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SHP 08-159 – HSR&D Study

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SHP 08-159
Understanding Variations in the IRB Review Process: Pilot Study
Aram Dobalian PhD MPH JD
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, CA
Funding Period: April 2008 - September 2008

BACKGROUND/RATIONALE:
The existence of variation among IRB review processes and outcomes is well-documented. However, the underlying structures and processes that lead to variation are understudied.

OBJECTIVE(S):
This project was designed to improve our knowledge regarding underlying sources of variation among VA IRBs.

METHODS:
To meet this objective, we undertook three main activities: (1) literature review and collection of IRB application forms to assess their possible contributions to variations in IRB processes and outcomes; (2) development of instruments for qualitative interviews based on the literature review and consultation with experts; and (3) interviews with Principal Investigators (PIs) and IRB staff and members to determine their views regarding IRB variations and factors contributing to variations.

We identified eligible studies at 6 VA sites and contacted PIs to obtain their agreement to participate in this study. We conducted semi-structured interviews with the PIs to assess their perspectives on the IRB process for the identified studies. We also conducted in-depth qualitative interviews with (1) IRB chairs and members, and (2) IRB administrators and coordinators. In total, 22 PIs across 3 groups (clinical, health services research, quality improvement), and 5 IRB staff and members were interviewed. The study team compiled a meta-matrix that captured the collected data for analysis of cross-cutting themes and development. Data reduction and coding were performed as a team.

FINDINGS/RESULTS:
Respondents identified a number of sources of variations in IRB review processes and outcomes, including: a lack of expertise on the IRB committees for certain types of research (e.g., social sciences, health services research, surveys, quality improvement, qualitative research, exploratory research not aimed at hypothesis testing); the lack of a systematic approach to weigh risks and benefits that is consistent across studies and across time; that IRB decisions may be influenced by institutional risk aversion; that IRBs are more concerned with the content of the consent document rather than the process or the readability of the consent; that regulations sometimes provide conflicting, inadequate or no guidance; unclear or duplicative forms or instructions; inconsistencies in the level of review (exempt, expedited, full board); and limited resources within the IRB, a problem that some indicated had been exacerbated by recent changes in data security reporting requirements. This study also allowed us to develop the necessary instruments and provided pilot data for a broader study to more fully document sources of variations in the IRB review process.

IMPACT:
This project represents the first attempt to evaluate sources of variations in the IRB review process in VA settings. The consequences of variations in IRB review (e.g., delays in study timelines) are significant for all research, but are particularly important in studies addressing growing, high-priority treatment challenges facing VA (e.g., polytrauma, TBI, PTSD) for which the current treatment evidence base is still developing. IRB variations can adversely affect research designs and procedures, add unanticipated costs, introduce protocol variability that may affect response rates, cause delays in project initiation and completion (including delays in implementing interventions designed to improve care), and may impair rather than support the protection of human subjects.

PUBLICATIONS:

Conference Presentations

  1. Dobalian A, Mittman BS, Simon B, York LS, Gammage CE, Mittman D. Understanding Variations in the Review Process Among VA and University-Affiliated IRBs. Poster session presented at: AcademyHealth Annual Research Meeting; 2009 Jun 29; Chicago, IL.
  2. Mittman BS, Dobalian A, Mittman D, Simon B, York LS. A Situated Learning Approach to Enhancing the Responsible Conduct of Research. Poster session presented at: Public Responsibility in Medicine and Research Advancing Ethical Research National Conference; 2008 Nov 18; Orlando, FL.


DRA: Health Systems
DRE: none
Keywords: Decision support
MeSH Terms: none

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