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U-M Authorization Agreement Process Reference
U-M Authorization Agreement Signatory
Lois Brako, Ph.D.
Assistant Vice President for Research-
Regulatory and Compliance Oversight
University of Michigan
1600 Huron Parkway
Ann Arbor, MI 48109-2800
U-M Study Team Requirements
Work with the applicable U-M IRB to:
Confirm with the external collaborator/institution that an authorization agreement may be used in place of duplicative IRB approval
Obtain the information necessary to prepare the agreement
Facilitate the signature process with the external collaborator
An Authorization Agreement (also referred to as a Collaborative Agreement or Reliance Agreement) may be used under certain circumstances to document the cedeing of IRB oversight to a particular IRB when a human subjects study has external collaborators engaged in the conduct of the research.
Working with External Collaborators
The U-M IRBs have regulatory oversight responsibility for the human subject research activities of U-M faculty, students, and staff. The research activity of an external collaborator engaged in a U-M human subjects study must also be reviewed by either the:
- IRB at the collaborator's institution, or
- Applicable U-M IRB
An Authorization/Collaborative Agreement may be established between the parties to cede regulatory oversight to one of the IRBs as the IRB-of-Record. This same process may be used when a U-M investigator engages in human subjects research as an external collaborator.
If two or more federally-assured institutions collaborate on human subjects research supported by a Common Rule agency, the institutions may rely on a single IRB (an "IRB-of-Record") for review and continuing oversight of the research, in order avoid duplicate review. ~ National Academies: Federal Demonstration Partnership (FDP)
U-M investigators should not initiate an Authorization/Collaborative Agreement with another institution without first checking with the applicable U-M IRB (see contact information below) to:
- Verify that the collaborator's research activity meets the definition of "engaged" in research
- Identify the appropriate type of IRB agreement
- Facilitate the signing of the agreement by U-M's Institutional Official, as applicable. At U-M, signatory responsibility is delegated to the Assistant Vice President for Research – Research Policy and Compliance.
- Implement and manage the agreement
IRB staff may request changes to the listed study team members on the IRB application in eResearch based upon their initial review of your request for an agreement.
1. IRB Authorization Agreement (IAA)
An IAA is an agreement between U-M 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 U-M or the other institution). The IAA is signed by the Institutional Officials at each institution.
2. Individual Investigator Agreement (IIA)
An IIA is an agreement between U-M and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects. The IIA is signed by the:
- Individual investigator
- U-M Principal Investigator (PI)
- U-M Institutional Official (federally-sponsored projects) or IRB Chair (all other sponsors)
3. Collaborating Institution Agreement (CIA)
A CIA is an agreement between U-M 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, 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 U-M Institutional Official.
If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:
1. Is it research?
Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge ~ Federal definition, 45 CFR 46.102(l)
- Systematic investigation is an activity designed to test a hypothesis and to draw conclusions as described in a formal protocol that sets forth an objective and procedures to reach that objective.
- Activities such as the practice of public health, medicine, counseling, or social work are not research.
- Generalizable knowledge is information expressed in theories, principles, and statements of relationships that can be widely applied (e.g, by publishing findings or presenting findings at a professional meeting).
- Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.
2. Does the research involve human subjects?
Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens. ~ Federal definition 45 CFR 46.102(e)(1)
3. Is the university engaged in the conduct of the research?
The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities. See OHRP's Guidance on Engagement of Institutions for more information and examples.
- Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.
- If you answer "no" to any of these questions, you may have other obligations than IRB review. See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.
A study team needs to document IRB oversight of an external collaborator when:
- The project involves IRB-regulated research (i.e., project is reviewed by the full board or expedited review process), and
- The external collaborator is engaged in the conduct of human subjects research (e.g., obtain informed consent from subjects, interact or intervene with subjects as part of the research, obtain or analyze personally-identifiable subject data)
- Exempt or non-regulated projects are not considered IRB-regulated research; therefore documentation of IRB oversight for external collaborators is not required.
- Collaborators are not considered "engaged in research" if they do not interact with subjects or the identified data, analyze deidentified data only, or assist with recruitment only. For more information," see the OHRP Guidance on Engagement of Institutions in Human Subjects Research.
- When the collaborating institution is unwilling to cede IRB oversight to U-M or U-M is unwilling to serve as the collaborator's IRB-of-Record.
- When the interaction/intervention with the human subjects is taking place at the collaborator's institution, the U-M may determine that IRB review at the collaborator's institution is necessary.
References and Resources
U-M INSTITUTIONAL REVIEW BOARDS (IRBS)
IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)