The document also introduces a new model agreement, called the “individual audit agreement,” which allows for the flexibility offered in this guide and will replace all model agreements previously developed by the OHRP. Before the individual intervenes in human research, a fully executed individual investigation agreement must be concluded. When a non-exempt human research project is subject to federal insurance (FWA), anyone participating in human research must be subject to an FWA. The individual investigation agreement can be used by MSU to extend – for one or more research protocols – the applicability of their federal insurance to a person who is not related to the MSU or who is covered by the federal insurance of another institution. The MSU Principal Investigator directs and supervises all collaborative research activities conducted by the individual auditor outside the promised institution. 1) Single persons must enter into an Individual Investigation Agreement (IIA) for signature by the LBNL institutional official. Because they perform responsible tasks on behalf of LBNL and without other institutional authorization, they must have host/affiliateD LBNL status, an LDAP, EHS0740 Human Subjects Research Program (see training below) and be included in the protocol. After the signature by the staff member or contractor, the audit agreement must be attached to the associated protocols of the HARP system and submitted for review. Target Group: This document is intended to primarily support the directors of the Institutional Review Committee (IRB), research administrators, chairs and members of the IRB, investigators, institutional officials and funding agencies who may be responsible for auditing or supervising research on human issues conducted or supported by HHS. This mechanism would be authorized for any Department of Health and Health Services (HHS) that conducts or supports research for human subjects when research is conducted under the direction and supervision of a senior investigator of the insured institution.
This mechanism provides an alternative to the establishment of additional FWA for many institutions that do not have FWA (hereafter referred to as unsecured institutions) and do not regularly conduct research on human subjects. The agreement must be read and signed by the investigator, the lead investigator and the director or representative of the HRPP. Prior to January 31, 2005, the effective date of this guide, the Options for Engagement for Independent Investigators Cooperation (ICD) (1) the Non-Linked Auditors Agreement (IIA) for the cooperation of independent investigators who conduct research activities in collaboration with LWA institutions and who do not work as collaborators of an institution in the context of research activities; (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.