Unaffiliated Investigator Agreement

The OHRP will allow an insured institution to extend its TFA to a cooperating independent or institutional auditor, provided that all of the following conditions are met: “Sample Commitment Statement of a Individual Investigator to Institutional Human Subject Protection Policies and IRB Oversight (Institutions may use this text or develop their own agreement) The standard individual investment agreement is available on the OHRP website under www.hhs.gov/ohrp/sites/default/files/ohrp/policy/unaflsup.rtf. Institutions may also draw up their own agreements for individual auditors, provided that the following conditions are met. All researchers who meet the definition of “unrelated auditor” must submit an individual investment agreement as part of the IRB submission package in IRBNet. The individual investment agreement is available on IRBNet under “Forms and Templates”. Prior to 31 January 1005, the date of entry into force of this guidance document, the options for ensuring the cooperation of independent auditors (1) included the Agreement on Independent Auditors (UIA) for the cooperation of independent auditors who, in collaboration with FWA institutions, conduct research activities and do not act as collaborators of an institution with respect to research activities; (2) the Non-Institutional Investment Agreement (NIA) for the cooperation of independent auditors who participate exclusively in research programmes on cooperation protocols; and (3) the Independent Auditors Agreement (IIA) for the cooperation of independent auditors involved in other research conducted or supported by HHS on persons who are not covered by a UIA or NIA. .