Last week David Coil in my lab reminded me that he had been wanting to borrow a copy of “The Immortal Life of Henrietta Lacks” by Rebecca Skloot. I have read the book many many times and had told David I even had a preprint that Skloot or her publicist sent me before the book came out (I did not know Skloot then – I just got it because of my blog). As I went to grab the preprint off my shelf in my office he said he wanted to read it know because the genome of the HeLa cells which had been taken from Mrs. Lacks had been published a few days before. I was shocked. I asked him if he knew if the authors of said paper had gotten consent before publishing it. So I opened a web browser and googled and found the paper and some news stories and a press release from the group who did the sequencing.
Holy fuck. They did not seem to have permission. Uggh. I had thought about this a lot because a few years ago I was thinking of writing a review of “The Immortal Life of Henrietta Lacks”. As part of that started to write about the possibility of sequencing the HeLa genome and what that might mean. I also did an April Fools joke relating to the topic: http://therealhela.blogspot.com. And every time new sequencing technology comes along I have thought about – and discussed with others – the possibility of sequencing the HeLa genome. And every time I got to this point I decided that it would be unethical, inappropriate, and downright stupid to do this without consent. Note – my original plans for the book review involved a focus on the strange balance between openness and sharing in the history of HeLa and the lack of consent (e.g., see this blog post).
I was so angry about the lack of consent here that I took to Twitter.
A bit stunned that the people publishing the #HELA genome appear to not have gotten consent from the family g3journal.org/content/early/…
— Jonathan Eisen (@phylogenomics) March 18, 2013
The sequencing of #HeLa genome w/o family consent is appalling – I literally feel like throwing up @downfortylove
— Jonathan Eisen (@phylogenomics) March 18, 2013
And after that there was remarkably little discussion of the issue by others. What the fuck? People get up in arms about all sorts of minor things so why not get up in arms about this? Where were all the supposed genomic ethicists out there? How did this happen? Thankfully, yesterday a piece on the topic came out from Rebecca Skloot (it was in this mornings New York Times) and it has launched this issue into a much more public discussion. So much discussion that I decided to storify it. See below.
//storify.com/phylogenomics/hela-genome-sequenced-w-o-consent.js[View the story “#HeLa genome sequenced w/o consent (by Jonathan Eisen)” on Storify]
Lots of discussions going on out there. And I think Rebecca deserves credit for writing this piece and bringing the story out more. I tried to get people going on Twitter and it was a slog — people did not seem that interested to be honest. Now – everyone seems interested. Including some who say they agree with Rebecca (and me) that it was a mistake to publish this genome.
Alas, am wondering what these people thought before the Skloot article. Why did so many people just stand by and say nothing? Too busy? Did not occur to them that this could be an issue? Or something else. Oh – and why did it not occur to Francis Collins and all the people behind encode that this could be an issue. They published a lot of genomic data from HeLa cells and never once asked for consent or apparently even thought about it.
Anyway – it’s about time we as a community got off our butts and started discussion how to deal with the ethics of personal genome data. This data will be coming out more and more. We need to figure out how to handle it and the consent issues around it. And we also need to do a better job of figuring out what to do with samples for which consent was not given but which are used. Should we stop using HeLa cells? Possibly. If we want consent to use them – who will give it? I don’t know the answers. But I do know one thing – science should not simply proceed forward just because these questions are hard to answer. Publishing the genome without consent or talking to the family was a very very very bad idea given that the ethical issues around consent here are murky.
UPDATE – 5 PM 3/24/13
- “To date, no genomic reference for this cell line has been released, and experiments have relied on the human reference genome”
- “Our results provide the first detailed account of genomic variants in the HeLa genome, yielding insight into their impact on gene expression and cellular function as well as their origins.”
- “produced nearly 1 billion reads of length 101 nt” (thus they produced 101 billion bases of DNA sequence information).
- The read data are available in the European Nucleotide Archive (ENA) database under the accession number ERP001427.
