November 2, 2007

1. OHRP Requests Comments on Categories of Research Eligible for Expedited IRB Review

2. Bush Nominates Peake as VA Secretary

1. OHRP Requests Comments on Categories of Research Eligible for Expedited IRB Review

The Office for Human Research Protections (OHRP) requests comments on the list of categories eligible for expedited review by institutional review boards. OHRP intends to revise the current list, last published in the Federal Register in November 1998. The Alliance for Academic Internal Medicine (AAIM) requests input from the membership for inclusion in a comment letter that will be submitted to OHRP.

Aside from a general review of the list of categories, OHRP is specifically soliciting comments on an amendment to clarify category five on the expedited review list, which pertains to research involving materials that have been or will be collected solely for nonresearch purposes. Responding to confusion from the research community, OHRP has proposed amending expedited review category five to clarify that “the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research.”

In addition, OHRP is soliciting comments on expedited review category seven based on a recommendation from the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections. Category seven pertains to research on individual or group characteristics or behavior as well as research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

AAIM asks that you please submit comments to policy@im.org no later than Friday, December 7, 2007, to ensure the alliance meets OHRP’s December 26 deadline for comments. To submit input to OHRP directly, please visit the HHS website.

2. Bush Nominates Peake as VA Secretary

President George W. Bush nominated retired Army Lieutenant General James B. Peake, MD, Tuesday, October 30, 2007, to serve as the new Secretary of Veterans Affairs (VA). If confirmed by the Senate, Dr. Peake will be the first physician—he is a former Army Surgeon General—and first general to serve as VA Secretary. His nomination comes after former VA Secretary R. James Nicholson stepped down from the position October 1. While citing a desire to reenter the private sector, Secretary Nicholson’s resignation was preceded by public criticism over VA’s handling of private electronic data and health care for veterans from Iraq and Afghanistan.

Following President Bush’s announcement of his nomination, Dr. Peake commented that though he was honored to be chosen to assume the Secretary position, “this is not an honorary position, and there’s a lot of work to be done.” President Bush suggested that the new secretary’s first priority would be to enact the recommendations of a bipartisan commission charged with studying ways to improve the care of wounded soldiers upon return from Iraq and Afghanistan.

Although his medical background is viewed favorably in light of VA’s priority of providing high quality health care to the nation’s veterans, some senators have raised concerns regarding Dr. Peake’s experience leading the Army health care system from 2000 to 2004. According to Senator Patty Murray (D-WA), Dr. Peake “will have serious and significant questions to answer about failed preparations for our returning wounded warriors. For months we’ve been hearing horror stories from Walter Reed and other military care centers, and I will want to know what role, if any, Dr. Peake played in the failures of the system.” In addition, some veteran services organizations are concerned about Dr. Peake’s limited knowledge of the VA system, having actively served in the military throughout his career.

Dr. Peake is a graduate of the US Military Academy at West Point and a former platoon leader with the 101st Airborne Division in Vietnam. He received his medical degree from Weill Medical College of Cornell University. He previously served as the Executive Vice President and Chief Operating Officer (COO) of the international health foundation, Project Hope, and is currently the Chief Medical Director and COO of QTC Management, an occupational health and disability examination provider.

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.