The latest news from Rutgers IRB

HRPP/IRB Bulletin

May 1, 2023

Hot Off the Press

Inclusive Research Panel Discussion

In partnership with the Division of Diversity, Inclusion, and Community Engagement department and as part of furthering the Office for Research's Diversity Strategic Plan join us for an event.

We are pleased to present a safe space for learning and sharing your perspectives around systemic racism in Research and Research Administration.

Please join us on May 4 from 2:30-4:00 p.m. at the Inclusive Research: Disruption for Equity and Justice panel discussion.

The event will be in-person and online. Please click here for more details and event registration.

Free Webinar: Returning Individual Research Results and Data to Participants

The Multi-Regional Clinical Trials Center (MRCT) is pleased to announce the release of case studies that describe the experience of returning individual results and data to research participants.

Join us on May 2 at 12 PM EST for a moderated conversation with leaders in patient advocacy, the clinical trial industry, and academia. They will share lessons learned and discuss what's next to ensure that research participants are able to access their individual results and data. Register here.

Physician Members Needed

The Rutgers IRB is seeking physician scientist members to serve as IRB members. IRB members ensure the protection of the rights and welfare of participants as well as contribute to the evaluation of research on its scientific merits and standards of clinical practice. Physicians with oncology experience are greatly needed.

Expectations:

Conduct reviews via eIRB (electronic submission system)
Attend at least 5-6 meetings a year
Commit to a term of at least 1 calendar year

Qualifications: A Medical Doctor (M.D.) or Doctor of Osteopathic Medicine (D.O.) degree

Time commitment: 4 hours a month

Meeting structure: Meetings are held each week via Zoom and members are asked to attend at least 1 monthly remote meeting.

Benefits: Exposure to new areas of research, developing knowledge outside of one’s expertise, networking, professional development, and a better understanding of IRB processes.

Training: Members receive onboarding training and observe meetings prior to receiving assignments. Attendance can be flexible with your schedule.

Interested parties should contact the HRPP IRB Training and Communications Manager, Michelle Watkinson, CIP (michelle.watkinson@research.rutgers.edu).

Planning to Submit to the IRB? Check out These Helpful Tools

The Rutgers' Human Research Protection Program (HRPP) offers several interactive resources to provide guidance and recommendations to investigators preparing a submission to the Rutgers IRB.

The IRB Review Type and Template Recommendation Tool is a Qualtrics-based tool developed by the Rutgers IRB that uses branching logic to:

Recommend which Rutgers Templates to utilize and indicate the level and type of IRB review that a study may qualify for.

Determine a non-Rutgers site’s degree of involvement and/or engagement in research within a Rutgers research study.

Provide a self-certification mechanism to evaluate whether a project or activity may qualify as non-human subjects research or a quality assurance/quality improvement (QAQI) activity.

A Rutgers Net ID is required to access these tools.

To report broken/expired links, please email irbprereview@research.rutgers.edu.

Learn more here.

Pre-Review Service Announcement

Are your documents ready for IRB review? The Pre-Review Service may be just what you need to confirm your readiness for review.

The Rutgers’ Human Research Protection Program (HRPP) offers a Pre-Review Service to all investigators. This service is designed to improve submission outcomes and cut down on the back-and-forth between the IRB and the investigative team.

Use of the Pre-Review Service is optional* and easy to use.

When you engage in Pre-Review Services, you will have the assistance of highly knowledgeable IRB and HRPP staff, as well as key Committee Members on the IRB. All Pre-Review services include feedback for all study documents, access to individuals with subject matter expertise, and education on best practices for a successful submission and review.

Have questions? Contact the team at: irbprereview@research.rutgers.edu or visit our informational site.

In some instances, the IRB may require that the study team consult with the Pre-Review Team prior to re-submitting to the IRB.

Reportable Events

During the course of research, investigators may encounter certain types of occurrences or situations such as unanticipated problems or adverse events, protocol deviations and violations, which investigators must report to the IRB.

For additional information please visit the Reportable Events Summary.

New Departmental Approvers

The following have completed eIRB Departmental Approver (RBHS) training and been included online under the IRB's eIRB Departmental Approvers Listing:

Victoria Heenan Wagner, who is the Associate Director and Coordinator of Medical Education, at the Robert Wood Johnson Library of the Health Sciences

New IRB Member Spotlight

Krista Smokowski, JD (she/her) has joined the Rutgers IRB as an expedited reviewer. Ms. Smokowski is an attorney with a diverse background involving the Americans with Disabilities Act, corporate, litigation, real estate, and regulatory work. We welcome Dr. Smokowski onto the IRB and look forward to working with her.