- We report a compendium of genomic variation (CN, SNVs and SVs) as well as the first HeLa genome draft, which are available as VCF and FASTA files respectively
- We provide a tool to perform the translation of coordinates between GRch37 and our HeLa reference,
- Most variants in these HeLa cells thus represent common variants in the human population. The African-American population (to which Henrietta Lacks belonged) is spread between the African and European clusters, with the HeLa sample overlapping both. This demonstrates that although the genomic landscape of HeLa is strikingly different from that of a normal human cell, the population-specific SNV patterns are still detectable.
- Since the establishment of the HeLa cell line in 1952, it has been used as a model for numerous aspects of human biology with only minimal knowledge of its genomic properties. Here we provide the first detailed characterization of the genomic landscape of one HeLa line relative to the human reference genome
- “The results provide the first detailed sequence of a HeLa genome,” explain Jonathan Landry and Paul Pyl from EMBL, who carried out the research. “It demonstrates how genetically complex HeLa is compared to normal human tissue. Yet, possibly because of this complexity, no one had systematically sequenced the genome, until now.”
- “The HeLa genome had never been sequenced before, and modern molecular genetic studies using HeLa cells are typically designed and analysed using the Human Genome Project reference. This, however, misrepresents the sequence chaos that characterises HeLa cells, since they were derived from a cervical tumour and have since been adapting in laboratories for decades.”
- “The study provides a high-resolution genetic picture of a key research tool for human biology. It highlights the extensive differences that cell lines can have from the human reference, indicating that such characterisation is importahttp://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html?_r=0nt for all research involving cell lines and could improve the insights they deliver into human biology.”
- Can we infer anything about Henrietta Lacks or her descendants from this sequencing?
- No, we cannot infer anything about Henrietta Lacks’ genome, or of her descendants, from the data generated in this study. Firstly, the subtype of HeLa cells sequenced in this study has spent decades in labs, dividing and thus undergoing mutations and changes – they are very different from the original cells that started growing in 1951. Secondly, these initial HeLa cells were taken from Henrietta Lacks’ cervical cancer tumour – as cancer is a disease of the genome, the DNA of cancer cells is usually different to that of the patient. Without any genetic information from the http://www.genomeweb.com/blog/learnt-lessonsoriginal tumour or from Henrietta Lacks, it is impossible to distinguish which parts of the genome sequenced here originate from Mrs. Lacks, her tumour, or laboratory adaptation. The goal of this study was not to gain insights into Henrietta Lacks’ cancer or personal biology, but rather to provide a resource for researchers using HeLa cells.
UPDATE 2: Some links to other discussions out there on the topic
- David Kroll: The Henrietta Lacks Genome: Consent, Trust, and Common Decency
- Rebecca Skloot: The Immortal Life of Henrietta Lacks, the Sequel.
- Michael Eisen: The Immortal Consenting of Henrietta Lacks
- NextGenSeek: HeLa Cell Line Genome Sequencing Raises Ethical/Privacy Concerns
- Anne Buchanan: HeLa cells and cavalier scientists
- Razib Khan: Henrietta Lacks’ genome and familial consent
- Ivan Oransky: Geneticists take HeLa sequence off-line after Lacks family notes they hadn’t given consent
- GenomeWeb: Learnt Lessons
- Peter Lipson: The Frontiers of Medical Privacy
- The OpenHelix Blog: The HeLa genome – there’s more to this conversation
UPDATE 3: 11: 40 PM 3/25/13 Presidential Commission
President’s bioethics commission recs 4 genome seq policies “2 ensure progress” & “protect #privacy” bioethics.gov/cms/node/764 #HeLa #bioethics
— Rebecca Skloot (@RebeccaSkloot) March 25, 2013
The report was release on October 2012 but got very very little coverage and I have never seen/heard it mentioned anywhere. But it covers a lot of ground of direct relevance to this HeLa story. The whole report is available here. Here are some choice statements (bolding by me)
“Large-scale collections of genomic data raise serious concerns for the indi- viduals participating. One of the greatest of these concerns centers around privacy: whether and how personal, sensitive, or intimate knowledge and use of that knowledge about an individual can be limited or restricted (by means that include guarantees of confidentiality, anonymity, or secure data protec- tion). Because whole genome sequence data provide important insights into the medical and related life prospects of individuals as well as their relatives— who most likely did not consent to the sequencing procedure—these privacy concerns extend beyond those of the individual participating in whole genome sequencing. These concerns are compounded by the fact that whole genome sequence data gathered now may well reveal important information, entirely unanticipated and unplanned for, only after years of scientific progress.”
