Institutional Review Boards (IRBs) ensure that research meets ethical guidelines and adheres to federal regulations. The involvement of research partners from numerous institutions and the collaborative nature of the study (e.g., research assistants in Arizona collected data from women in Oklahoma) made it necessary to involve five IRBs: Arizona State University, the Cherokee Nation, Johns Hopkins University, the Oklahoma State Department of Health and the University of Oklahoma Health Sciences Center. Each IRB interprets ethical and federal guidelines somewhat differently, but they all have the same goal: to ensure the ethical treatment of research participants. As we prepared for the start of the study, we needed to resolve several issues related to the protection of human subjects:
- Community partners did not understand IRB requirements and federal regulations. The police partners, for example, wondered why they had to read a specific statement when they asked participants whether they would like researchers to contact them. We explained how the requirement ensured that no woman felt coerced into participating, thereby protecting each woman's right to refuse participation in the research study.
- Although, as nurses and social workers, we were mandated to report child abuse by state law, the Department of Justice's confidentiality statute (42 USC 3789g) requires a separate consent form to allow reporting of current abuse when that abuse is revealed during data collection. Therefore, we used two consent forms: one for participating in the research and another that would allow us to report child abuse if it was revealed during an interview. This process protected the women's right to be informed about all study procedures and ensured that the women understood that we would have to report child abuse. We did not ask questions about child abuse during the interviews.
- Under federal regulations, pregnant women can be enrolled in a research study only if it directly benefits the mother or the fetus or if the research has no more than minimal risk. We justified the inclusion of pregnant women in the study, arguing that their exclusion would deprive them of a potentially helpful intervention. We also provided all study participants, including pregnant women, with a packet of health-related resources (including domestic violence resources) after their second interview.
Because the project extended to so many different populations, we needed approval from all related IRBs. We therefore submitted the initial study application, annual continuing reviews, protocol modifications and adverse events through the five IRBs each time issues arose. Although this was cumbersome at times, it ensured the protection of all study participants, a goal that is of utmost importance in research studies, particularly those studies that include vulnerable populations such as IPV victim-survivors.
About This Article
This article was published as part of NIJ Journal issue number 275, July 2015, as a Sidebar to the article Research Designs in the Real World: Testing the Effectiveness of an IPV Intervention by Jill Theresa Messing, Jacquelyn Campbell and Janet Sullivan Wilson.
[note 1] HHS (1993). Chapter VI: Special Classes of Subjects, Institutional Review Board Guide Book.