Christopher Hawryluk, MBS (he/him) has joined the Rutgers IRB as an expedited reviewer. Mr. Hawryluk is currently a medical student (YR II) at Rutgers New Jersey Medical School. He has both biomedical science training and clinical research experience working as a clinical coordinator on Clinical Trials prior to medical school. We welcome Mr. Hawn onto the IRB and look forward to working with him.

Emily Kokush (she/her) has joined the Rutgers IRB as an expedited reviewer. Ms. Kokush is a medical student at New Jersey Medical School (YR I). She has experience in the biomedical field as an EMT and holds a B.S. in Mathematics and Quantitative Biology. We welcome Ms. Kokush onto the IRB and look forward to working with her.

Elena Cromeyer (she/hers) has joined the Rutgers IRB as an expedited reviewer. Ms. Cromeyer is a Ph.D. student at the School of Public Health (YR III). Her research experience is in Public Health (One Health intersection between animal, human, & environmental health). We welcome Ms. Cromeyer onto the IRB and look forward to working with her.

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 by contacting our Training and Communications Manager, Michelle Watkinson, CIP.

Interested in Being a Featured Board Member in a Future Issue of this Bulletin?

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 if interested.

HRPP Staff Updates

Jeffrey Lai

Jeffrey Lai was born near the major city of Toronto in the neighboring country of Canada. He has been a United States resident for 25 years, and a U.S. citizen for over 10 years. Many years ago, Jeffrey earned a B.A. in Psychology from the University of Southern California (USC) and will have his Master of Public Policy degree from Rutgers University – New Brunswick in May 2023. Jeffrey strongly believes in the mission of the IRB office, and prides himself in having a strong moral compass to guide his work. As a 2022 Summer Intern with the U.S. Department of Agriculture, he perused the U.S. Code of Federal Regulations to conduct compliance reviews for the Alaska field offices at the Natural Resources Conservation Service. He has a personal interest in music and prior to his college career, he performed double bass at Carnegie Hall multiple times with the New York Youth Symphony. Jeffrey is excited to join the team and looks forward to meeting his colleagues at the IRB Office!

HRPP Website

Website Revisions

Human Research Protection Program (HRPP) | Rutgers Research

The Rutgers HRPP and IRB website has undergone a makeover to enhance user interaction and streamline information access.

The improved website design offers easy-to-navigate menus and intuitive interfaces, making it easier for users to find the information they need quickly.

Additional changes are forthcoming, with new features and resources being added to further improve the user experience. These updates reflect Rutgers' ongoing commitment to providing top-quality HRPP and IRB services and support to its community.

AAHRPP Accreditation Updates

Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Learn more.

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ClinicalTrials.gov News

ClinicalTrials.gov Tip: Don’t forget to click the “Entry Complete” button!

When you update your ClinicalTrials.gov record, be sure to click the "Entry Complete" button at the top of the record summary page when you are done!

Clicking the “Complete” button tells the Rutgers ClinicalTrials.gov administrator that your record is ready to be reviewed and released to ClinicalTrials.gov’s PRS staff for QC review and publication.

If your record has been started or changed, but not marked as “Completed”, it will display the following Problem status:

Entry Not Completed

Log in to view your records here. For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.

Single IRB News

All Things Reliance:

The Reliance page of the HRPP website has additional upcoming changes!

The latest updates include the addition of three charts to assist with the submission process of Administrative Review, Advarra IRB and WCG IRB application(s). The charts can be found in the respective sections referenced below on the HRPP Website: Reliance - External IRBs | Rutgers Research

The Administrative Review Flowchart is designed to help Rutgers University Principal Investigator(s) select the appropriate eIRB submission type when Rutgers University has ceded review of their research study to an external IRB acting as the Reviewing IRB*. The flowchart can be found in the “Administrative Review Submission Guidance” tab.
The WCG IRB Submission Chart is designed to help Rutgers University Principal Investigator(s) when to submit to eIRB and/or WCG IRB (formerly WIRB) based on the application type. The submission chart can be found in the “WCG IRB Study Submissions” tab.
The Advarra IRB Submission Chart is designed to help Rutgers University Principal Investigator(s) with the order of submission between eIRB and Advarra IRB based on the application type. The submission chart can be found in the “Advarra IRB Study Submissions” tab.