“Whole genome sequencing dramatically raises the privacy stakes because it necessarily involves examining and sharing large amounts of biological and medical information that is not only inherently unique to a single person but also has implications for blood relatives. Genomic information is inherited and determines traits like hair and eye color. Unlike a decision to share our hair or eye color, which does not reveal anything about our relatives that is not observable, a decision to learn about our own genomic makeup might inadvertently tell us something about our relatives or tell them something about their own genomic makeup that they did not already know and perhaps do not want to know. More than other medical information, such as X-rays, our genomes reveal something both objectively more comprehensive and subjectively (to many minds) more fundamental about who we are, where we came from, and the health twists and turns that life might have in store for us.”
“Because whole genome sequence information directly implicates relatives, psychological harms often are not limited to the person whose genome is voluntarily being sequenced and publicly disclosed. Even individuals who learn that they do not carry a harmful variant may experience “survivor’s guilt” if another family member is affected.”
“At the same time, individuals have a responsibility to safeguard their privacy as well as that of others, by giving thoughtful consideration to how sharing their whole genome sequencing data in a public forum might expose them to unwanted incursions upon their privacy and that of their immediate relatives. To be indifferent to the implica- tions of disclosure of sensitive data and information about one’s self is to act irresponsibly. That being said, it can be good and virtuous to share sensitive data about oneself in appropriate circumstances, for example, for the good of public health research or public education.”
“Risks might also fall to blood relatives of these individuals who carry similar genomic variants, thereby raising the stakes of privacy concerns in whole genome sequencing compared with most other types of research.”
UPDATE 4: 3/26/13 – Some new stories / links
- The Scientist: Privacy and the HeLa genome
- Genomes Unzipped: Henrietta Lacks’s genome sequence has been publicly available for years
UPDATE 5: 3/26/13 – Rebecca Skloot on Morning Edition
UPDATE 6: 3/26/13 – Some more stories / discussion
- Debra Matthews: Engaging Individuals in the Research Process
- HeLa discussion on Huffington Post Live: http://live.huffingtonpost.com/r/segment/514fae11fe3444426e00038d
UPDATE 7: 3/26/13 2 PM PST Still waiting for ENCODE to say something about whether they are going to take down their #HeLa data. See for example my Tweet from a few days ago
Wondering if/when ENCODE project will take down their #HeLa genome data since they did not get consent either nytimes.com/2013/03/24/opi…
— Jonathan Eisen (@phylogenomics) March 24, 2013
- Andrea Peterson at Think Progress The Ethics of Publishing Genomes: Can Today’s Family Members Give Consent For The Next Generation?
- Ewen Callaway: HeLa publication brews bioethical storm
- Just been pointed to this from Thomas Lumley which was posted 3/19: How could this possibly go wrong?
- Curtis Brainard in the Columbia Journalism Review “HeLa-cious coverage”
- New Scientist Andy Couglan:: Storm erupts over publishing of Henrietta Lacks genome
- PGP: HeLa’s Genome: Help Us Create Well-Consented Cell Lines …
- Newsy: HeLa Cell Genome Published, Causes Privacy Controversy (VIDEO)
- Harvard Law blog: Henrietta Lacks, Publishing Genomes, and Family Vetos |
- Tabitha Powledge at NASW: http://www.nasw.org/science-blogs-immortality
36 thoughts on “HeLa genome sequenced w/o obtaining permission/consent from family – some comments and background”
It is long overdue that we all agree on clear ethical guidelines.
On the one hand, for sure even if just as a matter of courtesy the family should have been asked. On the other hand, family or not, most of my DNA is the same as that of Lacks, Watson or Venter. Which family members have to be asked? How far a family member should be to not be relevant anymore? Nobody asked my permission when any of the human DNA sequences out there were made public, most of which are with almost certainty identical to mine.
