The latest news from the Rutgers HRPP/IRB

HRPP/IRB Bulletin

June 30, 2023

Hot Off the Press

Virtual IRB Office Hours Pilot

DRAFT Services (formerly known as Pre-Review Service) will pilot virtual office hours in July 2023!

When:

Tues, 7/11 from 1 – 1:30 PM
Thurs, 7/20 from 10 AM – 10:30 AM
Tues, 7/25 from 1 PM – 1:30 PM
Thurs, 8/3 from 10 AM – 10:30 AM

Where: ZOOM.

As July is the pilot, please email DRAFT Services for office hour link.

What is offered?

Please join us if you have a question on process, design, best practice, regulations/policies, or need help in the development of a document!

Each individual consultation is limited to ~10 minutes. If there are multiple attendees, we may limit the consultation time accordingly.

When you join the Office Hours Zoom, you will remain in the waiting room until the prior attendee’s session has ended.

All those who join the Office Hours Waiting Room during the designated times (1-1:30 PM Tues and 10-10:30 AM Thurs.) will have their questions addressed.

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.

Community-based Participatory Research

Next month, please look out for our special education topic regarding the review process for research involving community members, also known as Community Based Participatory Research (CBPR). We will go over specific requirements for community-based participatory research and what criteria IRB members look for to ensure equitable partnerships between the investigators and the community partners, as well as compliance with all regulatory standards and practices.

Preliminary review materials: Strategies for reviewing CBPR research

Welcome to the HRPP/IRB Team!

Judy "HeeChung" Kwak has joined the IRB/HRPP team as the Sr. IRB Operations Manager.

Judy was born in South Korea and immigrated to the United States as a baby. She has been a New Yorker for most of her life, identifying herself as a Brooklynite. She graduated from New York University (NYU) with a bachelor's degree in psychology with the desire to provide guidance in areas of mental health, especially self-care. She earned her advanced master's in educational psychology from NYU while working as a research assistant in the psychology department at the College of Arts and Sciences.

Judy took a few years off to take care of her family as she completed her advanced master's. During this time, her love of research resulted in pursuing a career in the Institutional Review Board. Judy had an extensive 8-year tenure at the NYU Langone Medical Center IRB office, encompassing a wide array of responsibilities. These include engaging with the research community, conducting comprehensive reviews, and granting approvals for IRB submissions as both an exempt and expedited reviewer. Additionally, Judy has actively served as a member of the IRB Committee. She has six years of experience working with External IRBs, SIRB and CT.gov.

Tiffany Maderazo is the newest Coordinator of Administrative Services in the HRPP Office, spending half of her time with the Quality Assurance and Evaluation (QAE) team and the other half with DRAFT/Pre-Review services. She joined the HRPP at the end of May 2023.

Tiffany is a proud Rutgers alumna, having graduated in 2008 from Livingston Campus. Tiffany and her husband met here at Rutgers, and have two daughters, Kaileigh (10) and Everleigh (5). Prior to returning to her alma mater, Tiffany was the Center Director for the KinderCare in South Brunswick for 12 years, where she was responsible for the day-to-day operations of the center, including during the COVID-19 pandemic. Although she is new to the research regulatory field, she is very eager to learn and bring all her diverse experiences in administration to her new position here. We are equally excited to have her join the HRPP Team.

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.

New IRB Member Spotlight

Jeremy Grachan, PhD (he/him) has joined the Rutgers IRB as an expedited reviewer. Dr. Grachan is an assistant professor in the Office of Education at Rutgers New Jersey Medical School. Dr. Grachan's has taught clinical anatomy, biology histology, and embryology. He also has experience with animal research along with advising and conducting research related to anatomy education in professional programs. We welcome Dr. Grachan onto the IRB and look forward to working with him.

Carmen Kathera-Ibarra, BS, MBS, ACRP-CCRC (she/her) is a Clinical Trials Manager in the Division of Cardiovascular Diseases & Hypertension at Rutgers New Jersey Medical School. She has general psychology and biomedical science training. We welcome Ms. Kathera-Ibarra onto the IRB and look forward to working with her.

