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HRPP/IRB Bulletin
January 31, 2024
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Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Learn more.]=
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Virtual Institutional Review Board (IRB) Office Hours
with DRAFT Services and the Reliance Team
Please join Virtual IRB Office Hours if you have a question on process, design, best practices, regulations, policies, or need help in the development of a document.
Each individual consultation is ~ 10 minutes, and attendees joining the Office Hours Waiting Room during designated times will have their questions addressed.
When:
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Every Tuesday from 1 – 1:30 pm with the Reliance Team
- Every Thursday, 10 – 10:30 am
Where: All Office Hour Sessions are virtual via Zoom.
More information on what to expect during Virtual IRB Office Hours.
The mission of DRAFT (Document Revision And Feedback Team) Services is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices.
Click here for the full process of submitting to the DRAFT Services team.
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Exciting New Changes to the Rutgers IRB
Submission System: eIRB+
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We are thrilled to share updates regarding the Rutgers eIRB submission system. In late Spring 2024, we will be launching eIRB+, a revised version of our current eIRB platform, to enhance your experience and streamline the research proposal submission process.
Currently, a select group of researchers and administrative staff are actively beta-testing the updated eIRB+ application. This group will utilize the system to submit research proposals and monitor the workflow of their submissions. The valuable feedback collected during this User Acceptance Testing (UAT) phase will be crucial in identifying areas for improvement before the official release.
Rest assured, any insights gained from the UAT will be used to fine-tune the eIRB+ application, ensuring a seamless experience for all researchers. We are committed to providing you with a robust and user-friendly platform.
In the coming weeks, we look forward to sharing more details about the new system, including eIRB+ Workshop sessions. These sessions will offer you an opportunity to familiarize yourself with the updated features and address any queries you may have.
We appreciate your ongoing support and collaboration in making these enhancements to our research infrastructure. Stay tuned for further updates and thank you for being a valued part of the Rutgers research community.
Please also visit the revised Human Research Protection Program (HRPP) | Rutgers Research website
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Conversion of Paper-based IRB Protocols to eIRB | |
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A notice was sent out by the Research Regulatory Affairs unit at the Rutgers Office for Research in December 2023 to Principal Investigators of IRB protocols that were approved outside of the eIRB system.
The deadline for converting these studies, often referred to as paper-based protocols, is August 30, 2024.
Transitioning these protocols to eIRB will streamline and improve the efficiency of the IRB protocol management process and provide you with a user-friendly platform to submit, manage, and track your protocols.
Key Highlights of the Transition:
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eIRB System Benefits: The eIRB system offers several advantages, including enhanced accessibility, real-time monitoring, improved compliance, and centralized data management. This transition aligns with the evolving needs of researchers and regulatory requirements and our recent AAHRPP accreditation.
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Support for Transition: The IRB team is committed to supporting you throughout this process. We will assist in drafting your applications in the eIRB system and guide you through the electronic submission process. Once the applications are drafted, you will have the opportunity to review and verify the information within a week.
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We will also provide Information Sessions and comprehensive training resources to support the migration of your studies.
Transition Timeline: We encourage you to begin the transition process at your earliest convenience by familiarizing yourself with the eIRB system, gathering pertinent paper-based study documents and information, and submitting your conversion prior to the August 30, 2024 deadline.
To register for a “Paper Conversion Session”, please visit crs.research.rutgers.edu, the Research Course Registration System. When there, please click on “IRB/eIRB” to find a Paper Conversion Session that fits your schedule.
HRPP Compliance: Please note that any study that is not converted to the eIRB system by the August 30, 2024 deadline will be considered inactive and closed by the Human Research Protection Program (HRPP). Once a paper study is closed by the HRPP, no research-related activity can continue without a new eIRB submission. Closed paper submissions cannot be reactivated.
If you have any immediate questions or concerns, please feel free to reach out to the HRPP/IRB office at IRBOffice@research.rutgers.edu using ‘Paper Conversion’ as the email subject.
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Fizza Sulaiman is a graduate student in the Master of Science Clinical Research Management program at the School of Health Professions and has joined the Rutgers IRB as a member. Ms. Sulaiman has clinical research expertise in biochemistry, neuroscience psychology, and genetics. She is a former EMT who has worked with incarcerated populations. We welcome Ms. Sulaiman to the IRB and look forward to working with her.
Omar Kawam is a medical student at Rutgers Robert Wood Johnson Medical School (RWJMS) and has joined the Rutgers IRB as a member. Mr. Kawam has expertise in bioethics and qualitative & immunology research and has worked with incarcerated populations. We welcome Mr. Kawam to the IRB and look forward to working with him.
Interested in Being a Featured IRB Member
in a Future Newsletter?
Share your background, interests, and area(s) of expertise by being a featured board member in an upcoming issue of the HRPP/IRB Bulletin
Please contact Claribel Vega or Angela Cartmell-McGlynn.
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Interested in Becoming an IRB Member? | |
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Interested in Becoming an IRB Member?
Do you (or someone you know) have an interest in biomedical or social science research?
Or do you know someone from the community that might be interested in serving as a community member on the Rutgers IRB?
