Bioethics scholars fault requirement that all women in clinical drug trials use contraception

September 30, 2010

(Garrison, NY) Research ethics review committees often require all women of childbearing age who enroll in clinical trials to use contraceptives to protect against a developing fetus being exposed to potentially harmful drugs. A mandatory contraceptive policy is often imposed even when there is no evidence that a trial drug could harm a fetus or when women have no chance of becoming pregnancy. This requirement is excessive and can safely be relaxed in many cases, according to a report in IRB: Ethics & Human Research.

Policies on contraceptive use in research should reflect the level of potential risk the study drug poses to the fetus, write Chris Kaposy, an assistant professor of Health Care Ethics at Memorial University of Newfoundland, Canada; and Françoise Baylis, professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University in Halifax. They point to the U.S. Food and Drug Administration's categories for prescription drug labeling for drug use in as a helpful guide. The FDA has five categories, each with different degrees of evidence of risk to fetuses.

Category A, for example, indicates that "adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities." And yet the policy of the University of Nebraska Medical Center's institutional review board - which Kaposy and Baylis reviewed as a typical example of IRB contraceptive use policies - permits researchers to petition the IRB to impose a mandatory contraception or abstinence requirement for trial participants in studies that use Category A drugs. However, the authors argue that an ideal policy for Category A drugs would not require contraception or abstinence.

The authors also say that contraception should not be mandated for women who have no chance of becoming pregnant while participating in a clinical drug trial. "Consider, for example, women who are not sexually active (e.g., nuns) or who are not sexually active in a heterosexual relationship (e.g., lesbians)," they write. Mandating for these groups sends "a paternalistic message of mistrust" that undermines the normal practice of treating research participants as autonomous decision-makers.

"Our recommendations are an attempt to find an appropriate balance between the interests of potential fetuses and the autonomy and well-being of women," they write.

Explore further: Hormonal contraception does not appear to increase HIV risk

Related Stories

Hormonal contraception does not appear to increase HIV risk

December 7, 2006

Using hormonal contraception does not appear to increase women’s overall risk of infection with the AIDS virus, report the authors of a large study commissioned by the National Institute of Child Health and Human Development ...

New warning OK'd for birth control patch

January 21, 2008

The U.S. Food and Drug Administration has approved a warning for the Ortho Evra Contraceptive Transdermal Patch label concerning the risk of blood clots.

Epilepsy drug may increase risk of birth defects

July 21, 2008

Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology, the medical journal ...

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.