45 CFR 46 Subpart B regulations need updating

By: Wendy R. Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad has blogged every day from the conference, and these are the final onsite posts. Continue to check back for more updates from the Blog Squad.

For me, Subpart B of the Heath and Human Services (HHS) regulations always raises more questions than it answers. It’s not that I don’t understand this portion of HHS regulations. I have read them several times and feel that I understand them quite well. My questions are brought up because I feel they are no longer applicable to today’s society.

Question 1: Why must the consent of the father be obtained?

Subpart D regulations allow a waiver of one parental signature if there is a prospect of direct benefit to the child. Subpart B requires the consent of the father if there is potentially direct benefit only to the fetus. Why the discrepancy? Consent of both the mother and father should not be necessary if there is prospect of direct benefit. A waiver, similar to the one described in Subpart D, should be included into regulations affecting pregnant women.

Question 2: Why require that “the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means?”

This one sentence in the regulations makes almost all social behavioral research with pregnant women impossible to conduct. The majority of social behavioral research is minimal risk, especially when it comes to interactions that only involve surveys. The inclusion of pregnant women is highly unlikely to affect the pregnant woman or the fetus. There is no justifiable reason to exclude pregnant women from this work, or make the researchers jump through unnecessary hoops to get IRB approval.

Question 3: Why are pregnant women excluded from almost all clinical trials?

This was the topic of a panel on Wednesday titled, Research on Pregnancy: A Necessary Risk? In 1993, the FDA recognized the need for more information on how drugs work in the pregnant body and affect an unborn fetus, so they lifted the ban on the inclusion of women in clinical research. In 1997, the FDA deemed the inclusion of pregnant women in clinical trials as appropriate. The current problem is that most sponsors, researchers, and IRBs do not feel that the inclusion is appropriate. Because of this, we are left with a gaping hole in knowledge on what drugs are effective and safe in pregnant women.

Like any population, the use of pregnant women in research must be justified. This is the Belmont principle of justice. Pregnant women should be enrolled in clinical trials when there is the potential for direct benefit for serious medical conditions.

The FDA (which has not formally adopted Subpart B) has made a bold and necessary move to state that pregnant women should be included in research. Valuable research that does not contribute to important biomedical knowledge (i.e. social behavioral research and some public health research) should not be required to exclude pregnant women because of an outdated regulation. The majority of pregnant women are perfectly able to make informed decisions, and do so for their normal medical care. The current Subpart B needs extensive revision. Experts in the field of obstetrics, maternal health, public health, and pregnancy must be consulted and contribute to the process in order to ensure an applicable, robust set of regulations.