Human Research Protection Program

The purpose of this SOP is to set forth the determination process used by the Brandeis University Institutional Review Board in its decision to cede review or become the IRB of record when human subjects research is being conducted by a Brandeis University investigator in collaboration with a non-Brandeis University investigator.

This SOP applies to collaborative human subjects research projects conducted under the auspices of Brandeis University.

Assured Institution

An institution with an institutional review board working under a federalwide assurance  negotiated with the Office for Human Research Protections of the National Institutes of Health.

Cede Review

Refers to an agreement whereby one assured institutional review board relinquishes its oversight responsibilities to a second institution's assured IRB for collaborative human subjects research between investigators at both institutions.

Collaborative Research

Refers to human subjects research conducted by an investigator at an institution with an assured institutional review board and an investigator not affiliated with this same institution.

Independent Investigator

A collaborating investigator who is not acting under the auspices of an assured institution.

Individual Investigator Agreement

A formal written agreement in which an assured institutional review board agrees to serve as the IRB of record for collaborative human subjects research between an investigator at its institution and an independent investigator.

IRB Authorization Agreement

A formal written agreement in which an assured institutional review board agrees to serve as the IRB of record for collaborative human subjects research between an investigator at its institution and a collaborating investigator at another institution with an assured institutional review board.

IRB of Record

An agreement whereby one institution's assured institutional review board assumes oversight responsibilities of another institution's assured IRB, or an independent investigator.

Joint Review

When the assured institutional review boards of two or more institutions with investigators participating in collaborative research retain oversight of the portion of a research project in which their investigator is engaged.

It is the standard operating procedure of Brandeis University that when a Brandeis University investigator collaborates with a non-Brandeis University investigator, the Brandeis University Institutional Review Board may agree to become the IRB of record, may cede review to the IRB of the collaborating investigator's institution or may retain oversight of only that portion of the research in which the Brandeis University investigator is engaged.

When conducting collaborative research, the Brandeis University investigator must communicate with the Brandeis IRB and clearly delineate the portion of the research each investigator — both Brandeis University investigator and non-Brandeis University investigator — will be conducting. After confirming that both Brandeis University and non-Brandeis University investigators are engaged in the research, the Brandeis University IRB has three options:

1. The Brandeis University IRB agrees to joint review of the research with the assured IRB of the collaborating investigator’s institution.
2. The Brandeis University IRB agrees to become the IRB of record for the complete research project.
3. The Brandeis University IRB agrees to rely on the assured IRB of the collaborating investigator's institution.

Conducting Collaborative Research With an Investigator at an Assured Institution

When a Brandeis University investigator is conducting collaborative research with an investigator at an institution with an assured institutional review board, the Brandeis University IRB, in conjunction with the IRB of the collaborating investigator's institution, will determine whether joint review of the research is appropriate or whether one institution's IRB will cede review to the IRB of the collaborating investigator's institution, which then becomes the IRB of record. This decision is based on a number of factors, such as:

• The level of risk to subjects associated with the research.

• If funded, which institution is the prime recipient of the funding.

• If funded, whether the funder specifies which IRB is to act as the IRB of record.

• If a multisite project, whether one institution is coordinating the research.

• If the research is subject to the NIH Single IRB (sIRB) policy for multisite research (NOT-OD-16-094).

• The components of the research being conducted at each institution.

• If the majority of contact with research subjects is at one institution.

• If one institution's IRB has more appropriate experience and expertise to review the research.

• If one IRB does not feel it has sufficient understanding of the context in which the research is being conducted.

When the Brandeis University Institutional Review Board agrees to either cede review or serve as the IRB of record, a formal IRB Authorization Agreement is required and must be in place naming the Brandeis University IRB as IRB of record, or stipulating that the Brandeis University IRB cedes oversight to the IRB of the collaborating investigator's institution.

If both institutions agree to joint review, the two IRBs will collaborate to ensure those aspects of the research that depend on both IRBs' approval (such as recruitment or consent procedures and materials) will meet the approval of both IRBs.

Conducting Collaborative Research With an Independent Investigator

When conducting collaborative research with an independent investigator, Brandeis University must enter into an Individual Investigator Agreement with the independent investigator naming the Brandeis University Institutional Review Board as the IRB of record.

It is the responsibility of the Brandeis University investigator to bring to the attention of the Brandeis University Institutional Review Board administrator that they will be collaborating with an independent investigator.

The U.S. government Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) contains the following requirements involving research collaborations:

1. Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, reach institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. [§46.114 (a)]

2. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single institutional review board for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research. [§46.114(b)(1)]

3. The following research is not subject to this provision:

   • Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) [§46.114(b)(2)(i)]

   • Research for which any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. [§46.114(b)(2)(ii)]

4. For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB or make similar arrangements for avoiding duplication of effort. [§46.114 (c)]