Earlier this year I wrote about a case where the National Institutes of Health (NIH) was alleged to have acted improperly in a case involving a research study. Public Citizen lodged a complaint with the Department of Health and Human Service’s (HHS) Office of Inspector General claiming that senior officials from the NIH and HHS interfered with the decision process of the Office for Human Subjects Research Protection (OHRP). The specific case involved a research study on premature infants and optimal oxygen levels.
Earlier this month the Office of Inspector General issued its report on the allegations (H/T ScienceInsider). The main conclusions were that senior NIH and HHS officials did not interfere in the initial decision of the OHRP, and that the subsequent communications between those officials and the OHRP was permissible under the law. The OIG issued a separate report on how OHRP conducted its evaluation of the research study. Public Citizen is not happy with the decision, characterizing the investigation as a ‘whitewash.’
While the OIG report indicated that OHRP is not an independent organization, part of the Public Citizen complaint indicated (page 2) that moving OHRP out of the NIH was done in part to insulate the office from interference by NIH officials. It seems worth revisiting whether or not OHRP and related ethics organizations within HHS and NIH should be independent from those entities.
In related news, the ScienceInsider article (and the behind a paywall, Chronicle of Higher Education reporting it references) suggests that OHRP may soon be ready to issue new proposed rules on human subjects research. This would seem to be forward progress on the Common Rule, which was the subject of a public comment period back in 2011. As it hasn’t been revised in decades, it’s long overdue.