This week we can read about how National Institutes of Health (NIH) and Department of Health and Human Services (HHS) officials may have influenced the investigation of a study by the HHS Office of Human Research Protections (OHRP). In short, Public Citizen is claiming, based on documents obtained from a Freedom of Information Act request, that NIH and HHS officials worked to change the response of OHRP to concerns about informed consent procedures in a study involving premature babies. Public Citizens complaint is with the HHS inspector general and at least one member of Congress, Rosa DeLauro of Connecticut, has expressed interest in the case.
This matter comes to light just as a sister office at HHS, the Office of Research Integrity (ORI), is closing the submission process for its Director search. The former Director, David Wright, resigned in March due to what he characterizes as a ‘remarkably dysfunctional’ bureaucracy. He served for just over 2 years, and the office was without a director for two years before then. He described his frustrations to a Science reporter in April, and felt that greater authority, if not outright independence, would make it easier for ORI to deal with its caseload.
While the two offices, ORI and OHRP, and separate, and deal with different parts of the scientific process, they both serve the broader interest of providing guidance toward more ethical research conducted with federal dollars. But these two incidents suggest the Department, and NIH, are not committed to that goal. The lack of progress on proposed changes to the ‘Common Rule’ that guides research involving human subjects adds to this negative impression.
If an Inspector General investigation recommends changes to the authority and resources of OHRP, it seems likely such changes could benefit ORI. Hopefully a new HHS Secretary will have the interest and will to make the necessary changes to demonstrate the Department’s commitment to ethical research oversight and guidance. (And if they shove the changes to the Common Rule forward, all the better.)