Guidance for the Review of Participant Inclusion in Clinical Research and Clinical Trials

The guidance for inclusion review criteria for both funding opportunities using the Simplified Review Framework and those using the Non-Simplified Review Framework was updated on March 28, 2025.

For information about the latest NIH Consolidated List of Reviewer Documents, scroll down to Review Criteria Information.

There you will see Guidelines for the Review of Inclusion PDF - (03/28/2025). The guidance provided here were updated to address the Simplified Review Framework, and gives insight on what the reviewers should be looking out for in Section 2 – Study Population Characteristics of the ‘Study Record: PHS Human Subjects and Clinical Trials Information’ form.

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CIRTification Refresher Course Available

The CIRTification program is a training alternative for individuals in community organizations, with limited understanding of conducting human research and protecting potential research participants. This option provides training that focuses on establishing the skills in community partners to conduct human subject research effectively and safely in their communities.

There is now a “refresher” version of CIRTification Online.

The Refresher Course provides continued research ethics training for those who have already completed the initial CIRTification training. The Refresher Course reviews key concepts and covers new topics:

• Review of the research process, the people involved and the tasks.
• Review the importance of following the IRB-approved research protocol, keeping data safe, and protecting privacy and confidentiality.
• Review key components of informed consent and good practices for responding to participants’ questions about enrollment, withdrawal other issues.
• Review considerations for doing research with people from different communities, including people who do not speak English, adults who cannot legally make decisions for themselves, and people who may have trouble saying “no” to an invitation to research.

Learners who have completed CIRTification Online will be able to access the Refresher by logging in to their account.

HRPP Guidance for Those who Receive a Stop Work Order from a Federal Agency

These guidelines are intended to assist investigators who may or have received a directive from a federal funding agency to stop, pause, or otherwise prematurely end a human research study.

• Send any Stop-Work order questions to federal-tracking@rutgers.edu with copy to your assigned RSP Grant Specialist, and you will receive a response with guidance. 
• Notify the Rutgers HRPP/IRB (if the IRB of Record is an external IRB, notify both the external IRB and the Rutgers IRB Office):
• IRBOffice@research.rutgers.edu and
• HRPP/IRB Director, Dr. Swapnali Chaudhari chaudhsw@research.rutgers.edu

As a general reminder, researchers should not sign any documents related to sponsored awards. There are established review processes to ensure proper protection of the university and your research.

Visit our Frequently Asked Questions page for information about what is known, what the Office for Research is working to understand better, and how we move forward together.

Federal Stop Work Order for SMART IRB

On April 14, 2025, the National Institutes of Health (NIH) issued a Stop Work Order to Harvard University regarding the SMART IRB federal funding contract. The order required an immediate cessation of all federally funded work on SMART IRB, but did not provide a reason or explanation. 

Despite this, Harvard University is continuing its support of SMART IRB at this time. Harvard Medical School staff will continue to provide support, though all of their work on SMART IRB is now voluntary. The initiative remains committed to advancing collaborative research, supporting over 1,350 institutions and 12,000 researchers nationwide. 

What this means for you:

• The SMART IRB Agreement V 3.0 remains operative, allowing participating institutions, such as Rutgers University, to continue using it to activate new joinder agreements.
• Existing arrangements under the prior Legacy Agreements remain valid.
• Help Desk tickets and other tasks will continue to be addressed by SMART IRB ambassadors and team members. Please note, during this time, any work completed by them on SMART IRB is voluntary. Please be considerate of their time and efforts.

If you have any questions, please contact the IRB Reliance Team at IRBRelianceTeam@research.rutgers.edu.

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.