January 16, 2001
Rich picked for federal
monitoring human subjects
By Eric Rangus firstname.lastname@example.org
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
its important that the research community be represented on these
advisory panels, Rich said.
Indeed, more than half the committees members have backgrounds
in clinical work, and their areas of expertise range from genetics to
bioethics to Richs 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. Richs 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. Bushs choice to head the department.
Rich said he isnt sure what Thompsons reaction to the committee
will be, but he added that it probably is not high on his agenda upon
entering office. Thompsons 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 hell
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 FASEBs
president-elect, was an ideal candidate. His FASEB presidency begins July
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.