Institutional Review Board Authorization Agreement
Note: It is not uncommon for new authorization agreements to take months. It is recommended that researchers keep this in mind when considering an application for dependency [either the PSU requirement as an audit or confidence in the IRB]. 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. The audit conducted by the designated IRB will meet the requirements of the FWA approved by the OHRP of Institution B for the protection of human subjects. The institution/organization A`s IRB will follow the written procedures for reporting its results and measures to the relevant officials of Institution B. The corresponding minutes of the IRB meetings are made available to Institution B upon request. Institution B remains responsible for complying with the provisions of the IRB and the conditions of its FWA approved by the OHRP. This document must be stored by both parties and made available to the OHRP upon request.
A CIA is an agreement between U-M and an institution/organization that does not have a FWA. This type of contract is generally used for research projects not funded by the federal government, involving several collaborators linked to the organization (for example. B, research assistants affiliated with a non-profit agency, teachers who offer educational interventions in a public school). It describes the responsibilities of the cooperative institution in protecting human beings. The CIA is signed by a representative authorized to make commitments on behalf of the organization and by the official institution of the U-M. Authorization agreements do not replace the need for NI authorization. Even in the case of an authorization agreement, researchers still need to obtain IRB authorization for the IRB audit before starting their studies and unlocking funds. The PSU Senior Auditor remains responsible for ensuring that all of Penn State`s institutional requirements are met before the research begins and throughout the research.
This depends on the nature of the submission and demand (Cede/Rely) required for the study. To process a Nu IRB application as an IRB protocol, we must ensure that the site is included in the research and that the protocol accurately reflects the role of each site involved. The external site should also have a Federal Wide Assurance (FWA) before the agreement can be implemented. For studies that request the Nu IRB withdrawal review at an external IRB, we should review the protocol, approval document and all other relevant study documents.