4. External IRB and Independent Investigator Agreements

Updated July 1, 2019

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The University considers an external IRB to be any IRB that is not the University IRB (i.e., the local IRB*) including:

  • Independent IRB: a review board that is not owned or operated by the research organization for which it provides review services; an independent IRB may or may not charge for these services.
  • Central IRB: an IRB that provides review services for multiple sites participating in a clinical trial.

* Local IRB: an IRB that provides review only for the researchers of its organization. (For the University, this includes researchers at its Affiliate sites.)

NOTE: An independent IRB may act as a central IRB for multisite trials. However, the role of a central IRB can be filled by an institutionally based IRB or by a regional IRB formed by a consortium of institutions.

Independent investigators include individuals who are affiliated with a non-University entity (i.e., external/outside organization, business, or agency) that does not have an IRB.

Agreement Requirements for Exempt Human Subject Research

For research that is exempt under 45 CFR 46.101, item (b), the University requires one of the following processes for review/approval of exempt research:

  1. University or Affiliate investigators planning to conduct exempt research at or on behalf of an external institution with an Federalwide Assurance (FWA) must obtain both an exempt determination from the external institution and acknowledgement from RI or vice versa. (For submission processes, see the exempt research section in the IRB policy for using an external IRB.)
  2. Independent investigators planning to conduct exempt research at or on behalf of an institution that does not have an FWA may submit a Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption (available from the FORMS page of the OHRP website) for review and exempt determination by the RI. (For details, see the exempt research section in the IRB policy for external investigator to use the University IRB).

Types of IRB and Investigator Agreements for Non-Exempt Human Subject Research

Federal regulations require written agreements between/among institutions when IRB review and oversight of non-exempt research is not provided by the investigator's home institution.

Templates for all three types of agreements are available in the Researcher and Committee Member Libraries in IRBNet. The RI will prepare or assist the investigator in preparing IAA and Independent Investigator Agreements and obtaining the requisite signatures of the two Institutional Officials. The University templates specify responsibilities for the participating sites (including the University) that are relevant to the protection of human participants. Therefore, the University IRB prefers investigators use its templates but on a case-by-case basis may allow use of the external site's IAA or the investigator's agreement form, or the applicable OHRP form for IRB Authorization or Individual Investigator Agreement available online.

IRB agreements may apply to one or more specific projects; to select aspects of a project; or to all projects conducted by a single investigator or overseen by a specific IRB. The agreement should specify research to which it applies.

The University has existing IAAs with institutions whereby the University IRB is the IRB of Record. The University considers these Affiliate Institutions. Investigators from Affiliate Institutions follow the same submission requirements as University investigators. For a list of University Affiliates, see IRB policy for designation of IRBs.

The University also has existing, open-ended IAAs with institutions whereby the external institution's IRB, or either the University or the External IRB is designated as the IRB of Record. (For a list of institutions with existing IAAs, see IRB policy for designation of IRBs). University/Affiliate PIs planning use the IRB at one of these institutions do not need to obtain a new IAA but must comply with IRB policy to use an external IRB.

When an IRB Authorization Agreement Is Required for Non-Exempt Research

The University requires an IAA when University or Affiliate investigators, students, or staff will be engaged* in non-exempt human subject research under one or more of the following conditions.

  • The research will be conducted at an external site and the site's designated IRB will be the IRB of Record.
  • The research will be conducted at an external site and the University IRB will be the IRB of Record.
  • The research will be conducted at multiple sites and the sponsor requires that investigators use a designated central or independent IRB.
  • The University receives a direct federal award to conduct human subject research and activities involving human subjects are carried out by a subcontractor at an external site and an external IRB specified by the subcontractor is the IRB of Record.
  • Research for which the University/Affiliate PI is the Lead Researcher will be conducted at multiple sites and involves external investigators and the external IRBs agree to cede review to the University IRB.

*See online Policy Manual Definitions for engaged in non-exempt human subject research.

When an Independent Investigator Agreement Is Required for Non-Exempt Research

In Independent Investigator Agreement is required when an individual wishes to conduct human subject research at or on behalf of an external entity that does not have an IRB, and she/he wants the University IRB to be the IRB of Record.

Requesting an IAA or Independent Investigator Agreement

University/Affiliate investigators planning research that requires an IAA with an external IRB, and independent investigators requiring an Independent Investigator Agreement should contact the RI for development of the appropriate agreement.

Management of IAAs and Independent Investigator Agreements

Before entering into an IRB Authorization Agreement (IAA) with an external IRB as the IRB of Record, the RI Director or senior staff will review the external IRB's policies and procedures for compliance with AAHRPP standards. The external institution must provide copies or share web access if the IRB policies/procedures are not a public resource.

When an institution without an IRB receives support from the Department of Health and Human Services (DHHS) for research involving human subjects, federal regulations and University policy require the institution to obtain a Federalwide Assurance (FWA). See DHHS flow chart for obtaining an FWA and registering or relying on an IRB. The University will verify the FWA before finalizing the agreement.

If an IAA or Independent Investigator Agreement is denied, RI staff will notify the researcher who initiated the request and if applicable, the external IRB or institution.

RI staff maintain electronic versions of all fully executed IAAs and Independent Investigator Agreements for three years after project closure. When an agreement applies to a project/package in IRBNet, RIO staff add the fully executed agreement to the project/package as a Board Document.