In 1995, the OPRR
"came roaring back into life." Even previously exempted research now fell under IRB review.
What I heard that day would, like that picture of the OPRR
police that was yet to appear a few years later, leave a lasting impression.
After the death of Ellen Roche, a volunteer in an asthma study at Johns Hopkins University, the OPRR
suspended human subject research at that university (ABC News, 2001).
The FHCC has posted a copy of the letter on its website along with one from the OPRR
stating that "although there was room for improving procedures of informing the Institutional Review Board (IRB) of research outcomes during the course of IRB-approved research, there was no material failure to comply" with US policy for the protection of human beings.
If IRBs fail to exercise diligence in their review procedures, OPRR
and the FDA have proven themselves ready to exercise their powers.
Both Duke University and a Veterans Affairs facility in Los Angeles had their research shut down this spring by NIH's oversight arm, the Office for Protection from Research Risks (OPRR
In essence, the IRBs are managed or controlled by the Office for Protection from Research Risks (OPRR
) of the Federal government.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Office for the Protection of Subjects from Research Risks, (OPRR
) Reports, (April 18):2-8.
The findings from investigations of the Office for Protection from Research Risks (OPRR
) generally focus on failures in the institutional administrative processes and include a requirement for corrective institutional actions.
(8) Protection of Human Subjects: Code of Federal Regulations 45 CFR 46 (Washington, D.C.: OPRR
Reports: NIH, PHS, HHS, 8 March 1983) 46.209.
"We are aware of loopholes," Thomas Puglisi of NIH's Office for Protection from Research Risks (OPRR
) acknowledged at the hearing.
regulations, had been previously located in NIH, where it was known as the Office for Protection from Research Risks (OPRR