Quality Assurance & Evaluation

AAHRPP Accreditation and the Quality Assurance and Evaluation Team

Now that Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), you may be wondering how that will impact you as a researcher.

What is AAHRPP?

The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is an independent, non-profit accrediting body, that uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection.

Accreditation benefits not just research organizations, but participants and the whole research enterprise. Obtaining and maintaining AAHRPP accreditation requires a comprehensive look at our Human Research Protection (HRP) Program as a whole in order to identify and address any weaknesses and to build upon our own strengths. The result of this process is a more cohesive HRPP, with the systems in place not only to protect research participants, but also to advance research endeavors more efficiently and effectively.

How does being AAHRPP accredited affect the Quality Assurance and Evaluation Team?

The QA review process is an essential element of our accreditation and means we have made a commitment to continuous quality improvement. To help maintain our AAHRPP accreditation, we regularly monitor and evaluate our research program and find new ways to make our program better.

Two important ways we work to accomplish this is:

Collaborating with our researchers and monitoring active research protocols by way of Routine, For Cause, and Quality Assurance Reviews.
Another equally important aspect of our mission is to also evaluate the HRP Program itself to ensure that internal policies are working for the research community we serve.

Some ways we our team works toward achieving this internal goal is by working with the IRB team to strengthen systems that are already in place and being utilized. We monitor the IRB applications, worksheets, and IRB meeting minutes to ensure the IRB follows policies and procedures for making proper determinations. We review various IRB reviewer forms and the documentation on Reportable Events as well as ensure our eIRB system is being utilized correctly. Based on this internal review, the HRPP can make internal recommendations and improvements.

If you have any suggestions on how our Quality Assurance and Evaluation Team can continue to improve the quality, efficiency, and effectiveness of the Human Research Protection Program, please share your ideas with us. You can email Andrea Dragan, Director of Quality Assurance and Evaluation at: andrea.dragan@rutgers.edu.

For assistance please contact:

Andrea Dragan, Quality Assurance and Evaluation Director

andrea.dragan@rutgers.edu

Barbara LoDico, Quality Improvement Senior Analyst

Barbara.lodico@research.rutgers.edu

Kathleen Villipiano, Compliance Administrator

Smithk6@research.rutgers.edu

Education and Training Opportunities

eIRB Virtual Training Workshops Sessions will include a step-by-step tutorial on the electronic submission system, eIRB and Q&A.

These workshops are open to Rutgers faculty, staff, and/or students regardless of campus location or specific Rutgers IRB of Record.

Upcoming eIRB Workshops (all dates available online):

Thursday, May 4^th at 11:30 am
Wednesday, June 7^th at 11:30 am
Tuesday, June 20^th at 2:30 pm
Monday, July 10^th at 11:30 am
Thursday, July 13^th at 2:30 pm
Tuesday, July 25^th at 11:30 am

Education Items

(some articles might require subscription access)

The articles below highlight the importance of Belmont Report's Ethical Principles of Respect for Persons (operationalized by informed consent), Beneficence (operationalized by minimalization of harms while increasing benefits), and Justice (which is meant to promote equitable representation in research in terms of fairly distributing the risks and benefits of research):

National Cancer Institute, FDA Eye Clinical Trial Modernization (Bloomberg Law) NCI’s latest cancer study is straying from the typical approach for testing new treatments in a way that aims to remove common roadblocks to accessing these trials. The announcement is part of a broader federal effort to modernize clinical trials and is focused on lung cancer, one of the most common cancers in the US.

Why Nature is updating its advice to authors on reporting race or ethnicity (Nature, Editorial) It is regrettable but true that researchers have used and abused science to justify racist beliefs and practices. As previous editorials have acknowledged, Nature has played its part in perpetuating racism — and has now pledged to play its part in tackling it, together with colleagues in the research community.

HIPAA Privacy Rule To Support Reproductive Health Care Privacy (Federal Register Notice, Comments Due 6/16/23): Notice of proposed rulemaking; notice of Tribal consultation. The Department of Health and Human Services (HHS or “Department”) is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act).

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