HSPP/IRB Bulletin
April 29, 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.
Germin Fahim, Pharm. D., BCPS 2015-2022
Department of Pharmacy Practice and Administration
Ernest Mario School of Pharmacy
7 Years of Service
Cati Coe, Ph.D. 2016 -2022
Department of Sociology, Anthropology and Criminal Justice - Camden
6 Years of Service
Robrecht Van Der Wel, Ph.D. 2017-2022
Department of Psychology - Camden
5 Years of Service
From the Office of Human Research Protections (OHRP)
Pending Implementation of a Human Subjects Training Program known as CIRTification
The rollout of CIRTification at Rutgers will begin soon. Additional details about roll-out will be included in future Bulletin newsletters. The CIRTification program provides research ethics training alternative for individuals in community organizations, with limited understanding of conducting human research and protecting potential research participants. This option provides training that focuses on establishing the skills in community partners to conduct human subject research effectively and safely in their communities.
CIRTification training will not be available to Rutgers faculty, staff, and students; instead Rutgers faculty, staff and students are required to complete the CITI training. The CIRTification program is only for individuals from community organizations who are working with Rutgers faculty, staff, or students on human subjects research. The community-based partners cannot have access to Protected Health Information (PHI) and they cannot be associated with an institution that has its own Human Subjects Training requirements.
Pre-Review Process for Full Board Studies
The Pre-Review Process for Full Board Studies Standard Operating Procedures were finalized and are effective immediately.
The process is being expanded to include studies reviewed by the Full Board when the study is either tabled or revisions are requested with subcommittee re-review.
The new process will include the following:
- A mandatory pre-review/consultation by the Pre-Review Team for studies the full board determines are tabled and require full board re-review.
- An optional pre-review/consultation by the Pre-Review Team for studies the full board determines can be re-reviewed by an IRB subcommittee.
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Luigi Brunetti, PharmD, PhD
Luigi Brunetti, PharmD, PhD, is an Associate Professor of Pharmacy Practice and Administration at Rutgers Ernest Mario School of Pharmacy. In 2015, Dr. Brunetti became a member of the IRB to learn more about the regulatory aspects of clinical studies/trials. Since joining, Dr. Brunetti has gained an appreciation for the work of the talented researchers at Rutgers University. Dr. Brunetti enjoys the interaction with the other members of the IRB who also share a passion for research.
Dr. Brunetti conducts his own research into the identification of factors that influence an individual's response to medications. An alumnus of Rutgers, Dr. Brunetti has extensive experience in the conduct of observational studies and translational research. The wealth of Dr. Brunetti’s experience is an asset to the Rutgers IRB.
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Manisha Bajpai, PhD
Manisha Bajpai, PhD, is an Assistant Professor of medicine at Rutgers Robert Wood Johnson Medical School in the Department of Medicine – Gastroenterology and Hepatology. Dr. Bajpai conducts and supervises clinical and translational research studies funded by the NIH and other sponsors. She trained as a Molecular, Cell and Developmental biologist at the Indian Institute of Chemical Biology, Jadavpur University a premier scientific research institution in Kolkata, India.
In 2011, Dr. Bajpai became a member of the IRB out of pure curiosity. Since joining, Dr. Bajpai had found her role on the IRB to be a great learning experience. Through her membership with the IRB, Dr. Bajpai feels that she is doing her part in ensuring that responsible conduct of science is as important as innovation. Dr. Bajpai’s expertise in clinical research is of great benefit to the Rutgers IRB.
New Board Members
Brigette Cypress, EdD, RN, CCRN (she/her) has joined the Rutgers IRB as an expedited reviewer. Dr. Cypress is an Associate Professor at Rutgers School of Nursing (Camden) and has been a critical care registered nurse (CCRN) since 1993. Her clinical expertise is in adult medical, surgical, neuro-surgical, and trauma intensive care.
She earned a doctorate in Nursing education from Teachers College Columbia University Executive Program for nurses. Her area of research is qualitative with a clinical focus on critical care, specifically, patient-family-nurse lived experiences. She has taught research in the baccalaureate, master's, and doctoral level for many years and has been on six dissertation committees at the Ph.D. level as a qualitative research methodologist.
Dr. Cypress is a phenomenologist who published one book, and numerous peer-reviewed articles from her research studies. Her other scholarly interests are evidence-based practice, concept analysis, theory development, development of nursing knowledge, and philosophy of science.
We welcome Dr. Cypress onto the IRB and look forward to working with her.
