U-M Research & Compliance

Authorization Agreement Process

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.

U-M Authorization Agreement Process Reference

HRPP Operations Manual, Part 5, Section IV

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.

Common Rule

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 Study Team Requirements

Work with the applicable U-M IRB to:

  • Facilitate the signature process with the external collaborator
  • Obtain the information necessary to prepare the agreement
  • Confirm with the external collaborator/institution that an authorization agreement may be used in place of duplicative IRB approval

Agreement Process

U-M investigators should not initiate an Authorization/Collaborative Agreement with another institution without first checking with the applicable U-M IRB 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. 

IRB Agreement Types

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.  

 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:

  • U-M Institutional Official (federally-sponsored projects) or IRB Chair (all other sponsors)
  • U-M Principal Investigator (PI)
  • Individual investigator

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.

FAQs

A study team needs to document IRB oversight of an external collaborator when:

  1. The project involves IRB-regulated research (i.e., project is reviewed by the full board or expedited review process), and
  2. 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)  

Notes:  

  • 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.

A study team needs to document IRB oversight of an external collaborator when:

  1. The project involves IRB-regulated research (i.e., project is reviewed by the full board or expedited review process), and
  2. 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)  

Notes:  

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.

Exempt or non-regulated projects are not considered IRB-regulated research; therefore documentation of IRB oversight for external collaborators is not required.

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.

Caveats:

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.

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.  

References and Resources

IRB Authorization Agreement Flowchart

Flowchart to identify when an IRB Authorization Agreement between U-M and other institutions or non-UM investigators is warranted.

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

Questions?

U-M Institutional Review Boards (IRBS)

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)
Phone:  734-936-0933
Email:  [email protected]
IRB-HSBS Website

IRBMED
Phone:  734-763-4768
Email:  [email protected]
IRBMED Website

Related Information

U-M Federal Wide Assurance

FWA 00004969

Expiration date changes frequently.  Look up the current date on the OHRP web site (enter U-M FWA #).

Working with Central (Commercial) IRBs

For information about ceding IRB oversight for industry-sponsored, late-phase clincial trials, see IRBMED’s Single IRB (sIRB) web page.