HRPP/IRB Bulletin

May 31, 2023

Hot Off the Press

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).

New IRB Member Spotlight


  • Naveena Yanamala, PhD (she/her), has joined the Rutgers IRB as an expedited reviewer. Dr. Yanamala is an Associate Professor at RBHS/NJMS within the Division of Cardiovascular Diseases and Hypertension. Her research experiences and interests include Artificial Intelligence in Medicine, Machine Learning for Occupational Safety and Health and Computational Biology & Bioinformatics. We welcome Dr. Yanamala onto the IRB and look forward to working with her. 


  • Nicholas Flugrad, MD (he/him) has joined the Rutgers IRB as an expedited reviewer. Dr. Flugrad is an unaffiliated Psychiatrist with experience in  Psychiatry; Criminal Justice & Social Science Research; Genetic Research; Big Data, Data Security or Research Repositories. We welcome Dr. Flugrad onto the IRB and look forward to working with him.


  • Ayana King, MPH (she/her) is currently a medical student (YR II) at Rutgers New Jersey Medical School. She has both biomedical science training, public health research experience and is a Certified pharmacy techican. We welcome Ms. King onto the IRB and look forward to working with her.


  • Mosope Fofah, BA (she/her) is currently a medical student (YR II) at Rutgers New Jersey Medical School. She has general psychology and biomedical science training. We welcome Ms. Fofah 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 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.

]=
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
Reliance icon for IRB Bulletin

All Things Reliance:


We are happy to share that the Reliance Webpage has been completely redesigned to be more user-friendly with a better search and share feature. The Reliance Webpage is accessible in the provided link: Reliance - External IRBs | Rutgers Research

 

A Master Reliance Agreement has been established between Rutgers University and Barnabas Health, Inc. for Non-Oncology Clinical Trials!


What does that mean?


This means Rutgers University will serve as the IRB of Record for certain Barnabas Health sites involved in Non-Oncology Clinical Trials. By having this agreement in place, it reduces the burden of establishing a study specific reliance agreement for each submission and relying site.


The Master Reliance Agreement covers the following site(s):

  • Barnabas Health Medical Group, P.C.
  • Children's Specialized Hospital
  • Clara Maass Medical Center 
  • Community Medical Center, Inc. 
  • Cooperman Barnabas Medical Center Inc.
  • Jersey City Medical Center, Inc. 
  • Monmouth Medical Center, Inc. 
  • Monmouth Medical Center Southern Campus - Lakewood 
  • Monmouth Medical Center Faculty Practice Plan, Inc.
  • Newark Beth Israel Medical Center, Inc.
  • Robert Wood Johnson University Hospital at Hamilton, Inc.
  • Robert Wood Johnson University Hospital Somerset 
  • Saint Barnabas Behavioral Health Center, Inc.
  • Robert Wood Johnson Physician Enterprise, P.A.
  • Trinitas Regional Medical Center, Inc. 



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

Quality Assurance & Evaluation

7 Ways to Help Prevent Common Non-Compliance Issues

 

The HRPP Quality Assurance and Evaluation Team’s commitment to compliance includes the development of educational initiatives and appropriate oversight and monitoring to assist research faculty. This monitoring enables us to identify common pitfalls in the implementation of research and tailor ongoing QA initiatives accordingly.

 

Below will briefly outline steps that research teams can take throughout the life cycle of a study to help reduce instances of noncompliance. One of the most common noncompliance findings uncovered during study audits is that the research team altered or did not adhere to the IRB-approved study protocol in some way. Over the next few months our team will roll out more detailed information on each topic below to help reduce the potential for noncompliance related to study protocol findings:


Assess your research plan feasibility: Prior to IRB approval and periodically during the study, determine whether the research plan can be carried out as written. This includes whether participants will be/are able to complete the study as written. An effective research plan is clear, consistent and allows for variation (e.g., visit/procedure windows) wherever possible. If the research plan includes confusing or overly narrow language or discrepancies between documents (e.g., consent form and protocol), work with the IRB responsible for oversight of the study and sponsor/funding agency (if applicable) to clarify the language and ensure that the research plan can be implemented. Note that if the research plan must be altered for feasibility or any other reason, you must obtain IRB approval through a modification prior to implementing those changes.


Create data collection forms and checklists: These documents can increase compliance with the research plan by reminding study team members what the research plan requires at each point in the study. These documents should be thoroughly reviewed to ensure consistency with the research plan prior to being used. For example, a checklist could be used to document the consent process and its related components (e.g., that a subject received a copy of the form and was able to ask questions). A checklist could also be used to document each study visit and the different procedures to be performed at the visit. Please reference this link for additional checklist tools:


Create Standard Operating Procedures (SOPs): SOPs are beneficial and recommended for all study teams conducting research, especially clinical research. Key SOPs should address processes such as:

a)    roles, responsibilities, training, and delegation

b)   informed consent procedures; and

c)    adverse event management


Resource AvailabilityEnsure that training materials, protocol, consent forms, surveys/questionnaires, checklists, and other documentation are accessible to study team and are updated promptly as needed. Study team members should also know where to go to when questions about study implementation arise.

 

Training: Train study team members on the IRB-approved research plan prior to their involvement in the research as well as when any changes to the IRB-approved materials are made or when new staff join the team. Staff need to be aware of the tasks that they are assigned to perform and principal investigators (PIs) must ensure that staff are properly qualified and trained to perform the tasks assigned.

 

Document: Complete data collection forms and checklists in a timely manner. If a deviation occurs, proper documentation will tell the story of what happened and hopefully reduce the time between the deviation and its discovery.

 

Reporting: When deviations from the IRB-approved research plan occur, the investigator must act quickly to ensure subject safety as well as report to sponsor and/or IRB according to each policy and procedures. Information about deviation submission and reporting can be found here:


 

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):   


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

 

Women’s health research lacks funding – these charts show how (Nature) These results come from the work of US applied mathematician Arthur Mirin, an independent researcher who initially published the analysis1 in 2021. The data shown here are from his updated analysis of the latest NIH information on funding and burden. The overall pattern remains the same. The 2021 analysis “demonstrates that the funding of research for women is not aligned with burdens of disease”, says Sarah Temkin, associate director for clinical research at the NIH Office of Research on Women’s Health in Bethesda, Maryland. https://www.nature.com/immersive/d41586-023-01475-2/index.html (Source: COGR)


Interested in Participating in Dementia Research? Planning Could Reduce Barriers to Inclusion  

Many people living with or at risk for dementia are interested in taking part in research, but they face an ethical and a legal barrier: how to make their wishes known when they no longer have decisional capacity to give informed consent for participating. Advance planning for research is a promising strategy, write Nola M. Ries and Briony Johnston in Ethics & Human Research. Read more. (Source: The Hastings Center) 

 

It matters who does science (Science, Editorial) Scientific research is a social process that occurs over time with many minds contributing. But the public has been taught that scientific insight occurs when old white guys with facial hair get hit on the head with an apple or go running out of bathtubs shouting “Eureka!” That’s not how it works, and it never has been. https://www.science.org/content/blog-post/it-matters-who-does-science 


‘It’s got everyone’s attention': Inside Congress’s struggle to rein in AI (Politico) The planet’s fastest-moving technology has spurred Congress into a sudden burst of action, with a series of recent bills, proposals and strategies all designed to rein in artificial intelligence. There’s just one problem: Nobody on Capitol Hill agrees on what to do about AI, how to do it — or even why.  

https://www.politico.com/news/2023/05/04/congresss-scramble-build-ai-agenda-00095135. (Source: COGR)



See also: 

 

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