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Added Human Subject Protection Needed as Well as Improved Consent

Posted by plosmedicine on 31 Mar 2009 at 00:08 GMT

Author: Robert Reinhard
Position: Member, Community Advisory Group
Institution: San Francisco Dept of Public Health, Research Section
Submitted Date: April 24, 2007
Published Date: April 25, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

The authors deserve thanks for laying out decent principles of communication. But serviceable consent language is insufficient to address all issues of protection. That was the point of recent NIH workshops to develop a genome wide association studies program. [1]

Risks associated with personal identification may be incurred if information is subject to code breaking. Legal means are available to compel identification and across national boundaries. Privacy protections under HIPAA are subject to exceptions, including for law enforcement, downstream data users or other reasons and are not available internationally. Even with authorization, the complexities associated with a repository may frustrate attempts to achieve meaningful comprehension. Use of data for purposes other than pharmaceutical product development or biomedical interventions would be an abuse resulting perhaps in travel restrictions or discrimination.

For these reasons, safeguards should be added, including:
- Securing amendments to prevent nonmedical health access to personal identification information;
- Restrictions on recruitment of populations especially vulnerable to disclosure risks such as prisoners or immigrants;
- Prohibitions on disclosure to or use by employers or third party payors to deny medical coverage, assign differential premium risks, restrict access to therapies or unfairly discriminate in employment.

Another risk from creation of a genomics repository is the potential for unjust stigmatization.[2] A workable program would state that the data are appropriate only for limited public health purposes involving product development or professionally derived biomedical intervention, are insupportable for other use or by political or nonmedical entities.

A researcher publishing results based on the genomic data should state affirmatively a boilerplate recognition of the abuse potential for stigmatization. This mechanism could prevent others from the wayward misappropriation of data for purposes other than those intended by professionals. The boilerplate could read:
"Conclusions derived from the genotypic or phenotypic characterization of individuals, groups or families in this [publication] are meaningful or supportable only for the purpose of biomedical intervention or treatment and are unethical, insupportable or inappropriate for use in other purposes. Use of the data to support any result of stigmatization, discrimination or adverse social harm would constitute a misuse or abuse of the data."

To increase the connection of benefits to participants, individuals should be given personal opportunities to receive news reports if they wish and learn of particular clinical trials directed at their characteristics. Users of the data to develop pharmaceutical products should also be directed to plan and explain early on how targeted populations may have reasonable access to treatment or therapy if successfully brought to market.[3]

Improved consent: Yes, but linked to and inseparable from strong protections and added benefits for participants.


2. See for example the Council for International Organizations of Medical Sciences current draft "Special ethical
considerations for epidemiological research,” p. 7; accessed
October 12, 2006. The draft states: “One must also remember that potential "harm to subjects" may not be restricted to them, but may extend to their family members or, more generally, to a group to which they belong; for instance, findings of a higher than average prevalence of certain genetic traits or diseases among the study subjects may stigmatize the family or the group in the eyes of others.”
3.These comments are consistent with the program outlined by Senator Barack Obama in S. 3822, the Genomics and Personalized Medicine Act of 2006.

No competing interests declared.