Project Background/Rationale: Although site to site variation is marked in Institutional Review Board (IRB) assessment of risk to human research participants, there is a paucity of research published specifically about variation in allowed methods for recruitment of subjects. In addition there are few models that attempt to explain variation in IRB decision making. Excess variation may hinder research progress or prevent qualified Veterans from participating in research, while not increasing protection from harm. Variation may be perceived by investigators as arbitrary and inconsistent, undermining their confidence in the research protection process. Project Aims:
The aims of this qualitative study are to: 1. Describe the views and experiences of Veterans Affairs (VA) Health Services Research &Development (HSR&D) investigators about how IRB requirements affect recruitment practices. 2. Describe IRB Chairs'views on recruitment methods and experiences with ethically difficult recruitment decisions;and explore the role of heuristics as a model for explaining variation. 3. Explore Veterans'preferences on how they wish to be contacted, notified and educated about research opportunities;and Veterans'concerns about research recruitment methods. Project Methods: This will be a 30 month, three phase, qualitative, cross-sectional study conducted through the Portland VAMC HSR&D Center, in collaboration with investigators from VA HSR&D Centers in San Antonio, San Francisco and the Bronx. In Phase 1, phone interviews will be conducted with approximately 80 HSR&D investigators about active and recently completed studies that recruited human subjects. Interviews will focus on any institutional and IRB barriers to subject recruitment, the reasons for the restrictions, and the effect on the study. In Phase 2 we will interview approximately 40 VA IRBs chairs about their views on various recruitment methods, experiences around ethically difficult recruitment plans, and interpretations of guidelines on protecting research subject durin recruitment. We will use a method for examining for heuristics, which will potentially inform a model of how IRB members balance benefit and harm to research participants. In Phase 3 we will conduct eight focus groups at four ethnically and geographically diverse VAs to explore Veterans views on and preferences for methods of being notified about the opportunities to participate in research. Qualitative content analysis will be used to analyze the data in all three phases of the study.
Recruitment of volunteers to participate in research studies is possibly the most difficult part of research. Concerned about patient privacy and undue influence of vulnerable patients, Institutional Review Boards (IRBs) that govern research restrict a variety of recruitment practices. The manner in which they do this, and their reasoning, has not been studied. Our proposed study will interview Veterans Affairs researchers about the types of research recruitment restrictions they encounter, how they work with their IRBs to resolve issues and the influence of these restrictions on their studies. We will also interview IRB Chairs and Veterans about their views on and experiences around recruitment restrictions. We will examine the interviews with IRB Chairs for rational and non-rational arguments mediated by cognitive shortcuts called heuristics.
