HSPP/IRB Bulletin
September 29, 2021
Hot Off the Press
IRB Board Changes and Restructuring 
Beginning on October 1, 2021, four Full Board meetings now convene once a week on Wednesday afternoons at 1:00pm. One board is reserved as an ad-hoc committee, when necessary, and the other two boards review expedited submissions but currently do not have monthly meetings. In addition to the change of meeting dates, all boards have been renamed:

All board members have been emailed assignments to each of the new IRB boards. Please note that the above changes do not affect the Full Board Meeting submission deadline dates. Thank you again for your service on the IRB.

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. 

Marsha Bates 1994-2021
27 Years of Service

George Karp - 2001 -2021
20 Years of Service

Judy Flax 2005 -2021
16 Years of Service

COVID Study Pre-Review Services for Investigators Expanded

Good news. The IRB has expanded the COVID Study Pre-Review Services to include all types of studies.

The purpose of the Pre-Review process is to facilitate a complete submission for human subject studies by providing an optional Pre-Review Service to investigators prior to submitting new studies or substantial modifications to existing studies in eIRB. 

The Pre-Review Team consists of experienced IRB members and Human Subjects Protection staff experienced with protocol review, criteria for IRB approval at 45CFR46, HIPAA Regulations at 45CFR46 Parts 160, 162, and 164, FDA Regulations at 21CFR50 and 56, the Rutgers HSPP Policies and Procedures, the Rutgers HSPP toolkit worksheets and checklists, as well as Rutgers University Policies and Procedures and NJ State Laws as they pertain to human subjects research. 

The Pre-Review Team reviews the protocol and ancillary documents such as the consent form, recruitment materials, data collection forms and related documents to provide feedback and suggestions to the investigator for revisions or clarifications prior to submission in eIRB.

To take advantage of this service and begin the process please follow the instructions below. 

For studies/modifications that have already been submitted please refer to Options for studies recommended for Pre-Review after submission in eIRB below

*Pre-Review Instructions:

  • Upload the relevant documents in Rutgers OneDrive (see Rutgers OneDrive Instructions below).

  • This Pre-Review should be done simultaneously as you work on the following:

  • eIRB application (please do not submit the application or upload the documents until they have been pre-reviewed by the pre-review team and then finalized by you). 

  • If your research will be conducted on Robert Wood Johnson University Hospital (RWJUH) New Brunswick property or involve RWJUH New Brunswick patients, their data or biospecimens you must submit an application to the RWJUH Research Utilization Group (RUG). 

  • To access the RUG form, please visit our website under 'Performance Site Approval Forms': https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit . 

  • If your research will be conducted on University Hospital (UH) property or involve University Hospital patients, their data or biospecimens you must submit a UH Registration and Research Plan through the Office of Clinical Research Administration. 

  • Please refer to our website at https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit and view instructions under ‘Performance Site Approval Forms’ then under University Hospital. 

  • eCOI disclosures/CITI for the Principal Investigator and all research personnel 

  • Rutgers CITI training requirements can be found at https://research.rutgers.edu/researcher-support/research-compliance/research-integrity/collaborative-institutional-training . CITI training can be completed at https://about.citiprogram.org/en/homepage/ 

  • eCOI - Please click the ‘Create financial disclosure certification in eCOI’ in the eIRB study workspace and select all study personnel. 

  • Any other required approvals applicable to your protocol such as Biosafety, Radiation Safety, Scientific Review Board, University Behavioral Health Care signoff, etc. 

  • Any contracts or agreements applicable to your protocol such as Clinical Trial Agreements, Data Use Agreements 

  • IRB Reliance Agreements, to accept another IRBs approval or for Rutgers to serve as the IRB of record for other sites involved in your research. For information regarding IRB Reliance Agreements please contact the IRB Reliance Administrator: IRBRelianceAdmin@ored.rutgers.edu 

*Pre-Review Completed 

  • We will notify you via email once the pre-review is completed. Please keep in mind that this courtesy pre-review is intended to help expedite the approval process and the comments are recommendations - individual IRB members (who are faculty familiar with a variety of research) may have additional comments during the review process, after you submit your protocol through eIRB. 

  • Log into Rutgers OneDrive to review the comments and address as you deem appropriate. 

  • When your revisions are complete upload the final versions in eIRB before submitting your application.

*Options for studies recommended for Pre-Review after submission in eIRB: 

Option 1: 
  • Withdraw the study in eIRB.
 
  • Upload the protocol and relevant documents to OneDrive and share with the Pre-Review Team listed below. 

  • Once you are notified the Pre-Review is complete, address the comments/suggestions as you deem appropriate. 

  • The PI creates and submits a new application in eIRB and submits for IRB review. 

