FOR IMMEDIATE RELEASE
Congressional Letter:
“Critical” to Include Pregnant Women in Medical Research
Thirty-six members of Congress have joined the Second Wave Initiative, a
group of concerned physicians, scientists and bioethicists, in urging the U.S.
Department of Health and Human Services (HHS) to ensure the inclusion of
pregnant women in federally funded medical research. The action comes as
Congress revises the “Common Rule” regulations for research involving human
subjects.
In
a letter addressed to HHS Secretary Kathleen Sebelius last week,
Representatives including
Donna Edwards
(D-Md.),
Elijah Cummings (D-Md.),
Chris Van Hollen Jr. (D-Md.) and
Eleanor Holmes Norton (D-DC) expressed
“concern at the lack of attention to improving guidance on research with
pregnant women.”
Reiterating the concerns of an earlier letter sent by the
Second Wave Initiative in October 2011, the members noted, “It is critical
that we understand how to safely and effectively treat pregnant women,
including the 500,000 women who face serious medical illness while pregnant
each year in the United States.”
“Pregnancy poses a unique set of health care concerns due to
hormonal and metabolic changes,” says
Ruth
Faden, Ph.D., M.P.H., director of the Johns Hopkins Berman Institute of Bioethics and
co-founder of Second Wave. “It is vital that we learn more about how a pregnant
body reacts to treatment, for the welfare both of women and newborns,” she
adds.
Representatives
Nita
M. Lowey (D-N.Y.) and
Rosa DeLauro
(D-Conn.) led the campaign among their colleagues to sign and send the second
letter. Both legislators are veterans of the movement to expand medical
research to better address women’s health. They were involved in the “first
wave” effort in the late 1980s and early 1990s to make clinical trials more
inclusive of women.
The congressional letter noted that “researchers have
avoided the issue and are often deterred by the vague and overly broad nature
of current regulatory language,” calling the lack of research a “public health
issue.”
“It is imperative that these regulations encourage the
gathering of this critical information in safe and appropriate ways,” the
congressional letter concluded.
The Initiative was formed after the Second Wave Workshop
in April 2009, co-sponsored by Faden, Margaret Little, Ph.D., Director of the
Kennedy Institute of Ethics at Georgetown University and Anne Lyerly, Associate
Director of the Center for Bioethics at the University of North Carolina,
Chapel Hill.
The Second Wave Case Statement:http://secondwaveinitiative.org/Case_Statement.html
For more information on the Second Wave Workshop: http://kennedyinstitute.georgetown.edu/secondwave/
For more information on Faden: http://www.bioethicsinstitute.org/mshome/?id=64
