If a particular case becomes easy to identify the donor it should be published only in medical journals. I have found that researchers and students have an enormous respect for those who donate for science (even anonymously.) Perhaps what we need is a medical research privacy ombudsman that can help maintain high standards. I believe the researchers want high standards as much as the donors do. We can do this without adding layers of bureaucracy.
Leslie (California)
Medical journals are readily available to anyone. For years they published full profile and facial photographs of individuals where only a black band was marked across the eyes of the subjects presented.

I have found several researchers, students and practitioners who are clueless about the meaning of privacy, confidentiality, consent, and even asking or telling patients and their families. From photographing to genetic profiles to detailed family histories from small communities where individuals could easily be identified by description or photographs.
Eddie M. (New York City)
It's fascinating that there is so much concern about the privacy of our genome sequences when we give away so much information about ourselves and our personal lives every day and every minute that we use the internet. Biological samples are valuable for scientific research that can improve health; data collected by web sites is purely for profit.
charlie (NYC)
Medical ethics includes being respectively of personal identity and choice which should not be confused with compromising advances in science. Granted science benefits from studying large populations but research has to be permission based on grounds of privacy and ones religious views
Thinker26 (north bergen, NJ)
Rebecca Skloot failed to provide the government website where public opinios can be posted (it is like: lets disclose but not so much)
Strict lanuguage consents should be required for all types of research. Today, the main goal of research Is to develop lucrative therapeutics. Remember the biotechnology companies patenting genes and charging everyone for what is universally owned by all human beings?
Academic Centers are obligated to obtain approval from their Internal Review Board to perform research with their subjects' biological materials and subjects must provide consent for these materials to be used. No one should have the right to use our biological material without our consent, even if anonymous.
David Carter (New York)
The address for posting comments is provided in the story in several places though hyperlinks. You can find instructions here: http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html
ACW (New Jersey)
if your identity is thoroughly removed, no big deal. It's discarded tissue. Medical waste. The issue here is not the research, it's the guarantee of anonymity, which needs to be ironclad, with penalties for unauthorized reidentification. (I suspect a lot of people would like to enable reidentification of their tissue if medical research turned up a hitherto unsuspected risk factor, such as a recessive gene as a risk factor for autism spectrum disorder, schizophrenia, or multiple sclerosis, which have currently mysterious causes that may include genetic factors.)
That said, organ donation - as opposed to the re-use of removed tissue - should be opt-in, and there should be some kind of financial incentive for donors, say, a donation to a charity of the donor's choice, taken as a percentage of the fees of all the medical professionals who stand to profit from the transplant.
Peter (Indiana)
"The first thing the scientists do when they make a discovery is to patent it."

As a research scientist for over 40 years, I found this statement rather remarkable. But perhaps it isn't - let's see the data that clearly supports such an assertion.
Hoyle (California)
Should a barber obtain informed consent concerning how the cut hair is disposed of? It contains the same DNA as any other tissue. For that matter, we cannot provide informed consent concerning how our bodies are treated after death. Once any part of our body leaves the coherent whole that includes a functioning brain that we call an individual, it belongs to no one but nature and, if indicated, the study of nature that is science.
Carol (No. Calif)
Thanks to Ms. Skloot and the NYT for this. I did write a comment for this reg, and posted this article on FB. Encourage others to do the same.
Chris (Missouri)
Just wait until Monsanto and the like get into the game. They will patent products developed using your own cells and then try to take away your right to exist without changing you cellular makeup.
W.A. Spitzer (Faywood)
The Supreme Court has ruled that you cannot patent naturally occurring genetic material. Period.
W in the Middle (New York State)
A more appropriate thing for Gray to have done would have been for each person to keep their own phone - but search for images and tweets of the person sitting behind them, using some of the common tools of cyberthieves.

This sort of consent is farce.

What happens if one identical twin gives consent, and another doesn't. This isn't like organ donation - what's being donated would never be noticed/missed.

Further, people leave traces of themselves everywhere - with absolutely no expectation of privacy.

Further still, this type of done-once-and-irrevocable consent makes a joke of things. Why would it be any harder to bury this in some terms/conditions similar to the ones folks agree to, when they sign up for something like a social website.

Bluntly, I think you're looking for a topic for a sequel.

PS - "...Some believe their souls live on in the disembodied cells...

And some people believe the ACA has them covered, if they need hospital care.
What me worry (nyc)
I totally agree w. having my cells broadly used. I actually own Ms. Skloots book...and Ms. Henrietta Lacks was born on a tobacco farm but living in Baltimore at the time of the discovery of her cervical cancer. Should her familyh be compensated for their relatives huge if unintended gift to all of humanity -- a never dying yes immortal cell line? Yes indeed..

But how horrible for all of us had this highly unique individual's cells never made it into the lab. What statistically. Ms Skloot is the probabilty of another individual's cells having the same highly unique characteristic? How many years would all kinds of science have been delayed.

Emotional thinking in this case is destructive to the greater good. Be rational please.

PS I signed the consent form for my blood DNA to be used/saved for research YES. Sadly, my name will never be attached to it. Hela cells are truly famous..
TSK (MIdwest)
We live in a private ownership society/government/economy and that must include our bodies. Permission must be granted like in other industries but we don't have to make it draconian. There are plenty of people who will give carte blanche permission for science to use their tissues so science should work with them and we can all move on.

In the case of people who will not give permission science should leave them alone or risk jail time and fines.
RichWa (Banks, OR)
I refuse to allow the use of my genetics for any research unless the end result will be open-sourced and/or used for the general good as opposed to providing profits for the 0.1%. An no facility locally, (Portland, OR) will agree to abide by my demands, no research will be done on any tissues and/or blood taken from me. I wish it was different but until we have a Bernie Sanders type President and more Senator/Representatives like Merkley, Warren, Grijalva, et al and redo our laws, using our cells is yet another means of ripping us off :(
Michael F (Yonkers, NY)
What a foolish notion. I am not some speck of blood left behind at a doctors office. I couldn't care less what they did with it. If they need more they can hook up to my sewer system and they will be provided with a few samples a day. Seriously and some clown wants to to spend $215 million of my money for this. Give me a break.
Arthur Layton (Mattapoisett, MA)
The problem with consent is that some potential donors couldn't possibly understand what you are talking about. How can they consent when they don't understand how their cellular material will be used? This was my conclusion after reading about Henrietta Lacks in Ms. Skloot's book.
Indira (United States)
Scientific research is about managing the trajectory of the human population. Unfortunately science profits the well to do and the elite much to the detriment of the uneducated and disenfranchised. Hard science would be nothing without a sample on a petri dish so why not financially reward the donor or their family for the sample??
Robert (Connecticut)
What about companies -- ones that exist and ones that are about to be launched -- that "harvest" our biological "material" and make millions distributing it to researchers who need the "material" for their work. A liver harvested for transplant is worth so much... divided into smaller samples and sent out to however many researchers is worth a 100 times or 1000 times as much.

