When reviewing allegations of noncompliance, OHRP
identifies the following as acceptable research standards:
(11) United States Department of Health & Human Services, Office of Human Research Protections, "About OHRP
," United States Department of Health & Human Services, http://www.hhs.gov/ohrp/about/index.html (accessed March 9, 2015).
Prot., http://www.hhs.gov/ohrp/ (last visited November 22, 2014) (OHRP
is the division within HHS that "provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported" by HHS).
(238) As the regulationist Gail Javitt admits, and as the nonsensical results when the right to withdraw and mandatory re-consent are imposed on archival research make clear, "the use of tissue in research was not contemplated at the time current regulations were put in place." (239) Indeed, the fact that today the OHRP
has to recommend that the 1991 Common Rule's definition of "human subject"--which as written does not clearly apply to archival material--be taken to include archival material, suggests as much.
After the study report was published, OHRP
indicated that Hopkins and the participating hospitals should have obtained full IRB approval with patient consent prior to initiating this study.
Department of Health and Human Services (DHHS), la Office of the Human Research Protections (OHRP
) y la aprobacion del Federalwide Assurance (FWA) for the Protection of Human Subjects.
Bienvenu is a sociologist by training and before assuming his current position served on the policy staff of the HHS Office for Human Research Protections (OHRP
Research Protections ("OHRP
") made a determination that the
TABLE 1 A framework for remedies for some regulatory burdens faced by research institutions Exempt Harmonize/avoid Tier to risk universities duplication and or eliminate redundancy Human subjects Harmonize human Tier human subjects subjects protections research for between the exemption from Office of Human Institutional Research Review Board Protections review (e.g., (OHRP
) and the social science Food and Drug research vs.
At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP
) oversight system, is wider reaching, and has no exclusions.
These regulations are enforced by the Office for Human Research Protections (OHRP
) and establish the IRB as one mechanism through which human subjects are protected.