The group also wants officials to rescind the accreditation of the University’s human subjects protection program.
This comes after the recent independent review of the U’s programs showed major problems in its human research protection program.
Public Citizen said further investigation by the U.S. Department of Health and Human Services’ Office for Human Research Protections is needed because of the external report’s findings of “apparent failure to adequately protect human research subjects.”
As for accreditation, Public Citizen says the Association for the Accreditation of Human Research Protection Programs should “immediately rescind its accreditation of the human subjects protection program at UM.” [PDF]
Said Dr. Michael Carome, director of Public Citizen’s Health Research Group:
“The alarming findings by the external review team echo some of the most serious instances of systemic failures of human subjects protections uncovered at major academic institutions over the past two decades. These finding also appear to represent a clear danger to the rights and welfare of human subjects enrolled in medical research studies at UM.”
Public Citizen pointed to two major findings of great concern:
“First, the UM medical institutional review board (IRB) appears to lack appropriate expertise among its members for the research that it reviews. Under HHS regulations, when reviewing research protocol applications, there must be sufficient expertise among the members present at the meeting to make the determinations required for research approval.”
The second troubling finding was that when reviewing and approving research, the UM medical IRB appears to have failed to adequately assess the risk and benefits of the research. … The external review team found that according to the majority of the minutes from meetings, there was little discussion of the risks and benefits to subjects.