The pressure to bypass the transplant candidate for money will be intense... if no controls are put on how much people can profit from the movement of our "material."

And if there is profit to be made shouldn't the people who provide the "material" receive a healthy portion?
W.A. Spitzer (Faywood)
Unless you as an individual know the very specific details of your genetic information (and you don't) that genetic information is no more private and personal to you than the wind. Heck, most people can't even tell you the names of the four bases yet alone know what the billions of combinations, most of which don't code for anything, mean. The whole business about Henrietta Lacks is a complete and total farce. That her cell line is widely used today is totally and completely the result of the diligent work by scientists building a research tool and had absolutely nothing to do with her or her descendants. The concept that science using your discarded tissues or cells is somehow an invasion of your person or your privacy is total nonsense. Science needs to know and study the intricate detail of the genetic information for example in cancer cells, in order to understand what went wrong, and how patients can be most effectively treated in the future. It is sufficiently important that anyone who would refuse to freely release the uuse of their cells and tissues for scientific study, should be denied medical treatment.
RG (upstate NY)
The discourse needs to include a discussion of the costs and benefits of making biomedical science more difficult. Research will not get done and people will die. Given the growing possibilities for pademics , drug resistant strains of bacteria, etc., the costs of slowing down or stopping research in lives lost is substantial. People lacking any working knowledge of the medical issues cannot reasonably evaluate the costs.
Leslie (California)
The 'fear' model you use seldom produces lasting or beneficial results. It further erodes confidence and trust. A lot of research gets done and people still die. Sometimes because of it.

A working knowledge of medical issues that is hidden from view has produced some of the most unreasonable costs for basic healthcare in the world. And there is a persisting claim that R&D justify any exorbitant costs without any evidence or accounting.
James Lee (Arlington, Texas)
Public sensitivity about informed consent relates to the broader issues of privacy and individual autonomy. We live in an age when our neighbors frequently do not know us, but a variety of government and private institutions know us very well, at least with respect to certain areas of our life. Horror stories about hackers gaining access to some of this data cause widespread anxiety, and for good reason. Information is power, and the loss of privacy that accompanies our heavy reliance on advanced technology can entail a reduction of personal autonomy.

Most Americans live enmeshed in public and private bureaucracies that constrain their independence. Employers control their work life; government regulations limit their freedom outside the work place; and even the companies they patronize can control the process for settling customer complaints.

The health industry's power to perform experiments on our tissues without permission will seem to many people one more example of outside control over their lives. Whether such experiments really affect individual autonomy depends on how the test results are used, and on whether promises of anonymity can be kept.

Equally important, the requirement of informed consent restores a sense of some control over one's life. The cost of this requirement should be weighed against the potential damage resulting from a reduction in public support for valuable medical research. The U.S. is still, after all, a democracy.
Stephen (San Francisco)
It is crucial to realize how essential it is that researchers have access to primary human samples if they are to understand the basis and treatments for disease. Privacy is certainly important, but let's not cripple disease research in the process. A consent form so severely phrased that no one would agree will impede research on disease due to lack of samples. A careful balance here is necessary.
Harry Shaefer (Johnson City, TN)
When Hela's descendants were informed that their ancestor's cells were beneficial to research, this essay says they felt proud to have contributed to the advance of science. But they wished they had been informed so as to avoid difficulties.
What difficulties? It is hard for me to imagine what difficulties come from having one's genetic information discussed by scientists--and I imagine it is unlikely for scientists to imagine those difficulties.
Big Ten Grad (Ann Arbor)
You are assuming scientists are somehow different, higher minded than the rest of us?
DennyInChicago (Chicago)
I was asked if extra tissue could be extracted during my breast cancer surgery, and I didn’t hesitate in agreeing. If a few of my cells can help other women, that’s all the compensation I need.
Lynn (Nevada)
The real issue is ownership and profit. Drug companies have made their bed by charging Americans so much for medicine and reaping huge rewards. They are despised. If they were not so greedy perhaps it would not upset people so much to have their tissues used. I for one will write to support consent.
W.A. Spitzer (Faywood)
Give one example where drug companies have profited from the cells or tissues discarded during medical treatment?
JustAreader (DC)
Every health care lawyer can point you to the seminal case Moore v. Regents of the University of California (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479).

No drug company - but the University made a profit from discarded tissue without informing the patient.
Bridget Haire (Sydney)
I agree that this is the key issue - and not just for Americans, but globally. So much research is private and for profit, and can lead to outcomes that may be in the public interest for those with optimal health care access, but not necessarily for all. I'd favour a consent process that stipulated what kinds of institutions could use my samples - publicly funded research institutions yes, private pharmaceutical companies no.
Having read Ms Skloot's book, one of the big issues was the grinding poverty endured by the family whose cells were revolutionising science. It also harks back to the pre-WW2 days when any patient at a public hospital was deemed fair game for research, without consent (no surprise that this changed earlier for white Americans than for Black Americans).
John Perry (St Johnsbury, VT)
So let's take a Wall Street view on all this. Body parts. My body parts. So, you're going to take my body parts (with permission, of course, with an arbitrage waiver), and use them to discover a cure for Alzheimer's, sell it to Merck, for six billion, and what I get is a "thanks." Oh, and the feeling that I gave for science. And your bank account. At least donate me a break.
Bubba (Bristol, Va)
Compensation for HeLa cells, sure. Right after the family pays Johns Hopkins Medical center for the free surgeries, hospital stays, blood tests, X rays, and all the other cost for which her family never paid. Then the money earned by the sale of HeLa cells can be shared by the family. But wait, the researchers never charged a profit fee for the cells. The point was to advance medical knowledge so that fewer people in the future will have to suffer and die.
Jan Bone (Palatine IL)
As one who (18 years ago) donated my husband's brain to Northwestern University's Alzheimer's research--with the unanimous consent of all my adult children and their spouses, all of whom had discussed with each other the pros and cons during his year and a half care in an excellent --and kind--Alzheimer's care facility, and watched this research scientist in food technology who had bicycled with me 500 miles in Europe decline and die in the 3 years since those trips, I think tissue and cell research can be significant in future medical discoveries. As a family, we sought out Northwestern, knowing that Dave, who had a 41-year career as a research scientist would have been happy about this.

Representatives from the research group whom we alerted to imminent death took Dave's body within a few hours after he died, returning it after the autopsy that confirmed Alzheimer's. We had an open casket funeral, followed by a closed casket church service--then flew with his body to a family cemetery. He's buried next to his parents, as he'd wanted to be. Northwestern sent a staff member to the two-day wake, and to the church funeral. We are proud we consented. Dave's brain tissue is still being used in research. I think including consent, preferably of close family, but certainly of a surviving spouse, should be in the coming rules.

