Awareness and Acceptable Practices: IRB and Researcher Reflections on the Havasupai Lawsuit

In 2003, Havasupai tribe members in Arizona discovered that their DNA samples, collected for genetic studies on Type II diabetes, had been used for studies on schizophrenia, migration, and inbreeding without their approval. The resulting lawsuit brought by the Havasupai reached a settlement in April 2010 in which tribe members received monetary compensation and the return of DNA samples. In this study, we examine the perceptions of Institutional Review Board (IRB) chairpersons and human genetic researchers about the case and its impact on the practice of research.

Twenty-minute semi-structured interviews were conducted with 26 Institutional Review Board (IRB) chairs and researchers at six top NIH-funded institutions. Participants were questioned about their knowledge and perceived impact of the Havasupai case and their perceptions of informed consent in genetic research studies.

We found that most study participants did not perceive that the Havasupai case had a large impact. However, we identified key concerns and opinions of the case, in particular, increased awareness of culturally sensitive issues with informed consent and secondary uses of samples.

The results provide a deeper understanding of how informed consent issues are understood by IRB members and human genetic researchers and the implications for research ethics education.