Lets say that I have a unique variant of a particular gene, can I claim it is mine? Can I patent it? What if by chance another copy of this variant appears in the population?
I am certainly in favour of not excluding the wishes of relevant parties in the decisions but it is really difficult to draw clear ethical lines…
There are many areas where it is difficult to draw lines like this. Age of consent. Other age restrictions on all sorts of things. Minimum distance from Planned Parenthood clinics where protestors are allowed. Vision deficiencies at which we declare people blind. We draw lines all the time. Even when there are not lines and there are gradients. This is a similar case to me. Yes, it is hard to know how / where to draw lines on who gets to consent for genetic/genomic data. But it is pretty clear when NOBODY consented that something is amiss … That being said – for the future – I think one could draw lines based on genetic relatedness to the person being sampled. If that person gives consent then perhaps (and only perhaps) other people of a certain degree of relatedness should be consented too. My gut says this is probably a very risky / potentially bad / messy thing. So my gut says even close relatives probably should not have the power to deny consent. But I just don't know. And I think we NEED to discuss this NOW.
There are so many human cell lines out there and the genomes of all of them will be sequenced eventually because, as the HeLa genome has shown, they can be so different from the normal ones that you really want to be doing your functional genomics by aligning against the proper genome and not against the reference.
Is it really practical to ask for consent for all of them? And what happens with all the ChIP-seq/DNAse/etc. data that is already in GEO and SRA for those cell lines (including a lot of data for HeLa, and not just from ENCODE – there has been probably at least a couple of dozens of sequencing-based functional genomic papers on it in the past 5 years)? Do we lock it down behind the wall of dbGAP and make it inaccessible for most of the community as is the case with the Epigenome Roadmap, GTex, and other projects of the sort?
I don't see this being a practical approach for the indefinite future.
I agree that consent should have been asked (although, ask who?), but I think it's dubious to think that the problem originated with this research team. The real problem is that a good proportion of the biomedical research establishment has been casually using HeLa cells for decades, when they were originally propagated and passed on without consent in the first place. In that situation, sequencing HeLa cells probably seemed no different than sequencing E. coli.
Basically the lack-of-consent mess started back in the 1950s and has yet to be resolved.
Well, it doesn't really matter (to me, or I think, in principle) whether this is impractical because there are lots of non consented cell lines out there. We NEED to do things in the right way. If we do not have consent done correctly for these cells we need to pause the work and figure out how to reconsent / ask for consent / pull the lines / hide the data. As you may know I am nearly obsessed with openness in science – mostly because I hate it when roadblocks get in the way of research. But that being said – this kind of roadblock is one we need to fix not run around.
Completely agree. I was trying to get at this with the “Should we stop using HeLa cells? ” line above. And the comment about ENCODE. It was screwed up in the past. And we keep screwing it up. I do not place all the blame on the current authors. But they really should have known better. And to their credit – they pulled the data.
I know very well you're obsessed with openness in science. Which is why I am a little surprised you are also obsessed with hiding SNPs behind walls. I personally don't see a way of hiding genetic information into the indefinite future that is not going to be extremely painful for everyone involved. The only rational way forward would be for people to simply get over it and accept that their genetic information is not going to stay private. Of course, it would be really nice if we did not live in a society with a health care system like the one in the US, but I would rather work on changing that than on blocking research in the name of protecting genetic privacy.
I disagree that that is the only rational way forward. We attempt to protect people's medical records right now – those are not posted publicly by MDs. And one's lab tests generally are not posted either. We don't have to post genome data either. Certainly, I think there are ENORMOUS benefits to publicly sharing all this info. But that does not mean we gloss over the possible risks and ethical issues with doing so. As for health care – certainly it would be better if we had a better system. But genomic data has the potential to affect more than insurance and health care. It can lead to negative treatment by others – even if discrimination is illegal. I think it is completely irrational in fact to move forward blindly without working this stuff out.
This comment has been removed by the author.
