May 2025

A Participating Site [pSite] is defined as a non-Hopkins entity that is engaged in human subjects research and has ceded IRB oversight to the JHM IRB via a reliance agreement. This page contains resources and frequently asked questions for pSites when relying on the JHM IRB as the single IRB of record (sIRB). 

Important JHM IRB Policies for pSites

JHM IRB guidelines and policies can be found here. It is the expectation that all participating sites carefully review the JHM IRB policies and guidelines to ensure familiarity with JHM IRB expectations: https://www.hopkinsmedicine.org/institutional-review-board/guidelines-policies

A few of the key JHM IRB policies relevant to pSites are listed below:

• Organizational Policy on Prompt Reporting of Reportable Events. JHM prompt reporting timelines should be followed for reporting of these events to the JHM IRB in addition to any local reporting requirement that differ from JHM IRB reporting timelines. pSite investigators are still responsible for adhering to institutional and state law requirements for their own site.
• Organization Policy on Review of Changes in Approved Research
• Organization Policy on Electronic Submission of Information to the JHM IRBs
• Organization Policy on Communicating JHM IRB Actions to Investigators
• Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc.
• Organization Policy on Continuing Review of Approved Research
• Organization Policy on Payment or Remuneration to Human Subjects
• Organization Policy on Informed Consent Process and Documentation

Tools and Resources

• pSite Local Context Tip Sheet
• Adding a pSite Instructions
• pSite Continuing Review Summary Sheet
• pSite Review Workflow
• Continuing Review Workflow
• Contact the Reliance Team

Frequently Asked Questions

What are the responsibilities of participating sites when relying on the JHM IRB?

For studies where the JHM IRB is the single IRB (sIRB) of record, each pSite that relies on the JHM IRB remains responsible for adhering to all applicable state or local laws, regulations, and institutional policies that pertain to the conduct of research at their site. Additionally, pSites must communicate to JHM IRB the requirements of relevant laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the research (“Local Considerations”) that would affect the conduct or approval of the research at their site. When relying on the JHM IRB, pSites are expected to adhere to the IRB approved protocol and the requirements of the JHM IRB and follow applicable JHM IRB guidelines and policies.

How will I be notified of IRB determinations [e.g., site approval, continuing review approval]?

JHM IRB will notify the lead PI/study team of all IRB determinations. The lead PI/study team is primarily responsible for providing study and site approval documentation to pSite PIs.

 

How do I communicate with the JHM IRB?

Although the lead PI/study team is primarily responsible for providing study and site approval documentation to pSite PIs, the pSite PI/lead site contact may additionally have access to pSite approval and local context documents via the JHM electronic IRB (eIRB) system or an alternate electronic IRB reliance system. Please contact your lead PI/study team to determine how shared materials will be communicated to you.

 

How do I submit a site-specific modification or event report for my site?

If your site has ‘direct access’ to eIRB [e.g., the lead PI has granted pSite’s access to our eIRB system], you may submit your own site-specific modifications [pMods] or event reports. If you do not have direct access, you must communicate your required actions to JHM IRB via the lead PI/study team, who will submit the actions on your behalf.

 

• Submit a pSite Modification
• Submit a pSite Problem Event Report

What should I do if my local IRB/HRPP takes action for the study (e.g., suspension/termination, requires an event report)? Does this need to be reported to the JHM IRB?

JHM IRB is required to review any notifications of suspension or termination relevant to the applicable study from the pSites. pSites are required to report any notifications of suspension or terminations to the lead PI/study team to ensure they are promptly reported to the JHM IRB. pSites with direct access to the eIRB should submit a protocol event report to the JHM IRB promptly to report any study termination or suspension issued by your local IRB/HRPP.

 

What can I do to prepare for the local context review process?

To support a streamlined review process, it is important to understand how local context review is operationalized at your institution. Important questions to ask your local IRB/HRP include:

 

• Who has the authority at the institution to review and “sign-off” on the local context review?
• Is a formal submission to the local IRB/HRPP required?
• What study-specific documents must be submitted locally to have the review completed?