Would you (or they) like to be involved with protecting the rights, safety, and welfare of individuals who volunteer to participate in research?
Please read more information online about IRB Membership or contact our Training and Communications Manager, Michelle Watkinson, CIP.
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All Things ClinicalTrials.gov | |
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FDA’s Pre-Notices for Potential Noncompliance
with ClinicalTrials.gov
The Pre-Notices for Potential Noncompliance with requirements for submitting registration and/or results reporting to ClinicalTrials.gov has become publicly available information. FDA released these Pre-Notices as of December 2023 and announced that FDA intends to post these notices on a quarterly basis.
Examples that may trigger an issuance of a Pre-Notice for potential violations with federal law include failure to register an Applicable Clinical Trial (ACT), failure to submit required clinical trial information for an ACT, and submission of false or misleading clinical trial information.
The Pre-Notice informs a Responsible Party (i.e. Principal Investigators per Rutgers policy) of potential noncompliance with the legal requirements for registration and/or results submission to ClinicalTrials.gov.
After receiving the notification, the Responsible Party is granted 30 days to address any noncompliance issues. FDA further reviews and assesses the clinical trial record and other relevant information to determine whether the Responsible Party has failed to submit required clinical trial information to the ClinicalTrials.gov.
If FDA determines that the Responsible Party failed to comply with the legal requirements, FDA will issue a Notice of Noncompliance.
Visit Pre-Notices for Potential Noncompliance to view FDA issued notifications since 2013. Review FDA’s Guidance for detailed procedures the FDA takes to identify noncompliance and make determinations.
For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
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Reliance Workshop
The Human Research Protections Program (HRPP) Spring Reliance Workshop is tentatively scheduled for May 2024. Further details will be shared at a later date.
For any inquiries or further information regarding the submission process, we encourage you to contact the IRB Reliance Team at irbrelianceteam@research.rutgers.edu. They will be more than happy to assist you with any questions you may have.
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All Things Quality Assurance & Evaluation | |
Education and Training Opportunities | |
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New Registration Process
for eIRB Workshops
The Rutgers Human Research Protection Program (HRPP) and Institutional Review Board (IRB) is pleased to announce that registration for eIRB Virtual Training Workshops is now completed directly via the Research Course Registration System (CRS). CRS provides each registrant with an instantaneous email confirmation along with the session’s Zoom link and calendar event invite.
eIRB workshops are offered through March 2024, with additional 2024 dates forthcoming. These workshops are designed to provide a step-by-step tutorial on using the electronic submission system known as eIRB and offer a Q&A session. They are open to all Rutgers faculty, staff, and students.
To obtain session dates/times and register for a workshop, please visit the Research Course Registration System.
Registration is required to secure your spot, and you'll receive the Zoom meeting link from the CRS system.
For more information, please visit “eIRB Workshops” under HRPP/IRB Educational Resources.
Education Items:
Montclair State University held its 4th Annual Virtual Black Lives Matter in Research Symposium in November 2023. The theme of the symposium was "Transforming the Health Research Landscape for Justice and Equity."
Links to the symposium recordings are available online.
Day 1: Diversity in Research: Challenging Assumptions Regarding Minority Participation by Dr. David S. Kountz
Day 1: Navigating Health Science Research as a Graduate Student
Day 2: Black Women and Maternal Health Inequities: Addressing the Role of Racism by Dr. Ndidiamaka Amutah Onukagha
Day 2: IRB Process for Reviewing Health Research with an Inclusive Lens
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FDA permits IRB informed consent waivers for minimal risk clinical trials (COGRI)
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. We have summarized this rulemaking below, which mostly mirrors the proposed form of the rule, with the notable exception of codifying the “identifiable private information or identifiable biospecimens” criterion previously laid out in FDA guidance. The final rule is effective on January 22, 2024.
Of note, the FDA will allow a waiver or alteration of informed consent providing that “an IRB approving a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in 21 CFR 50.25, or waiving the requirements to obtain informed consent when the IRB finds and documents that:
- The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
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- The clinical investigation could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.”
Please see the full FDA Guidance for more information.
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Fifty Years of U.S. Mass Incarceration and What It Means for Bioethics (The Hastings Center)
A growing body of literature has engaged with mass incarceration as a public health problem. This article reviews some of that literature, illustrating why and how bioethicists can and should engage with the problem of mass incarceration as a remediable cause of health inequities. “Mass incarceration” refers to a phenomenon that emerged in the United States fifty years ago: imprisoning a vastly larger proportion of the population than peer countries do, with a greatly disproportionate number of incarcerated people being members of marginalized racial and ethnic groups. Bioethicists have long engaged with questions of health justice for incarcerated people, including consent issues for those participating in research and access to health care.
This article provides an overview of the individual and public health impacts of mass incarceration. The article argues that mass incarceration is a bioethics issue that should be addressed in medical education, identifies opportunities for bioethicists to guide hospitals’ interactions with law enforcement officials, and calls on bioethicists to be in conversation with medical and nursing students and health care professionals about these groups’ advocacy efforts concerning structural racism, police violence, and mass incarceration.
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