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24. September 2021

Institutional Review Board Authorization Agreement

Penn State`s IRB offices cannot guarantee their willingness to support the use of the SIRB, which was selected without prior consultation or agreement, documented in a letter of support. When an IRB CATS institution is on the „external IRB“ list, an authorisation agreement must continue to be requested. Decisions are made on a case-by-case basis. Penn State will not enter into authorization agreements for research deemed exempt. Chop has completed a master-reliance with Columbia University (CU) for NAMDC research studies. Columbia University will be the exam IRB for these studies. The NAMDC Columbia University Central IRB Determination Agreement should be completed by the CHOP examiner, who requests dependence on the CU IRB (Reviewing IRB). The signed and completed finding form must be sent in eIRB as part of the IRB application. Authorisation agreements do not replace the need for an IRB authorisation.

Even with an authorization agreement, researchers must obtain IRB authorization from the control IRB before the start of studies and before releasing funds. The PSU Principal Investigator remains responsible for ensuring that all of Penn State`s institutional requirements are met prior to the start of the research and throughout the research. If two or more state-secured institutions collaborate on research on individuals supported by a common rule agency, institutions can rely on a single IRB (an „IRB of Record“) for verification and ongoing monitoring of the research, in order to avoid double checks. • National Academies: Demonstration Partnership of the Confederation (FDP) We can create a Memorandum of Understanding (MOU) to recognise a relationship between ongoing and strategic institutions. A Memorandum of Understanding must be a long-term agreement and/or support a specific research study. The agreement generally describes a very broad concept of mutual understanding, objectives and plans shared by the parties. It may also list possible areas of joint activities without creating financial obligations or committing resources. An IRB Authorization Agreement (IAA) is a special agreement between two institutions that deal with human research in order to set up the single verification of the IRB.

An ILO allows an institution with Federalwide Assurance (FWA) to extend the applicability of its FWA to another institution. . . . .