The latest news from Rutgers IRB

HRPP/IRB Bulletin

December 31, 2022

Hot Off the Press

IRB Tool Launches – January 2023

The IRB will be launching two interactive tools in January 2023.

The IRB Review Type and Template Recommendation Tool is a Qualtrics-based tool developed by the Rutgers IRB.

This tool asks a series of questions to provide investigators with recommendations on which protocol and consent templates to use based on the type of research indicated.

This tool also provides insights into the level of IRB Review that the study may qualify for ---- a determination of Non-Human Subjects Research, Exempt research, Expedited research, or Full Board Greater Than Minimal Risk Research.

Finally, this tool provides information on which consent waivers may be applicable --- Waiver of Consent, Waiver of Documentation of Consent, and/or Waiver of HIPAA Authorization. The recommendations and insights are summarized upon completing the Qualtrics Form.

The Engagement in Research Tool is another Qualtrics-based tool. This tool has been adapted and modified from a tool initially developed by The Ohio State University IRB in 2019. In the Rutgers version of this tool, a series of questions is asked to help investigators determine whether or not a collaborating external (non-Rutgers) site is considered to be “engaged in research.”

Upon completion of the Qualtrics Form, guidance and recommendations are provided on how to proceed with including the external site in a Rutgers IRB submission.

Upcoming Changes to the eIRB system for Committee Members

Our electronic submission system, eIRB, has been updated for changes to the Committee member "Submit Designated Review" activity area to now include regulatory-required checklists (e.g., research involving children as subjects) instead of these being separate documents to be completed and uploaded per each submission. In addition, the Submit Designated Review activity will include a new area for the review of Reportable Events: Unanticipated Programs (UAPs).

All individual COI-management plans are available in eIRB for currently active studies. Specifically, COI management plans are now present in the attachments section of the eIRB record for that study. All IRB committee members will need to regularly to view the status of COI disclosures in the eIRB system to complete their review(s). HSPP IRB Staff will provide updates at IRB meetings and through email communications.

The NIH 2023 Data Management and Sharing Policy

Previously, the NIH only required grants with $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared.

The 2023 NIH policy is entirely new. Beginning January 25, 2023, ALL grant applications or renewals that generate Scientific Data must include a robust and detailed plan for managing and sharing data during the entire funded period. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches, and more. You must provide this information in a data management and sharing plan (DMSP). The DMSP is similar to what other funders call a data management plan (DMP).

The policy does not state specific requirements for how you share your data. When you share your data, you should address the NIH’s goal of making data as accessible as possible. The NIH expects all shareable data to be made available, whether or not it is associated with a publication. All data used or generated as part of a grant must be managed, but not all data should be shared. You should not share data if doing so would violate privacy protections or applicable laws. You may share data related to human subjects, but your plan should address how data sharing will be communicated in the informed consent process (e.g., consent forms, waivers of consent). For more information, please see https://libguides.asu.edu/NIH-2023-DMS#s-lg-box-29379406

NJ ACTS Needs Assessment Survey

The NJ ACTS team is looking to conduct a needs assessment of barriers researchers commonly encounter while conducting their translational research. They hope to help establish feasible institutional solutions and initiatives for overcoming these commonly experienced barriers.

The survey also aims to identify at what stages in the translational research process these barriers most often arise. This survey should take approximately 5-10 minutes to complete and consists of three sections – Demographics and Background, Self Reporting of Barriers, and Comments and Feedback. Upon completion of the survey, participants can enter a raffle for a $25 Starbucks gift card.

The link to the survey is included below, if you have any questions or concerns, please contact sm2097@scarletmail.rutgers.edu and ag954@rbhs.rutgers.edu. Please feel free to share this survey with other investigators at your institution and within your research community.

Translational Research Needs Assessment Survey

If you have trouble with the link above, please copy and paste this link into your browser; https://redcap.link/zf8san6p

eCOI+

Do you have eCOI+ questions? or Need help with your disclosure forms?

University Ethics and the Office for Research COI Team are hosting help desk hours every Wednesday and Thursday. Zoom links posted here: https://research.rutgers.edu/researcher-support/research-compliance/conflict-interest No registration required.

New Departmental Approvers

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

Stanley Ort, MS, RVT, RDCS who is the Program Director in Cardiovascular Sonography and is the Interim Chair CLMIS in the Rutgers School of Health Professions.

IRB Member Spotlight

Angela M. O'Donnell, PhD

Angela M. O’Donnell, PhD is a Professor and Chair for the Department of Educational Psychology at Rutgers University. Dr. O’Donnell earned her PhD in the field of Experimental Psychology from Texas Christian University. Her research interests include studying conditions in which students learn best from one another.

