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 and almost none in research in VA. Excess variation may hinder research progress or prevent qualified veterans from participating in research, while not increasing protection from harm. Excessive variation may be perceived by investigators as arbitrary and inconsistent, thus undermining their confidence in the research protection process.
The aims of this qualitative study were to:
1. Describe the views and experiences of VA HSR&D investigators and VA IRB Chairs about how IRB requirements influence recruitment practices and success.
2. Describe HSR&D investigators and IRB Chairs views of other institutional barriers to study completion.
3. Explore Veterans' preferences on how they wish to be contacted, notified and educated about research opportunities; concerns about research recruitment methods; and their overall trust in VA research.
This was a three phase, qualitative, cross-sectional study conducted through the VA Portland Health Care System HSR&D Center, in collaboration with investigators from VAs in Ann Arbor, Denver, and the Bronx. In Phase 1, phone interviews were conducted with HSR&D investigators and research coordinators about active and recently completed HSR&D studies that recruited human subjects. Interviews focused on institutional and IRB barriers to subject recruitment and study completion and the impact on the study. Sampling was purposive to include variation in VA location, types of studies, single versus multisite studies, profession of the investigators, and studies of special populations including VA clinicians, vulnerable subjects (e.g., homeless or cognitively impaired), and family caregivers of Veterans.
In Phase 2, we interviewed VA IRB Chairs about their views on issues identified by investigators including interpretations of guidelines on protecting research subjects during recruitment, experiences with addition of privacy officers and information security officers to the research approval process, roles of clinicians in approving patient participation, use of incentives to improve participation, and differences in practice across VAs.
In Phase 3, we conducted eight focus groups at the four VAs to explore Veterans' views on and preferences for methods of being notified about the opportunities to participate in research as well as issues identified by investigators including the role of primary care providers in approving research participation and methods of providing incentives. Qualitative content analysis was used to analyze the data in all three phases of the study. Transcripts were double coded by the principal investigator and qualitative analyst in Atlas TI.
Of 61 investigators who were asked to participate in the study, 42 principal investigators/research coordinators were interviewed, with revision of the interview guide based on the analysis of the first 16 interviews. In addition, 8 VA IRB Chairs were interviewed. Recruitment continued until saturation was achieved on the main themes (investigators), or no more participants were available (chairs). Eight focus groups were completed that included 40 Veterans.
Because the themes were so similar between IRB Chairs and investigators, we combined the two groups for analysis. Sixty-two codes with specifiers were identified. Investigators noted several positive aspects of their research experience. IRB Chairs were uniformly identified by investigators as helpful advocates who were willing and available to problem solve around a variety of issues. Helpful processes available at some VAs included the willingness of the IRB staff to prescreen submissions, availability of IRB coordinators who had good customer service attitudes, being allowed to attend the IRB meeting to answer questions from IRB members (which often prevented tabling of the study), and a permissive approach to opt-out recruitment strategies. Novel strategies that facilitated recruitment were identified. IRB-related barriers to study progression included: 1. Use of paper processes--Those who had experiences with electronic IRBs at their academic affiliate particularly found the dependence on paper processes cumbersome and frustrating. 2. Lack of understanding of IRB members on some types of study design used in health services research-for example, some IRB members applied standards for quantitative studies to qualitative studies in terms of sample size and recruitment strategies. 3. New requirements that privacy officers (POs) and information security officers (ISOs) approve studies--These personnel were at times not timely or responsive in their reviews. In addition, there was no method for challenging ISO decisions if they seemed arbitrary. 4. The requirement that clinicians approve approaching patients for study participation, even if the study had no impact on the patient's clinical care--Most clinicians were simply too busy to respond to these approval requests. Other institutional barriers that were not related to the IRB included limitations in the ability to advertise studies and limitations in methods of incentivizing patients to participate, particularly new requirements that all payments go into the patient's bank account. In studies of the views and practices of VA health care providers, HSR&D investigators struggled to recruit because they were so limited in providing any incentives to clinicians' participation.
Focus groups of Veterans revealed their desire to be notified about studies in more ways, particularly by email. Those who had previously participated in research studies were accepting of opt-out practices. They overall did not want their primary care providers involved in approval of their participation in VA studies as they felt this would take away clinicians' time spent on more important Veteran-centric activities. They particularly did not want limited time during clinicians' health care visits spent on research-related activities.
Examining variation in IRB-permitted practices on recruitment may lead to transparent guidance in this area. Many of the barriers we have found are outside the purview of the IRB, related to other VA imposed regulations, and impact study progression throughout the research process. Highlighting the impact of these barriers may result in increased efforts to reduce them.
None at this time.