As regulations place an ever-tightening grip on medical research, a new US federal advisory commission on protecting human research subjects has met for the first time to draw up plans to ensure that research institutions abide by ethical concerns.

The 12-member National Human Research Protection Advisory Committee (NHRPAC), chaired by Mary Faith Marshall, director of the program in bioethics at the University of Kansas Medical Center, was established last June and reports directly to the Office of Human Research Protection (OHRP), in the Department of Health and Human Services (Nature Med. 6, 946; 2000). Members discussed financial conflicts of interest, the Declaration of Helsinki and the ethics of placebo use, and special issues in research involving children.

When the Committee begins to make recommendations, these could be crafted into new policy or regulations by the OHRP, which currently oversees only research conducted with federal funds. “That's how I see our job—to make real change in terms of policy and action,” says Marshall, adding, “I think there will be some wholesale changes coming.”

Those changes will not focus solely on institutional review boards, but the operation of these groups, which oversee research involving human subjects, will be among the first to be examined. “I think for the most part IRBs do a good job and are well-intentioned,” says Marshall, “but they need increased accountability, increased professionalism and much more interaction with the public.”

Some researchers are worried by the increasing number of regulatory bodies and oversight groups that are being created. Committee member Adil Shamoo, a professor in the department of Biochemistry and Molecular Biology at the University of Maryland School of Medicine, told Nature Medicine he hoped the panel would increase study participants' protection without adding a new layer of bureaucracy. He has a particular interest in reducing financial conflicts of interest and increasing federal researchers' accountability, and he is about to publish research charging that the National Institutes of Health severely underreports adverse events in studies they fund.