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

We performed a content analysis of reliance agreement templates from 73 of the top U.S. research institutions ranked by research funding. 67.1% of institutions in our sample use the Office of Human Research Protections (OHRP) template and 8.2% use the SMART IRB template. Although a significant percentage of institutions (45.2%) use their own custom template, many of these also use the OHRP template or the SMART IRB template. 21.9% of institutional templates have only the OHRP minimum 10 contractual provisions (or elements), 27.4% have 11 elements, 26% have 12-19 elements, and 24.7% have 20 or more elements. 5.5% of institutional templates require the relied-upon institution to indemnify the relying institution, 6.8% require the relying institution to indemnify the relied-upon institution, 8.2% require the relied-upon institution to have liability insurance, 15.1% require the relying institution to have liability insurance, 2.7% require the relied-upon institution to have accreditation, and none require 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 which 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.