January 4, 2008

1. Physicians Question OHRP Regulations, Impact on Health Care Quality

2. NIH Announces RFA for Additional CTSAs

1. Physicians Question OHRP Regulations, Impact on Health Care Quality

As the line between quality assurance implementation and medical research becomes increasingly blurred, a number of physicians have commented on the role the Office of Human Research Protections (OHRP) should play in regulating quality initiatives. Most recently, Atul Gawande, MD, criticized the OHRP decision to halt a Johns Hopkins University School of Medicine program that used a five-step checklist to ensure proper safety measures in intensive care units in Michigan hospitals (“A Lifesaving Checklist,” The New York Times). According to Dr. Gawande, OHRP argued that the use of a checklist and the subsequent tracking of health outcomes without patient permission violated scientific ethical regulations.

In a letter to Johns Hopkins University School of Medicine, OHRP—a Department of Health and Human Services agency that “provides clarification and guidance to research institutions…and promotes innovative approaches to enhancing human subject protections”—argued that “although Johns Hopkins University asserts that the interventions carried out by the Michigan hospitals were not human subjects research, but quality improvement activities, OHRP notes that quality improvement activities can also be research activities.” In his article, Dr. Gawande asserted the argument in favor of the government’s actions: “a checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal.”

However, critics like Dr. Gawande propose that quality efforts are different from experimental drugs in that “a failure to carry it out poses a vastly greater risk to people’s lives.” He argues that in an increasingly complex health care arena, high-quality care is impossible without the use of checklists and other organizational strategies. An expansive view of the activities that require informed consent could obstruct such programs as the Centers for Disease Control and Prevention initiative to assess infectious disease outbreaks and military programs to study long term care of wounded soldiers.

According to Dr. Gawande, efforts to improve health care quality were initially exempted from research regulations because they were considered unscientific. But as quality initiatives have become more “systematic,” they are increasingly regulated under traditional ethical guidelines. Dr. Gawande argues that OHRP “should allow this research to continue unencumbered. If it won’t, then Congress will have to.”

Some critics have also used this incident to draw attention to the limited federal portfolio on health outcomes research. On an online blog, Roy M. Poses, MD, Associate Professor in the Department of Medicine at Warren Alpert Medical School of Brown University, argued “it is galling to see an apparently worthwhile study shut down...while doctors are endlessly criticized for medical errors and poor quality care [and] there has been little financial support for quality improvement research available from government, foundations, or commercial sources.”

2. NIH Announces RFA for Additional CTSAs

The National Institutes of Health (NIH) announced Thursday, December 27, 2007, it is accepting applications for the Institutional Clinical and Translational Science Awards (CTSAs). NIH currently funds 24 CTSA awards through the National Center for Research Resources and intends to fund an additional six awards in this application cycle for approximately $14 million. Letters of intent are due by May 17, 2008, and September 21, 2008, with applications due by June 17 and October 21, respectively.

According to NIH, CTSAs allow an institution “to create an integrated academic home for clinical and translational science that has the resources to train and advance multi- and inter-disciplinary investigators and research teams with access to innovative research tools and information technologies that apply new knowledge and techniques to patient care.” The initiative is part of NIH’s broader Roadmap for Medical Research, dedicated to promoting clinical and translational research as a means for improving health outcomes.

NIH plans to host a webcast March 7, 2007, to assist potential applicants in understanding the goals and objectives of the CTSA program. Additional information on the CTSAs can be found on the NIH website.

The Alliance for Academic Internal Medicine—the nation’s largest academically focused specialty organization—consists of the Association of Professors of Medicine, the Association of Program Directors in Internal Medicine, the Association of Subspecialty Professors, the Clerkship Directors in Internal Medicine, and the Administrators of Internal Medicine.

Please contact AAIM Vice President for Policy Charles P. Clayton (cclayton@im.org), AAIM Policy Associate Nicole V. Baptista (nbaptista@im.org), or AAIM Policy Assistant Allison L. Haupt (ahaupt@im.org) at (202) 861-9351 with questions or comments about this week’s Merlin.