Research ethics review committees often require that all women of childbearing age who enroll in clinical trials use contraceptives to protect against a developing fetus being exposed to untested and therefore 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 pregnant and a report in IRB: Ethics & Human Research says that isn't necessary.
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.
Though the whole point of clinical trials is because researchers are unsure of the effects and want to limit variables.
They cite the U.S. Food and Drug Administration's categories for prescription drug labeling for drug use in pregnancy as a helpful guide. The FDA has five categories, each with different degrees of evidence of risk to fetuses - yet those are approved drugs that already passed clinical trials, so it may be that bioethicists don't actually understand how science works.
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 - meaning all of those Catholic nuns participating in clinical trials are currently taking the pill? These authors' knowledge of Catholicism is even more flawed than their knowledge of fetus development and FDA rules.
And setting up an artificial barrier between lesbian and heterosexual women is exactly the kind of thing lesbians want to stop.
It seems to be more of an issue of The Man dictating what a women can do with her body, as they write that mandating contraception 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.