UW is a Participating Site
A participating site in multi-institutional research is typically under the control of a local investigator at that institution. The local investigator (also called the participating site investigator) is responsible for conducting the study at that location. Participating sites may receive subawards or subcontracts from the lead institution, which receives the grant or contract directly from a federal agency, or they may receive their own award directly from a federal agency. The responsibilities of a participating site under single IRB (sIRB) review vary with each study phase.
Grant or contract application
NIH Single IRB (sIRB) Policy
The policy requires the lead PI to include a Single IRB Plan in the funding application. This plan must name the sIRB to be used and state that confirmation has been obtained from each participating site that the site is willing to rely upon the identified sIRB. To provide that confirmation, a UW participating investigator must first obtain HSD’s written willingness to rely on the sIRB. HSD is the only office that can make this commitment on behalf of the UW.
Common Rule Mandate
The Common Rule does not specify that information about single IRB review be present in any funding applications, and non-NIH funding agencies have not issued guidance about their requirements. The Common Rule does indicate that some funding announcements may have specific instructions about how to describe IRB review. The PI should follow any instructions given. Although funding agencies have not issued guidance requiring funding proposals to document sites’ agreement to the single IRB arrangement, HSD strongly recommends that PIs obtain this confirmation from HSD at the time a funding proposal is submitted to the agency in order to avoid delays at the time of funding. HSD cannot guarantee that UW can rely on other IRBs if HSD has not been consulted in advance.
UW Requirements and Process
Contact HSD at least one week in advance to request confirmation that the UW is willing to rely on the sIRB selected by the lead site. To make the request, email the following information to firstname.lastname@example.org.
- 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 sIRB
- The title of the study/funding proposal
- A brief description of the study (can attach a protocol or draft portions of the grant proposal)
- 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 (can attach a scope of work)
- Whether this request is for a single study, multiple studies and/or a network that will design and conduct studies
After assessing the acceptability of the proposed IRB, HSD will typically provide the UW participating site investigator with a letter of support. This should be provided to the lead PI and retained for study records.
If your funding commitment includes the involvement of 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 to provide the lead PI with confirmation of the agreement.
Study set up
The sIRB Reliance Agreement
HSD’s letter of support for the funding application is not an IRB reliance agreement. After the grant is awarded or as part of Just-in-Time, HSD must negotiate and sign a formal written agreement with the sIRB. The reliance agreement documents the arrangement and establishes expectations about communication, reporting, and procedures. HSD is the only office authorized to do this on behalf of UW researchers.
UW already has several established reliance agreements with other institutions. This does not mean that the reliance agreement process is completed. A short, study-specific agreement is usually required – but it can be accomplished quickly when HSD has all of the necessary information.
How to Initiate the Reliance Agreement Process
Follow the instructions to Ask for Non-UW IRB using Zipline. As part of your submission you will need to provide a copy of the protocol, template consent materials and any documents you receive from the reviewing IRB that are to be filled out by the UW IRB office (sometimes called the HRPP office). You may need to contact the reviewing IRB or lead site in order to obtain these.
Local Context Information for the sIRB
Local context information is information about state laws and mandatory UW policies that is important for the sIRB to know when it reviews the UW site. For example, Washington State laws affect the elements that must be included in a HIPAA authorization form for access to healthcare records as well as the age at which individuals under the age of 18 are considered able to consent to research (i.e., without requiring parental permission).
There is currently no national standardization or consistency in what and how local context information is provided to sIRBs. If the lead site, coordinating center, or sIRB asks you for local context information (for example, by sending you a form or webpage to complete), contact HSD at email@example.com.
Address Other Regulatory Issues
The sIRB (or coordinating center or lead site) may require you to provide documentation related to other regulatory requirements, if they are relevant to the research and its IRB review. This is the responsibility of the UW researcher, not HSD. Examples include:
- Any relevant Financial Conflict of Interest Management Plan
- Documentation of completed human subjects training for all key personnel
- Documentation of completed GCP (Good Clinical Practice) training for all key personnel
- Radiation Safety approval
- Institutional Biosafety (IBC) approval
Apply for IRB Approval
Each participating site must apply for the approval of the sIRB. There is currently no national standardization or consistency regarding who prepares and submits the IRB application for each participating site – it could be the local PI (you), the lead site, or the coordinating center. The lead site or coordinating center will inform you:
- Who should prepare and submit the IRB application on behalf of the UW site
- If it is you: what application forms and submission system you should use
- If it is not you: what information you will need to provide to the individuals preparing the application for the UW site
During the study
The UW participating site PI is responsible for following the policies of the sIRB. This includes using the sIRB forms and processes (or assisting the lead site with them), following the sIRB reporting requirements about unanticipated problems and other issues, and complying with the stipulations of the sIRB’s approval.
UW participating site PIs are also responsible for:
- Providing HSD with a copy of the sIRB’s approval for the UW site via email at firstname.lastname@example.org.
- Ensuring that any relevant financial conflicts of interest are disclosed to the sIRB and that conflict of interest management plans issued by the Office of Research are given to the sIRB.
- Obtaining any required ancillary reviews and approvals and providing the results of these reviews to the sIRB if requested.
- Making copies of sIRB approvals available for inspection by monitors and auditors.
See the External IRB Checklist for UW Researchers for a detailed list of responsibilities.