Unaffiliated Investigator Agreement

Prior to this guide, OHRP had not put in place a routine formal mechanism for a secure institution to extend the applicability of its FWA to cooperating institutional investigators. Researchers involved in research initiated or centered by Lehigh University who are not university staff and who are not agents of an external agency capable of providing IRB audits must sign an individual investigation agreement to ensure that they consider their commitments to be human research agents. The Individual Investigation Agreement serves as a written agreement between Lehigh University and an external auditor cooperating for research on non-exempt human issues, which describes the responsibilities of the external auditor and the supervision of research by the Lehigh IRB. In addition, Lehigh University`s Individual Investigation Agreement extends the application of Lehigh`s Federal Federal Insurance (FWA) to cooperating external investigators. For information on the regulatory requirements of external/unaffiliated auditors: www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/ Effective January 31, 2005, OHRP has replaced the UIA, NIA and IIA with the standard agreement for individual reviewers, which offers more flexibility and simplicity. The previous AII, NIA and UIA may remain in force until all research already undertaken is completed or until the previous agreement has been replaced by a new individual investigation agreement or other written agreement drawn up by an insured institution. The standard agreement on the individual examiner is available on the OHRP website at www.hhs.gov/ohrp/sites/default/files/ohrp/policy/unaflsup.rtf. Institutions can also develop their own agreements for individual examiners, provided the following conditions are met. All researchers who meet the definition of “unconnected examiner” must submit an individual verification agreement as part of the IRB submission package on IRBNet. The individual trial agreement is available on IRBNet under “Forms and Models.” This agreement must be signed by both the unaffiliated examiner and the official lehigh institutional (or Designee) before the IRB approves.

Unaffiliated examiners are also required to train all necessary training to protect human research (i.e. PHRP; GCP) before authorization. The new model of agreement on individual investigators can be used by a promised institution to extend, for one or more research protocols, the applicability of their FWA to either cooperating independent investigators or cooperating institutional investigators. The OHRP will enable an insured institution to: extend their FWA to a cooperating independent or institutional auditor, provided that all the following conditions are met: before 31 January 2005, the effective date of this guide, the insurance options for the cooperation of independent investigators (1) the Independent Investigation Agreement (IUU) for the cooperation of independent investigators who conduct research activities in collaboration with FWA institutions and who do not work as collaborators of an institution in the field of research; (2) the Non-institutional Investigation Agreement (NIA) for the cooperation of independent auditors who participate exclusively in the research programmes of the Cooperation Protocol; and (3) the agreement for Independent Investigators (IIA) for the cooperation of independent investigators involved in other HHS-led or assisted research for human subjects outside the UIA or NIA.

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