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January 16, 2001

Rich picked for federal group
monitoring human subjects

By Eric Rangus

Robert Rich, executive associate dean of the School of Medicine, was named to the National Human Research Protections Advisory Committee (NHRPAC) in December by Secretary of Health and Human Services Donna Shalala.

“I was pleased that I was appointed, particularly because I think it’s important that the research community be represented on these advisory panels,” Rich said.

Indeed, more than half the committee’s members have backgrounds in clinical work, and their areas of expertise range from genetics to bioethics to Rich’s own specialty, immunology.

The committee was created last June, and it met for the first time in Bethesda, Md., this past December. NHRPAC falls under the Office for Human Resource Protections, also created by Shalala. It is intended to strengthen the protections of human research subjects in clinical trials and reinforce the responsibilities of research institutions to oversee their clinical researchers and institutional review boards.

The committee charter states that it must meet twice a year, but Rich said it could get together more often. Rich’s appointment carries a four-year term.

“The recent explosion in biomedical research has presented new challenges and created new potential ethical dilemmas,” Shalala said in a statement. “The advice and insights we receive from this new committee will be invaluable in helping us achieve our goal of further strengthening government oversight in protecting individuals who volunteer to participate in human research studies.”

The death of a participant in a gene therapy study at the University of Pennsylvania, Rich said, is an example of where universities must do a better job of informing participants of the risks they take when they agree to be research subjects.

Rich, however, is not an over-regulator. While he readily agrees that regulation is a good thing for biomedical research, too much regulation can be just as serious a problem as none at all. Achieving a balance between responsible regulation and research freedom is the paramount goal.

“Sometimes the people who are charged with conducting regulation internally, like me, are so concerned about keeping themselves protected that they become overzealous in interpreting what the regulations really are,” Rich said.

Shalala, of course, will no longer be HHS secretary. That position, pending his confirmation, will go to former Wisconsin Gov. Tommy Thompson, President-elect George W. Bush’s choice to head the department.

Rich said he isn’t sure what Thompson’s reaction to the committee will be, but he added that it probably is not high on his agenda upon entering office. Thompson’s hard line against unnecessary regulation may factor into his views as well, Rich said.

“I would imagine that there will be a year or so that goes by before we really know the view of the new secretary toward the activities of a commission like this,” Rich said. “But my hope is that he’ll make it better. And he may make it better by making it a little leaner.”

Rich was nominated for the committee position by Mary Hendrix, president of the Federation of American Societies for Experimental Biology (FASEB).

Shalala had invited FASEB to nominate a candidate and Rich, who is FASEB’s president-elect, was an ideal candidate. His FASEB presidency begins July 1.

Rich has served as executive associate dean at Emory since 1998, when left the Baylor College of Medicine, where he was vice president and dean of research for eight years.


Back to Emory Report Jan. 16, 2001