Subject: Institutional Review Policy – IRB Review of UMS Cooperative Research

Effective: 1/25/13
Last Revised:

1.0 Objective:

1.1 The purpose of this policy is to avoid duplicative efforts of Institutional Review Boards (IRB) when a research activity requires review based on the “Common Rule” 45 CFR 46; 21 CFR50 at multiple Universities within the UMS. While intended to encourage reviews in a timely manner, it is not intended to diminish the individual University’s role and responsibilities in accordance with relevant laws, regulations and guiding principles.

2.0 General Description:

2.1 In accordance with section L. Cooperative Research of the Administrative Procedures for the UMS Policy on Human Subject Research [Section 601], this SOP articulates how the Universities within the UMS will enter into a joint review arrangement with each other when participating in a cooperative research project.

3.0 Definitions:

3.1 Cooperative Research Project: Cooperative research projects, including external multi site projects, are those projects that involve more than one University within the University of Maine System. In the conduct of cooperative research projects each University is responsible for safeguarding the rights and welfare of human subjects. An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort [45 CFR 46.114]. While relying on any of these arrangements, a University engaged in the research project remains responsible for the rights and welfare of human subjects interacting or intervening with the research activities occurring at their institution and can investigate allegations of noncompliance.

3.2 Lead Principal Investigator: One investigator within the UMS who accepts overall responsibility for a cooperative research project and who is responsible for seeking appropriate IRB review and approval as necessary from the local (University) IRB.

3.3 Lead IRB: The IRB located at the lead principal investigator’s University within the UMS. If the lead principal investigator is a student, this will be the University from which s/he will obtain his/her degree. The lead IRB is the designated IRB responsible for the initial and continuing oversight of a cooperative research project.
3.4 Engaged: In general, an institution is considered engaged in a particular human subjects research project when its employees or agents, such as a principal or primary investigator, for the purposes of the research project such as a project director or principal investigator obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

3.5 The University of Maine System (UMS): Consists of seven Universities (University of Maine, University of Maine at Augusta, University of Maine at Farmington, University of Maine at Fort Kent, University of Maine at Machias, University of Maine at Presque Isle, University of Southern Maine).

3.6 IRB Authorization Agreement: A formal written agreement designating the IRB of record for a research project, such as a cooperative research project, that usually involves federal funding. The IRB of Record will usually be the Lead IRB, unless the institution does not have a Federalwide Assurance. Though cooperative research projects may utilize an IRB Authorization Agreement, it is not limited to such projects. For example, it can be employed by an institution receiving federal funding but without a federally registered IRB to designate an external federally registered IRB.

3.7 Institutional Official: The administrative officer at the University who is authorized to act for the institution and assume overall responsibility for compliance with the federal regulations for the protection of human subjects, and signs the Office for Human Research Protections (OHRP) Federalwide Assurance.

4.0 Responsibility:

4.1 Execution of SOP: Lead Principal Investigator, UMS IRB Staff, IRB Members, IRB Chair(s), and Institutional Official(s).

5.0 Procedures:

5.1 It is the responsibility of the lead principal investigator to seek appropriate IRB review and approval prior to initiation of any cooperative research activity.

5.2 The lead principal investigator should contact his/her local IRB to discuss IRB review and submission requirements prior to submission.

5.3 If the local IRB determines it is not appropriately qualified to act as the lead IRB (see section 6), they will contact a qualified IRB within the UMS to serve as the lead IRB for the project.

5.4 The lead principal investigator will be advised to submit to the lead IRB who will communicate with all UMS engaged sites throughout the procedure.

5.5 The lead IRB will review the project. At the time the submission is received the lead IRB chair/staff will send email notification to all UMS engaged sites IRB chair/staff and all co-investigators at each University. At this time the cooperative institutions may send a written request to the IRB of record if they would like to have an IRB member at their institution consult and provide comment on the project. These comments will be taken into consideration during formal IRB review (by the IRB of record) of the project, and must be received no later than 10 business days after the initial request is made.

5.6 The lead IRB will retain jurisdiction for all project revisions or amendments as well as continuing reviews.

5.7 The lead IRB staff and/or Chair will notify the lead principal investigator, in writing, when a determination has been made or the project has been approved. All co-investigators and relevant IRB staff and Chair(s) at the cooperative sites will be copied on the letter. The letter will explicitly outline the lead principal investigator’s obligations and terms of approval. Relevant minutes of IRB meetings will be made available to cooperative sites upon request

5.8 This policy shall not preclude any local IRB at an engaged site from investigating allegations on noncompliance, adverse events, or potential violations of relevant laws, regulations, and guiding principles in regard to the human subjects interacting or intervening with the research activities at their Institution. The lead IRB, all co-investigators and relevant IRB staff and Chair(s) at the cooperative sites will be notified of any investigations and the lead IRB will conduct an inquiry into the allegations and share its findings with all engaged sites.

6.0 Federally Funded Research:

6.1 If the project is federally funded, the institution of the lead IRB must have a Federalwide Assurance

6.2 If the project is federally funded or when otherwise required, the lead IRB will prepare an IRB Authorization Agreement prior to review of the research project. This IRB Authorization Agreement will formally designate the IRB of record, which will conduct the review for the research project. All engaged sites will be required to have their institution’s Institutional Official or otherwise delegated representative sign the agreement.

See: Policy Manual Section 601: Human Subject Research

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