Georgi Marinov3/24/2013 7:10 PM
I am aware of all the horrible things that can happen. The difference between my view and yours is that from your perspective, only one variable changes – genetic information being kept behind bars, while everything else stays the same. If that is the situation I actually agree with you. But from my point of view, more than that changes because I assume that a society that has reached the level at which people do not feel scared of other people knowing their SNPs will also have presumably become enlightened enough for discrimination not to be a problem either. Obviously, we do not live in that society, but that's another thing to work on.
Anyway, the reason I commented on this story is that I saw the reference to ENCODE data and got scared that if we go down the road you suggest, we will have to put functional genomic data behind a wall too, and while there is plenty of great research to do in mice, I would still like to be able to work in human too without silly restrictions.
I am with you about the restrictions. It would be horrible to have this put a crimp in all sorts of human research. But that just means we need to sprt this out quickly and find solutions that are ethically sound
I am obviously not a specialist in human genomics but I would like to voice an entirely opposite view: once the person dies, the privacy should end (unless the direct descendants demand otherwise). I am totally opposed to all these attempts to make anyone's genome some kind of a secret. This DNA sequence defines (not entirely, though) what I am and hiding it does not really benefit anybody. Nobody is perfect, if I carry some mutations that predict an early onset dementia, so be it, you could say I already have it. Yes, making all those data public would usher an entirely different world but probably a better one than what we have right now.
Michael – I agree with some of what you say here. But regardless. Even if I agreed 100% that the world SHOULD be one where such data can be made public. That is not my decision to make. And it is not yours. Some people do not want this information shared and I believe they have a right to be part of this discussion. Therefore I do not think we should release such data at this time without their informed consent. If we get to some point in the future where there has been a fuller discussion of these issues and where society generally agrees that it is OK to release such data without consent, well, so be it. But we are not there now. I note – it is generally considered an invasion of privacy to post all sorts of other details about people. Much of this is LEGAL but also considered rude, unethical, or bad practice. I don't want scientific / genomic data to be viewed like other types of privacy invasions.
I'm curious why you think nobody brought this issue up when the ENCODE papers came out? You can essentially assemble a large portion of the HeLa genome from ENCODE data.
I was thinking today about some adoptees that I know, who are eager to get their sequence details precisely because they don't have any family medical history or genealogy.
What should they do? Who can they notify? Can they publish their own sequence data?
I have no idea what happened there … clearly they screwed up too.
I hope all this will not end up giving vulturelawyers brilliant ideas like charging scientists with a 'heritage fee' for the family that originated every single cell line used for research (fee to be split 90/10 between lawyer and family, of course). And retroactively.
I think right now if the person who is being studied gives consent one is pretty safe that this is a much better thing that doing it without permission from anyone. But should they post their own sequence data online with their name attached to it? I am not sure. What if they have kids? The data will affect their kids too. I think we really need a broader discussion of this to figure out just what the ideal thing to do is.
you see – this is why we need to discuss these issues asap and make sure when one does informed consent that people find a way to prevent the lawyers from coming into it
I completely understand your frustration Jonathan. Every event like this, sets the industry back. Personal genomics is at a critical juncture. Broader public support will require that we show value from the data, not just when you're sick, but every day. We also have to build trust, and show that we're good stewards of people's private information. Coming from the online marketing industry, we've completely blown that too. State and federal laws sometimes hurt, rather than help us. Obtaining my full EMR is nothing short of frustrating, so if we want to go down that route, I think we'll all lose in the end.
Respect my data, give me access to my data, show me value for my data, and I'll share what I feel comfortable sharing.
Thank you for bringing these issues to the forefront.
Sorry, I wasn't logged in. This is @taulpaul.
Exactly my feeling – events like this set the industry back are are unnecessary. How about this – they could have announced “We have sequenced the HeLa genome for research but don't know what to do with the data” – and call for a public discussion of it. Or they could have done 100 other things that could have been better …
I highly doubt they even thought about it. I personally didn't – I personally saw the paper, read it, and all I said was “That's cool”, without ever thinking about the consent issue; in fact, sequencing HeLa and other cell lines has been discussed before, I have myself thought about it in the past too, but the consent issue never came up in conversations or occurred to me. I am sure there was no malicious intent behind this.
