by Wendy Tate, PSM, CIP
By this time almost everyone is familiar with the advance notice of proposed rulemaking (ANPRM) that recommends vast changes to the human subject regulations known as the “Common Rule.” As I read the memorandum, table of changes, and 92-page document, one thing kept popping into my mind: What about the subparts?
Being “in the trenches” at a university that supports both medical and social/behavioral research, I find it frustrating to apply subpart B (research involving pregnant women) to non-biomedical research and/or minimal risk biomedical research. Granted, subpart B is not technically part of the “Common Rule,” and as such is not included in the recent ANPRM. However, its omission is disconcerting for IRB members, IRB staff, and researchers who use the “Common Rule” as a litmus test for our decisions involving human subjects research.
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.
I hope that individuals and institutions responding to the ANPRM will join me in commenting on the absence of content that addresses the subparts, including those that might adversely affect the ability to conduct ethical research. Comments are due no later than October 26. As we haven’t seen this level of revision in almost 30 years, we can expect that it may be 30 more before we have this opportunity again. Let your voice be heard.
What’s missing in the ANPRM?Tags:
by Wendy Tate, PSM, CIP
Thanks, Wendy, for bringing up this issue for online discussion. I wholeheartedly agree with you that pregnant women must be included in research, and that the regulations governing human subjects research should not be a barrier to such inclusion. I’d love to hear what other members of the PRIM&R community have to say about your suggestion that people use the ANPRM comment process to call attention to these issues. Have any of you who have already submitted comments to OHRP mentioned the subparts?
Please add the "tag" ANPRM to this post. Also, please add an ANPRM reference to the PRIM&R "Resource Center: Government/Legal News."
I referred in the comments I prepared to the SACHRP "Subpart D" subcommittee's 2004 recommendation that pediatric research should employ a "uniform standard" in evaluating risks for pediatric subjects: i.e. compare the risks to those encountered in daily life for normal, healthy, average children living in safe environments. I haven't heard whether that recommendation was ever adopted or repudiated. What is the status?