Before a participating site (pSite) can be added to a study in the Huron IRB system, the parent study must be designated as multi-site or collaborative research during the study’s initial review or during a modification review. A pSite may then be added through a submission that is linked to the parent study. 

On the study SmartForm, indicate if the study is a multi-site or collaborative research study, then select "Yes" to the question "Will your IRB act as the single IRB of record for other participating sites?" Complete the rest of the SmartForm and attach all required materials. Participating sites are added separately by executing the "Add Participating Site" activity. The PI can submit the SmartForm by clicking the "Submit" activity. The participating sites will not be able to reach final approval (i.e., be declared active) until the Ohio State initial main application is approved. 

External site personnel (who rely on Ohio State as the IRB of record) should not be listed in the Huron IRB system. Relying sites are responsible for ensuring that their study personnel are locally approved and have completed local training and conflict of interest reporting requirements.

Although the sIRB mandate streamlines IRB review, it does not eliminate the participating institutions’ many other responsibilities for oversight of human subjects research. Each institution remains responsible for:

• researcher training
• conflict of interest disclosures
• HIPAA
• conducting ancillary reviews such as IBC or radiation safety
• compliant research conduct
• maintaining oversight with respect to state and local laws and other institutional policies

Communication Plan

Consistent communication between the lead site and all participating sites is the key to successfully conducting a multi-site or collaborative research study. The NIH policy allows awardee institutions to decide who will be responsible for managing communications to the participating sites. Whoever is responsible for communication will require processes to manage and document the exchanges. Some institutions have IRB systems that automatically send notices of approval and updates to all sites. Most academic institutions do not have IRB systems capable of this level of communication. Ohio State’s Huron IRB system is not structured to enable external sites to submit event notices or receive approval notifications. Instead, the responsibility lies with the principal investigator to have in place a communication plan in place and designated people to manage it. For communication templates:

• HRP-830 - WORKSHEET - Communication and Responsibilities
• Communication Plan for Single IRB Review (SMART IRB template)

Institutional Profile and Study-Specific Local Context for Relying Sites

The Huron IRB system enables management and review of multi-site or collaborative research, including local context worksheets and participating site documents HRP-815 - FORM - Institutional Profile equips the IRB with additional information about participating relying sites in multi-site or collaborative research studies. The worksheet collects information to create an institutional profile about collaborating sites and study-specific considerations such as local laws that may affect the conduct of research. This form should be submitted when the participating site will recruit or obtain consent from research participants, or if any research interventions or participant interactions will occur at the site.

Investigator Manual for Participating Sites 

The HRP-103 – pSite Investigator Manual is designed to guide participating site (pSite) researchers through policies and procedures related to the conduct of Human Research that are specific to Ohio State serving as the sIRB. 

The lead study team will provide the forms below to the pSite study team. The pSite study team is then responsible for completing and returning the following documents to the lead study team at initial review: 

• HRP-811 – FORM – Basic Site Information
• Site-specific study documents, including consent, authorization form if requested, and recruitment material 

The documents below are tools to report ongoing submissions to the lead study team, who will submit to the sIRB on your behalf: 

• HRP-812 – FORM – Site Continuing Review
• HRP-813 – FORM – Site Modification
• HRP-814 – FORM – Site Reportable New Information

pSite investigators are responsible for ensuring safe and appropriate performance of the research at their site and following their own local institution’s processes and requirements for relying on an external IRB, including completion of local institutional ancillary reviews.