Option 2: 
  • Allow the study/modification to proceed through the regular IRB process as submitted without pre-review 
____________________________________

HSPP Website Updates
Stay tuned for updates to the Website

Education & Outreach Corner

  • OHRP’s 4th Annual Exploratory Workshop, “Review of Third-Party Research Risks: Is There a Role for IRBs?” will be held on Friday, September 24th from 9:45 AM to 4:00 PM EDT. This workshop will examine third parties impacted by research, ethical considerations for third-party risk in research, possible framework for IRBs on reviewing third-party risks, why and how bystander protections may make for good ethics and policy, and much more! This event does not require registration and qualifies for CIP credits! Bookmark the following link to access the live event: https://videocast.nih.gov/watch=41987. Find details about this event at: https://www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2021-workshop/index.html 

  • The Office for Human Research Protections (OHRP) releases a new incident reporting form and instructions, which is effective immediately. The human subjects protection regulations at 45 CFR part 46 require that organizations engaged in or reviewing non-exempt HHS-conducted or supported human subjects research establish and follow written procedures for ensuring prompt reporting to OHRP of incidents such as unanticipated problems.  As such, the new OHRP incident reporting form is intended for non-exempt submissions related to:  

  1. Unanticipated problems involving risks to subjects or others;  
  2. Serious or continuing noncompliance; and  
  3. Suspension or termination of IRB approval  

  1. The OHRP Incident Reporting Form is now required for any incident report made to OHRP in accordance with 45 CFR part 46. OHRP’s website provides both Instructions for completing the form as well as a mini-tutorial video, entitled Reporting to OHRP (1): Unanticipated Problems (18:05 minutes). A future educational item on this topic will be recorded and shown at an upcoming, monthly IRB meeting.   

When does research qualify as minimal risk? Advarra’s A Beginner’s Guide to Minimal Risk Research blog aims to provide a beginner’s overview to the regulatory concept of “minimal risk,” and which regulatory flexibilities research might be eligible for.  

IRB Member Spotlight


Meet one of the IRB Vice-Chairpersons for all Rutgers IRB Committees 
 
Jonathan McCoy, MD 
 
Jonathan McCoy, MD, is an Associate Professor and Research Director for the Department of Emergency Medicine at Rutgers Robert Wood Johnson Medical School. An alumnus of John Hopkins University Schools of Medicine (Baltimore, MD), Dr. McCoy completed his residency in emergency medicine at the Hospital of the University of Pennsylvania (Philadelphia, PA) and a fellowship at UMDNJ-Robert Wood Johnson Medical School, Cooper University Hospital (Camden, NJ).
  
While Dr. McCoy’s focus is emergency medicine, he has a special interest in therapeutic hypothermia and sepsis resuscitation. While with the Hospital of the University of Pennsylvania, he helped create the first elective in severe sepsis and septic shock resuscitation. Dr. McCoys’ keen interest in research has led to his undertaking of avid human subject research projects and contributing multiple peer review articles to journals. Furthermore, Dr. McCoy is a member of renowned professional organizations, recipient of several awards and an active member of the community.
 
Dr. McCoy’s mentor, Dr. Stephen Trzeciak, encouraged Dr. McCoy to join the IRB several years ago. Dr. Trzeciak emphasized to Dr. McCoy the significance of the IRB. Although the commitment to the Board can be time consuming, Dr. McCoy recognizes the importance of the committee and his role. Dr. McCoy perceives his role as Vice Chairperson as an excellent opportunity to witness some of the most exciting investigations happening at Rutgers. In closing, Dr. McCoys’ professional commitment, research contributions and knowledge are valuable qualities that contribute to his role as Vice Chair for the conduct of human subject research.  

 Interested in being featured in an upcoming issue of this bulletin?

Please contact Donna Hoagland.
eIRB System Announcements
Stay tuned for updates to the eIRB System! 
AAHRPP Accreditation Updates

Step 1 application is currently under committee review with the AAHRPP council. For more information, please contact Swapnali Chaudhari and Malica Dock.

ClinicalTrials.gov News
Under the FDAAA801 law and Rutgers policy, the Responsible Party/ Principal Investigator is held accountable for study registration and results reporting on ClinicalTrials.gov. On September 1, FDA issued the 1st notice of non-compliance to an individual investigator. The statement ClinicalTrials.gov – Notices of Noncompliance and Civil Money Penalty Actions includes a letter that warned Andrey Petrikovets, a Los Angeles surgeon, for failing to report study results to ClinicalTrials.gov, which could result in significant monetary fines. Dr. Petrikovets ran a Phase 4 study for University Hospitals Cleveland Medical Center, an affiliation with Case Western Reserve University, which is an academic medical center just like Rutgers. 

Rutgers investigators have been notified the above matter, and institutional ClinicalTrials.gov Administrator Rebecca Chen has been working closely with investigators whose records are outstanding in results reporting. We will assist investigators to reach required compliance as soon as possible, and avoid penalties specified in the Food and Drug Administration Amendments Act of 2007 (FDAAA801)

If you or someone you know might require support, please contact Rebecca Chen and the HSPP Office immediately at rutgersctgsupport@research.rutgers.edu

Quality Assurance/Quality Improvement

As part of a new process for the HSPP’s monitoring activities, Self-Assessment Checklists are now being distributed to researchers as a first line of Quality Assurance. These checklists provide guidance on evaluating whether there are any areas in need of attention or quality improvement.
Single IRB News

Guidance on requirements of NIH Single Institutional Review Board (IRB) plan.
 
The purpose of this Notice is to remind the extramural research community that providing the name of the single IRB (sIRB) of record at Just-in-Time submission suffices to fulfill the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research requirement to provide an sIRB plan for NIH grants.
 
Below is the link:
 

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HSPP / IRB Education

eIRB Virtual Training Workshops

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.
 
  • 10/5/2021 at 11 am    
  • 10/12/2021 at 11 am        
  • 10/21/2021 at 2:30 pm   
  • 10/28/2021 at 2:30 pm 
  • 11/9/2021 at 11 am 
  • 11/18/2021 at 2:30 pm 
  • 12/7/2021 at 11 am 
  • 12/16/2021 at 2:30 pm
Stay Tuned!

In the works:

  • Consent Form Revisions

  • IRB Orientation Workshops

  • New IRB Appointment Letter