Ethicists Charge that OHRP Inaction Weakens Protection System, Thwarts Trials, Citing Reporting by AIS Editor

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The May issue of Atlantic Information Services' Report on Research Compliance takes a look at issues raised in two new books critical of the agency overseeing federal-funded clinical research in the United States, with one citing the investigative work conducted by “dogged reporter” Theresa Defino, the editor of RRC.

“I think OHRP can, and should, be doing a better job, a different job.” — Robert Klitzman to AIS's Report on Research Compliance

Two recently released books cast a highly critical eye on the agency overseeing federal-funded clinical research in the United States. The May issue of Atlantic Information Services, Inc.'s (AIS) Report on Research Compliance (RRC) takes a look at the issues raised in the two books, with one citing the investigative work conducted by “dogged reporter” Theresa Defino, the editor of RRC.

In Galileo’s Middle Finger, Alice Dreger, a professor of clinical medical humanities and bioethics at the Feinberg School of Medicine at Northwestern University, described her interactions with the Office for Human Research Protections (OHRP) regarding a National Institutes of Health (NIH) funded trial among other experiences in her career.

Dreger was hesitant to believe that OHRP’s inaction on a complaint was part of a “conspiracy” until she learned from the “independent analysis of a dogged reporter,” identified as Defino, of the erosion in the number of formal investigations OHRP opens. Last year, RRC reported that OHRP investigated only one institution in all of 2013, compared with more than a dozen in previous years. Dreger concludes that, “in practice, protections for people who become subjects of medical research may be their weakest in decades.”

In addition, Robert Klitzman, director of the master’s of bioethics program at Columbia University and author of the new book The Ethics Police? The Struggle to Make Human Research Safe, told RRC he laid much of the blame for problems with oversight of clinical trials at the feet of OHRP. In interviews with nearly four dozen officials associated with institutional review boards (IRBs), Klitzman revealed a largely unflattering picture of IRBs that make decisions sometimes based less on the merits of protocols than on personal peccadilloes, and of members appointed for “punishment” while others are removed if their approvals don’t come fast enough.

“I think OHRP can, and should, be doing a better job, a different job,” he tells RRC. Klitzman also said OHRP needs to act on the recommendations that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has submitted to it.

Since 2011, RRC has documented a decline in oversight actions by OHRP, as well as the recent declaration by the agency director that there was virtually no purpose to issuing guidance or acting on recommendations of its advisory committee. IRB officials told Klitzman they are frustrated and adrift without such guidance, considering OHRP “the mouth of God” on significant issues they must consider when reviewing protocols.

Visit http://aishealth.com/archive/nrrc0515-01 for more information, including a claim from the nation’s top bioethics advisors, the Presidential Commission for the Study of Bioethical Issues, that OHRP has thwarted promising brain research because it has failed to issue guidance related to the inclusion in research of “individuals with impaired decision making.”

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., RRC 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 http://AISHealth.com.

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