A longtime member of the IRB at Rutgers, Dr. O’Donnell was motivated to join out of interest in learning more about the IRB. Dr. O’Donnell also planned to use the knowledge gained to provide guidance to colleagues and students. Since joining the IRB, Dr. O’Donnell has enjoyed learning about the range of research being conducted at Rutgers. Dr. O’Donnell’s experience and knowledge make a her a great asset to the IRB.

Paul Lehrer, PhD

Paul Lehrer, PhD is a professor emeritus from the Department of Psychiatry at Rutgers Robert Wood Johnson Medical School. Dr. Lehrer earned his PhD in the field of Clinical Psychology from Harvard University. His research credentials include a vast array of topics, including studies about heart rate variability biofeedback as a treatment for asthma and chronic drug and alcohol abuse, psychophysiological factors in human optimal performance, and exploring psychophysiological treatment approaches for patients with multiple unexplained physical symptoms.

Dr. Lehrer became a member of the IRB in 2014. At the time, his department wanted someone on the IRB with training in behavioral issues. Since becoming a member, Dr. Lehrer reports to enjoy seeing the various research projects and their progress. Dr. Lehrer is an asset to the IRB with his vast experience and knowledge.

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 @claribel.vega@rutgers.edu or Angela Cartmell-McGlynn if interested.

HRPP Website

Website Revisions

New eIRB Workshops through July 2023 have been posted online: Electronic IRB Submission Online System (eIRB) | Rutgers Research

IRB Fee Schedule has been updated: IRB Fees | Rutgers Research.

Pre-Review Team and instructions have been updated: IRB Pre-Review Service | Rutgers Research

AAHRPP Accreditation Updates

The Rutgers University has just submitted their improvement plan and is currently awaiting the council's review.

Stay Tuned!

]=

ClinicalTrials.gov News

Clinicaltrials.gov Tip: Interventional vs. Observational Study Design

Understanding and selecting the appropriate study design for your clinical study at registration is very important, and has regulatory, funder policy, and journal publication implications.

In short, it comes down to whether the researcher is assigning participants to receive an intervention so that they can study how that intervention relates to a health outcome, or if they are observing health outcomes in patients who already naturally belong to a group of interest (for example, having a certain condition, are receiving a certain treatment as part of standard of care).

Interventional studies are clinical studies in which participants are prospectively assigned to groups (e.g., experimental and control arms) to receive an intervention(s) or a placebo/no interventions so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Observational studies are clinical studies in which participants are identified as belonging to groups of interest for study (e.g., patients scheduled to have a tooth extracted, patients that have a pacemaker, patients living in a high-pollution zone). Those identified patients are then assessed for biomedical or health outcomes.

Participants may receive diagnostic, therapeutic, or other types of treatments/interventions such as standard of care, but the investigator does not prospectively assign participants to receive an intervention for study.
A patient registry is a type of observational study.

Nearly all interventional studies are required to be registered and many must report results, while most observational studies (except those with funding from the Patient Centered Outcomes Research Institute (PCORI)) are not required to register or report results.

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

Single IRB News

Be on the Lookout:

An Administrative Flowchart is underway.

There are upcoming revisions to the Reliance component of the eIRB application.

Quality Assurance/Quality Improvement

How to Prepare for your Post Approval Monitoring (PAM) Routine or Directed Review

Initial Contact:

A written notification will be sent to the Principal Investigator (PI) that will outline the type of review to be conducted and provide information about the process that will be followed for the review.

How to Prepare:

Allocate enough time to prepare for the monitoring review prior to QA/QI Analysts coming out
Fill out the Self-Assessment Checklist that will be provided to you upon our original contact, this will help you in preparation for the visit.
Prepare all study documents for review for the day of the visit.
Ensure all study documents are available and easily accessible on the day of the review.
Review our General Overview of the Post Approval Monitoring (PAM) Process HRPP Quality Assurance Team | Rutgers Research
Please feel free to call or email us to ask any questions!

As the year closes out and all look forward to a new year ahead, we wanted to go back to basics!

We have enjoyed working with you all throughout this past year. The QA/QI Team is excited to meet and work with more of our talented Researchers in the upcoming year! Please remember we appreciate your expertise and work and are here to assist you in your regulatory and compliances needs.

