IRB: Ethics & Human Research

A Study of Reliance Agreement Templates Used by U.S. Research Institutions

Abstract: We performed a content analysis of reliance agreement templates from 73 of the top U.S. research institutions ranked by research funding. Of the institutions in our sample, 67.1% used the template developed by the Office for Human Research Protections (OHRP), and 8.2% used the SMART IRB template developed by the Clinical and Translational Science Awards Program of the National Institutes of Health. Although a significant percentage of institutions (45.2%) used their own custom template, many of these also used the OHRP template or the SMART IRB template. Of institutional templates, 21.9% had only the OHRP minimum 10 contractual provisions (or elements), 27.4% had 11 elements, 26% had 12 to 19 elements, and 24.7% had 20 or more elements. Of institutional templates, 5.5% required the relied-upon institution to indemnify the relying institution, 6.8% required the relying institution to indemnify the relied-upon institution, 8.2% required the relied-upon institution to have liability insurance, 15.1% required the relying institution to have liability insurance, 2.7% required the relied-upon institution to have accreditation, and none required the relying institution to have accreditation. The number of elements in the template was positively associated with total research funding and private institutional control. Our data indicate that institutions that are seeking reliance agreements for cooperative research involving human subjects are not likely to encounter many difficulties because most are using commonly employed templates and are not imposing potentially disputable requirements on parties to the agreement.

Key words: human subjects research, cooperative research, multisite studies, single institutional review board, reliance agreements

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