On BioScience and Life and Such

Quote of the month

In Uncategorized on April 24, 2008 at 11:51 am

Key features of the “Open Consent” policy from the Personal Genome Project (Nat Rev Genet. 2008 May;9(5):406-11)

“Open consent as part of the Personal Genome Project implies that research participants
accept that:
• Their data could be included in an open-access public database.
• No guarantees are given regarding anonymity, privacy and confidentiality.
• Participation involves a certain risk of harm to themselves and their relatives.
• Participation does not benefit the participants in any tangible way.
• Compliance with monitoring of their well-being through quarterly questionnaires is required.
• Withdrawal from the study is possible at any time.
• Complete removal of data that have been available in the public domain may not be possible.
The moral goal of open consent is to obtain valid consent by effectuating veracity as a
precondition for valid consent and effectuating voluntariness through strict eligibility criteria,
as a precondition for substantial informed consent.”

While it is commendable to be this honest, one must wonder what it will do to participation recruitment. I have knowledge in the field and I have a fundamentally positive attitude towards these research projects, but even I would think twice before accepting this, what then will the layman do ?

I cannot help but wishing strongly for this approach to work though. If this is the consent for the future then the world is better off than I thought, – and that is most definitely a good thing.

  1. I think this is a brave and necessary approach. I have spent too much time trying to obtain consent for anonymized tissue for research that just ends up in the autoclave or burn pile. A senseless waste of valuable material for research.

    The fact is that the whole “Informed Consent” is impeding progress because it has falling into the realm of “Regulatory Affairs” rather than common sense.

    As a case in point, I was nearly blue in the face disputing with a certain RA person from AZ UK who insisted they needed have an “Informed Consent” document from each donor that was verified to have been presented to the donor in their “native” language.

    To which I simply responded: “Sir, these are cadeveric donors. How would suggest I approach this topic with them?”

  2. Jim, thank you for the comment, I agree with you fully. Congratulations on your invitation to my (big)brother in names, Sci Foo.

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