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Research on Human Subjects

Aug. 17, 2012

A case involving research on blood samples from members of the Havasupai Indian Tribe in Arizona provides some real lessons about obtaining and managing human tissue and blood samples in research. Certain individuals in the tribe and the tribe itself have sued the university involved for about $50 million. It is alleged that blood samples were obtained for the purpose of research regarding the high rate of diabetes within the tribe but have been used for research to determine if there is any linkage to persons who may have migrated to North America through the Bering Strait. At the core of the case is a basic premise: individuals who have donated blood for research may still have a protected privacy interest in their blood. Invasion of privacy can be a compensable injury under state law, even if there is no physical harm to the person or even if the informed consent is otherwise compliant with research standards.

The risk to Baylor is increased liability for breach of contract or invasion of privacy. Invasion of privacy is a civil wrong that could create liability for the individual researcher involved as well. There is the additional risk of reputational harm to Baylor.

There seems to be some conventional wisdom that principal investigators own the samples and can do with the samples as they wish, including transferring the samples to another university or conducting research that differs from the originally intended purpose. However, as in many areas of the law, the conventional wisdom may have dangerously little truth to it because it has lost its moorings from the documents and relationships involved.

The complexities of informed consent: Over time, it seems that the requirements for informed consent in research on human subjects are viewed as simply a matter of compliance. However, the informed consent document is also evidence of ownership of the samples as well as any continuing privacy interest of the research participants in the samples. In many cases, the informed consent document demonstrates that the institution, not any individual researchers, the research sponsor or the research participant, actually owns the samples.

Additionally, the document is critical to fully understand any potential for a continuing privacy interest in the sample. Invasion of privacy is a tort under our civil law; however, liability is avoided if the person has consented to the invasion of privacy. Consequently, the document may not only demonstrate compliance, but provide a defense to the invasion of privacy if the research activity is within the scope of the consent.

If activities are not within the scope of the informed consent, the conservative legal advice would be to obtain a new, complete consent form in order to ensure compliance and a defense to any potential invasion of privacy claim.

The sponsored program contract or grant: The informed consent inquiry can be further complicated by the sponsored program contract or grant between the institution and the sponsoring agency or other grantor. These two parties must be careful not to contract in manner that is inconsistent with the rights of the research participants who are not typically parties to the contract or grant. Additionally, the institution must be sensitive to the needs of other researchers and students who are involved in the research.

The many legal or other interests: Baylor must be sensitive to the relationships and legal interests of Baylor, the research participants, the sponsoring agencies, the principal and other investigators, and students. It is a worthy goal that everyone should understand the end game at the beginning to avoid any surprises. Also, if research is conducted overseas, international standards may also attach. Laws of the host foreign country may also affect and regulate the research. Some ethical standards require review of protocols by an independent review board that also considers the requirements of the host country. Some information relating to legal, ethical and host country standards can be found at U.S. Department of Health & Human Services.