Collaboration and Agreements

What is an Institutional Authorization Agreement (IAA)?

Federally-funded cooperative (i.e, "multi-site") human research studies are required per the Common Rule (45 CFR 46.114) to utilize a single IRB-of-Record (sIRB) to streamline the review process for human participant protections and to avoid duplicate review by an institutional review board at each site. Although not required, collaborative projects that are non-federally funded, or unfunded may also use the sIRB mechanism, to eliminate duplicate IRB review.

Under the sIRB model, an IRB at one of the collaborating institutions agrees to provide IRB oversight for all participating institutions via an authorization agreement (a.k.a. "reliance" or "collaborative" agreement) or a commercial IRB is contracted to provide the oversight functions for the project. These agreements/contracts document the respective authority, roles, responsibilities, and communication plans among the IRB-of-Record (i.e., the "reviewing IRB") and the institutions relying on that IRB (i.e., "relying site" and "relying IRB") for project oversight.

At Florida Atlantic, authorization agreements are negotiated and officially signed by the HRPP and Institutional Official (IO). No one on the study team (or at the Florida Atlantic IRB) has the authority to negotiate or sign an Institutional Authorization Agreement (IAA). Refer to Florida Atlantic Division of Research Policy 10.3.18, “Institutional Authorization Agreements (IAA) and Reliance Agreements" for additional details and requirements.

When to Use a Single IRB (sIRB)

An Authorization Agreement (also referred to as a Collaborative Agreement or Reliance Agreement) may be used under certain circumstances to document the ceding of IRB oversight to a particular IRB when a human subjects study has external collaborators engaged in the conduct of the research.

Agreement Types:

IRB Authorization Agreement (IAA)

An IAA is an agreement between Florida Atlantic and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) receiving funds from HHS must have an FWA. This agreement type is used to establish the IRB of Record (whether that's Florida Atlantic or the other institution). The IAA is signed by the IOs at each institution.

Individual Investigator Agreement (IIA)

An IIA is an agreement between Florida Atlantic and an individual collaborator who is not affiliated with an institution that has a FWA. Examples of when to use an IIA would be former student working after graduation with their faculty mentor, professional in the community with specific expertise, or community partners. This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects. The IIA is signed by:

• Individual investigator
• Florida Atlantic Principal Investigator (PI)
• Florida Atlantic Institutional Official

Collaborating Institution Agreement (CIA)

A CIA is an agreement between Florida Atlantic and an institution/organization that does not have an FWA. This agreement type is typically used for non-federally sponsored research projects involving multiple collaborators who are affiliated with the organization (e.g., research assistants affiliated with a non-profit agency, private providers, teachers offering educational interventions in a public school). It outlines the responsibilities of the collaborating institution for the protection of human subjects. A CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the Florida Atlantic IO.

Using SMARTIRB

Florida Atlantic is a participant in SMARTIRB. This NIH sponsored initiative serves as a submission and communications platform for projects using a single IRB. Projects do not require NIH funding to use this platform. The Florida Atlantic HRPP staff can provide guidance on how to use the system.

Using a Commercial IRB

Florida Atlantic's Division of Research uses the services of commercial IRBs as an additional resource for overseeing specific types of research.

• Industry-sponsored clinical trials involving drugs, biologics, devices (FDA-regulated)*
• Investigator-initiated clinical trials involving drugs, biologics, devices (FDA-regulated)*
• Certain multi-site studies.

Florida Atlantic has agreements with WCG IRB Connexus (WIRB) and Advarra.

Commercial IRBs are fee-based and submissions must first be approved by the Division of Research. Some federal granting agencies do not allow grantees to bill for IRB fees and charge direct costs. These studies may not be eligible for submission or you may need to identify an administrative source of funding for IRB fees. When planning your budget, make be certain to include IRB fees as direct charges and plan enough funds to cover all submissions including initial reviews, amendments, continuing reviews, and other actions during the life of the study. Please contact The Office of Sponsored Programs for additional assistance regarding budgeting for IRB fees.

*Current Florida Atlantic practice does not allow for Phase 0 or Phase 1 clinical trials, regardless of sponsor.

Guidance and Resources

OHRP GUIDANCE

Engagement of Institutions in Human Subjects Research : HHS definitions and examples of human subjects research terminology

Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement

FLORIDA ATLANTIC RESOURCES

Collaborator Agreements: Selecting the Right Agreement for Your Project