JHM IRB requirements include:

• Confirmation of willingness to cede from the local IRB/HRPP
• Documentation of the reliance agreement [SMART IRB Letter of Acknowledgment]
• A local context questionnaire [LCQ] signed by the pSite PI AND an institutional representative designated to verify local laws, policies, etc.
• If pSite will enroll participants, complete/exact site-specific consent language provided via the JHM IRB approved site-specific information template.

Please seek guidance from your HRPP/Research Office/IRB regarding how to complete these requirements. Most IRBs require a local submission in order to initiate the local context review process.

 

Can I start research without receiving my pSite approval letter?

No. A pSite application must be submitted and approved by JHM IRB before any research activity can begin at the site. A pSite approval letter and JHM IRB stamped, site-specific consent form [if applicable] will be shared with the pSite PI upon IRB approval. Note: Your local IRB/HRPP may require receipt of the JHM IRB stamped consent form for use at your site BEFORE your site can be activated locally. It is your responsibility to check with your local IRB/HRPP to determine if there are any additional requirements to activate your site.

 

How do I receive my IRB approved study materials?

The lead PI/study team is primarily responsible for providing study and site approval documentation to pSite PIs. Additionally, the protocol should include a communication plan which will describe the mechanism by which materials will be shared [e.g., via email, via an electronic study management system, etc.] pSites should be aware of how documents will be communicated to them via the lead PI/study team.

 

Can I use my local IRB’s consent form template?

No. When JHM is serving as the sIRB for a study using a written consent process, a two-part consent form is required. The master consent form [Part 1] will cover the primary components of the study [i.e., procedures, risks, benefits, study purposes, etc.] that apply to all participating sites. The master template consent form cannot be edited by sites.

Site-specific required language [e.g., site-specific procedures, payments, research-related injury, HIPAA] should be condensed in the Site-Specific Consent Information [SSCI] Form [Part 2].

The JHM IRB consent form specialist will combine the master consent form [Part 1] + SSCI [Part 2] to create site-specific consent forms for pSites [a process that occurs after the initial IRB study is approved]. A clean, word document version of the SSCI will be issued at the time of site approval to be used to submit tracked edits for IRB approval in future pSite modifications.

Please note: The consent form is ONLY approved for use after the components (Part 1 and Part 2) have been combined. Neither component may be used on its own.

What are my minimum responsibilities as a pSite?

• Maintain an active FederalWide Assurance [FWA]
• Check with your IRB/organization about the types of items that will require “local” review during the life of the study. Examples:
  • Changes that affect local drug dispensation/dosing
  • Changes that may trigger a local ancillary review
  • Personnel changes/new conflicts
• As part of the continuing review requirements, provide annual enrollment data, deviations and AEs that do not otherwise meet JHM or your local institution's prompt reporting policies.
• Use only the JHM stamped version of the consent form. Written consent will include two parts, combined. The part 2/ site-specific consent information [SSCI] addendum cannot be used as a stand-alone document.

What is a FWA?

The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by the Office for Human Subjects Protections (OHRP) for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Your institution must have FWA to rely on JHM IRB, and the FWA must remain active.

• FWA Information Sheet

What are my continuing review responsibilities as a pSite?

pSites must complete a pSite Continuing Review (CR)/Progress Report (PR) Summary Sheet and provide it to the lead/coordinating center ahead of the lead/coordinating center’s anticipated CR/PR submission date. Upon receipt, pSites should submit the sIRB continuing review approval letter to their local IRB/HRPP. Often, the local IRB/HRPP will require receipt of the sIRB CR/PR approval letter before the site can continue research activity. A delay in submitting your CR summary sheet can lead to a lapse in approval, requiring all research activity at JH [and pSites] to cease until the continuing review is approved.

How do I contact the JHM IRB reliance team?

Please contact the JHM IRB Reliance Team at [email protected] with any questions.

Education Opportunities

Save the Date for upcoming education sessions focused on pSite responsibilities and other helpful information.

• Date: July 30th, 2025
• Topic: Local Context Tips and Tricks

Registration link coming soon.