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. At the discretion of the Human Subjects Committee, the entity may be asked to appoint a single person responsible for the protocol, but it will individually ensure that everyone working on the research has received appropriate training. The company will keep a separate recording of its employee training and make it available to LBNL`s Human Subjects Committee upon request. The LBNL`s in-house training to humans (see training page) can be used to meet this requirement. 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. 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. An IIA agreement is an agreement between U-M and a single staff member who is not linked to an FWA institution (for example. B former student who works with her faculty advisor after graduation, who works in the community with specific expertise, community partner). This agreement outlines the responsibilities of each examiner in protecting human beings.
The AI is signed by the: the lead investigator should inform the MSU IRB of all persons who must obtain an individual investigation agreement. In addition, if necessary, the IRB MSU will seek clarification from the lead investigator to determine if individual investigation agreements are required. U-M investigators should not initiate an authorisation/cooperation agreement with another institution without first checking with the relevant U-M IRB (see contact information below): a fully executed individual investigation agreement must exist before individuals are engaged in human research. 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.