UW is a Participating Site
A participating site in multi-site research is under the control of a local investigator of that site. The local investigator (also called the participating site investigator) is responsible for conducting the study protocol at that site. Participating sites typically receive subawards or subcontracts from the lead site, which is the site that receives the grant or contract directly from NIH. The requirements and responsibilities of a participating site vary with each study phase.
Grant or contract application
The NIH Single IRB (sIRB) policy requires the lead PI to identify the sIRB in the grant application and to 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.
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. HSD cannot provide confirmation 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
After assessing the acceptability of the proposed IRB, HSD will provide the UW participating site investigator with an email or emailed letter of support. This should be retained for study records. If desired, a copy can be provided to the lead PI.
If your grant commitment includes the involvement of 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 to provide the lead PI with confirmation of the agreement.
NIH requirements. There are two requirements:
- Provide the lead (overall) PI with confirmation that the UW is willing to rely upon the specific single IRB identified by the lead PI. NIH does not specify how to do this. HSD will provide you with an email communication or emailed letter of support that you can use for this purpose, if you wish.
- Fill out the grant application forms as required by NIH. See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
Study set up
The sIRB reliance agreement
The HSD Letter of Support provided to you for the grant 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 single IRB. The reliance agreement documents the arrangement and also 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. Note that 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 University 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 single IRBs. If the lead site, coordinating center, or single IRB asks you for local context information (for example, by sending you a form or webpage to complete), contact HSD for help at email@example.com.
Address other regulatory issues
The single IRB (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 single IRB. 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 for the UW
- 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:
- 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 review 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.