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A Call for Improved Guidance on Research with Pregnant Women

Posted Dec 14 2011 6:04pm

kate-greenwood_high-res-2011-comp1 This month, the thoughts of Christians around the world turn to a laboring mother in “ a stable at midnight in Bethlehem in the piercing cold .” It seems an appropriate time to direct your attention to the work of the Second Wave Initiative , “a collaborative academic effort to advocate for, and help find, ethically and scientifically responsible solutions for increasing our knowledge base for the treatment of pregnant women who face medical illness.”

At the end of October, the Initiative submitted comments on the Department of Health and Human Services’ Advance Notice of Proposed Rulemaking (ANPRM) regarding revisions to the regulations governing human participation in federally-funded research, known as the Common Rule.  The Initiative’s comments, of which I am a co-signatory, call attention to the fact that the ANPRM fails to address “vagaries and constraints” in the current regulations “that make it difficult for researchers to feel comfortable understanding the parameters of responsible research with pregnant women.”

The Initiative recommends that HHS take the following five steps.

First, amend the Common Rule to allow for research in pregnant women, fetuses, and neonates that creates a minor increase over a minimal risk of harm, as is already permitted in children. The Initiative’s comments explain that the regulations currently provide that “any research that does not carry the potential for direct health benefit to pregnant woman or fetus is disallowed unless it involves ‘no more than minimal risk.’”  Some government officials have concluded from this that even pharmacokinetic studies which involve nothing more risky than drawing blood and which are vital to determining dosing in pregnancy are ruled out.

Second, eliminate the requirement that, with certain delineated exceptions, fathers must consent to research that “holds out the prospect of direct benefit solely to the fetus.” The current regulations do not require paternal consent where there is a prospect of direct benefit to the pregnant woman or, oddly, where there is no prospect of direct benefit to the pregnant woman or the fetus.  The regulations governing pediatric research seem more sensible, requiring that both parents give consent where the research involves greater than minimal risk holds out no prospect of directly benefitting the child.

Third, amend the regulations so that they no longer label pregnant women as “vulnerable.” As Seton Hall Law’s Carl Coleman has explained , the Common Rule does not define vulnerability and the examples it gives of vulnerable populations are diverse.  With regard to pregnant women, “it is not clear why any special issues related to capacity or coercion would necessarily arise.”  The Initiative recommends changing the word “vulnerable” to “population meriting special regulation.”

Fourth, confirm that HHS’ proposed changes with regard to research that is excused from ethics review and research that is eligible for expedited review encompass research with pregnant women. The Initiative contends that explicit confirmation is necessary “to avoid inappropriate exceptionalism about pregnancy on the part of researchers and institutional review boards.”

Finally, “establish and formally charge a working group to propose new model language for the special regulation of clinical research with pregnant women that strikes a more appropriate and more just balance of rights, needs, and interests.” As I explained here , “[w]e lack data on the efficacy or safety or both of most drugs when used by pregnant women. … Without denying or dismissing the real moral conundrums that arise in maternal-fetal medicine, the information gap is deeper and wider than that.”  To the extent that the Common Rule creates unjustified barriers to desperately-needed, ethically-appropriate research, revisions must be made.

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