Compliance Administrator Wants ANPRM to Address Subparts

Writing for PRIM&R's blog, amp&rsand, Wendy Tate, assistant director of process improvement and compliance at the University of Arizona, complains that the ANPRM fails to address the subparts of 45 CFR 46.

[Wendy Tate, "What's Missing in the ANPRM?," amp&rsand, 5 October 2011.]

Tate points to Subpart B, which imposes special restrictions on research involving pregnant women. She writes,

Subpart B is a good discussion point for understanding how important it is for the subparts to be included in the ANPRM discussion. Having been a pregnant woman myself and speaking to other women who have been pregnant, there are very few times in a pregnancy when a woman is vulnerable. These times generally center around labor and delivery. Pregnant women make decisions every day that can affect their unborn children. These decisions range from what to eat and drink, to taking prenatal vitamins, to long distance travel, to choosing medical care. Research needs to be done in this population.

The FDA has stated that excluding pregnant women from clinical trials is unethical. Revision or removal of subpart B will go a long way toward harmonizing regulations and gathering important information on how drugs work in women, as well as to avoid the discriminatory status of being a “woman of childbearing potential.” It seems to me that combining necessary changes to the subparts with the ANPRM review process would be the most expeditious way to accomplish this.

So far, so good.

Subpart C could also use rethinking, since it was written with biomedical research in mind but has been used to block important social research requiring interviews of prisoners.

Subpart D could also use reconsideration. It limits research on children, defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." But what jurisdictions specify the legal age for being interviewed, surveyed, or observed? This confusion between patient and subject disrupts important research on adolescents.

Canada has made progress on these fronts. Article 4.3 of the 2010 TCPS states that "Women shall not be inappropriately excluded from research solely on the basis of their reproductive capacity, or because they are pregnant or breastfeeding." And Article 4.4 states that "Children shall not be inappropriately excluded from research solely on the basis of their age or developmental stage." The TCPS does not offer similar language about prisoners, but neither does it suggest restrictions as strict as those of Subpart C.