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

Sep 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: German Merck to buy St. Louis-based Sigma-Aldrich

Provided by The Hastings Center

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Hormonal contraception does not appear to increase HIV risk

Dec 07, 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

Jan 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

Jul 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 journa ...

Recommended for you

German Merck to buy St. Louis-based Sigma-Aldrich

18 hours ago

German drug company Merck says it has agreed to buy St. Louis-based chemical firm Sigma-Aldrich Corp. for $17 billion in a deal Merck says will strengthen its business in chemicals and laboratory equipment.

The human race evolved to be fair for selfish reasons

Sep 19, 2014

"Make sure you play fairly," often say parents to their kids. In fact, children do not need encouragement to be fair, it is a unique feature of human social life, which emerges in childhood. When given the o ...

User comments : 0