Now I have Parkinson's, and am 85. If there is a similar group/center for it at my death, I too want my brain/tissue used for research. I'll donate it.
Historic Home Plans (Oregon)
Isn't it wonderful that you have the right and opportunity to perform this service, by your own choice?
Nancy (New York)
The people who push to have everyone give over their cells and their DNA for free are almost invariably people who plan to use the information to make money. Many already have biotech start ups, others soon will. And no 0- you and I can not make a start up ourselves and make money from our own DNA.) But I promise you, they will be making money off your cells and your DNA. (And remember - if you pay taxes, you have already paid for most of the research they will ever do.) These pro-gve-me-your-information-now people are, alas many of the same people who make drugs that many can not afford to buy or take. Do you really want to give them your information for free as well? It's one of the great scams of all time. Bordering on fraud.
Follow the money - works best when dealing with the biotech/dryg crowd.
BJM (Tolland, CT)
Forgive me, but Ms. Skloot has milked Henrietta Lacks' story and her family's misfortunes to a far greater extent than the scientists involved. When researchers use human tissue samples, they are trying to learn how the body works and how it can be fixed. It is not a diabolical plot to take advantage of or reveal secrets about anyone. It is irresponsible of Ms. Skloot to use a 60-year old case to argue that scientists are the bad guys here.
Bill (Evanston)
You've completely "missed," perhaps intentionally, the core issue here. Ms. Skloot's motivations may very well not be pure. But, motivations are rarely pure, and that goes for all of us, including the researchers, academic institutions, and private companies involved in bio-medical research.

Openness and autonomy, and their offspring, informed consent, are core European Enlightenment values. Living out these values don't solve all of our problems, but they hold out the promise of doing far more good than harm in addressing issues of how the bio-matter of individual persons is used in research.
Eric (baltimore)
This is heading in the wrong direction, Biomedical research is already hugely overburdened and expensive due to regulatory requirements. We should be making it easier to discover and innovate, as we all benefit from the results. Also, anyone who receives healthcare is benefiting from the research that has gone on before - there should be an obligation to give something back.
idnar (Henderson)
I would agree with you if we weren't paying so dearly for this health care...
Charlie (Philadelphia)
Eric, I resent being told I owe something to the medical community. I had brain surgery in 2002 to remove a tumor. I wish the doc had been to carpentry school, because folks there are told to measure twice so they may cut once. My surgeon opened the wrong side of my skull, then lied to me and my family claiming the surgery took 4 times as long as it should have because of a bleed. The hospital helped him to keep my surgical records from me until many years had passed. Doctors before that misdiagnosed the brain tumor, prescribed me high doses of steroids for years that destroyed me, treated me abusively in emergency rooms because the tumor caused mental symptoms, and one once told me to put my son in sports, to protect him from "turning out gay." Our once family doctor seduced my (20 yrs younger) daughter. Another doctor consistently pushed newer more expensive medications, with greater side effects, until I learned she was being rewarded by the pharmaceutical companies with trips to give talks and confronted her about it. All of these people were paid handsomely for their services. So are the companies, universities and people who do biomedical research. Patients owe nothing but the insurance cards that are demanded of us and without which we are denied care. I do agree that we should make it easier to discover and innovate, so let's limit medical patents, not patients' rights.
jb (ok)
We're being bankrupted for "receiving healthcare" now. What the heck do you want?
njglea (Seattle)
Everything taken from a person's body should be returned to the individual UNLESS they give specific permission and state how the specimens can be used - like organ donation on driver's licenses. NONE of them should be used FOR PROFIT and university researchers and students material should belong to the public - That's US - because WE fund them. WE want the profits to support OUR infrastructure and free college for every American.
Eric (Michigan)
The idea of not using tissue for profit is true, up to a point. As a researcher at a University, some of my funding comes from the NIH (the taxpayers) to perform research. But some comes from industry or foundation sponsors (private companies) as well. That research (hopefully) will turn into something that will better mankind, cure a disease, help another person. Who owns it?

And it really isn't practical (or safe, from a public health standpoint) to return ANYTHING removed from a person to the individual. Explain what good can come from getting a chunk of liver cancer in a jar back after your doctor has made the diagnosis. Or worse yet, a lung washing that shows tuberculosis. That concept is just asking for trouble...
ACW (New Jersey)
'Everything taken from a person's body should be returned to the individual '

'The operation was a success. Here's your tumour.' Yeah, lots of people are clamouring for that option.
The only people I know of, up to now, who've cared were some religious groups who believe that at the end of the world god will resurrect everyone, but needs all the pieces to put us back together. Believe it or not, medieval theologians drove themselves bonkers with such hypotheticals as: if a man is eaten by cannibals, who gets what pieces?
Seriously, folks, it's medical waste. As long as it's unidentifiable, so what?
Juvenal (Bronx, NY)
Sorry, but it would be frankly ridiculous and unsafe to return surgical specimens to patients. Do you really want every woman who gets a hysterectomy to have her uterus returned to her in a bag when she leaves the hospital?!

Physicians do not collect patient specimens with the expectation of profit. The specimens have no value unless they are being used for 1) organ donation or 2) research. In the first case, they are going to help another patient. In the second case, they are going help physicians understand the disease, and if the research is successful, lead to new or better treatments. There is no profit-making scheme here in play, and as a physician-scientist at an academic institution, I take offense to the suggestion.
Steve (Massachusetts)
Ms Skloot addresses the point that people deserve to give informed consent on all use of their biological samples. But how can we have this debate when public understanding of genetics and biology is simply lacking? Look at the widespread perception that genetically modified foods are harmful or poisonous and the continuing belief that vaccines cause or contribute to autism. Even among well-meaning journalists, few if any grasp the biology. Having the open, fair, and informed debate that we would all like simply is not possible. Dr Collins is right to request time for public comment and then move on.
paul (stewart)
As a Surgeon who has spent his entire career seeking "Informed Consent " ,an oxymoron if there ever was one , I couldn't agree more.
Jackie Lee (Wisconsin)
What Skloot fails to mention is that while the proposed rules are changing for biological specimens, there is no similar change proposed for people's data.

This means that while someone would have to have provided their informed consent for their residual tissue or blood sample to be used in future research, they would not have to do the same for their data - for example: the sequence of their entire genome, their parental history of genetically inherited diseases, etc.

Additionally, how will hospitals and biomedical researchers keep track of who has given consent and who has not? A federal "system" of color-coded stickers has been proposed. Absurd.