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 Website

Website Revisions

Have you seen the revised Human Research Protection Program (HRPP) | Rutgers Research website? 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. Please check out:

DRAFT Services | Rutgers Research (formerly known as Pre-Review Service) stands for "Document Revision And Feedback Team". The mission of the DRAFT Service is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. It is highly recommended that the DRAFT Service is used by investigators prior to submitting new studies or substantial modifications to existing studies in eIRB.

Interactive IRB Tools | Rutgers Research: Not certain if your research requires IRB review? See our Non-Human Research Self-Certification Tool (HRP-310b). Need help figuring out what kind of review your research qualifies for and what protocol template to use? Check out our IRB Review Type and Protocol Template Recommendation Tool. A Rutgers Net-ID is required for access.

Human Research Protection Program Toolkit | Rutgers Research: Check out our revised Toolkit page containing downloadable templates including protocol templates, consent templates, assent templates, performance site (authorization) templates and more. Please use the chapters to locate the specific templates that can be downloaded and modified for your research and eIRB applications.

Reliance | Rutgers Research, do you know that Rutgers has a team of professionals who can assist with collaborative research between Rutgers and other entities? To conserve resources and enhance and streamline the Institutional Review Board (IRB) review process when such collaborations occur, regulations allow research partners to agree to rely on a single IRB for review and approval of their non-Exempt study. Please see our Administrative Review Flowchart for guidance and/or the Reliance page for more in-depth information.

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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All Things ClinicalTrials.gov

To Serve You Better: ClinicalTrials.gov Modernization

As the world’s largest database of privately and publicly funded clinical trials, ClinicalTrials.gov provides access to clinical trial information for millions of users every month. In 2019, the National Library of Medicine (NLM) launched an effort to modernize ClinicalTrials.gov with the goal of delivering an improved user experience on an updated platform that will accommodate future growth and enhance efficiency.

In December 2021, NLM announced the launch of the beta versions of the modernized ClinicalTrials.gov website and its clinical information submission and management portal, the Protocol Registration and Results System (PRS). The two systems have been further enhanced through user testing and feedback, and demonstration videos for ClinicalTrials.gov Beta and PRS Beta are available for selected updated features. See additional PRS Beta Release Notes.

In June 2023, the current website will be replaced with the modernized ClinicalTrials.gov website. This revamped site will include improved functionality for searching, viewing, and downloading information about clinical trials. The current ClinicalTrials.gov website will remain accessible through 2024.

Because the ultimate success of the modernization effort is best measured through feedback, all stakeholders are encouraged to get involved by sharing their comments and suggestions via the feedback buttons on the ClinicalTrials.gov Beta and PRS Beta sites.

For additional information about modernization-related events and resources, visit the ClinicalTrials.gov Modernization webpage.

For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu..

All Things Reliance

We are happy to announce upcoming changes to the Reliance Submission Documents (HRP 1812A/B, HRP 830 and HRP 811).

The forthcoming updates are designed to reduce the amount of documents required in order to establish a reliance agreement and to streamline the reliance process.

Please also visit the re-designed Reliance Webpage for all of your reliance and External IRB needs. Our page has been optimized to be more user-friendly with an improved search and share feature. Link: Reliance - External IRBs | Rutgers Research

If you have any questions, feel free to contact the IRB Reliance at irbrelianceadmin@research.rutgers.edu.

All Things Quality Assurance & Evaluation

7 Ways to Help Prevent Common Non-Compliance Issues

The May issue of the HRPP/IRB Bulletin introduced our series, "7 Ways to Help Prevent Common Non-Compliance Issues" and listed seven common compliance pitfalls:

1. Assess your research plan feasibility

2. Data collection forms and checklists

3. Standard Operating Procedures (SOPs)

4. Resource Availability

5. Training

6. Documentation

7. Reporting

The June issue will begin our exploration by taking a deep dive into Assessing your research plan feasibility.

