Letters of Support for a Single IRB

NIH and other funding agencies will require that the lead PI provide the name of the selected the single IRB (sIRB) as part of the funding process. In most cases, investigators are not authorized to commit an institution to rely on a particular IRB or for that institution to serve as the sIRB, instead that commitment must come from the institution’s IRB office, or other research regulatory office or official.

At UW, this agreement is made by HSD, typically in the form of a letter of support. Although NIH and other funding agencies do not require letters of support, HSD recommends obtaining letters of support from non-UW institutions as a best practice.

Contents

For UW lead or coordinating sites

It is UW policy that the lead PI consult with HSD when selecting a non-UW single IRB (sIRB) or when identifying the UW IRB as the sIRB in a funding proposal. HSD will typically issue a letter of support. You should keep this letter in your study files. You may choose to include it in the funding application; however, funding agencies do not require this. Contact HSD at hsdrely@uw.edu to request a consult. HSD recommends you begin this consult early in the funding proposal preparation process.

Your request should include the following information:

  • The name and titles of the UW PI (as you would like it to appear on a letter)
  • The name of the non-UW organization that will serve as the proposed sIRB, or your request that UW serve as the sIRB
  • The title of the study/funding application
  • A brief description of the study (attach a protocol or draft portions of the grant proposal if available)
  • The funding application deadline
  • A copy of or link to the Request for Applications (RFA) or Funding Opportunity Announcement (FOA)
  • What role(s) the UW will play in the research (attach a draft scope of work if available)
  • Whether the proposal is for a single study, multiple studies and/or a network that will design and conduct studies
  • Whether the study(ies) will be conducting under an IND or IDE
  • A confirmation that the study (including all relying institutions) will comply with UW’s Diversity in Clinical Trials policy
  • The number of participating sites, and how many are domestic vs. foreign

For UW participating sites

It is UW policy that the UW PI consult with HSD in order to obtain confirmation that UW will rely on the sIRB selected by the lead PI. HSD will typically issue a letter of support. You should keep this letter in your study files and provide it to the lead PI for inclusion in the grant application at their discretion. Contact HSD at hsdrely@uw.edu to request a consult at least three days before you need confirmation.

Your request should include the following information.

  • The name of the UW site investigator (site PI)
  • The name of the lead PI and the lead site
  • The organization that will serve as the proposed sIRB
  • The title of the study/funding application
  • A brief description of the study (attach a protocol or draft portions of the grant proposal if available)
  • The funding application deadline
  • A copy of or link to the NIH Request for Applications (RFA) or Funding Opportunity Announcement (FOA)
  • What role(s) the UW will play in the research (attach a draft scope of work if available)
  • Whether this funding application is for a single study, multiple studies and/or a network that will design and conduct studies

For non-UW participating sites

Most universities, academic medical centers, and research institutes have their own processes to request their confirmation that they are willing to rely on the selected sIRB. Investigators should follow those processes.

For other institutions, this template has been created for the convenience of UW investigators who will be the lead investigator for a lead or coordinating site for a multi-institutional study. It can be provided to non-UW investigators to assist them in obtaining confirmation that their institution is willing to rely on a sIRB.

Instructions

  • Insert the indicated information in the template below and send to the non-UW investigator.
  • The non-UW investigators provide it to the appropriate office at their institutions for review and signature on their institutional letterhead.
    • For institutions with an IRB: The IRB office should sign it.
    • For institutions without an IRB: The letter should be signed by a compliance office or other person with authority to sign on behalf of the institution.
  • The non-UW investigator provides a scanned copy to the UW PI.

Template

Date

Name of Participating Site PI
Title
Department / Division
Institution

RFA Number and Title

Dear [INSERT NAME OF PARTICIPATING SITE PI],

I am pleased to write this letter in strong support of a grant application proposing that [INSERT NAME OF INSTITUTION] will become one of the study sites for [CHOOSE ONE: a multi-institutional human subjects study OR a research network/consortium] called [INSERT NAME OR TITLE] that will [INSERT BRIEF DESCRIPTION]. The research will be led by [INSERT NAME OF UW PI] at the University of Washington.

Reliance upon a single IRB. This letter confirms the willingness of [INSERT NAME OF PARTICIPATING INSTITUTION] to rely on another IRB for the review of your activities. [CHOOSE ONE: I understand that [INSERT THE NAME OF THE IRB] is likely to serve as the single IRB for this research, and we are willing to rely upon their review. OR I understand that the single IRB will be identified later by NIH and the lead PI].

Sincerely,