This is what happens when the rules are changed based on popular literature such as the Lacks book, as opposed to expert opinion - arbitrary lines that make people feel better without meaningfully changing the process as a whole.
Raincheck (Nyc)
The author makes a mountain out of a mole hill to create unnecessary buzz. Anonymous means anonymous...very few issues here.
Thinker26 (north bergen, NJ)
Not correct
Jim Waddell (Columbus, OH)
I wonder how this does or should apply to fetal tissue from abortions. We know that fetal tissue is used in research but is there any consent required by the mother, or even the father since half the DNA is his?
Eric (Michigan)
As someone who manages a biorepository, I can say that the proposed Common Rule change becomes a slippery slope. It doesn't "have the potential to," it WILL. Under the proposed rules, I must go back and get permission to use an already-existing sample to perform research that hasn't even been dreamed up yet. While I understand the importance of fully informed consent (I am an MD, after all), I also understand the impracticality (or worse yet, the barbarism) of asking the widow/widower of a patient who donated samples 3 years ago and who subsequently died if I may now study something else within the remaining sample that we've just started to understand better.

I consent patients very often for clinical studies and for the biorepository - without fail, they tell me "if it can help someone else, I want to do it." These are selfless people who have chosen to help us understand human health and disease and shouldn't be encumbered by scientists they've never met or heard of calling them randomly to say "by the way, I heard you once donated blood and I'd like to use some now to study something that you can't ever possibly get." So yes - there are ways to consent people for the life of the sample, in a fully informed manner, that will allow us to do the work we need to do without having to go back and get consent again. We shouldn't make it more burdensome than it already is.
David Carter (New York)
No, you would not have to "go back and get permission to use an already-existing sample to perform research that hasn't even been dreamed up yet." As Ms. Skloot says in her article, and as the NPRM clearly explains, these proposed changes would only apply to *future samples* -- all existing, previously collected samples now stored for research would be grandfathered in and regulated exactly the way they are today. As someone who manages a biorepository, you should carefully read the proposed rules before forming your opinions.
Eric (Michigan)
Thanks for your comment, David, and for your concern. Perhaps you also need to understand that samples, as they are regulated today, are typically (and in my case definitely) NOT approved for "as yet undefined study." They are ONLY collected on the premise of the study being proposed. So yes, I have carefully read the proposed changes, and yes, the author has told you what you want to hear. And yes, i have made a comment during the public comment period, both individually and through my institution. But no, it doesn't change my opinion because your interpretation is, frankly, wrong.
Susan (Paris)
Several weeks before I had my operation for breast cancer (in a leading French public hospital ) my oncologist gave me a form to read, asking for permission to keep my tumor tissue in a special library which doctors could then consult to help with their research in treating this disease. My doctor explained carefully and gently that I should not feel any pressure to say yes. I did give my permission as I felt the request was handled appropriately and I was properly informed. No one should be contributing biological material without giving legal consent.
W.A. Spitzer (Faywood)
"No one should be contributing biological material without giving legal consent."....If you believe that, than I say that no one should receive medical treatment unless they consent. After all, if you are not willing to help science, why should science be willing to help you?
m.pipik (NewYork)
W,A, Wait! "No one should receive medical treatment unless they consent."

Don't we all have to consent unless we are unconscious at the time of need (emergency)? I've never been given medical care without my consent. Isn't that the law (at least in NYS)?
jb (ok)
WA, we pay huge prices for our medical care. We also pay taxes for government research. Many people suffer bankruptcy, in fact, paying for it. So it's not charity we're receiving, you may be sure, nor a gift being bestowed by poor and noble scientists.
Shakespeare Fan (New York)
Researchers may be altruistic in securing access to tissue samples but big pharma does not care really. With privacy and abuse of it in the forefront of our daily lives absolutely nothing can be deemed totally private or anonymous. The logistics or costs of getting and maintaining privacy is an expense many organizations are paying now. Additionally, individuals, like Ms. Lacks or her family, should have been ultimately compensated for the use of her cells and the profitable medical advances from their use as should everyone else. Consumers get nothing for free, medical care is not free, drugs are not free. Those Common Rule agreements should build in compensation if it ultimately leads to profitable advances in medical research.
Charlie (Philadelphia)
I will willingly share my genetic material for free with any research institution that will willingly share it's research for free with the public. For profit researchers: let's make a deal. Unless, of course, you've already made one with my representatives in government.
W.A. Spitzer (Faywood)
Did you know that genetic information that occurs naturally cannot be patented? Did you know that anything that is published cannot subsequently receive a patent? Did you know that the details of everything that receives a patent is published and made available to the public? Did you know that patents expire after 20 years? Your concern is pretty much groundless.
Charlie (Philadelphia)
You're saying it's complicated? No doubt. But Monsanto used natural DNA to create patented seeds which interfere today with folks rights to grow food. And 20 years is a long time for people who can't afford their medicine.
Leslie (California)
Succinct and precise! Thank you.

(I have no interest or connection to the poster of the comment and voluntary made mine)
Michael (Denver)
"Some question whether people even care what happens to a vial of blood or bits of a tumor after they leave the doctor. But trust me, they care."

A. I don't trust you, and
B. You're wrong. People only want the *illusion* that they are in control.

This will become nothing more than another form for people to sign when they give blood--written in a sort of vague medical legalese for blood donors who, on the majority, don't read much above a 9th grade level.

Awesome! Another release form to sign!

Thanks, bioethicists.
Vera (Montreal)
Thanks for this op ed piece and for your book on Henrietta Lacks, better known in biomedical community as HeLa cells. I teach the book in a university course on the Law and Biomedical Ethics to students who would never give up their smart phones, but seem not to have a problem with the taking of human tissue and genetic information for scientific experiments with neither informed consent nor compensation. Apparently things are valued over persons.

Of course the knowledge gained from HeLa cell has benefited humankind, Unfortunately, Henrietta Lacks, a poor Black tobacco farmer, and her descendants could not, and cannot now, afford health care. Johns Hopkins Hospital, one of the major research hospitals that has benefited from research using HeLa cells, sponsors and annual Henrietta Lacks Memorial Lecture that is free and open to the public, but few people outside of law, medicine, or academia seem to be interested.

It is so much easier to listen to the inane sound bites of political hacks.
MG (Durham, North Carolina)
For a long time now, I've said and advocated not only that people be asked before these 'things' are used, but that they also be compensated for it--somewhat along the lines of royalties paid for music played. In fact, I would go even further and say the same thing about the use of any 'data' that reasonably identifies 'you'--people should be paid a 'royalty' for the use, transmission, or trading of it.
W.A. Spitzer (Faywood)
Compensated for what? I say that people who donate cells or tissues for scientific use should be compensated for their knowledge and their work that that might contributed to anything of value which may result....which is exactly nothing.
Michael (Denver)
I look forward to the day when my barber has me sign a consent form to clip my (biologically encoded) hair.

