Examining the impact of federal regulations on abortion research in the United States: An exploratory, qualitative study.

Objectives: We aimed to identify and characterize barriers faced by researchers studying abortion in academic medical centers in the United States. We specifically focused on regulatory restrictions on abortion research related to institutional review board (IRB) or research ethics committee interpretations of Subpart B of the 2001 Code of Federal Regulations, which states that researchers cannot take part in decisions involving the timing, method, or procedures used to terminate a pregnancy. We aimed to document investigators' experiences obtaining approval from their IRBs and to identify obstacles that prevent investigators from generating evidence related to abortion care.
Study Design: We conducted semistructured telephone interviews with family planning researchers at 15 US academic institutions across the country. We coded transcripts using an iterative process, and analyzed the data for content and themes.
Results: Interviewees reported significant variations in the way that IRBs at their institutions applied federal regulations to abortion research. At several institutions, the regulations represented barriers to conducting abortion research and discouraged some investigators from conducting such research altogether. At other institutions, interviewees did not face significant barriers related to their IRB's interpretation of Subpart B. Many interviewees discussed creating and maintaining positive professional relationships with members of their IRB as a way to overcome barriers and successfully conduct abortion research.
Conclusions: Our study suggests that IRBs interpret Subpart B in varying ways. At some institutions, this creates barriers to conducting abortion research. However, abortion researchers have also found ways to navigate these challenges successfully.
Implications: This exploratory study identified barriers that may constrain the generation of evidence in abortion care at some academic institutions, and can inform future endeavors to overcome limitations to abortion research.
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