HSPP/IRB Bulletin
April 29, 2022
Hot Off the Press
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)

New and improved International Compilation of Human Research Standards:  OHRP has updated its International Compilation of Human Research Standards document! This document contains over 1,000 standards from 131 countries and many international organizations.  
  
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. 
IRB Member Spotlight

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.
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

The following have completed eIRB Departmental Approver (RBHS) training and been included online under the IRB's eIRB Departmental Approvers Listing:   

  • 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

Please contact Donna Hoagland if interested.




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?

You can read more information online about IRB Membership or by contacting our Training and Communications Manager, Michelle Watkinson, CIP.

HSPP Staff Updates

Jacquline Treatman
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. 
HSPP Website

Website Revisions
AAHRPP Accreditation Updates
Rutgers University IRB is in the next phase of the AAHRPP process. 
We are scheduled for our on-site visit for 2022 summer for the evaluation of our program in accordance with the AAHRPP Accreditation Standards.
For more information, please contact Swapnali Chaudhari and Malica Dock.
ClinicalTrials.gov News

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
Quality Assurance/Quality Improvement
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)
Single IRB News
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.
 
The Quickguide 'Short Form Q & A' (https://ncicirb.org/institutions/institution-quickguides/managing-study/short-form-q) on the CIRB website has been updated to reflect this clarification.
 
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.
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
  • Thursday, July 21, 2022 at 11:30 am
  • Wednesday, July 26, 2022 at 2:30 pm


From COGR News Digest

‘The Time is Now’ to End Racial Inequities in Medical Research (1) (Bloomberg Law) The National Institutes of Health established the UNITE initiative in February 2021 to identify and end structural racism within the biomedical research enterprise, both within the NIH and the universities and research institutions it funds. It’s a high-level initiative whose co-chairs must report updates to the NIH Advisory Committee to the Director, which is one of the most influential advisory panels at the agency. While the NIH has policies dating back nearly three decades to increase the diverse representation in both the research and the scientists who conduct it, it’s the first time the agency has used the power of its $45 billion purse to tackle structural racism head on.  https://news.bloomberglaw.com/pharma-and-life-sciences/the-time-is-now-to-end-racial-inequities-in-medical-research?context=search&index=3 
  
Research Volunteer Protection Rules Move Toward Agency Harmony (1) (Bloomberg Law) FDA regulations to protect research volunteers will catch up to their HHS counterpart in a significant rulemaking step that’s more than three years past the deadline….. The initiative means that the research infrastructures of academia and industry will be concurrent and consistent, Mark Barnes, a research attorney at Ropes & Gray who is also co-chair of a federal advisory panel to harmonize the two rules, said.  https://news.bloomberglaw.com/pharma-and-life-sciences/research-volunteer-protection-rules-move-toward-agency-harmony?context=search&index=6 

Black Americans Remain Wary of Trusting Medical Researchers (Bloomberg Law) The Pew Research Center’s latest findings underscore the diversity of experiences and perceptions within the Black community based on age, education level, and other factors. They could inform policymakers, drug companies, federal agencies, scientists, and others as they work to improve diversity in clinical trials and improve equity in research and health-care settings.  https://news.bloomberglaw.com/pharma-and-life-sciences/black-americans-remain-wary-of-trusting-medical-researchers?context=search&index=14 

Public Research Universities Have Spent $14.5B on COVID Relief (Inside Higher Ed) An analysis by the Association of Public and Land-grant Universities has found that public research universities had spent nearly $14.5 billion, or over 70 percent of the federal COVID-19 relief grant dollars they received, as of Dec. 31, 2021. This includes the nearly $10 billion from the first two pandemic relief bills—the Coronavirus Aid, Relief, and Economic Security Act and the Coronavirus Response and Relief Supplemental Appropriations Act, as well as a substantial portion of the third round of funding that came from the American Rescue Plan Act. Funds were used to meet students’ basic needs, mitigate the spread of COVID-19 and shift to digital then hybrid instruction formats with unprecedented speed. Spending has continued this year.  https://www.insidehighered.com/quicktakes/2022/04/06/public-research-universities-have-spent-145b-covid-relief See also:  APLU Analysis Finds Pandemic Relief Funding Delivered Critical Relief to Students & Public Universities  https://www.aplu.org/news-and-media/News/aplu-analysis-finds-pandemic-relief-funding-delivered-critical-relief-to-students--public-universities 


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. 
Stay Tuned!
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.
  • Implementation of a Human Subjects Training Program known as CIRTification.