At least I'll be in control of my privacy!
Thinker26 (north bergen, NJ)
If he throws your hair in the trash, then no one can use it for research.... The same happens to any biological material, blood or other tissue. No consent is needed if materials are discarded. Your cynicism doesn't apply here
Michael (Denver)
Thanks for setting me straight, Thinker!
jpduffy3 (New York, NY)
If discarded biomedical materials can be used anonymously to benefit humankind, what is the big issue? Don't we have more important things to worry about?
Thinker26 (north bergen, NJ)
DNA is not anonymous. It identifies just one individual
Jerry Sturdivant (Las Vegas, NV)
Oh, cut it out, for Pete’s sake. This ‘privacy’ thing is going too far. They’re not interested in me, personally. Science pokes and prods in everything, everywhere; and often finds things important and helpful. The fact they found DNA itself shows that. If they find something that can actually help me, more the better.

Same goes with the NSA checking email and phone calls. They’re looking for dangerous things in order to protect you and me. Don’t take everything so personal.
PQuincy (California)
The problem is that corporate interests have been eager and willing to treat valuable things as 'property' -- as THEIR property -- when it benefits them, but tend to turn around and deny that there's any property interest when others might be the proprietors.

As ye sow, though, so shall ye reap: our medical-industrial system is now paying a (rather modest) price for the sins of others, I'm afraid.
Pete (West Hartford)
Transparency is an ideal - in this example, getting 'informed' consent. The fear expressed by some, that the onerous transaction of asking people's consent will thwart research, is a red herring: every time you get admitted today to a hospital, or to a lab test center (say, for a blood sample), you have to fill out all kinds of forms anyway, including every year at your doctor (HIPA forms or whatever).

The real issue is future compulsion: that if you refuse to allow use of your cells for research, the hospital won't admit you, your doctor won't treat you, and the lab center won't take that sample requested by your doctor. I don't think this article addressed how the legislation proposes to handle that.
Eric (Michigan)
The legislation doesn't propose to handle it. The reason is simple: They are separate and distinct entities. I work in an academic medical center where we see patients and do research side-by-side. But it is clear at our institution (and all others) that agreeing or disagreeing with participating in research has NO bearing on your ability to receive the best medical care we can offer.

I fear some people cannot fathom that some of us do our jobs not because they're our jobs, but because we want to help others.
worc0670 (NY)
Honestly, I'm struggling to see a real problem here. Except that the author is building a straw man in order to promote her book.
TCJ (Duluth, MN)
I have no problem with the medical community using my left over tissue and blood samples for research purposes, without my express permission.
Thinker26 (north bergen, NJ)
So you should say so in the consent form
Laura (<br/>)
I get my health care in a system that, by default, seeks consent for unspecified research on biological samples that may be obtained in the course of diagnosis and treatment. It's pro forma, and frankly pretty meaningless. I'm fine with the request, but without information about how it's going to be used, it tells me almost nothing.
Anne-Marie Hislop (Chicago)
I have little or no problem with the current system as long as the sharing is anonymous, but when I read the possible general permission it gives me pause. The line that bothers me most is about sharing my identity with other researchers. That means 1) that my sample is not stored anonymously, but is MY tissue located I know not where and accessible to I know not who; and 2) that I am giving blanket permission for my ID to be shared with unknown person or persons - I do not necessarily trust the assurance of "privacy protections." I am not saying that I would say 'no,' but only that it is far more comfortable to think of my blood in a tube without my ID going off somewhere in the name of science.
Eric (Michigan)
There are very few instances where the sample is permanently linked with identifiable information in an open way. Almost all studies (all that I can envision, anyway) assign every subject an identifier code. Only a small number of people (the primary study team) has access to that code. So when I share a sample, I may well be able to say "this blood sample came from a 45 year-old African-American woman who smoked 1 pack of cigarettes daily for 20 years and whose lung function and CT scan shows mild emphysema" but I cannot (and would not) associate your name, address, social security number, or any other personally-identifiable information with that sample. The institutional review board (IRB) at my institution would never allow that type of data sharing, and it would serve no useful scientific purpose.

The problem comes, in my opinion, when we try to regulate the "what if" doomsday scenario of a rogue investigator searching for individuals by name in databases rather than the 99.99+% of us who want to find answers to common and not-so-common diseases.
Mark Thomason (Clawson, Mich)
This sounds very like the fine print on contracts, or the update notifications that come from banks and credit card companies.

Who reads them? Who really understands them? Who feels they have a real choice in the matter, if they need the service?

The law calls that a "contract of adhesion." That means it is not really a "meeting of the minds" on a contract term, and so not enforceable.

This proposal is worse than an administrative burden. It would only produce contracts of adhesion. Who is going to refuse medical care, or understand or negotiate this when in medical need?

Informed consent misses the point. For this, we need to establish that some things are wrong, and some are allowed. We need a rule, not more paperwork to get around rules.
Eric (Michigan)
I think I have to disagree here. Nobody is saying in the medical field that you can't have a medical procedure if you don't also agree to donate your specimens to science. In fact, almost all Informed Consent documents clearly state that if the patient chooses to not enroll in the study, they still have the right to have their usual standard medical care, without penalty. This is a very important point, but one I think that may not be germane to this conversation.
Charlie (Philadelphia)
Do you mean to say, Mark, that you would like a rule disallowing the use of patient tissue for research? Or rules to control it? What sort of rules do you feel would be useful, if you do not find patient consent useful? I hope, if HHS did bring consent into the picture, as they should, that medical practitioners would not be allowed to deny care to patients who deny permission for use of their samples. Your point about contacts of adhesion is important, but perhaps you'd be interested in a recent NYT series on arbitration, which makes clear that such contracts are indeed being held up in American courts today.
JoanMcGinnis (Florida)
Such things already exist, Mayo Clinic's Biobank for one. And no it is not like a MS read all this in small print then click I accept. Extensive information is provided, an individual has the opportunity to read, ask questions, digest, etc.

