Ok,
So after fielding a ton of questions regarding Coriell and sending a bunch of people towards their site, I figured I should give all of you some key points about the Study
Launched by Coriell Institute for Medical Research in December 2007, the CPMC is an
evidence-based research study designed to determine the benefit of using personal
genome information in clinical decision-making.
Goals
The CPMC is a forward-looking, collaborative effort involving physicians, scientists,
ethicists, genetic counselors, information technology experts and volunteer study
participants. The goal is to better understand the impact of genome-informed medicine and
to guide its ethical, legal and responsible implementation.
The CPMC also aims to understand why people often respond differently to treatments, and
to discover presently unknown genes that elevate a person’s risk of cancer and other
complex diseases.
Key Points of Differentiation
The CPMC is unlike any other organization that supplies personal genetic information to
individuals.
▪ First, the CPMC is a research study that has been approved by an Institutional Review
Board, whose mission is to review research studies involving human subjects to ensure that
the rights of research participants are protected.
▪ Second, the CPMC is a research study that provides participants with information about
themselves. Many research studies ask for subjects to participate for the good of science
while supplying little or no information back to participants.
▪ Third, the CPMC is not returning all personal genetic information back to participants but
only variants that an external advisory board (the Informed Cohort Oversight Board) has
deemed potentially medically actionable. The actions of this board are completely transparent.
▪ Fourth, the CPMC is requiring participants to complete web-based surveys. After
establishing an account on the web portal, participants will be asked to complete a series of
questionnaires regarding their medical history, family history and lifestyle. Some of this
information will be used to customize participant genetic variant reports, by adding
information provided in the surveys (age, smoking status etc) that affects risk for a health
condition.
▪ Fifth, participants are given control of their personal genetic variant information and can
opt to allow access to their genetic result data to physicians, CPMC genetic counselors or
others.
▪ Sixth, participants in the CPMC study can opt to release their de-identified genetic and
medical history information to the biomedical research community. It is completely voluntary.
▪ Seventh, the CPMC plans to enroll individuals with cancer through their healthcare
provider as well as participants from the general public through open informed consent
sessions.
The Sherpa Says: Phase one has commenced, phase 2 will begin in April when participants will be given access to their data.....For free and they can view it forever....not just for 1 year......
7 comments:
I'm a participant in the Coriell project and was bummed - after driving to scenic Camden NJ - to find out that I have zero control over what (of my DNA) data I can explore. They never once mentioned the possibility that I could surf my data ad lib in the future - in fact stated that such a possibility was outside their ethical bounds. Its clear they have collected lots of samples and now are fumbling around trying to monetize all the samples sitting in liquid N2 vats in the basement where we had our 'spit party'. Their operation seems more like a bunch of MDs posturing over their samples, but I'll be surprised if they make a scientific breakthrough.
@ Anonymous,
I think perhaps you may have missed what the study was about in aims to get a "free" test. This study is about looking at behaviors and health outcomes.
It is not to monetize your DNA. This is plain and simple, medical research to better your healthcare.
The only MDs involved are the collaborating institutions.....
This institution, unlike some fly by night companies, is a world respected institution that was essential to the HapMap and HGP as well as biomedical research all over the world.
So next time you want to flame some one you better get your facts straight and think about who the venerable participants in medical research are....
Shame on you!
-Steve
I am just wrapping up a project highlighting some of the hurdles to personalized medicine (which, of course, depends on how you define PM) and your blog has been so helpful! At this point in my project it is incredibly encouraging to learn that Coriell is doing this research. Thanks for keeping your finger on the pulse and the rest of us informed, Dr. Murphy!
Driving to Camden NJ: yes, Camden sucks. I empathize.
Surf data ad lib in the future: primary research objective in this study is to determine the clinical application of some genomic test results. As far as I know, these test results were always planned to be reported via the web. However, this is controlled medical research, not a consumer product. Good studies constrain variables ---hence a limited set of results and a study only provided in a controlled medical setting. I don't understand what "ad hoc" means in this context.
samples sitting in liquid N2 vats: Those are living cell lines used in other medical research. Coriell is a biobank founded in the 1950's ---long before any of this new medical genomic testing.
'spit party': Yes, that was a lame party, but actually it was just a concluding gesture of providing a few cans of soda and crackers for the study group after they had sat through the informed consent powerpoint presentation and spitting into the sample collection tubes.
Their operation seems more like a bunch of MDs posturing over their samples, but I'll be surprised if they make a scientific breakthrough. That's amusingly pithy, but I'm unable to understand how you came to this conclusion from the content of your comment.
Oh, I forgot one:
fumbling around trying to monetize: Coriell is a non-profit medical research institution. Thus, profiting from their research would be illegal. If you have information regarding a crime, please report it to the appropriate authorities.
However, you are right that Coriell must pay their operating costs, and to do so, they plan to accept donations, research grants, and license the results of their research ---exactly like any other non-profit medical research institution.
Ouch ! Pretty harsh responses to Anonymous - even though he/she certainly could have been more tactful. Nevertheless, one would think some thanks were in order on both your parts since this person went out of their way (I've been to Camden and will never again venture there!) to participate and support the Coriell project (to which both of you seem affiliated with in some way).
This exchange perhaps makes the point as to why some folks would rather have personal control over their own genome data - and subsequent to that - graciously agree to participate in research projects where they can grant access rights to the physicians to peer at their sequence data.
It is apparent that if you leave the physicians and scientists in control of the genomic data, the participants can feel frustrated (or bummed as Anon seems to be) and can wind up getting 'slapped down' by these very doctors and scientists when they express dissatisfaction (or, in the case of Anon, it would seem contempt).
I'm not sure what the ethical best practices are for the blogosphere, but I think the participants deserve better consideration than were provided here. You're supposed to be above the fray and handle such frustrations with compassion - rather than shaming a frustrated study participant.
@ Anonynous supporter of Anonymous,
Yes, I was harsh. The Anonymous participant should be lauded for deciding to join the study. I would ask the participant why they thought they would be able to have access to the whole set of data? Were they confused.
But as for trying to insult such a venerated institution......I have a little problem with conjecture but no proof.
True I have been hard on Yale and other institutions. But I have proof of illegal shennanigans and improper behavior.
Coriell has demonstrated no Impropriety or fumbling. They have behaved without hype and in an ethical manner.
-Steve
Post a Comment