Reliance (Single and Central IRBs)

The ORRC provides resources and support for studies engaging in research activities with external collaborators.

A Reliance Agreement in research is a document that allows one institution to depend on another institution’s ethics review board (IRB) for the oversight of a study. Engaging in reliance minimizes the need for duplicative IRB review while protecting the rights and welfare of human research participants. ​​​Instead of each institution conducting its own review, they agree to let one IRB manage the review process for a particular study. This can streamline the approval process and ensure consistency in the ethical oversight of the research.

Quick Links

SMART IRB
45 CFR Part 46

Definitions

  • Central IRB: An IRB of Record that is specifically established to conduct the ethical review for all sites participating in a program that usually includes more than one multi-site study. (e.g. the NCI Central IRB)
  • Collaborative Study: Human research involving more than one institution and/or site participating in the same research protocol, where each site completes a portion or portions of procedures. 
  • Cooperative Research: Human research covered by (45 CFR 46) involving more than one institution and/or site.  When conducting cooperative research, each institution and/or site is responsible for safeguarding the rights and welfare of human participants and for complying with this provision.  Any institution and/or site located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
  • IRB of Record: The IRB that is responsible for the ethical review of human research on behalf of an institution and/or site or individual investigator.
  • Lead Site: The primary awardee of a federally funded grant who is responsible for identifying the selected sIRB for cooperative research. For non-federally funded research this role is identified as the primary institution and/or site whom develops a research protocol.
  • Multi-Site Study: Human research involving more than one institution and/or site participating in the same research protocol.
  • Participating Site: An institution or site engaged in multi-site research, where a local investigator is responsible for the conduct of human research at their institution or site.
  • Relying IRB: An IRB that has designated through an agreement to cede review to an external IRB for a particular study.
  • Single Institutional Review Board (sIRB): An sIRB is the selected IRB of Record that conducts the ethical review for one or more sites participating in cooperative research.

(Unless required by the FOA or contract solicitation, you do not have to create a Central IRB. For many studies, the institutional IRB can serve as the single IRB of record).

In cases where the HU IRB is relying on another IRB for the ethical oversight of a research study, it is critical for the HU investigator to report all ongoing study activity to the HU IRB after initial approval. The HU IRB must be able to ascertain that study activity remains in adherence to institutional policies and requirements.

Reliance Agreement Processing Workflow

HU IRB is Reviewing HU IRB is Relying

Specific Single IRB Requirements

GHUCCTS IRB

The Georgetown-Howard University Center for Clinical Translational Science (GHUCCTS) IRB is a single IRB (sIRB) that was developed to review qualified collaborative human subject research projects between the  GHUCCTS member institutions. 

Please note that the GHUCCTS IRB is not a substitute for the Howard University IRB.

Howard Investigators may use the GHUCCTS IRB as the Single IRB (sIRB) for a multi-site project when EITHER of the conditions listed below are met:  

  1. The study is funded by the GHUCCTS.
  2. The study is initiated by a GHUCCTS institution other than Howard University and involves three or more GHUCCTS institutions.

Otherwise, all human subjects research projects initiated by a Howard University Investigator must be submitted to the Howard University IRB for regulatory and ethical oversight. When the GHUCCTS IRB is serving as the sIRB for a human subjects research project that was initiated by a Howard University Investigator, all research protocols and protocol updates submitted to the GHUCCTS IRB for review must also be submitted to the HU IRB to be reviewed for local context.

Nonetheless, Investigators must confirm with the ORRC before submitting any protocol to the GHUCCTS IRB.

Howard University is a member of the SMART-IRB portal supported by the National Institute of Health (NIH). Currently, over 558 institutions are registered with the platform.

The ORRC will process single IRB application [Relying or Reviewing] through the SMART-IRB portal.

To initiate an application through the portal, please follow this link: SMART IRB

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