For assistance please contact:

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, January 9^th at 11:30 am
Tuesday January 10^th at 2:30pm
Wednesday, January 18^th at 11:30am
Monday, January 30^th at 11:30am
Thursday February 2^nd at 2:30pm
Wednesday February 8^th at 11:30am

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):

The Most Compelling Science Graphics of 2022 (Scientific American) Words alone cannot capture the full wonder (or horror) of all the stories science had to tell this year. That’s where graphics come in. Whether visualizing the most important data emerging around the COVID pandemic, explaining some mind-bending idea in quantum physics or synthesizing the incredible journey of a parasite through three different hosts, Scientific American’s graphics editors have helped cover a plethora of fascinating topics this year. Here is just a tiny sampling of our favorites.

https://www.scientificamerican.com/article/the-most-compelling-science-graphics-of-2022/

NIH plans grant-review overhaul to reduce bias (Nature) The US National Institutes of Health (NIH) has released a tentative plan to change how its research grant applications are scored, with the aim of reducing bias and lowering the burden on reviewers. Under the new system, reviewers would no longer rate researchers’ expertise or their institutions’ access to resources, and there would be fewer scoring criteria overall.

https://www.nature.com/articles/d41586-022-04385-x

Accessing U.S. data for research just got easier (Science) The U.S. government has just made it easier for social scientists to get their hands on federally collected data they need for research. Starting today, an online portal offers one-stop shopping to apply for access to protected data sets maintained by 16 federal agencies. Scientists can search the site to find the data set they want and then, with one click, file an application. The site also allows them to track the status of their request. “This will be transformational,” says economist Margaret Levenstein of the University of Michigan, Ann Arbor, where she manages the country’s largest curated social science data archive. “I work with thousands of researchers, and I know what they have to go through to find what they need and then get access to it.”

https://www.science.org/content/article/accessing-u-s-data-research-just-got-easier

Experimental Drugs to Get New Reporting System With FDA Proposal (Bloomberg Law) Sponsors of investigational drugs would need to comply with an internationally adopted standard for annual reporting under a new rule proposed by the FDA Thursday. The draft rule (RIN 0910-AI37), if finalized, would replace the Food and Drug Administration’s current annual reporting system with a new requirement for a development safety update report (DSUR), which includes consistent formatting and content standards for periodic reporting on drugs under development.

https://news.bloomberglaw.com/pharma-and-life-sciences/experimental-drugs-to-get-new-reporting-system-with-fda-proposal?context=search&index=3

Safeguarding Science toolkit launched to help researchers defend scientific integrity (NSF Press Release) The U.S. National Science Foundation joined federal and university partners to announce a unique collaboration between U.S. government and academic stakeholders to aid researchers facing a broad spectrum of risks to research integrity and security. The Safeguarding Science toolkit was designed with the scientific community for the scientific community. It provides research stakeholders with a single location to access security best practices from across government and academia and to select tools tailored for their individual needs. https://beta.nsf.gov/news/safeguarding-science-toolkit-launched-help See also: Security tool kit released to help scientists identify threats (Chemistry and Engineering News) https://cen.acs.org/research-integrity/Security-tool-kit-released-help/100/i41

Federal Agency Outlines Psychedelic Research Priorities And Guidance For Studies Involving Animals, Adults And Children (Marijuana Moment) A federal health agency is giving researchers guidance on the types of studies it’s interested in funding for the development of psychedelic drugs to treat certain mental health conditions, pointing out limitations for animal-based research and rules for trials involving children. The National Institute of Mental Health (NIMH) published a notice of information last week, providing additional information about research criteria and priorities for psychedelic studies. https://www.marijuanamoment.net/federal-agency-outlines-psychedelic-research-priorities-and-guidance-for-studies-involving-animals-adults-and-children/

Bill To Reschedule Psychedelic Breakthrough Therapies And Remove Research Barriers (Marijuana Moment) Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill on Thursday that would require the Drug Enforcement Administration (DEA) to transfer breakthrough therapies like psilocybin and MDMA from Schedule I to II, while also removing research barriers for strictly controlled substances. The “Breakthrough Therapies Act” was filed on the same day that bipartisan House lawmakers announced the formation of a congressional psychedelics caucus that’s meant to promote the development of novel treatments derived from currently controlled entheogenic substances. https://www.marijuanamoment.net/cory-booker-and-rand-paul-file-bill-to-reschedule-psychedelic-breakthrough-therapies-and-remove-research-barriers/

Notice of Information on NIMH's Considerations for Research Involving Psychedelics and Related Compounds (NOT-MH-23-125) The purpose of this Notice is to outline NIMH priorities and considerations for potential applicants investigating the effects of psychedelic drugs and their derivatives or analogues (i.e., related compounds) on mental health and mental illness. https://grants.nih.gov/grants/guide/notice-files/NOT-MH-23-125.html

Visit our webpage