HRPP/IRB Newsletter

November 2024

Contact the IRB

Contact IRB Reliance Team

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Contact Quality Assurance and Evaluation Team

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NIH to Require New Data Management and Sharing (DMS) Information in Progress Reports

On October 1, 2024, NIH added a new set of questions within the Research Performance Progress Reports (RPPR), asking NIH recipients for details on how they are adhering to their approved Data Management and Sharing (DMS) plan. These new questions align with the NIH Final Policy on Data Management and Sharing.


Which researchers are impacted, and what does this mean for them?

Researchers awarded an NIH grant for which the NIH DMS Policy applies (i.e., you have an approved DMS plan) will be asked to complete these new questions within the RPPR.


The system will automatically determine if the DMS Policy applies to your research. The new questions will only appear in the RPPR if applicable.


What will these researchers be asked in the RPPR?


  • Whether data has been generated or shared to date;
  • What repositories any data was shared to and to provide information about the unique identifiers assigned to the dataset(s) (i.e., a digital object identifier (DOI) or other URL handle);
  • If data has not been generated and/or shared per the award’s DMS Plan, why and what corrective actions have or will be taken to comply with the plan (i.e., being prepared for submission, submitted to repository, not yet expected to be shared);
  • If significant changes to the DMS Plan are anticipated in the coming year, recipients will be asked to explain them and provide a revised DMS Plan for approval.


For more information, please see the Guide Notice NOT-OD-24-175.


In addition, NIH is updating the way you submit a request to revise or update your approved DMS plan through the Just in Time (JIT) Module, the Prior Approval Module, and the RPPR Module in eRA Commons (See Guide Notice NOT-OD-24-176).


The updated NIH RPPR Instruction Guide is available as of October 1, 2024 from the Research Performance Progress Report (RPPR) page.

World Medical Association Updates Declaration of Helsinki

Originally adopted in June 1964, the World Medical Association recently released an update to the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants.


This is the eighth revision and first update since 2013.


The HRPP will explore the impacts of this release in a future newsletter. 

Introducing New IRB Resources

Meet the HRP-503+ IRB Protocol Guide for eIRB+


This brand new resource is intended to help researchers prepare their eIRB+ application. Researchers may use this as a worksheet as they prepare their application narrative. This document should not be uploaded/submitted in eIRB+.


Why did we create this?

When eIRB+ launched in April 2024, the content from the Rutgers protocol templates were integrated into the eIRB+ application. As a result, the prior protocol templates (HRP-503a, HRP-503b, and HRP-503c) no longer needed to be attached to new applications. However, as some researchers would like to plan their submission outside of eIRB+, this tool can be used for just such needs.


Are researchers required to use the HRP-503+?

Researchers are not required to use the HRP-503+. The document is NOT intended to be submitted with the IRB application in eIRB+. The document is meant to be used as a tool for preparing the IRB application.


What is in the document?

The document is a combination of the prior protocol templates (HRP-503a, HRP-503b, and HRP-503c). This means that some sections may not be applicable to every investigator’s research.


This document gives researchers the opportunity to draft and plan their responses before entering them into the eIRB+ application. The HRP-503+ document is annotated with the corresponding eIRB+ application sections so researchers will know where in the eIRB+ application to copy/paste the responses they drafted outside of the system.


What is the alternative to using the HRP-503+?

Researchers may choose not to use the HRP-503+. Instead, researchers can go right to the application in eIRB+ and type in their responses to questions directly into the form.

(HRP-503+) Research Protocol Guide for eIRB+

Meet the IRB Reliance Team's Collaborative Research Tool


The purpose of this tool is facilitate the eIRB+ submission of collaborative research between Rutgers University and an external (non-Rutgers) site.


Based on user responses, this tool generates a summary that provides guidance about the relevant eIRB+ application type and provides insights on how to submit a collaborative research study to the Rutgers IRB.



Please note: The Collaborative Research Tool summary provides guidance and should not be viewed or used as an official determination by the Rutgers IRB.

Collaborative Research Resource Tool (Net ID Required)

The Rutgers IRB is dedicated to finding innovative ways to support our researchers. We have a whole suite of Interactive Tools at your disposal.


Check out all of our tools here.

eIRB+ Quick Guide Spotlight:

Updating your eIRB+ Profile

Have you ever submitted a new study or a modification to add study personnel and received a request for a study team member to update their eIRB+ profile to reflect Institutional Status?


Do you need to update your contact information on file in eIRB+ so that records sync across eIRB+, eCOI+, and the CITI Training portal?


The How to Update Your eIRB+ User Profile Quick Guide Resource was designed specifically to provide you an illustrative walkthrough of how to edit and update your user profile.


Quick Guide Resources are available for all eIRB+ applications.

eIRB+ PDF Quick Guides

Consult with HRPP/IRB Subject Matter Experts

Virtual Institutional Review Board (IRB) Office Hours


DRAFT (Document Revision And Feedback Team) Services hosts IRB Office Hours weekly.

When:

  • Tuesdays, 1 – 1:30 pm (with IRB Reliance Team)


  • Thursdays, 10 – 10:30 am


Where:

Office Hours Zoom Link

Passcode: 133269



More information on what to expect during Virtual IRB Office Hours.

The mission of the Document Review and Feedback Team (DRAFT) is to improve IRB submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices through pre-reviews and consultations.


Learn more about DRAFT.


The IRB Reliance Team provides subject matter expertise and consultations on the IRB requirements for collaborative research.


These subject matter experts are adept at assisting study teams with navigating IRB requirements for engaging in multi-institutional research.


Learn more about Reliance.


Workshop and Training Opportunities

Attend a virtual eIRB+ Workshop to learn more about the updates to our submission platform and business processes.



eIRB+ Workshop sessions offer a comprehensive walkthrough of updated features, step-by-step application tutorials, and an opportunity to address any questions you may have.


Register now on the Course Registration System to secure your spot in upcoming training sessions. Multiple sessions will be available weekly throughout each month/semester.

Register for an eIRB+ Workshop

October is Both Health Literacy and Disability Awareness Month


Rutgers IRB Training & Communications Manager Michelle Watkinson, BA, CIP was invited by the Multi-Regional Clinical Trials Center (MRCT) to speak at their webinar on October 22 at 12 PM ET.


Her session, PowerPoint Presentations to Support Health Literacy and Accessibility, discussed the importance of accessible communication from an IRB perspective, along with the initial steps IRBs can take to advocate for inclusive participant-facing materials.

Contact Us / Jason Lin


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