All requests for reliance must first be submitted through the reliance request survey that is available on the JHM IRB website at https://www.hopkinsmedicine.org/institutional_review_board/about/agreements/. 

You, as PI, will need to make sure that all study personnel receive appropriate training and are qualified to perform their duties, and that the study is conducted in accordance with the sIRB approved protocol and IRB policies. These requirements are outlined in the “Statement of PI Responsibilities when Relying on an External IRB”, which must be signed and submitted with your reliance request.

A local context review is still required so that we can address any local concerns, perform ancillary reviews, and ensure compliance with institutional policies and local requirements. A new application is required in eIRB2 to facilitate this local context review. This application is pre-reviewed by our reliance team and reviewed by designated reviewers within our Human Research Protection Program. Relevant ancillary reviews are triggered and conducted through normal procedures. 

JHM IRB charges review fees for commercially funded studies with financial support in excess of $15,000. This includes local context review fees [initial review, changes in research [with consent form changes], and study closure] when JHM relies on an External IRB [e.g., JHM is not the IRB of Record]. Please refer to the Fees for JHM IRB Review guidance for more information.

No. A continuing review application is not required for studies where JHM is not the IRB of record. In cases where the reviewing IRB has determined that continuing review is required and will provide an annual re-approval letter you should use the “Upload External IRB Approval” activity, located on the parent application workspace, to upload the external IRB’s annual approval letter under “Continuing Review Approval Letter”. This will notify our reliance department to update the expiration date based on the external IRB approval letter and ensure we are aware that your study remains active. Please Note: If the External IRB issues updated consent forms to reflect a new approval and expiration date, do not upload the consent forms via the “Upload External IRB Approval” activity. Updated study documents should be submitted via Change in Research application.

Our HRPP is responsible for tracking all active research, including research that is reviewed by an external IRB. Our HRPP may require a local progress report for external IRB applications, even where the reviewing IRB requires no continuing review or progress report. The purpose of this progress report is to provide a local update about the status of the research at our site. Where the reviewing IRB does not require a continuing review and a progress report has not been required by our HRPP, a one-year or three-year expiration will be assigned to the study based on pre-determined criteria. Study teams must keep their study’s status “active” by submitting an “extend approval” request. Failure to submit an extend approval request will result in the termination of the study, meaning no research-related activity may continue at the JHM site. 

Under certain circumstances, a Continuing Review is no longer required under the Revised Common Rule. As a Relying Institution, we reserve the authority to require JHU investigators to submit on-going Progress Reports at intervals suitable for the research protocol or research study activities. For example, for studies involving secondary analysis of data, where JHM is contributing more than 500 records, a 1-year expiration date will be applied. The PI will be required to submit a Progress Report to JHM in 1 year.

External IRB applications are acknowledged rather than approved. The external IRB approves the research study. As a relying site, we are acknowledging that our local context review is complete, and research can begin. 

When relying on an external IRB, it is important for JHM investigators to recognize that the JHM IRB and the institution still retain important responsibilities for the oversight and ongoing local conduct of the study. The JHM IRB must have a copy of the current version of the protocol to address any questions or complaints. Please refer to the "Statement of PI Responsibilities when Relying on an External IRB" for examples of changes and other information that should be reported to JHM IRB.

After initial acknowledgment, the External IRB will serve as the source of record for any revised versions of your site-specific JH consent. Please refer to the “Statement of PI Responsibilities when Relying on an External IRB” for a list of changes that require local review prior to proceeding with implementation of the revised version of the site-specific consent form. While in all cases, you are required to submit all revised consent forms for JHM acknowledgment you must only wait for JHM acknowledgment to use the revised consent form if an additional local context review/issue is triggered. For changes that do not require local review before implementation, you may proceed with using the revised version of your site-specific consent forms upon receipt from the External IRB.

Final approved versions of any stamped documents must be secured from the reviewing IRB.

Documents approved by the external IRB [including consent forms] are not stamped by JHM IRB. In addition, we do not require the JHM logo to be included on our site-specific documents.

The final version of the site-specific JH consent initially approved by the external IRB will be available in your “Stamped Documents” tab. If you submit a revised version of the site-specific JH consent approved by the external IRB, it will be available in your “Stamped Documents” tab upon acknowledgment of the Change in Research.