The type of agreement may be based on the nature of the financial, legal or collaborative relationships between companies. The HHS Office for Human Research Protections (OHRP) example uses the term “authorization agreement”; The Food and Drug Administration (FDA) uses the term “agreement.” The agreement should clearly identify the IRB for a protocol or program and the delimitation of responsibilities. We can develop a Memorandum of Understanding (MOU) to recognize a permanent and strategic relationship between institutions. An agreement must be a long-term agreement and/or support a specific research study. The agreement generally describes a very broad understanding of the mutual understanding, objectives and plans shared by the parties. It can also list possible areas of joint activity, without creating financial commitments or freeing up funds. These are examples of the forms used by the IRB to document dependency agreements. The UNC reliance team is responsible for preparing these forms when specific dependency requests are made. They are provided here for informational purposes and should only be implemented by the study team in agreement with the reliance team.
CHOP had many agreements on the reliability of research in other paediatric facilities. In May 2014, Boston Children`s Hospital, Cincinnati Children`s Hospital and CHOP concluded a Master Reliance Agreement for research involving two or more institutions. This agreement was then amended and accepted by the other PEDSnet sites. A master reliance agreement avoids the need to negotiate individual agreements when two or more signatories participate together in a study. Apart from the 9 SITES of EDSnet, 12 other paediatric institutions or universities have signed up to participate in this agreement. For each study, it is necessary to complete a survey form on which the review and exit websites agree to apply the main reliability agreement to this specific study. CHOP has a long-standing master reliance contract with the National Cancer Institute Central IRB. Prior to 2011, NCI Pediatric CIRB used an facilitated verification model.
Since 2011, the Pediatric CIRB has served first as a pilot program and then as a widespread IRB review program for Cog clinical trials. The CHOP IRB issues a letter in which the paediatric CIRB is accepted as a control IRB; there is no survey form to complete. The auditor is responsible for ensuring that the authorization form has been processed in a manner that meets CHOP`s institutional requirements. Currently, CHOP can only enter into reliability agreements to rely on another U.S.-based iRB. The information on this page therefore applies to trust agreements between institutions and IRBs that are in the U.S. Reliance Agreement: a formal, written document, providing a mechanism for an institution active in the field of research to delegate audit by the Institutional Review Committee (IRB) to an independent IRB or an IRB from another institution. Institutions that deal with research on human issues and for which one institution relies on the other institution`s IRB must accept the terms of the reliance agreement before research can begin. An IRB approval agreement is an agreement between Northwestern and another institution that has federal insurance (FWA) with the U.S. Office for Human Research Protection (OHRP).