| The Department of Veterans Affairs (VA) mandates human research protection program (HRPP) accreditation for all VA Medical Centers conducting research involving human participants. This descriptive nonexperimental study aimed to investigate possible methods for evaluating HRPP effectiveness by examining the relationship between number and types of human research studies and the Association of Human Research Protection Program's (AAHRPP) accreditation outcomes. Applying concepts from Patton's approach to utilization-focused program evaluation, the study was designed with the specific needs of the VA Office of Research and Development as the primary intended users. Data were collected from AAHRPP applications submitted by 90 VA HRPPs between February 2006 and September 2008 and reports generated by AAHRPP following VA HRPP site visits and AAHRPP Council on Accreditation evaluations. Of 87 VA HRPPs included in the analyses, 57% (n = 50) used IRBs within their own VA institutions, 38% (n = 33) used IRBs of affiliated universities, and 5% (n = 4) used IRBs of other VA HRPPs. Time to obtain full or qualified accreditation decisions ranged from 7 to 32 months (M = 11 months, Mdn = 11.15, SD = 4.72660).;There were no statistically significant associations (p < 0.05) between length of time to obtain accreditation or number of AAHRPP elements reported as met and number of studies, percentage of studies initially reviewed by convened IRBs, and percentage of sponsored studies. A strong relationship existed between type of IRB used by the VA HRPP and length of time to obtain HRPP accreditation (eta2 = 0.163). Multiple regression results were statistically significant in predicting time required to obtain AAHRPP accreditation (n = 86; adj R 2 = 0.24, p < 0.0001), but only one variable (use of an affiliate IRB) significantly contributed to the model. This is not unexpected since fewer numbers of elements are evaluated in HRPPs using IRBs of organizations obtaining separate AAHRPP accreditation. Continued studies are needed to provide further direction for development of valid measurable indicators of AAHRPP accreditation and HRPP effectiveness. |
