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Brief Chronology of the Havasupai Case & Settlement -- with Reminders & Possible Implications for HRPPs, IRBs, Researchers, and the Common Rule. Secretary’s Advisory Committee on Human Research Protections (SACHRP) Wednesday, July 21, 2010 William L. Freeman. William L. Freeman, MD, MPH, CIP.
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Brief Chronology of theHavasupai Case & Settlement -- withReminders & Possible Implicationsfor HRPPs, IRBs, Researchers, andthe Common Rule
Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
Wednesday, July 21, 2010
William L. Freeman
Program Director, Northwest Indian College Center for Health; and
Human Protections Administrator
Northwest Indian College
with material for this presentation adapted from:
I assume Carletta Tilousi will report her & her tribe’s experiences
* 421 page report under ASU contract, Dec 23, 2003: Stephen Hart (Investigator, Burch & Crachiolo, P.A.) and Keith A. Sobraske (Investigator, Investigative Research, Inc.), "Investigative Report Concerning the Medical Genetics Project at Havasupai"
“[T]he presentation made by Dr. Benyshek to the tribal members in 1991-1994,... the proposal as presented by Dr. Martin to the Tribal Council and other meetings,... and the documentation provided to the Havasupai (and documentation from the Havasupai), reflect that diabetes was the focus and that schizophrenia or other behavioral disorders were not even secondary considerations. It is our assessment that considering the totality of the circumstances it is most likely that the donors understood this to be a diabetes project only.” (63)
(in my understanding of possible priority)
1.A. AZ issued formal apology
1.B. ASU returned bloods to Tribe
3. ASU & Tribe will collaborate in major programs for health, education, & economic development
- the Tribe still believes health research CAN be helpful
4. Havasupai Tribe recognized ASU’s efforts to improve oversight & conduct of research
5. $700,00 to 41 people in lawsuit
Different people have different values and concerns
(I do not, and will not, speak for the Havasupai Tribe.)
Those differences of values are a major justification for truly informed consent
People MAY have a “privacy interest” in their specimens
People MAY have a “privacy interest” in their specimens (continued)
Do participants have a continuing “privacy interest” in what research is done on their specimens?
Tribes AS TRIBES have “privacy interests” and can suffer “dignitary harm.” Do other communities as well?