The Department of Health and Human Services’ (HSS) 45 Code of Federal Regulations (CFR) part 46 requires extra protections for vulnerable populations in clinical research. Subpart B of this document categorizes pregnant women as a vulnerable population. This restrictive categorization has been criticized based on the lack of evidence that pregnant women, including women seeking abortions, face any increased risks of research compared to other populations, and it remains unclear what special protections for pregnant research participants, if any, should be required. The interpretation and application of these regulations by institutional review boards (IRB) may impede or prevent research with women undergoing abortions on the basis that these women are pregnant and, therefore, automatically vulnerable. 45 CFR 46 also dictates that “individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy”. The additional regulations imposed by the current interpretation of 45 CFR 46 subpart B on abortion related research potentially limits research benets for patients undergoing abortions. These benefits include the ability to develop evidence-based standards for patients seeking abortions, an improved understanding of medical conditions and pharmacogenetics in early pregnancy, and the altruistic benets of contributing to medical research.
The purpose of this study is to understand the attitudes of patients who have had an abortion regarding research participation. Specically, we hope to clarify what types of protections should be offered to patients seeking abortions and what these women consider to be acceptable research practices. For this qualitative study, we will recruit English-speaking women over the age of 18 who report having an abortion in the previous six months. Semi-structured one-on-one interviews will be conducted in person. We will collect basic demographic information, including a pregnancy history. The interviews will ask questions concerning participation of abortion patients in clinical research. The findings of this study will inform our understanding of how women seeking abortions view themselves in the context of research, providing a patient perspective regarding the vulnerability of this population and the need for special protections during research participation. The themes identied in this study will be used to develop theories on how to improve research methodology and the informed consent process to better accommodate the preferences of these women. These results may prove useful to researchers advocating for abortion-related research, IRBs evaluating study proposals, and proponents supporting changes to the CFR.