The Common Rule: Too commonly applied to pregnant women?

On Jan. 21, 2019, the body of law that protects people who participate in research (known as the Common Rule), was updated for the first time since its publication in 1974 to reduce administrative burden while improving protections. One important change I’m excited about is that pregnant women are no longer part of a category of research subjects considered to be especially “vulnerable to coercion or undue influence.”

This might seem like an odd thing to be excited about. After all, shouldn’t it be a good thing that pregnant women have had this additional special protection in research? Well actually, no, not really.

The Common Rule was created in response to a long history of unethical research practices, such as those that gave rise to public outcry in the Tuskegee Syphilis Study. Over the course of that study, 600 black men with syphilis in Tuskegee, Ala. were left untreated and subjected to research without their consent or knowledge.

The regulations that were enacted to address these ethical digressions are designed to protect human research subjects, and there are special protections for people who are considered particularly susceptible to being taken advantage of in research, such as prisoners and children.

In the intervening 40 years, the benefits that come from including groups of people in research and the disadvantages in limiting who is involved in human subjects research, even for their own protection, have become apparent.

For example, until 1993 many women were excluded from research. As a result, many medications are calibrated with men in mind so that women and non-binary people are sometimes given treatments that are ineffective.

While researchers have been actively trying to overcome this gap through new research trials with women, the same has not been possible with pregnant women. This is in part because of regulatory challenges that institutional review boards and researchers face. In part, these regulatory challenges arise from the Common Rule protections for pregnant women.

As a result, medical research is lagging when it comes to pregnant women. While people do not stop getting sick when they are pregnant, there is not enough information on which medications are safe and effective during pregnancy.

So, as a group of pregnant women recently experienced when requesting to receive a new Ebola vaccination, and as many people experience when trying to receive HIV treatment while pregnant, the need for pregnant women to be involved in medical research is ongoing and essential.

It remains an open question why pregnant women were included as a vulnerable class of subjects in the first place. The other groups that enjoy these protections include children, individuals with impaired decision making, and prisoners, to name a few.

While it’s possible to see how these other groups may be more likely to be unfairly coerced into participating in research, why have pregnant women been considered more at risk?

I would hazard a guess that this sort of protective and paternalistic stance resulted from unfounded beliefs about pregnant women and women in general. It’s long been noted that many doctors take women less seriously than men when they report that they are in pain, and many women have stories about being written off as overreacting when they report serious symptoms. These sorts of reports and stories reinforce the notion that many people have unconscious biases about how women manage and report on their own health.

Additionally, there is a myth that once a person falls pregnant, she is less likely to make rational decisions because she will be overwhelmed and emotional. While it’s possible that pregnancy may cause some changes in the brain, there is no reason to suggest that these changes prevent pregnant women from making important decisions about their own medical care.

These beliefs are likely connected to why pregnant women were thought to need special protections for the past 40 years. While there is still so much work to be done to ensure pregnant people receive equitable and just medical care, this change to the Common Rule is a step in the right direction. And it’s about time!

-By Isabel Canfield, research coordinator in the Center for Medical Ethics and Health Policy at Baylor College of Medicine