HSPP/IRB Bulletin
January 28, 2022
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With Sincere Appreciation to Our Retiring Board Members
As your time on the Rutgers Institutional Review Board draws to a close, we wanted to express our sincere gratitude for your service. IRB service is one of the toughest volunteer roles at an Academic Medical Center. Thank you all for your contributions and the expertise you brought to our deliberations.
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Jane Ziegler, DCN (Department of Clinical and Preventive Nutritional Sciences at the Rutgers School of Health Professions)10 years of Service 2012-2022
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Debra Keenan, Ph.D.(Department of Nutritional Sciences at the Rutgers School of Environmental and Biological Sciences)10 years of Service 2012-2022
Human Subjects Research Articles
Taplin S, Chalmers J, Brown J, Moore T, Graham A, McArthur M. Human Research Ethics Committee Experiences and Views About Children's Participation in Research: Results From the MESSI Study. J Empir Res Hum Res Ethics. 2022 Feb-Apr;17(1-2):70-83: 10.1177/15562646211048294. Epub 2021 Oct 12. PMID: 34636704. Available Online: at https://pubmed.ncbi.nlm.nih.gov/34636704/
Tsan MF. Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements. J Empir Res Hum Res Ethics. 2021 Dec;16(5):479-484: 10.1177/15562646211018665. Epub 2021 May 14. PMID: 33989094. Available Online at https://pubmed.ncbi.nlm.nih.gov/33989094/
Subject Compensation/Payments Guidance
The HSPP office would like to share with you the guidance for Subject Compensation/Payments. This document provides definitions for 'Reimbursement' vs 'Compensation', Guidelines for 'Amount of Payment', 'Timing of Payment', 'Completion Bonus', use of 'Third-Party Payments via Online Platforms', 'Raffles/Lotteries' for research, and Tax Reporting Requirements.
Newly Revised Templates
All HSPP|IRB Protocols & Consent Templates were revised to include gender-neutral language.
Pre-Review Process Update
The Pre-Review Instructions for Investigators are being updated to include the option for investigators to upload their Word Documents in Rutgers OneDrive or Rutgers BOX to be shared with the Pre-Review Team.
Investigators may begin to utilize the Rutgers BOX option immediately.
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James Dermody, PhD
James Dermody, Ph.D., is the Director of the Institute of Genomic Medicine and Assistant Professor of Microbiology, Biochemistry and Molecular Genetics at Rutgers New Jersey Medical School. Dr. Dermody is a graduate of Rensselaer Polytechnic Institute and the State University of New York at Stony Brook. In addition to his role with Rutgers, Dr. Dermody has an impressive research background in genomic medicine.
After discussions with IRB members and the chair about his own protocols, the IRB members suggested Dr. Dermody join the IRB. Since then, he has served as a member and vice-chair. Dr. Dermody reports enjoying reading different protocols from different places and the science behind them. Dr. Dermody brings a wealth of knowledge and experience to his role as vice-chair, and the IRB appreciates his contribution.
New Board Members
Oliver Sheldon has joined the Rutgers IRB as an expedited reviewer. Dr. Sheldon is an Associate Professor of Management and Global Business at Rutgers Business School, where he teaches courses on negotiation and organizational behavior. His research focuses on factors that shape pro-social behavior within teams and organizations. More specifically, his work seeks to better understand motivational and relational triggers of interpersonal competition and conflict within small groups, with the aim of shedding light on how organizations might improve coordination and collaboration among employees. His research has involved both undergraduate populations and crowdsourcing platforms. We welcome Dr. Sheldon onto the IRB and look forward to working with him.
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 HSPP/IRB Bulletin
New Departmental Approvers
- Dr. Justin T. Sambol (NJMS, Chief, Division of Cardiothoracic Surgery)
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?
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Website Revisions
- HRP-001
- HRP-012
- HRP-030
- HRP-090
- HRP-091
- HRP-096
- HRP-101
- HRP-103
- HRP-103a
- HRP-103p
- HRP-106
Revised Emergency Use Section with Updated Emergency Contact Phone numbers under Guidance Topics
Updates to eIRB Resource section to include all 2022 session dates under eIRB Educational Opportunities
"Circumstances Requiring Review of Protocols by a Rutgers IRB" to include “Single Patient Expanded Access”.
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AAHRPP Accreditation Updates |
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Only the beta of the public-facing website is available right now. The beta modernized PRS system (i.e. the register.clinicaltrials.gov site used to register studies and enter results) is planned to launch in early 2022. When the beta PRS launches, users will initially still be able to switch to the classic version.
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Quality Assurance/Quality Improvement |
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What is a Sponsor-Investigator?
A Sponsor-Investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the investigational device is administered, dispensed, or used. The term does not, for example, include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor. A Sponsor/Investigator Regulatory Checklist IND.IDE_Sponsor-Invest Checklist.doc is provided by the QA/QI Team to assist investigators in meeting these regulatory requirements.
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Change to the Advarra Submission Process
Effective January 10, 2022, all Advarra submissions must be submitted initially to the Rutgers IRB office for the preliminary review. Advarra IRB will not accept applications submitted without the initial review conducted by the Rutgers IRB. For further information regarding the submission process please feel free to contact the IRB Reliance Team.
Rutgers IRB must conduct a preliminary IRB Office administrative review of all Advarra IRB submissions to assure the local institutional requirements have been satisfied. All Rutgers Principal Investigator(s) are required to first submit an eIRB Administrative Review application to Rutgers IRB and obtain local institutional clearance from Rutgers IRB for their Advarra IRB submission. A clearance memo will be released to the Principal Investigator (PI) when the submission is ready for Advarra IRB review. Once the memo is issued, the PI can submit it directly to Advarra IRB and upload the Rutgers IRB clearance memo as the local institutional requirement document.
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Education and Training Opportunities |
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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.
- Wednesday, January 26, 2022, at 2:30 pm
- Monday, February 7, 2022, at 11:30 am
- Wednesday, February 9, 2022, at 2:30 pm
- Thursday, February 17, 2022, at 11:30 am
- Tuesday, February 22, 2022, at 2:30 pm
- Thursday, March 3, 2022, at 11:30 am
- Wednesday, March 9, 2022, at 11:30 am
- Wednesday, March 16, 2022, at 2:30 pm
- Thursday, March 24, 2022, at 2:30 pm
- Wednesday, March 30, 2022, at 11:30 am
Regulatory Education Events
Common Rule ABCs with OHRP Webinar on Friday, February 18, 2022, 12 pm to 1 pm (EST).
This presentation will explain why we have regulations to protect research participants, how they function, and who needs to comply with them.
It is intended for anyone who needs to know the general framework for how the review and approval process works for human research protections and is perfect for those who are new to the field! Must register by clicking on this link.
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In the works:
- Revisions to International Guidance
- IRB Orientation Workshops
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