UW Research

Letters of Support for a Single IRB

For UW lead or coordinating sites

It is UW policy that the lead PI consult with the Human Subjects Division (HSD) when selecting a single IRB. HSD will typically issue a Letter of Support documenting the UW’s willingness to use the specified single IRB (sIRB). You should keep this letter in your study files. You may choose to include it in the grant application; however, NIH does not require this. Contact HSD at hsdrely@uw.edu to request a consult. HSD recommends you begin this consult early in the grant preparation process.

Your request should include the following information. HSD cannot write the letter without this information.

  • The name of the UW PI (lead PI)
  • The name of the organization that will serve as the proposed sIRB, if already identified
  • The title of the study/grant
  • A brief description of the study (can attach a protocol or draft portions of the grant proposal)
  • The grant 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 (can attach a scope of work)
  • Whether this grant is for a single study, multiple studies and/or a network that will design and conduct studies
  • The number of participating sites, and how many are domestic vs. foreign

* If your grant commitment includes the involvement of other regional, non-UW, institutions or organizations (for example, Seattle Children’s or Northwest Kidney Centers) in obtaining consent, collecting identifiable data from research participants or conducting research procedures: Each of these organizations will need to agree to the sIRB arrangement and may need to provide their own Letter of Support for willingness to rely on a single IRB. Feel free to give them the UW Letter of Support to use as a template.

For UW participating sites

Neither NIH nor the UW require grant applications for participating sites in a multi-site study to include a Letter of Support for use of a single IRB. However, NIH does require the lead PI to “obtain confirmation” from participating sites that their institutions are willing to rely on a specific, single IRB. At the UW, this confirmation is provided by HSD, in writing (email or an emailed Letter of Support). This written confirmation should be saved by the UW participating investigator and can be provided 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. HSD cannot write the letter without this 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/grant
  • A brief description of the study (can attach a protocol or draft portions of the grant proposal)
  • The grant 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 (can attach a scope of work)
  • Whether this grant is for a single study, multiple studies and/or a network that will design and conduct studies

For non-UW participating sites

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-site study. It can be provided to non-UW investigators participating sites to assist them in obtaining confirmation that their institution is willing to rely on a single IRB. Note that NIH does not require these Letters of Support to be attached to the grant application.

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-site 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,