New Departmental Approvers
- Rosa E. Solis, B.S. (Faculty Practice Operations Manager, Division of Cardiothoracic Surgery at NJMS)
- Morgan Pesanelli, MPH, CHES (Research Analyst, Office of Research in the Rutgers School of Public Health)
- Mei R Fu, Ph.D., RN, FAAN (Professor & Senior Associate Dean for Research, The School of Nursing – Camden)
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
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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My name is Jackie Treatman. I’m very excited to join the HSPP group at Rutgers. I’ve spent the last 6 years working at Mount Sinai in NYC. I worked two years in Sinai’s IRB, and for the past four and a half years I worked with the hospital’s thoracic oncology program as a program coordinator. Recently I moved to NJ and decided to make the move to work closer to home.
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AAHRPP Accreditation Updates
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NIH Grant Recipients: Requirements Related to ClinicalTrials.gov
The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires investigators/awardees conducting clinical trials to ensure that these trials are registered, and that results information is submitted to ClinicalTrials.gov if:
- The clinical trial is funded in whole or in part by NIH; and
- The grant application was submitted on or after January 18, 2017; and
- The funded clinical trial was initiated on or after January 18, 2017.
NIH defines a clinical trial as: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
The policy applies to clinical trials funded in whole or in part by the NIH regardless of:
- study phase
- type of intervention
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Quality Assurance/Quality Improvement
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As part of the Human Subjects Protection Program’s efforts in providing Quality Assurance/Quality Improvement services to researchers, new Self-Assessment Checklists have been created as part of the HRP Toolkit.
Investigators may receive notification to complete these checklists as part of the routine Post-Approval Monitoring (PAM) process. Investigators may also choose to use these documents as a quality assurance review of their studies without notification.
These checklists can be found on Rutgers HSPP Website under resources located in Quality Assurance Square.
List of Self-Assessment Checklists:
- HRP-430a - CHECKLIST - Post Approval Monitoring Self-Assessment - Drug or Device Clinical Trial
- HRP-430b - CHECKLIST - Post Approval Monitoring Self-Assessment - Participant File
- HRP-430c - CHECKLIST - Post Approval Monitoring Self-Assessment - Biomedical Research
- HRP-430d - CHECKLIST - Post Approval Monitoring Self-Assessment - Social Behavioral Research
- HRP-430e - CHECKLIST - Post Approval Monitoring Self-Assessment - Humanitarian Use Device (HUD)
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National Cancer Institute CIRB
The CIRB Standard Operating Procedures (SOPs) have been updated. The changes were made to clarify that short forms should only be used if a CIRB-approved translated consent form is not available. When there is a Spanish version of the model consent form approved and posted on CTSU, the Spanish version of the consent form should be used. Institutions should have CIRB-approved translated boilerplate for insertion into the Spanish consent form. The changes are summarized in the Summary of Changes to the SOPs.
Common Practice for Continuing Review when Rutgers IRB does not serve as the IRB of Record
At the time of submission for Continuing Review of an Administrative Review application, the IRB of Record Continuing Review Approval should be uploaded as a supporting document in section 7.0 “Additional Supporting Information.” Rutgers IRB will not issue an Administrative Approval without the Continuing Approval from the IRB of Record. When Rutgers IRB does not serve as the IRB of Record, the approval date and expiration date from the IRB of Record Continuing Approval is required in order to process the Rutgers IRB Administrative Approval.
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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, May 4, 2022, at 2:30 pm
- Tuesday, May 10, 2022 at 11:30 am
- Wednesday, June 1, 2022 at 11:30 am
- Wednesday, June 8, 2022 at 2:30 pm
- Wednesday, May 4, 2022, at 2:30 pm
- Tuesday, May 10, 2022 at 11:30 am
- Wednesday, June 1, 2022 at 11:30 am
- Wednesday, June 15, 2022 at 11:30 am
- Wednesday, July 13, 2022 at 2:30 pm
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Thursday, July 21, 2022 at 11:30 am
- Wednesday, July 26, 2022 at 2:30 pm
From COGR News Digest
From Center Watch:
Remote and flexible trial approaches have been a hallmark of clinical trials during the pandemic and are widely believed to have been the primary factor in keeping trials open and operating. Now, there is evidence showing that such measures as telehealth visits, off-site diagnostic/monitoring procedures and remote consenting were at least partially responsible for the ability of lung cancer trials to weather the storm.
Sites conducting pediatric research continue to hit two barriers, according to a new analysis of pediatric trials. Trials are too often abandoned by sponsors focused on commercial, rather than scientific, success. And a lack of data-sharing and reporting of results limits what sites can learn from each other.
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In the works:
- “How to Write an IRB Review” Guidance for IRB Members.
- General IRB Member Survey
- Customer Service Satisfaction Surveys for Website & Email Interactions.
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Implementation of a Human Subjects Training Program known as CIRTification.
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