Veterans, Researchers and IRB Members Experiences with Recruitment Restrictions
Linda K. Ganzini MD MPH
Portland VA Medical Center, Portland, OR
Portland, OR
Funding Period: September 2012 - March 2015

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.

OBJECTIVE(S):
The aims of this qualitative study are to:
1. Describe the views and experiences of VA HSR&D investigators about how IRB requirements influence 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.

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 Francisco, San Antonio 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 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 subjects during 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.

FINDINGS/RESULTS:
Data collection is just starting; therefore there are no results to report at this time.

IMPACT:
Examining variation in IRB-permitted practices on recruitment may lead to more transparent guidance in this area.

PUBLICATIONS:
None at this time.

DRA: Health Systems
DRE: Research Infrastructure
Keywords: Best Practices, Research Measure Development
MeSH Terms: none