Until you or your family are hit with devastating diseases that at present there are no answers for, maybe you will give more thoughtful consideration and be glad to participate. Myself and all of my friends have.
Jonathan Baron (Philadelphia, Pennsylvania)
We support the idea of private property because it serves various social purposes. For example, farmers would have no incentive to grow food if people could legally come and take it for free. Home ownership gives owners an extra incentive to maintain their property for the benefit of future generations. Copyright gives authors incentive to write. And so on. But there is no social purpose in treating this information as property. People who want it treated that way are neglecting the reasons why we protect property in the first place. These reasons do not apply here. The only function of opt-in consent might be to prevent abuse of the information, to prevent the patient from being harmed by people out to do no good. Can people know enough about whether this is likely to make an informed decision? I doubt it. People will decide based on their inherent lack of trust. Far better to make, and enforce, laws against abuse. One such law was recently passed, the Affordable Care Act, which prevents the use of personal information for the purpose of denying health insurance. More such laws and regulations are needed. But we do not need to put the future of medical research in the hands of people who are unlikely to know what they are doing when they deny consent for use of their information. This information is now a public good, and refusing it is a public harm.
Charlie (Philadelphia)
If this information is a public good, as I agree it is, Jonathan, then the research it permits should be public too. When it is, I will gladly take part.
Jonathan Baron (Philadelphia, Pennsylvania)
I completely agree. But this new rule will be difficult to overturn once it is made. I'm doing my part to make research open. I edit and produce an open-access journal. And NIH is moving in this direction, all too slowly, but moving still. (And my identity is open too. You can google me.)
Cynthia Kegel (planet earth)
Let me get this straight: you have to give consent for use of tissue when you are dead but not when you are alive? I would give my permission, but don't like donating without it.
Rebecca Boivin (NY)
I have recently been in treatment at Sloan Kettering and was asked at several points to give my consent for the future use of my tissue. The consent form was explained to me and I was not under any pressure to sign. I was grateful to have some small way to give back to the institutions and professions who cared for me with such intelligence, kindness and dignity.
Leslie (California)
Alas, not everyone can get treatment at Sloan Kettering.
I am glad you do.
Sequel (Boston)
One's personal genetic information is becoming more storable and searchable with each passing day. Ten years from now, researchers and businesses will be able to access that information at a level that is now impossible.

The USA is one of the few developed countries that failed to pass laws protecting consumer privacy in the days before electronic payment systems mediated virtually all sales. As a result, that information is now linkable to everything else that has been recorded about a given consumer.

The time to protect genetic privacy is now.
Lkf (Nyc)
Although well-intended, this type of disembodied consent is almost meaningless.

Without knowing what specific use these cells are to be put to, the donor cannot possibly consent to anything. The general consent discussed here is entirely pro forma.

The practice of medicine and medical research is festooned with these types of laws (Hipaa is foremost) which while ostensibly serving a noble purpose tend to create a vast penumbra of uncertainty and extra dubious work to assure compliance while accomplishing little of what is intended.
Al Lewis (Chilmark, MA)
This is happening now. The third-largest health insurer, Aetna is leading the charge, collecting DNA from its own employees (and employees of other employers who consent). Despite financial incentives/penalties -- and (aside from a lot of very fine print on a website) a total lack of disclosure about storage, errors, re-use, re-identification and sale for profit -- only about 15% of employees are participating. The employees are told this is good for them, that it will help them prevent heart attacks etc.

Aetna's alleged "findings" of massive savings and health improvement from DNA-based wellness was published in an obscure journal. However, the study was so invalid that one of the journal editors, in a comment on the prestigious Health Care Blog linked below, took the unprecedented step of admitting this article never should have passed peer review.

Aetna's findings of massive savings were deliberately made up in order to justify the massive price tag, as it turned out...and Aetna itself had previously admitted it wasn't possible to save a dime in wellness.

Moral: under no circumstances let your health insurer access your DNA. (This should be self-evident and yet 15% of employees do.)

http://thehealthcareblog.com/blog/2015/12/16/genetic-testing-the-new-fro...
Jonny Justice (Dallas, TX)
Rebecca Skloot's hypocrisy is simply stunning. No individual or corporation has profited more from Henrietta Lacks and the Lacks family that she has. She has made millions off of them.
Laura (Florida)
"No individual or corporation has profited more from Henrietta Lacks and the Lacks family that she has."

You are kidding, right? You obviously have no idea of the uses HeLa cells have been put to over these decades.
donald surr (Pennsylvania)
Why the alarm? Why should any of us be concerned that cells, no longer part of our bodies or needed by us individually, may be recycled and made useful to someone else? I just don't get it.

To use an analogy: Every week I put plastic or paper objects, once of use to me, but no longer of use to me, into a recycling bin. Others reclaim that paper and plastic and reuse it in ways useful to them. Fine, I say.

Another analogy: Every atom currently part of my body once was part of something else in the course of planetary evolution. That happens repeatedly. That is how nature works. Every atom now part of my body will end up being recycled many times more after I am gone. Our body cells are just temporary things made up of atoms destined to be recycled endlessly, as they have been repeatedly since the beginning of time. So what?

Where is the logic in all this emotionalism?
MBR (Boston)
Good point, but itis even more tenuous than that. Atoms are composed of electrons and protons each of which are *identical particles*, i.e., there is no way in physics to distinguish between an electron in you body and in electron in an object in someone or something in Mongolia!

What is stored in your cells is an arrangement of atoms that contains information. It is the information in that arrangement and not the atoms themselves that is significant.
Cow (IN)
Those who think they stand to profit from something must do their best to convince everyone that they must acquire, protect and increase that thing. Without people's fear of losing it and their subsequent desire to possess it, nothing has inherent value.

So your attitude of sharing freely what you've received freely and not holding on to that which is simply temporary (which is the essence of every religion, by the way) will eventually lead to the collapse of a materialistic, greed-based society. This may or may not be followed by something more pleasing. Who can say?

However, there are many who would very much like to see the present state of affairs continue. So they will continue to find new resources to exploit and new ways of creating a sense of fear around an illusory scarcity of those resources.

The fundamental error here is the illusion of separation. Once I accept that everything that's "mine" is "yours" as well and that in fact everything belongs to everyone, all these problems simply disappear :)
lakegirl (Milwaukee, WI)
The problem is that your DNA may be re-identified as being yours, which may cause endless biases in the future.
Michael Mahler (Los Angeles)
The issues of privacy and informed consent are of vital importance. But, this is not only about individual rights balanced against the common good that may result from biomedical research. This is also about money, lots of it. The first thing the scientists do when they make a discovery is to patent it. They may be willing to gloss over my privacy rights, but they are very diligent about protecting their intellectual property rights!
Kathryn Tominey (Benton City, Wa)
The rules should require royalty sharing with owners of tissues or cells used.
Carol (No. Calif)
Yes. I added in my comment to this proposed regulation that all profits must be substantially shared (at least 50%) with the original tissue owner (i.e. producer) after consent is obtained.
Mary (Atlanta, GA)
Your private cells are worthless without the time and money and scientists and equipment to even analyze them, much less do something with that information.

The utter selfishness in most of these comments is stunning. Is it ignorance or pure greed?
John Aach (Boston)
Ms. Skloot passes quickly over the administrative burdens involved in the proposed Common Rule changes and gives the impression that this is not a genuine issue. But the burden is actually huge. This morning the Geo database, a public repository of gene activity data from experimental studies, reports data from 1,647,104 samples, up from 1,307,138 a year ago (http://www.ncbi.nlm.nih.gov/geo/summary/?type=history). This represents about 340,000 new samples in 1 year, and this is but a fraction of the samples analyzed as there are other repositories and also a great many studies that don't produce these kinds of data and so are not counted in any such repository.

