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Personal Genome Project


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#1 Darrel Manson

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Posted 17 July 2010 - 02:12 PM

Just an FYI for those interested. There is a research project (currently only open to US citizens) out of Harvard Medial School to get 100K people to share their DNA openly. I'm in the enrollment process at the moment. The informed consent form is long enough that it comes with a table of contents. You have to pass several tests showing you understand the concepts before you even get to the consent.

Among the possible risks, btw, are someone could use the coding of your DNA to manufacture DNA and leave at a crime scene to frame you. You may discover that you are prone to a disease you might prefer not to know about.

The wikipedia page on the project

Edited by Darrel Manson, 17 July 2010 - 02:49 PM.


#2 M. Leary

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Posted 19 July 2010 - 09:59 AM

I review research projects involving genetic data and tissue collection for ethical and regulatory issues on a daily basis. While your generosity is admirable, I don't think informed consent is actually possible at this stage given our limited understanding of how these databases/collections will work and what they will be used for.

Fact is, the FDA isn't even quite sure, and we currently treat these very carefully on a case by case basis. A lot of times we have no idea how DNA info or tissue will be used in 10, 20, 30 years, and in the case of things like cell lines... your info becomes physically immortalized. I haven't seen one consent yet that is more than around 60% definitive on the "future use" of these materials.

I don't mean to sound alarmist here. And there has been some great science coming out of these types of projects. But I would still be hesitant at this stage to participate in these kinds of collections given their open-endedness. The FDA and related governing agencies are going to catch up with the privacy ethics of this process and plug as many loopholes as possible, but we aren't even close to that yet.

Maybe in the future scientists will have enough data to say: We are going to collect your tissue, look for X, Y, and Z, and then destroy it. At this point, the typical process is: We are going to collection your tissue, make cell lines, and then... let scientists do stuff with it. We have a general sense of the boundaries of what could happen to your tissue right now, but we have no idea what that would look like 10 years from now. From an ethics perspective, that issue just becomes geometrically worse over time.

Also, their posted consent is expired. Come on, Harvard!

Edited by M. Leary, 19 July 2010 - 10:29 AM.


#3 Darrel Manson

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Posted 19 July 2010 - 10:59 AM

Also, their posted consent is expired. Come on, Harvard!

Is it after 3/31/11 where you live?

As I recall, The consent is fairly clear that the openendedness and the openness of the project means they don't know how material will be used. The risks section of the consent (beginning on p. 14) includes a lot of things that people might find objectionable (e.g., cloning or mixing your genetic material with lab animals such as mice). Surely in 5, 10, 25 years people will have thought of even more ways of playing with genetic material. In many ways I think the ethics will always be lagging in this field.

I have to say that the thing that gives me the most pause about the project is the openness. I think there probably should be some layer of anonymity to prevent, say, insurance companies from trolling the list for people to cut.

#4 M. Leary

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Posted 19 July 2010 - 11:32 AM



Also, their posted consent is expired. Come on, Harvard!

Is it after 3/31/11 where you live?

As I recall, The consent is fairly clear that the openendedness and the openness of the project means they don't know how material will be used. The risks section of the consent (beginning on p. 14) includes a lot of things that people might find objectionable (e.g., cloning or mixing your genetic material with lab animals such as mice). Surely in 5, 10, 25 years people will have thought of even more ways of playing with genetic material. In many ways I think the ethics will always be lagging in this field.

I have to say that the thing that gives me the most pause about the project is the openness. I think there probably should be some layer of anonymity to prevent, say, insurance companies from trolling the list for people to cut.


Yes, it is a year later here!

Most projects of this sort that I see are very careful about creating a process in which your data and tissue becomes de-identified as it is passed along to the repository. It becomes stripped of all 18 HIPAA identifiers as it leaves the hands of the clinician that has taken it. No one on the database end, and no researcher using it, would have any way to identify the source of the sample. (Further, no insurance company, employer, or lawyer would be able to troll the database, or even correlate an entry with an ID.) That scenario makes it more comfortable for me to recommend that people participate. All the issues involving privacy and health insurance liability almost evaporate, and scientists get to do their important work. But since this database is public, it is a bit of a game-changer with respect to privacy ethics. I am sure they have some confidentiality protections in place, but the consent form doesn't seem to describe any current institutional review standards.

And yes, the ethics lag... but it is even a geometric lag. Present day cell lines are going endure multiple scientific paradigm shifts, it isn't even possible to conceive of all the ways one (or one's descendants) may feel violated by participating in these open-ended public collections.

The one safety mechanism offered by that consent is that since everything is identified, you can withdraw your tissue and data if you want to. (Unless the cell-line has been picked up by a different protocol...) You can either have that layer of anonymity, or you can have the ability to withdraw. This study has opted for the latter.

On the flipside, it is exciting science. That will be a massive amount of information to have on hand. This project in particular is unique because a few of the PIs that initiated it volunteered to be its first participants. That is pretty brave given the privacy issues at hand.

#5 Darrel Manson

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Posted 19 July 2010 - 12:29 PM

Maybe instead of reading the consent forms they should require people to read Robert Heinlein's Friday. :)

#6 M. Leary

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Posted 23 July 2010 - 02:07 PM

Darrel, you may be interested in this book on Henrietta Lacks and her cell line. The book is just okay as reportage, but it does provide an excellent narrative introduction to the modern history of informed consent, the classic human research abuses, and what cell lines mean ethically.

In the book she talks a bit about some horrific abuses in the past (such as: injecting hundreds of patients with cancerous cells without telling them). At times, these things happened because a particular doctor just didn't care about people's well-being. At other times, these things happened simply because we didn't understand particular areas of biology and science at the time (such as: inserting radium bars in little pouches to reduce cervical tumors).

So during a lecture yesterday about the future of genetic/genomic research the following terrifying thought struck me: What we consider terrible abuses of the rights of human subjects 40 years ago often happened because at the time, the entire medical community truly thought they were doing legitimate, necessary research. We simply don't know whether or not something very painful and intrusive we are doing now won't be considered barbaric by science 30 years from now simply because they know things we don't. I shudder to think that genetic/genomic/cell line collections will end up as one of these ethical paradoxes.

#7 Darrel Manson

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Posted 26 July 2010 - 03:35 PM

I don't disagree with any of that, especially the last paragraph.

Is the alternative to not do any genomic research? Or should we go ahead with research in ways that seem appropriate at the time, knowing that there is danger ahead that we are liable to walk into?

#8 Darrel Manson

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Posted 10 October 2010 - 02:47 PM

I've now been enrolled as part of the project.