As of January 25, 2018, the NIH requires the use of a single IRB [sIRB] for the verification of NIH-funded multi-site studies, in which each website applies the same protocol with non-exempt research for humans, whether supported by grants, cooperation agreements, contracts or the NIH research program. This directive applies only to national websites. Implementation of the NIH policy should reduce unnecessary administrative burdens and systemic inefficiencies, while ensuring adequate protection for individuals. The directive defines “multi-site” as two or more sites. Harvard Catalyst Master Agreement with Independent IRBs: There is a master`s contract with WIRB/Copernicus and Advarra in case BCH determines that it will be based on one of these independent IRBs. This was negotiated on behalf of many Harvard Catalyst-affiliated institutions. JHM IRB will review IIRB applications as well as applications for an external BRI. As a general rule, applications for trust are submitted to our IRB on two dates: institutions differ on whether and how they will use the binding agreements. The findings regarding the binding agreements are very specific to each institution and each protocol.
For example, many IRBs will not enter into such agreements for exempt projects. Other institutions may have specific types of verification and standards in place for their human research program and will not participate in reliance activities for projects using these control structures. An IRB approval agreement is an agreement between Northwestern and another institution that has federal insurance (FWA) with the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (for example.B. university, medical centres, NGOs, local organization, investigative research organization) that receives funding from HHS must have an FWA. Companies use this type of contract to determine which institution serves as an IRB-of-Record. The institutional official or representative of each institution signs the ILO. In addition, study-specific agreements can be developed with outside agencies that allow Yale to serve as an audit IRB for another institution or to transfer an audit to another institution.
SMART IRB: Boston Children`s Hospital is a signatory to the IRB Master Smart Reliance Agreement. BCH`s preference is to use the SMART IRB agreement as a basis for dependency for all studies in which we rely on an external IRB or as an IRB. Where possible, the SMART IRB agreement will serve as the basis for reliability. Single Reliance/IRB Authorization Agreement (IAA): In cases where an institution does not meet the eligibility criteria for signing the SMART IRB agreement, BCH may use a trust and authorization agreement to establish a relationship of trust with an external institution. Master Reliance Agreements: These agreements are executed for one or more protocols of the same consortium by researchers/institutions. Such agreements can be used to facilitate the revision of protocols of the same cohort by researchers in several institutions.