The Havasupai Settlement: Implications for HRPPs, IRBs, and Researchers focused on the history, background, and analysis of the recent Havasupai Indian case.
This webinar addressed some of the questions that have surfaced in the aftermath of the settlement, including:
- What are the facts that led to the litigation and settlement of the Havasupai case?
- What are the potential implications of this case for human research protection programs (HRPPs) and institutional review boards (IRBs)?
- What does the Havasupai case say about implementing waivers of informed consent?
- What insight might this case provide about how to conduct informed consent in research involving future and possibly unknown uses of DNA?
- What might be inferred from this case concerning the return to subjects of clinically-important findings in DNA research?
- How might HRPP/IRB discussions about the Belmont Report’s principle of beneficence be affected by the Havasupai case?
Who should attend?
The topic of this webinar was relevant to researchers, and anyone working with HRPPs and IRBs.
William Freeman, MD, MPH, CIP Dr. Freeman is the director of tribal community health programs and human protections administrator at Northwest Indian College, and Program Director of the Northwest Indian College Center for Health. In these roles, he serves as teacher, IRB administrator, and is also the principal investigator for a diabetes research project. Dr. Freeman also works as a private consultant, advising numerous universities and organizations, including Northwest Indian College, American Indian and Alaska Native, Canadian First Nations, Inuit communities and organizations, Tribal Colleges Universities. He also consults for various IRBs and research ethics boards. Dr. Freeman is the past director of research with the Indian Health Service and has served in numerous leadership and advocacy roles for American Indian and tribal communities. His research and clinical experience have focused on health of native populations, diabetes, community and participatory research, and the ethics of research involving vulnerable populations. Dr. Freeman and PRIM&R Board or Directors member Dr. Warren K. Ashe jointly developed PRIM&R’s Institutional Capacity Building Scholarship Program, which was created to assist small, underfunded, minority-serving institutions of higher education with developing and operating fully functioning IRBs or HRPPs. Dr. Freeman has served as a member of PRIM&R’s Board of Directors since 1994.
Pearl O'Rourke, MD Dr. O’Rourke is the director of human research affairs at Partners HealthCare System, Inc in Boston and an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also chair of the Partners Healthcare System embryonic stem cell research oversight (ESCRO) Committee. Pearl has worked as a pediatric critical care physician at the Children's Hospital, Boston and at the Children's Hospital, University of Washington, Seattle, where she was the director of the pediatric intensive care unit. She was active in clinical research in extracorporeal membrane oxygenation (ECMO), liquid ventilation, high-frequency ventilation, and pediatric resuscitation. In Seattle she served many years as a member of the IRB. Pearl has also been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-1996, Pearl received a Robert Wood Johnson Health Policy fellowship and worked for the late Senator Edward M. Kennedy. Following this fellowship, she became the deputy director of the office of science policy in the office of the director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.
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