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DNA Helix

Coriell PMC Launches Web Portal

February 10th, 2009 posted by Andrew Yates

coriell-pmc-survey-instanceWhile genomic test results are still not yet available, participants (including myself) in the Coriell Personalized Medicine Collaborative (Coriell PMC) received an email today instructing them to log into the Coriell web portal to activate their accounts. Included in this account activation was a new, more rigorous consent form and list of consent conditions which presumably override the previous study consent (complete document: Consent to Participate in a Research Study, Coriell Personalized Medicine Collaborative). It is rather dubious that a medical research study would change the terms of consent after collecting genomic samples. However, the new consent form is more rigorous, and previous participants are no longer considered to be a consenting research participant until re-consent. Thus, according to the Consent to Participate: “You are free to withdraw your consent and discontinue participation for any of the procedures in the Coriell Personalized Medicine Collaborative at any time. You may choose to withdraw your saliva sample and DNA derived from it at a future date and your sample(s) will be destroyed at that time.” Thus, re-consent is a minor inconvenience, but a practical non-issue. Regardless, while I have outstanding respect for the Coriell PMC, and while I have never noted fault in any version of Coriell’s consent forms, collecting samples first and revising core consent terms months later is a troubling precedent. I hope that future genomic companies do not use this precedent to excuse sloppy pre-launch collections of biological samples. Be on the lookout…

After reviewing and completing the informed consent (consent form notes included below), the website prompts the user to complete a series of surveys, the completion of which are necessary to produce Coriell’s medically actionable genomic test report. Eventually, these surveys will begin to integrate medical information including blood pressure and cholesterol. Again, Coriell PMC is to be used to provide medical advice in a medical setting with the collaboration of medical providers, so basic medical measurements will be necessary to provide clinically useful tool. Until then, unverified participant survey data (apparently) will suffice. Note that one of the Coriell PMC study objectives itself is to determine the clinical efficacy of genomics test like Coriell PMC. This is why it’s registered medical research provided at no cost to participants. From the medical professional brief on the website:

“At this time, it is unknown if and how genomic information will help individuals improve their health outcomes. The CPMC aims to answer this question and we are hoping that you as the healthcare provider of a CPMC participant can help us answer this very important question.

coriell-pmc-my-account

Coriell PMC's opening account page with surveys

coriell-pmc-survey-instance

A screen shot of the first Coriell survey which collects basic personal information.

Coriell is Navigenics plus everything necessary to produce an ethical and clinically useful tool —minus the mail-order convenience, immediate availability of genomic results, and nation-wide availability. However, these detractions are sufficiently minor and temporal that I’m no longer interested in discussing Navigenics. It’s noise in a crescendo of medical genomic advances, and baring any self-evident news or a response to a direct inquiry regarding the company, this will be the last time I mention Navigenics on Think Gene. 23andMe is a different product and a different market, and while I consider 23andMe the perpetuation of a previous victory, that the wife of one of the richest men in the world succeeded in obtaining the publicity for launching the first “consumer $1000 genome,” it’s still an interesting subject and a highly relevant company. So, in my mind, that leaves 23andMe and Coriell PMC as common variant genomic test providers existing at opposite ends of the medical spectrum, with room for new competitors like Existence Genomics and Complete Genetics to compete for future mindshare. I would note, however, that this mindshare excludes existing genetic testing companies like Myriad which, while perhaps less interesting as potential leaders of medical genomics, currently provide vastly more significant medical products in both a medical and business context.

Coriell PMC Consent Form Excerpts of Note

Medically Actionable Reports

This study will only report back to participants those genetic variants that are potentially “medically actionable.” Potentially medically actionable genetic variants are those for which 1) there is a scientifically valid association between the variant and a specific health condition, 2) there are actions or interventions that can be taken to reduce the risk of the health condition, and 3) the risk of adverse events from these possible intervention(s) is likely small in relation to the risk associated with the genetic variant if no medical action is taken.

(optional) Healthcare Integration

7. Granting Access to your Personal Genetic Variant Information (optional)
Through the web portal you will be given the option to share your results with your healthcare provider and anyone else you would like to share the results with. To access the results , individuals designated by you will need to set up their own account on the web portal. These designated individuals will only be able to view the specific genetic variants that you authorize them to see.

(optional) Medical Records Inclusion

13. Releasing Medical Records (optional)
In order for us to verify some of your medical history information and/or your responses to surveys regarding particular genetic variant information, and for use in scientific research to discover genetic risk factors for disease and treatment outcomes, we may request your recent medical records. Releasing your medical records for use in this study is optional and will not affect your participation in
this study.

(optional) De-identified Data to be Shared with Biomedical Researchers

12. Granting Release of De-identified Data to Biomedical Researchers (optional)
With your permission (indicated at the end of this form) your DNA and/or the genetic data generated from it may be de-identified (stripped of personal identifiers such as your name and address and assigned a new barcode using a series of numbers and letters) and shared with other biomedical researchers.

Free Genetic Counseling

4. Your Access to Genetic Counseling
You will be able to speak with a CPMC genetic counselor about your results at no cost to you during your participation in the study.

Federally Protected Confidentially

3. Confidentiality Protections Through the Federal Government
Records that identify you in this study are strictly private. Only study staff can ever look at them unless you agree to it. This is because 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 the records of this 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.

Indefinite Duration, Annual Updates, Open Withdraw

At this point there is no plan to end the study, so your sample and information may be kept and used indefinitely… Should the study end, participants will be informed of the planned disposition of the data and samples. Transfer of the samples to a third party could only be done with your consent….

You must re-register on a yearly basis to remain in this study… It is necessary to re-register if you want to continue to receive updated information about medically actionable variants. Otherwise you will not receive any further notifications….

You are free to withdraw your consent and discontinue participation for any of the procedures in the Coriell Personalized Medicine Collaborative at any time. You may choose to withdraw your saliva sample and DNA derived from it at a future date and your sample(s) will be destroyed at that time.

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