Ms. Skloot suggests that getting informed consents is a simple matter of having people sign a simple form, but obtaining and managing this volume of consents is a major undertaking, not only for researchers working with the samples, but for the review boards and government agencies who oversee it. The burden entailed by requiring reconsents after 10 years is extremely high as it involves trying to recontact research subjects.

Scientists do not make light of the need for informed consent, & considering how this should be updated is a good idea. But the benefits of this proposal need to be weighed against the costs, especially as the funds
needed to manage consents will come out of those allocated for research itself.

Readers, these are your tax dollars. Think carefully about how you want to have them spent.
trudy (<br/>)
Every few visits to my doctor's office they image my health insurance cards and sometimes my driver's license. I am constantly having to reread and resign privacy paperwork. I am sure it would not add hugely to their burden to get a signature for use of the patient's body material. In any event, to do otherwise is stealing.
Charlie (Philadelphia)
Are we really talking about our tax dollars here, or are we talking about the profits of for profit companies and institutions? I think the administrative costs, which seem minimal to me in the case of broad consent, need to be weighed against patient rights, and the value of patient trust in the medical and research communities.
Suzanne (Denver)
This sounds like the "jobs, jobs, jobs" handwringing of corporate America anytime environmental regulations are proposed.
ed (honolulu)
Not only should consent be required. but compensation should be given. The notion that someone is giving his DNA to science or for research is absurd. Companies make a lot of money from government research and should have to pay for it.
Eric (Michigan)
While that may seem reasonable to the uninitiated, remember a few things:
1) Not all research is successful or can be "sold" or marketed for money. There may be no money to give to a subject. Many times subjects are paid a small fee commensurate with the sample they provide (I pay up to $500 depending on what I collect).
2) It costs a LOT of money to collect the sample, isolate the DNA or other cellular material, bank it, store it so it doesn't degrade, and have safeguards in place in case of a power outage or other disaster so samples aren't lost. That money comes from grants and institutions - asking them to pay more is hardly fair either.
ACW (New Jersey)
You seem to think your individual sample will be the one that yields the breakthrough. Doesn't work that way, usually. Henrietta Lacks' situation is rather like winning the PowerBall - a lottery she'd undoubtedly have preferred not to have won.
No, chances are that your DNA will be valuable to researchers, if at all, as part of a large group, say, of men between a certain age, of a certain ethnicity, controlled for certain variables. That group will almost certainly be large. Rather than the PowerBall payoff, you will more likely get one of those tiny checks sent to class action plaintiffs, for $3.87 or $1.59 or a free jar of mayonnaise. Or you may get nothing - the nature of science is that a great deal of research, even in large pharmaceutical companies and prestigious research labs, leads nowhere. (We really need to improve science education; but that's another rant.)
Laura D (Iowa City)
The vast majority of this type of research is funded by the NIH, for the good of everyone. There is no company involved. No one is profiting.
Tony S (Connecticut)
We actually need more medical advances. A lot of people die every year from cancer and other diseases. We need to facilitate research, as opposed to adding more burdens.

Creating more obstacles for research has consequences. It is possible that one day, you or someone you love may get a disease for which a cure isn't available because research was prevented from being done.
Leslie (California)
The incentives and burdens in research have not stopped me or someone I love from getting a treatment that was unnecessary, costly, or injurious.

Science and technology are neither imperative, nor limitless. If someone has a desire to live forever, they can be. A lot of people die every year. All from a cause.
obscurechemist (Columbia, MD)
If this is about Science, then we must remember that the unknown is actually unknown. Science is NOT engineering with a desired or predictable outcome, for goodness' sake. Specific permission is impossible, so stop this silly talk right now.
trudy (<br/>)
It certainly is not impossible. A general paper could be written up in about five minutes.

You might as well say theft should be permitted because no one could list all the items that can't be stolen.
cb (amherst)
Read the book ~ The Immortal Life of Henrietta Lacks, maybe you will reconsider your answer. Just ask for permission, the answer may well be yes, BUT ASK FIRST.
Frumkin (Binghamton, NY)
Obscurechemist: It is precisely this sort of arrogance, which dismisses as "silly," the principle of informed consent, that makes the public understandably distrustful of the medical profession.
Camila (here)
What worries me about the informed consent is that there are way to many people prejudiced against scientific research in the world, for the simple reason that they don´t understand how it works. Take a look at anti-vaccine people, people who are "against" anything genetically modified (until they understand that diabetics depend on recombinant insulin), people who believe untested and unknown products can´t have any unwanted effects (but forget many very dangerous poisons are 100% natural). We may end up loosing many precious samples for research (and may even have to use more lab animals because of that). An opt-out system is reasonable. Anything more could significantly hamper scientific progress.
Leslie (California)
We all know how effective opt-out has been for "do-not-call."
Do not send a robot a collect all my specimens. just yet.
David Gregory (Deep Red South)
Privacy should not have to be subject to new rules- it should have been protected all along. The same is true of digital privacy and the data mining that goes on in the online world.

Privacy was considered so important that the Bill of Rights- which was a condition many required to support the US Constitution- provides for privacy in our basic law. I personally consider the use of bio specimens without consent an invasion of privacy. I also consider the data mining that happens online an invasion of privacy.

I work in healthcare and my employer's policy regarding patient privacy is so stringent that an inadvertent click - say clicking on the 3rd name on a list instead of the 4th- opening a patient file is considered an offense that should be reported to the hospital privacy officer. Seriously. The HIPPA Law is taken very seriously in healthcare and this use of identifiable tissues without consent seems to me to violate the spirit, if not the letter, of that law.

Next, let us think about the massive profits gained by companies and individuals from your specimens gathered without your consent and with no compensation.

The rules need to change.
Frumkin (Binghamton, NY)
And now imagine (if you are female or an intact male) that those cell phones are foreskins. Every year, over one million male neonates in the U.S. have part of their bodies - their foreskins - forcibly amputated without their consent (usually with insufficient anesthesia) and in the absence of any medical reason to do so. (Please spare me the argument about the "health benefits": we could end breast cancer in one generation if every neonate had her breast buds removed at birth.) This human tissue and the practice of amputating it at birth, when the "donor" is incapable of giving consent and therefore incapable of saying "No," provides a huge revenue stream for OBGYNs and pediatricians to the tune of hundreds of millions of dollars per year for the physicians and, by some estimates, a billion dollars annually for biotech companies who use infant foreskins for everything from growing skin for burn victims to facial cream. (Oprah Winfrey has publicly extolled the benefits of the latter; one wonders if she would feel the same about a product made from the excised genital tissue of FGM victims.)

