Today the Coriell Personalized Medicine Collaborative website goes live. After many months of really hard work they are ready to show everyone what a Personalized Medicine Collaborative Study looks like. I maintain, without the information to be generated by Coriell, we have absolutely no clue what the heck these DTC SNP scans are clinically worth.
I can tell you what 23andMe thinks they are worth-$399 even for study participants.....
Navigenics- 2500 USD unless being a study participant, then it's $375.......or if you only want access for a year it's $495
Coriell says-They are FREE to participants $0, unlimited genetic counseling included!!!
This is a powerful statement and I am proud to be a member of the Informed Cohort Oversight Board of this "First of Its Kind" Cohort Study!
Why is this important:
1) We don't know if people actually do anything helpful with the tests that they buy from DTC.
2) We don't know whether they have any useful additional information to add towards our risk predicition capabilities. In fact 9p21.3 when added to standard clinical factors including family history, was absolutely useless in helping us risk prognosticate for heart disease. So 23andMe is useless in this aspect.
3) These tests should never have been sold as even "pseudo-medicine" without something other than basic science to back them up. As I said in Number 2, even excellent basic science can fail clinically.
4) No One, and I mean NO ONE, should be able to sell your data to another company without your permission!!!!!
The website is fantastic and lists some significant information. Including important Privacy Information.
Certificate of Confidentiality
The Coriell Institute has been granted a Certificate of Confidentiality under a federal law (Section 301(d) of the Public Health Service Act). This means that records from the CPMC study may not be disclosed, under federal, state or local court order, without your written approval. Data that are protected by a Certificate of Confidentiality may be disclosed to the Department of Health and Human Services if required for audits of research records.
The Coriell Institute has been granted a Certificate of Confidentiality under a federal law (Section 301(d) of the Public Health Service Act). This means that records from the CPMC study may not be disclosed, under federal, state or local court order, without your written approval. Data that are protected by a Certificate of Confidentiality may be disclosed to the Department of Health and Human Services if required for audits of research records.
This is stronger than HIPAA and nothing like this is offered by 23andMe or Navigenics!!!
Heck, those companies aren't even considered HIPAA protected agencies. IMHO, that is a risky thing!
Who is Coriell?
Get ready world! The team is world class and the research is the first of its kind in the world!!!
The Sherpa Says: Today marks a revolution in personal genomics, the day that the world sees this research and that it needs to be funded and carried out......AT ZERO COST to all participants!!! This is ethical research, plain and simple.
10 comments:
I would love to participate, but I can't attend an informed consent session. Sigh.
Signed,
N/A
A few comments on privacy...
On the Certificate of Confidentiality, who issued it to CPMC? What is the process to be certified? It sure sounds like a good thing, but this isn't a common trust mark, so without additional information the certificate doesn't mean much to the average consumer. It would be nice to view and read the image of the Certificate, too. Can you link to the full image so we can verify that it is for CPMC?
One other thing to note, the site talks about rendering people's personal data in a de-identified state. De-identification can be a tricky thing and can require more than simply removing a person's name from a record. There are statistical challenges, especially considering that some participants with rare genetic conditions will be known to researchers and others despite the name being removed. This issue can also extend to related family members, even if they aren't in the study.
Despite these comments, setting CPMC's policy to full disclosure and authorization for use and sharing of genetic information is laudable.
Coriell's study is unethical because it's super-paternalistic. Look at their consent terms: THEY will determine what information you get from your own genome. YOU are not trusted to know anything else.
I encourage people to boycott this study until Coriell agrees to give people access to their own data.
I think this test is sheet, as you take some paternalistic results after 7 years!
Oh, my god, 7 years later you get some results...
I prefer to scan my genome in any other company around...
Looks like the 23andMe crowd is out of the woods, lol.
@ anonymous "unethical"
What part of Institutional Review Board approved don't you get? Do you understand what an IRB is and its importance?
@ Anonymous "7 years"
Results will actually begin to be returned around April.....so much for 7 years.........didn't 23andME's results take several months in the beginning????
-Steve
"Coriell's study is unethical because it's super-paternalistic. Look at their consent terms: THEY will determine what information you get from your own genome. YOU are not trusted to know anything else."
That's because Coriell PMC a controlled medical research study to determine clinical applications of selected genomic tests. Good studies constrain variables. Releasing all possible results dilutes the effectiveness of the study.
"I encourage people to boycott this study until Coriell agrees to give people access to their own data."
I don't understand what "boycott" means in this context. Coriell PMC is non-profit medical research, not a consumer product. If you want all you genomic data, 23andMe provides an excellent genomic testing consumer product for $400.
"Oh, my god, 7 years later you get some results..."
I don't understand what this means. Yes, Coriell works at "non profit urgency," but results were supposed to already be released this Winter. So, ok, haha, non-profit research is slow, but "slow" means "consistently late by months with shoddy marketing," not "results in 7 years."
Dr. Murphy: I fully understand what IRBs are and what they are for.
But they are not Gods, they are made up of humans with agendas and beliefs, and they can be mistaken.
I submit to you that involving volunteers in research and then denying them access to their own files is unethical.
I will boycott Coriell until they change their heavy handed policies. This is too bad, because if they had a more open policy, I would be a great supporter of their efforts.
I submit to you that involving volunteers in research and then denying them access to their own files is unethical.
I submit to you that constricting the variables in medical research is necessary to perform proper research. However, comparing clinical outcomes with and without releasing the raw genomic data would be a great study.
If you want your raw data, again, go buy a 23andMe test. I personally am enrolled in both Coriell and 23andMe. But Coriell's first prerogative is to conduct research, not to provide service. It's nice when those two objectives coincide, but they don't necessarily. But, maybe Coriell will conclude that they can provide the raw genomic data without diminishing the focus of the study. An example would be comparing the clinical outcomes of full release with controlled release as I've suggested above.
Dr.Murphy: I was wondering if its feasible to participate in study without attending informed consent sessions personally, I am a student of M.S. Human Genomics at National Centre for Human Genome Studies and Research, India and for obvious reasons I can't attend informed consent session personally. Do they allow providing consent through electronic channels?
-Tarun
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