Research Administration Services & Resources – NORA

• Biostatistical Consultation
• Data Management Consultation Request
• Editorial Consultation
• Intent to Submit
• IRB Consultation
• Qualitative Core Request
• Professional Services/License Agreement Request Form

• Conflict of Interest Handbook (pdf)
• Institute for Clinical and Translational Research
• JHU Data Management Services
• JHM IRB Researchers Tool Kit
• JHM IRB Training Presentation
• Open Forum for Research Teams
• Remote Study Resources
• Research Compliance Training
• Research Coordinator Training
• Research Coordinator Tools
• Research Start Up Assistance
• Sample Applications
• Tools for Researchers
• Using Student Course Data for Research
• Welch Web
• 2023 JHSON Research Retreat Resource Guide

NORA Sponsored Handbook

Updated version will be available soon. This sponsored research handbook provides specific information and guidance. Should you have any additional questions, please contact us at [email protected].

• ICTR Services & Resources

JHM is willing to consider reliance agreements with private organizations that are collaborating with a JHM investigator on non-exempt research studies. A Reliance Request Survey must be completed as a first step to assess the organization’s level of engagement. If the organization is determined to be engaged in non-exempt research, the organization must meet the minimum requirements to execute a reliance agreement with JHUSOM.

Step 1: The organization must have an active FederalWide Assurance [FWA] or apply for a new FWA. Click here for guidance.

Step 2: A Reliance Agreement must be executed between the single IRB [Johns Hopkins University School of Medicine] and the organization. It is the preference of JHM IRB to use the SMART IRB reliance agreement as the basis of reliance. The SMART IRB master reliance agreement was created to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, clearly defines roles and responsibilities of relying institutions and reviewing IRBs, and eliminates the need to sign reliance agreements for each study [e.g., a non-SMART IRB agreement].

To get the process started, visit: https://smartirb.org/join/. There are SMART IRB regional ambassadors available to help with the process: https://smartirb.org/ambassadors/.  

In addition, if using the SMART IRB agreement, the organization must sign the JHM Letter of Indemnification [LOI] as indemnity is not covered in the terms of the SMART IRB agreement. JHM IRB requires a broad LOI to be kept on file and applied to all future studies where the organization agrees to rely on JHM IRB using the SMART IRB agreement. The LOI will be provided via email and must be signed by the organization’s signatory.

Once the organization signs the SMART IRB joinder agreement and the LOI, the JHM Reliance Team will issue a Letter of Acknowledgment (“Cede Letter”) confirming mutual agreement to use SMART IRB as the basis of our reliance relationship. The organization will have met the requirements for IRB approval.

Step 3: The organization will complete a local context review and subsequently be onboarded as a participating site. Instructions for completing this step will be provided in a separate SOP.

Other Considerations: In some cases, a private organization may be a ‘referral site’ rather than a participating site. For example, an investigator is conducting a retrospective chart review and wishes to obtain de-identified data from patient records at a private practice. The practice will need to access chart records to share de-identified data with Hopkins without participant authorization. In this case, the site could obtain permission from the participant to allow the Hopkins investigator to contact the participant, documented in the patient’s medical record. The Hopkins investigator could then create a consent form to consent remotely via e-consent or mailing the consent form. The private practice would only serve as a recruitment/referral source.