The question is what happens in the future. It's still expensive to do this routinely, but that's not going to stay that way for very long – so let's say we keep the data from this paper from becoming public. But everyone has these cells and can sequence them if they want to. Does it makes sense to keep the data private now and have each and every lab that wants to work with the actual HeLa genome rather than the reference resequence it separately? Even if sequencing itself is cheap, the analysis is not and will remain expensive for much longer than sequencing. And then each and every lab will have to keep their data from the public domain? That does not look like a good investment of time and effort to me…
Re: lawsuits, I suspect that's a dead issue at least with HeLa. Quoth wikipedia:
George Otto Gey and Henrietta Lacks
The cells were propagated by George Otto Gey shortly before Lacks died of her cancer in 1951. This was the first human cell line to prove successful in vitro, which was a scientific achievement with profound future benefit to medical research. Gey freely donated both the cells and the tools and processes his lab developed to any scientist requesting them, simply for the benefit of science. Neither Lacks nor her family gave Lacks's physician permission to harvest the cells, but, at that time, permission was neither required nor customarily sought. The cells were later commercialized, although never patented in their original form. Then, as now, there was no requirement to inform a patient, or their relatives, about such matters because discarded material, or material obtained during surgery, diagnosis, or therapy, was the property of the physician and/or medical institution (currently this requires ethical approval and patient consent, at least in the UK). This issue and Mrs. Lacks's situation was brought up in the Supreme Court of California case of Moore v. Regents of the University of California. The court ruled that a person's discarded tissue and cells are not their property and can be commercialized.
The legal issue is not synonymous with the ethical one, of course…
Hmm… but perhaps it's time to give up on the idea of privacy and consent in the context of genomic information. After all, we 'publish' our genome constantly – every time we throw away a coffee cup, for example. So what right do we really have to claim that our genome is private information? Perhaps, instead, our focus should be on strengthening legal safeguards against all types of discrimination on the basis of genotypes. If your genome, or some cells derived from your genome, are useful to the advancement of science, I think it's fair game for researchers to have at them.
I can honestly say I think you may have lost your bearings on this one. We talk on telephones all the time but tapping them is generally considered an invasion of privacy. We sometimes leave our blinds open but taking pictures of us in our own home with a super telephoto lens is considered an invasion too. We exist in the world and interact with it. That does not mean we do not have privacy rights and privacy expectations.
You could well be right, and I admit that I am being deliberately provocative here. However, I think it's worth considering further if genomic information is private in the same sense as a phone conversation. If it is, then issues of consent become very tangled. How can an individual publish their genome without first getting consent from all their extended family and all future decendants? Why is it okay for FT-DNA to host a project that characterizes the Y chromosome genotype associated with my family name without first getting my consent and that of everyone else with my surname? I'm just suggesting that there may be an alternate viewpoint that recognizes the communal nature of any individual genome: i.e. it's not your genome, it's our genome.
I too am surprised this series of experiments went forward with no attempt to get consent. All of the scientists arguing that pieces of the HeLa genome have been published before – I'm sorry, that doesn't make it ok, either then or now. Many, many years after consent has become the norm, we are still treating Henrietta Lacks as a scientific subject first and a person with privacy rights second. That's the definition of exploitation.
I get all the impracticalities, etc, of re-consenting in these situations, but let's not forget that we do science at the public's behest. However inconvenient, re-consenting is the right thing to do. And you can bet the public is not going to see the “inconvenience” as a justifiable excuse for short-circuiting personal rights.
“without ever thinking about the consent issue” – that's the problem. It makes no difference if you set out maliciously to ignore consent issues or if you simply didn't think of it, the end result is the same.
As a basic science researcher (I only do epidemiology now), I used HeLa cells in my work and I am truly grateful to Henrietta Lacks and her family for their generosity – consented or not. However, I can assure you that most people, who use the cell line, do not know where they came from – at least prior to Ms. Skloot’s book. But I find this quite normal for we use all sorts of cell lines and hard to take a moment to think where each came from.