No infant ever gives consent for a circumcision: that includes not only the use to which his amputated foreskin is subsequently put but the amputation itself. This essay by Rebecca Skloot reminds us not only that we need to have a conversation about human tissue, bioethics and the principle of consent, but that routine infant circumcision needs to be a part of that conversation.
Michael Mahler (Los Angeles)
The parents of infants give consent for medical treatment and procedures. You have strong reasons for opposing circumcision, but your judgement should not supersede that of the parents who may have important and valid reasons for having this done.
Michael (Denver)
Who said anything about a medical reason for foreskin amputation? It's purely an aesthetic issue!

Why not include ear-piercings for little girls?
Daniel (Washington)
Parents do not have the right to mutilate their children.
Mark (NY)
We have tortured countless animals as part of research because the research, we said, was so critical. Now when the research will infringe on people's privacy the criticality of the research changes.
Richard Luettgen (New Jersey)
This is hardly the same issue as people given access to unlocked phones.

Every day, studies are performed using real data from real people, but that data is summarized and made anonymous -- and the closest thing we've heard of abuse for decades of this is that the Chinese occasionally hack into our government's (!) databases to steal the names of spies.

So long as the use of such biological materials in research continues to be anonymous and its security is no MORE effective than it's been for so long, there's not a lot of danger of misuse. There's just no real evidence of a problem.
Julie Dahlman (Portland Oregon)
So does this remain in public domain or private domain. Our tax dollars set it and private entity use all the info and are enabled to make profits? and then claim they did it all by themselves without public funds?
Chris (Paris, France)
"There's just no real evidence of a problem."

Well, given that you think "that the Chinese" only "occasionally hack into our government's (!) databases to steal the names of spies", as if they didn't routinely hack into government AND private company databases to steal trade secrets, personal information, and other sensitive information, I guess that makes sense. Now try reconsidering your stance in the actual context instead of your downplayed view, and reassess..
Richard Luettgen (New Jersey)
Guys:

I've conducted such studies myself. One way of assuring digital security is by entering the data specific to individuals, that are summarized for use as a statistical universe, but not entering names, SS numbers or other identifying data, which are irrelevant to the study.
R.E.W. (Rochester, New York)
The Author argues strenuously to mandate consent for discarded tissue. She does not address the practical implications of sucha rule change. In practice, a lot of science that would be done under current regulations, would not be done with the proposed rule change. Is this price worth the more rigorous consent standard?
Leslie (California)
People are not "discarding tissue" when they consent to and received treatment. It is being taken. It is being used. There are at least two views of this issue.
Michael Anderson (Washington, DC)
Informed consent does not necessarily need to be massively complicated, nor should it be. Informed consent does, however, need to be well written so that the average reader can understand it, or explained to every subject in language they can understand. There is nothing new about this. I am confident that as we move forward, institutional review boards (IRBs) can help investigators find ways to accomplish informed consent that will offer subject protection and advance knowledge.
Tournachonadar (Illiana)
Nowhere else is the hypocrisy based on a false assertion of all citizens being equal more evident than in this genetic boondoggle. It's prohibited by EEO laws to discriminate against a job applicant or employee on the basis of [derogatory/deleterious] genetic information, such as the prevalence of cancer in a person's family. But in America, any legal principle fares ill once it comes up against money. And there's a massive investment based on decoding and manipulating the human genome just waiting to pay out its dividends. As always, the wealthiest will benefit handsomely both in terms of direct payout into their hedge funds and medically from access to the scientific advancements gained by exploiting the genes of the little people.
DMutchler (<br/>)
I wonder if it is not so much the question of consent, but the question of ownership in respect to creation of novel methods or means to, say, combat a disease (or worse, create a disease). I doubt that is an aspect of the Common Rule about which people will have a say.

So personally, to reiterate, I would be more concerned if my tissues and/or genetic material were used to create a life-saving means, and that means was given a price tag of, e.g., 100K per dose/use, and I had nothing to say about that. I am not thinking of personal profit; I am thinking of a medicine or what have you that is accessible and affordable for all.
cb (amherst)
Unfortunately I believe most medical research is about money, well in the good old USA.
Eric (Michigan)
I am profoundly sorry for your cynicism. Some of us do this for a living because we want to help. Not make money.
Lisa Wesel (Maine)
That is honorable. Unfortunately, the companies that may use your genetic material are ONLY interested in profit, often to the detriment of the patients they claim to want to help.
NRroad (Northport, NY)
It's worth pointing out that inflammatory pieces like this account for the vast majority of public information about HL cells. Simply another example of the trash media that populates our supposed news sources. However, if it were done with an eye to efficiency, "broad consent" would not be an undue burden. Patients are already often given massive complicated consent documents that the cannot comprehend or will not read before signing. Done in the worst possible way, this change in the Common Rule would only make that worse. It all depends on how its done. It also needs to be pointed out that this is simply one in a broad array of changes in the Common Rule, many of which simplify the restrictions on research use of information. Finally, the Common Rule only applies to organizations receiving federal research funds, so that the changes would not apply to entities that do not receive or seek such funds. Given the complex impact of the proposed changes this could lead to a private enclave of anonymously funded research entities that do not seek or accept such funds and are beyond regulation.
ebmem (Memphis, TN)
You are correct. It is far better to have the experts decide what is most convenient and profitable for them to do than to ask the people. One of the huge risks of democracy is that the people are not smart enough to know what is good for them.
trudy (<br/>)
ebmem, you forgot to include a sarcasm emoticon.
DaveD (Wisconsin)
But the comment was so clearly written; beyond the blunderbuss of emoticons.
Amanda (New York)
Of course one naturally has concerns about medical privacy.

But it seems wrong to use drugs developed from other people's tissues while refusing to share your own.

And if some people opt out, how do researchers get a fully representative sample of human cells?

There have been complaints that not enough medical research has been done using minority and/or female subjects. Allowing people to opt out could make it harder to address that by making the pool of persons studied even narrower.
CMD (Germany)
Amanda, I fully agree with you. If a researcher wanted to use some of my somatic cells to examine epigenetic factors, or heredity, under circumstances making it possible to eliminate methylization of CpG groups, or find a cure for my type of rheumatism, I would agree at once. My only stipulatio n would be that he/ she not patent processes.
Al (Baltimore)
Perhaps there is a kind of karmatic justice in this. If those who share their samples end up being the indirect participants of biological and medical research, that drugs, devices, technology, and treatment related knowledge will apply to them best. Those who choose not to volunteer may doom themselves and others genetically related to them to suffer the consequences of less effective medicine, all by their own hand in choosing not to participate.
joe (stone ridge ny)
Since "each and every" sample taken is not stored, let alone "researched", only with those that are "of interest" (to researchers), it is hard to conceive how this will have any bearing on building a "fully representative" sample of Human cells.
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