Legal Details of a USA Certificate of Confidentiality in Medical Research
The USA Public Health Service Act Section 301(d), 42 U.S.C. Section 241(d):
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.
Further, the United States Health and Human Services Department (HHS) has published this guide regarding Certificates of Confidentiality:
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local.
Some have asked about the legal specifications of Coriell PMC’s Certificate of Confidentially: here they are. Further, I note that despite encroaching common practices otherwise, legal protections exist for medical research to absolutely protect the privacy of participants. That absolute protection exists, yet some companies purporting to conduct medical research choose not to file it and disclaim legal confidentiality in their terms of service, seems to me like a sin of exuberance ignorance on behalf of both the companies and the participants and a precedent that I would like to see squelched soon. Yet, from top journalists to high school students, “encroaching violations of privacy” has been the cliche “Serious Business in American Healthcare” fluff topic lately, but I have yet to see any journalist covering recent genomic advances ever mention the Public Health Service Act or why direct to consumer (DTC) genomic startups purporting to be conducting protected medical research have actually not filed for such protection.
Think Gene at Technorati
Add New Comment
Viewing 39 Comments
Thanks. Your comment is awaiting approval by a moderator.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Do you already have an account? Log in and claim this comment.
Add New Comment
Trackbacks
Protection Against Voluntary Disclosure of Genetic Information | Think Gene
[...] Certificate of Confidentially as legally described protects the participants from all outside compulsion to disclose protected [...]