Genome consenting is one of the medical ethics challenges of our times. We have been struggling with this problem in research that was completely limited to just one person; now we are adding all the current and future generations – problem grew exponentially! Getting even closer to a resolution to this enigma will require a drastic cultural change and paradigm shift. I believe the social media generation will have a lot less problem with sharing their genetic information and will modify the insurance and job schemes accordingly. Of course, all solutions are circumstantial and following generations may have different issues to deal with.
In the current environment, however, we must decide who has the right to consent donating one’s own genetic material for research. It is paradoxical to get the consent of the current family members (assuming you can locate all of them) and not to consider future generations. If we take measures to protect future generations, there will not be much scientific progress involving genetic information. As an individual, I will not have the right to participate in a research that I believe my genetic material can make a contribution. This will be taxing on people’s generosity for contributing to the genomic science. In this context, we have to understand how to value each component of using genomic information – specifically in furthering humanity while addressing some the scientific challenges such as finding cure for diseases and preventing some of the debilitating health conditions.
I have an issue with the ICD discussion though. I have read the president’s bioethics committee report and found nothing that will actually protect anyone in the future generations, but only possibly the existing and known family members. It is a modified version of previous one (Belmont Report) to fit the genomic information. Sometimes we get too wrapped up about the conceptual meaning of obtaining an informed consent that overlook all the mishaps happen along the way. Despite research personal’s genuine intentions, in most instances research participants don’t thoroughly understand what they are consenting for – and that is for participating in RCTs; now imagine it in complicated world of genomics! However, obtaining a signed copy of ICD makes the investigator feel better –morally and legally. What I am trying to say is that I respect the desire to get the consent of an individual before hand, but getting a signature does not equate obtaining a true consent for the intended purposes. Please do not misunderstand me; I am all for consenting study participants and spent quite a bit of my time in regulatory affairs and did a masters thesis on understanding and improving of ICD – I truly care for this subject but feel that with all good intentions it is superficially conceptualized.
I personally believe we should invest more time and energy on anticipating the predicaments such as discriminations, which would result from identifying people through a piece of DNA, and start making policies to prevent them from happening and protect people if they happen – then failings in privacy protection will be irrelevant (note where the genome was sequenced and published; other countries have less concern about privacy issues than we do in US). The easy access to genomic data is a new uncharted territory and everyone is confused and unsure about the cost/benefit profile of our actions ranging from donating the DNA to putting it out there for science. Good news is we are discussing and although in baby steps, we are learning.
Sorry for the longwinded comment 🙂
I personally trend toward favoring the individual who is providing samples / DNA in terms of who gets to consent. If a person gets their genome sequenced and wants to post the data I think that almost certainly has to be OK. But I have a sliver of doubt there. And thus I think we need to have a broader discussion on this. I note – I am NOT saying I think posting ones own genome is necessarily a good idea. It could end up being akin to writing a tell all book about one's family or ex-spouse or such. Probably legal. But not cool.
As for sequencing a genome of a sample w/o consent – that is just not a good idea no matter how beneficial it is. Even in the twitter/facebook generation such a violation could damage scientific research severely.
I agree we need to spend a bit more time on trying to establish policies that would make discrimination illegal or more difficult but one has to realize that it will still occur no matter what laws are in place.
i agree with you on principle about getting consent before sequencing and i don't mean that gen y won't care if we did without consent or it is ok for scientists to think gen y's privacy is not important b/c they don't care :))), i mean they will have less issue with privacy hence consent will be less problematic (of course generation after them may be more concerned about privacy if this whole experiment goes south). hopefully we are more conscientious people (and learned lessons from history) and will not abuse participants' trust.
hmmm, a 'tell all book' ….. there is a good lead to follow 😀
btw also realize: “too much analysis leads to paralysis!”
Yes, TMALTP but NALTT (no analysis leads to trouble) and as far as I can tell there has been almost no analysis / thought given by the people working w/ #HeLa cells to what they should do w/o consent …
ditto, but not surprised. i've seen worse!
This reminds me of the argument over whether Google has the right to index web pages or books that they don't own. Some people seriously argued that Google needed to go and ask the maintainer of every page and author of every book to get permission first. Fortunately, the courts saw this as a silly requirement. Things like this don't scale in the era of big data.