The OHRP and the FDA allow an IRB to rely on the verification of another IRB. If this is the case, the two institutions enter into an agreement called either a cooperation agreement, an NI approval agreement or an NI trust agreement. These agreements are concluded between a review niRB and one or more original entities, and the roles and responsibilities of the parties involved are delineated. The agreements may apply to a single research study or several studies (for example. B a master reliance agreement). The NIH, study consortia and some support organizations have increasingly encouraged themselves to characterize the IRB Central IRB as an audit for all participating sites as part of multi-center research studies. Researchers who wish to rely on the IRB of another institution or who wish to have the Penn State IRB considered an IRB audit for another institution must have an IRB authorization agreement. These agreements are concluded between a review niRB and one or more original entities, and the roles and responsibilities of the parties involved are delineated. The agreements may apply to a single research study or several studies (. B, for example, a core trust agreement). The approval agreement is negotiated and concluded by Penn State IRB and, if applicable, verified by Penn State`s lawyer.
What are the relevant issues and therefore, what needs to be monitored and by whom can make the difference from one study to another. A study involving interviews with topics on health behaviours in 6 languages in 6 countries raises a series of different questions than a study of devices in 20 U.S. hospitals. The content of the reliability agreement often has to vary, as specific issues require different responsibilities on the part of the audit and the interests of the IRBer. For example, not all sites in a study have the same role. For example, an IRB specialist in a children`s hospital reported that we systematically collected and verified 34 public reliance agreements that we uploaded to websites. The use of SMART IRB does not replace or deny the internal transmission process at Penn State, whether Penn State is the IRB audit or relies on an external IRB. Investigators should never assume that the agreement can or will be used for a particular study or that it is informed to others, including a funding agency, that the agreement is being used without the consent of any expressly documented participating institution.