Investigation Activity Declines at OHRP, Finds Report on Research Compliance; Senator, Medical Ethicists Voice Concern

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Federal agency responsible for ensuring clinical trials are properly conducted only opened one investigation in all of 2013 and other enforcement activity has significantly declined in recent years, Atlantic Information Services’ Report on Research Compliance exclusively reports in its May issue, based on RRC’s analysis of data from the U.S. Department of Health and Human Services.

Perhaps chastened by last year’s public battle with the National Institutes of Health (NIH) over a study of oxygen levels in premature infants, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) opened just one investigation into allegations of violations of human subject protections in all of 2013, Atlantic Information Services, Inc.’s, Report on Research Compliance (RRC) exclusively reports in its May issue. OHRP also closed out the year with a record low number of unique “determination letters” that identify non-compliance and required corrective actions — just five — and as of mid-April, had not opened any investigations so far this year. The recent near-halt to the activities has caught the attention of Sen. Charles Grassley (R-Iowa), who, in an interview with RRC, called these developments, and the possibility of a threat to OHRP’s “autonomy,” “worrisome.”

Concern also is being voiced by medical ethicists and advocates for clinical trial participants. Among them is Art Caplan, director of the Division of Medical Ethics at New York University’s Langone Medical Center. “The drop in investigations is deeply disturbing since there is no reason to presume any shift in the research ethics climate,” Caplan told RRC. The decline “merits both an explanation and public concern,” he added. “Very disturbing” was how Michael Carome, director of the Health Research Group at Public Citizen, put it. “The only thing that would be more disturbing is if the number [of new investigations] was zero.”

In 2011, RRC documented a decline in OHRP’s enforcement activities, which seem to have accelerated in the last year. OHRP has oversight of the largest portion of human subjects research funded by the federal government, charged with safeguarding the well-being of “millions” enrolled in HHS-funded “biomedical and social-behavioral research.” It has jurisdiction over some 10,000 institutions that conduct research supported by agencies within HHS, including NIH.

OHRP opened 91 cases in 2000, its first year in operation. In 2005, it opened 43; in 2006 and 2007, OHRP opened 15 and 16 cases, respectively. But by 2008, however, the number of cases OHRP was opening per year was in the single digits. OHRP opened five investigations and closed six in 2011 and opened 10 and closed eight in 2012.

The only public evidence of investigations is determination letters that OHRP posts either during or at the conclusion of an investigation. OHRP posted five such letters in 2013, compared to an average of 35 letters each year in the mid-2000s.

OHRP cited a preference for “informal” means of addressing allegations of non-compliance as among the reasons for the decline in investigations and letters, and said it opens cases when appropriate.

RRC also asked whether NIH had exerted any influence on OHRP to not issue determinations. OHRP did not answer this question but referred it to NIH.

“To our knowledge, NIH has not asked OHRP for the opportunity to review determinations/actions OHRP is considering or planning,” NIH said in a statement. “OHRP routinely advises agencies about the status of its compliance evaluations. NIH is also copied on OHRP correspondence to institutions.”

Visit to read the article in its entirety, including background information on OHRP’s recent case history, and more commentary from Sen. Grassley, Carome and other medical ethicists, and HHS and OHRP.

About Report on Research Compliance
Report on Research Compliance is the only news source on research compliance created and written especially for college and university research administrators, and provides the best information there is to help institutions avoid the negative publicity, financial setbacks and management problems that compliance requirements can create. With offices located in downtown Washington, D.C., Report on Research Compliance is well-placed to track news from NIH, NSF and other agencies, Capitol Hill, and elsewhere. It addresses the issues of greatest concern to research compliance administrators, in critical areas such as security and biosafety, financial compliance, human subjects and scientific misconduct.

Editor Theresa Defino is well-versed in the ethical and compliance issues facing researchers and institutions, having worked for an academic medical center affiliated with a major Midwestern university and having written hundreds of articles based on research studies. A veteran health care journalist and writer, Theresa has been based in Washington, D.C., since 1989.

About AIS
Atlantic Information Services, Inc. (AIS) is a publishing and information company that has been serving the health care industry for more than 25 years. It develops highly targeted news, data and strategic information for managers in hospitals, health plans, medical group practices, pharmaceutical companies and other health care organizations. AIS products include print and electronic newsletters, websites, looseleafs, books, strategic reports, databases, webinars and conferences. Learn more at

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