arizona’s broken arrow
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Arizona’s Broken Arrow
November, 2008, Page 134
The Havasupai live in a picturesque village at the bottom of the Grand Canyon.
One of the strongest voices on this subject was the man who was Markow’s biology department chairman at the time. James P. Collins told Hart that, “informed consent consisted of the totality of the information imparted… and not individual components, such as an informed consent document.” Furthermore, Collins said, the “ultimate decision” about changing or expanding research lies with the donor, not the scientist.
Additionally, the Hart Report chronicles how ASU scientists handled the rules and regulations that govern human research. And although the report tried to sidestep the issue, saying its intent was not to analyze whether rules were broken or not, the narrative lays out a path that shows federal regulations, demands of granting groups and ASU’s own protocols weren’t respected.
Human research is governed by books of rules for obvious reasons. Universities that undertake human research with grants from national institutes and the federal government must attest that they’re following regulations. Internally, that job is done by ASU’s Institutional Review Board (IRB), which is “delegated the task of approving research projects involving human subjects,” the Hart Report notes. “The IRB must ensure that when some or all the subjects are likely to be vulnerable to coercion or undue influence, such as economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.” The Havasupai people clearly fell into this “vulnerable” category.
While there are dozens of points along the way when the IRB appears to have been little more than a rubber stamp for Markow, a few notes in the Hart Report stand out:
• Markow never sought IRB approval for the Havasupai project until January 18, 1991 – six months after blood had already been collected from at least 100 tribal members.
• The IRB appears ignorant to the claim that no consent forms were collected from 1991 to 1994 until well after the tribe discovered what was really happening.
• There was no IRB application or approval for at least three graduate student projects that used the Havasupai blood.
• There was no IRB approval for an inbreeding study conducted by Martin.
IRB officials told the Hart investigators in August 2003 that they were in the process of “significantly” revising their process of overseeing human research.
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