Multi-Site Research and Single IRB of Record (sIRB)

NIH: Effective for multi-site grant applications with due dates January 25, 2018 and beyond

DHHS: Effective as of January 20, 2020 – the single IRB-of-Record (sIRB) review requirement for all cooperative research projects sponsored by one of the federal Common Rule agencies.

Federally-funded cooperative (i.e., multi-site) human subjects research studies are required per the Common Rule (45 CFR 46.114)  to utilize a single IRB-of-Record (sIRB) to streamline the human subject/participant protections review process and avoid duplicate review by an institutional review board at each site.

Under the sIRB model, an Institutional Review Board (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).  This legal contract documents the respective authorities, roles, responsibilities, and communication plans among the IRB-of-Record (i.e., the “reviewing IRB”) and the institutions relying on that IRB for project oversight.  At UNCG, authorization agreements are signed by UNCG’s Office of Research Integrity Director.

  The reviewing IRB centrally handles the IRB review functions only.  Related local functions, such as ancillary committee reviews (e.g., conflict of interest review, verification of completed human subjects protections training) remain with the individual participating institutions.  The conduct and reporting of the research remain the study team’s responsibility.

UNCG Considerations

  Study Teams – Always contact the UNCG IRB to discuss the sIRB options before you begin a funding application for a multi-site study involving human subjects research!

The UNCG IRB requires lead time to evaluate whether UNCG IRB can serve as the IRB of record (see criteria below).

If requesting a UNCG IRB to be the IRB-of-Record, contact the IRB at least 8 (eight) weeks prior to the grant application submission date. If requesting UNCG IRB to cede IRB oversight to an external IRB, contact the IRB at least 3 (three) weeks prior to the grant application submission date.

When will UNCG IRB act as the IRB of Record?

The UNCG IRB evaluates serving as the IRB of record on a case-by-case basis based on whether they can effectively serve as the IRB of record for a proposed multi-site project or if an external IRB should be used. The main evaluation criteria are:

  • Whether the UNCG PI is the direct recipient of the federal grant
  • The risk level to the human subjects
  • At which site the majority of data collection will take place
  • The number of collaborating institutions and the research activity to be conducted by those institutions
  • The experience level of the UNCG PI/study team
  • The involvement of the UNCG PI/study team

  UNCG is a member of the SMART IRB organization, whose 600+ member institutions have agreed to streamline the process to cede review authority to an IRB of record by applying standard terms and conditions through the use of a common reliance agreement.  When applicable, the UNCG IRB will utilize the SMART IRB reliance agreement template and processes to facilitate the establishment of an IRB of record for a project.

The UNCG IRB reserves the right to decline being the IRB of record on any project but will provide support to the UNCG study teams to locate an external IRB to act as the IRB of record.

Study Team Process

Funding Proposals

For NIH-funded multi-site research, the study team must designate the IRB of record as part of the grant application at the time of proposal submission.  If the IRB of record charges an IRB review fee, please consult with your Grants Specialist as to how this should be budgeted.

  Some institutions (both healthcare and academic) charge IRB review fees.  Commercial IRBs post their rates on their websites.  Some academic IRBs may also charge a fee.

Please note, a collaborating institution charging an IRB review fee does not determine whether UNCG will serve as the IRB of record. See the criteria for UNCG serving as the IRB of record above.

  Reminder:  Contact the UNCG IRB eight weeks prior to the proposal submission date to determine whether UNCG IRB can act as the IRB of record for the project or whether UNCG will rely on another IRB for oversight.

When UNCG is the IRB of Record

The IRB application process is as follows:

  • Begin the IRB application at UNCG
  • Respond “yes” to screening question #4 – this will trigger the Multi-site Information section
  • Respond “yes” to question #3 in the multi-site section – complete the remainder of this section
  • Complete the remainder of the study application and submit
  • The study team must provide the IRB office contact information for the collaborating institutions in the study application (if you have not done so already)
  • The UNCG IRB office will contact the IRB offices at the collaborating institutions about a reliance agreement

When ceding IRB review to an external IRB

The IRB application process is as follows:

  • Login to IRBIS using your UNCG Credentials (IRBIS login can be found at: http://research.uncg.edu/sera/)
  • Once logged in, click “new study” in the upper left-hand corner of the IRBIS homepage
  • Begin a new study application
  • Fill in the general information sections 1-3 as normal
  • In general information section 4 (screening questions), respond “yes” to question 4 – this will trigger the multi-site section
  • Respond to the multi-site questions 1-3 as appropriate for your study, then respond to question 4 as follows in order to trigger the abbreviated application:
  • Multi-site Question #4. Is UNCG taking or being asked to take responsibility for the oversight of research by individuals, groups or organizations outside of UNCG (e.g., as   lead site, study headquarters or IRB of record for other sites)? RESPOND “NO”
  • Are you requesting that UNCG rely on an external IRB for continuing review and   approval of this study? RESPOND “YES”
  • The study team must provide the IRB office contact information for the collaborating institutions in the study application
  • The UNCG IRB office will contact the IRB of record about a reliance agreement (if the collaborating office has not already been in contact)

 

**Questions regarding the information on this page can be directed to Melissa Beck (mdbeck@uncg.edu / 336-256-0253)