Irb Indemnification Agreement

All applications for trust agreements must be submitted through the Reliance Request survey. The information gathered in the application allows the JIM IRB trust team to make a first provision of the CEDE (for example. B if JHM agrees to serve as a single IRB or to rely on an external IRB). JHM`s IRB auditors cannot require JHM IRB to serve as IRB without prior authorization [for example. B a letter of support] and they also do not have the authority to rely on an external IRB on behalf of the organization. The responsibilities of the trust institution are based on agreement and may vary from site to site. Both supervisory bodies and trusted institutions have a responsibility to keep in mind the different obligations and responsibilities defined in each IRB approval agreement. The Deputy Director of the IRB`s Reliance Program keeps letters of compensation executed. Cede decisions for JHM/JHHS are made based on the study, so a Reliance Request Survey must be presented. If JHM/JHHS agrees to enter into a reliability agreement that uses SMART IRB as a basis for reliability, a Cede decision can be made as follows: If the SMART IRB agreement cannot be used as a basis for reliability, another agreement can be used to facilitate trust. If you use SMART IRB as a basis for reliability, JHM requires the execution of a separate exemption letter [LOI], as compensation is not covered by the SMART IRB agreement. The LOI is specific to the organization`s role as an IRB verification institution or as a relying institution. If an organization originally signs the LOI as a trusted institution and these conditions also determine the dependency relationship, if it serves as an IRB reviewing institution with the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement, a second version of the SMART LOI must be performed between organizations in which the roles of organizations are reversed.

Reliance agreements can cover a project or a wide range of projects. If JHM IRB is the IRB audit, participating websites are required to fully execute a reliability agreement with JHM IRB before the search can begin on the participating site. If jHHS is the trusted organization, a withdrawal decision must be finalized and the local context review must be completed by JHM HRPP before a search can begin at the JHS/JHS sites.

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