HSPP/IRB Bulletin
July 27, 2021
Hot Off the Press
IRB Member Doodle Poll

During this re-organizational period, the IRB is seeking your feedback regarding full board meeting dates. At your earliest convenience please fill out the doodle poll with your preference for full board meeting dates and times. Please note this poll was sent out previously, but the IRB has not received enough feedback. Your feedback is very important to us. 

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HSPP Website Updates

The following web pages have been revised and are now working:

  • Contact us linked to IRBoffice@research.rutgers.edu 
  • Age of Majority 
  • Patient Bill of Rights 
  • Genetic Information Non-Discrimination Act 
  • Protection of Pupil Rights 
  • Nuremberg Code 
  • Basic Site Information HRP 811 
  • Investigator and Student Manuals
  • e-IRB Qucik guide for Department Reviewer 
  • e-IRB Quick guide for Research Staff 
  • e-IRB User Manual for Department Reviewer 
  • NIH Data Sharing Policy 
  • Rutgers Registration and Results Reporting Policy 
IRB Member Spotlight

Meet the IRB Chairperson for all Rutgers IRB Committees 

Cheryl Ann Kennedy, MD, DLFAPA, FASAM

Cheryl A. Kennedy, MD, Professor of Psychiatry at Rutgers New Jersey Medical School, Newark, NJ, has been on the Faculty for 30 years. She has served the disenfranchised mentally ill and substance using population of Newark and NJ for over 30 years with her expertise in General and Emergency Psychiatry, Consultation-Liaison Psychiatry, Neuropsychiatric Conditions, Trauma & Disaster Medicine, Addiction Medicine and Child and Adolescent Psychiatry. She has worked in former war zones. Dr. Kennedy’s research and expertise in clinical work have spanned HIV/AIDS, PTSD, Huntington’s Disease, mood disorders in children, transplant medicine, community trauma, and quality measures in psychiatric care. She is frequently sought out for Clinical Consultations; has many peer-reviewed publications and often gives invited scholarly presentations. She is known to mentor students and residents in active research projects or other scholarly activities. 
She is the Faculty Advisor for the student-run NJMS Physicians for Human Rights Asylum Network with the Rutgers Law Project, and serves on several Community Based Organizations’ Boards of Directors. She has received many awards and honors and is an elected member of the American College of Psychiatrists, a Distinguished Life Fellow of the American Psychiatric Association and a Fellow of The American Society of Addiction Medicine. She is President of the Tri-County Chapter of the NJ Psychiatric Association. 

MY THOUGHTS ABOUT being IRB Chair: 
Of the wide-variety of my medical school academic activities: administrative, clinical, educational or scholarly, being an active IRB member and being able to Chair many full board meetings is among my favorite. I joined the IRB in the early 1990’s and was fortunate enough to learn and contribute to the growth and development of the IRB at New Jersey Medical School (not without good IRB-mentoring!) and subsequently, University-wide. It has been a great privilege and honor to work with such a talented and knowledgeable staff of extremely well trained individuals and the many faculty and community reviewers from so many different disciplines and professions! For me, it is a continuous learning experience (really thrilling for me as an inquisitive physician!) and it really fills me with enormous respect for our researchers at all of our schools and how diligently they work to fulfill the academic mission!!! 
Thank you all!

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

Please contact Donna Hoagland.
New HSPP Staff Spotlight
Claribel Vega, BA

Claribel Vega joins the Rutgers Institutional Review Board as the Senior Reliance Manager. In 2010, she earned her bachelor's degree in Social Work at Rutgers University. Ms. Vega served as the Program Development Administrator at Rutgers Behavioral Health Sciences (RBHS) for four years. As one of the senior administrators, she was responsible for day-to-day operations leading a team of more than 15 professional clinicians and research staff. Prior to her tenure at RBHS, Claribel Vega served as the Management Assistant for six years at the Rutgers Institutional Review Board, where she aided in the analysis, implementation, and monitoring of the office. Ms. Vega is an experienced innovator with over 10 years of office management and client relation skills which are fully utilized in key leadership and support roles.


Griselda Villanueva

Griselda Villanueva joins the team as an IRB Administrator. She graduated from Rutgers University with a major in Public Health. Before this new role, she was a Research Project Coordinator for the Bloustein Center for Survey Research at the Edward J Bloustein School. In this role, she was responsible for the management of day-to-day data collection for clients, protocol compliance, as well as the supervision and training of the student part-time staff. She also assisted in the preparation of IRB submissions for continuing reviews and amendments. She is very excited to learn more about her new role and how she can contribute to the success of the team!


AAHRPP Accreditation Updates

The HSPP/IRB office will be submitting the Step 1 application for AAHRPP accreditation in the month of August 2021. Further updates will follow in the upcoming bulletins. For more information, please contact Swapnali Chaudhari and Malica T Dock.
ClinicalTrials.gov News
Recent federal court decision on Seife v. HHS requires researchers to post a decade’s worth of trial results under the FDAAA801 law, and the FDA and NIH may take action against responsible parties if the required information was not submitted. To avoid the potential consequences of non-compliance, the HSPP Office has been working diligently with investigators, since August 2020, to address issues impacted by this legal change. Eighteen Rutgers registered records were initially identified, six of them have met review criteria and the rest are work in progress. Support from research leadership and understanding cooperation of investigators is greatly appreciated for Rutgers to move forward and reach compliance.   
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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.
 
  • 8/10/2021 at 11 am 
  • 8/19/2021 at 2:30 pm 
  • 9/7/2021 at 11 am 
  • 9/14/2021 at 11 am 
  • 9/16/2021 at 2:30 pm 
  • 9/23/2021 at 2:30 pm 

Stay Tuned!

In the works:

  • Consent Form Revisions

  • IRB Orientation Workshops

  • New IRB Appointment Letter