#1: Assess your research plan feasibility:

Prior to receiving IRB approval, and periodically throughout the study's approval window, the research team should determine whether the research plan can be carried out as written.

One way to do this is by creating a “Feasibility Evaluation.” A Feasibility Evaluation is simply an assessment of the practicality of a proposed plan or project.

Feasibility Evaluation

Each study is unique. While studies are complex and multi-factorial, a standardized process for evaluation can be developed. The issue always boils down to whether the research site has the resources necessary to conduct the study.

Reasons to Assess Feasibility:

Saves time and money
Proactively identifies and addresses competing priorities
Avoids surprises and overpromising
Promotes better relationships between sponsor, clinical research sites, your staff, and your IRB
Makes the best use of staff time and possibly creates efficiencies
Enables staff to conduct the study effectively and compliantly

A feasibility evaluation should include, but is not limited to, assessing the following:

Time and space
Financial viability
Complexity of the protocol and current staffing
An understanding of federal regulations and state law associated with conducting research
An understanding of the IRB’s and institution’s requirements for conducting research
Access to protocol-required tests and procedures
Data collection procedures
Access to research participants
Study team experience and delegation of authority (who does what)
Effective and ongoing communication between the principal investigator and the study team (team meetings or other ways to share information on how the study is going)
Access to the participant population you plan to recruit to your research protocol
Competing trials and populations

Examples of Study Feasibility Questions:

When is enrollment scheduled to end?
How much time will it take to obtain IRB approval, finalize a contract and/or enroll subjects?
How many study subjects are needed (contracted number)?
How many potential study subjects who meet eligibility criteria does the clinical research site have access to, if known?
Are enough study staff members currently available to fully staff for the study, in order to meet the study procedures and IRB submission requirements?
Will it be necessary to hire new staff or transition staff from other studies?

We strongly suggest conducting a feasibility assessment during the study start-up process to increase compliance and reduce issues during administration of the research.

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):

Monday, July 10^th at 11:30 am
Thursday, July 13^th at 2:30 pm
Tuesday, July 25^th at 11:30 am

(Additional workshops for August through December 2023 are forthcoming)

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):

Draft Guidance – Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions (HHS) Comments Due August 15, 2023. The draft guidance can be accessed at this link. A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF - PDF formats at the Government Printing Office's Federal Digital system (FDsys) website right here.

The Use of Generative Artificial Intelligence Technologies is Prohibited for the NIH Peer Review Process (NOT-OD-23-149): The purpose of this Notice is to clarify NOT-OD-22-044 on Maintaining Security and Confidentiality in NIH Peer Review: Rules, Responsibilities and Possible Consequences and inform the extramural community that the NIH prohibits NIH scientific peer reviewers from using natural language processors, large language models, or other generative Artificial Intelligence (AI) technologies for analyzing and formulating peer review critiques for grant applications and R&D contract proposals. This Notice can be found here.

NIH toughens enforcement of delayed clinical trials reporting (Science): Last year, the U.S. National Institutes of Health (NIH) delivered a stern warning to two in-house clinical researchers who had broken an important rule. They had failed to submit the results of two clinical trials they had overseen to ClinicalTrials.gov, a database meant to inform the public about human studies and their results. The reporting requirement has often been ignored, but this time the agency took an unprecedented step: It told the scientists it wouldn’t approve any more of their research until they fell in line. Article here.

Sponsor Influences on the Quality and Independence of Health Research (NASEM Publication): Governments, philanthropic organizations, and private industry fund human health and medical research. Various funding sources might bias research so that the results are more favorable to their agents. Funders may influence investigative scope, specific questions posed, experimental design, and principal investigator appointments. Article here.

New Federal Bill Appropriates Millions Toward University-Sponsored Cannabis Research (NORML): The legislation, the Higher Education Marijuana Research Act of 2023, would appropriate up to $150 million in federal funding for university-sponsored medical cannabis research. The legislation also permits academic institutions to purchase state-licensed cannabis products for the purpose of “biological, chemical, agricultural, or public health research.” Article here.

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