|
HSPP/IRB Bulletin
September 30, 2022
| |
|
With Sincere Appreciation to Our Retiring Board Members
As your time on the Rutgers Human Subject Protection Program draws to a close, we wanted to express our sincere gratitude for your service. HSPP service is one of the toughest volunteer roles at an Academic Medical Center. Thank you for your contributions and the expertise you brought to our deliberations.
-
Paul Lehrer, PhD who has served as an IRB member since 2016.
| |
New Departmental Approvers | |
|
The following have completed eIRB Departmental Approver (RBHS) training and been included online under the IRB's eIRB Departmental Approvers Listing:
-
Antonina Mitrofanova, Ph.D. who is an Associate Dean for Research and Associate Professor in the Rutgers School of Health Professions
| |
|
Dirk Moore, PhD
Dirk Moore, PhD, is an Associate Professor within the Department of Biostatistics and Epidemiology in the Rutgers School of Public Health and at the Cancer Institute of New Jersey. He received a PhD in biostatistics from the University of Washington in Seattle. In addition to his IRB service, Dr. Moore has served as a member of the Rutgers Cancer Institute Scientific Review Board Committee and Chair, Data Safety Monitoring Committee at Rutgers Cancer Institute of New Jersey.
Dr. Moore joined the IRB approximately five years ago to maintain ethical standard in research and help others meet those standards. Dr. Moore enjoys the collegiality of the IRB and the opportunity to learn about the research activities of colleagues and students at Rutgers. His experience in research, having contributed to more than 90 publications, makes him an essential member of the IRB.
| | |
|
Ziva Petrin, MD
Dr. Ziva Petrin, MD, is a sports medicine physician and an Assistant Professor in the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School. She has advanced fellowship training in Primary Care Sports Medicine from the University of Utah Salt Lake City, UT, and completed her Physical Medicine and Rehabilitation residency at Thomas Jefferson University, Philadelphia, PA. Dr. Petrin has experience working with pediatric, adolescent, and adult populations. She has provided her expertise in working with a variety of sports organizations, including USA Climbing, USA Volleyball and others.
Dr. Ziva Petrin joined the IRB as a non-scientist in 2020. Dr. Petrin believes strongly in evidence-based health care and initially joined the IRB because she wanted to contribute to ensure excellence, equity, and efficiency in human subjects research at Rutgers. She reports that serving on the IRB has been a great opportunity to learn from the rest of the IRB committee members, many of whom have decades of experience. The IRB is thankful to Dr. Petrin for her commitment to the responsible conduct of human subjects research.
| |
|
Yingting Zhang, MLS
Yingting Zhang, MLS, is a Research Services Librarian at Rutgers Robert Wood Johnson Library of the Health Sciences. She is also an Adjunct Assistant Professor in the department of Medicine at Rutgers Robert Wood Johnson Medical School. Ms. Zhang serves on many professional committees and conducts her own research in the field of library science.
Yingting Zhang joined the IRB as a non-scientist in 2006, and became an essential member of the Executive IRB in 2016. She finds her role as a member to be a great privilege. She enjoys participating in IRB reviews to ensure that the research subjects' rights are protected, the informed consent is written in a layperson's language so that the subjects understand it, and that the conduct of research is publicly accountable. Yingting Zhang stated to have learned a lot about how research is responsibly conducted and what areas need to be improved. She became more aware that advocating ethical and responsible conduct of research is utterly important to ensure not only the protection of research subjects but also the high quality of research to advance science and mankind. The IRB is thankful to Yingting Zhang for her years of service in support of responsible conduct of human subjects research.
Julie Chapman Greene, PhD, MPH
Julie Chapman-Greene, PhD, MPH (she/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Chapman-Greene is a Project Manager in the Dean's Office (RSDM) and has experience in Health sciences and Public Health research plus international research in Nigeria and Binn. In addition, Dr. Chapman-Greene is working on several clinical trials. We welcome Dr. Chapman-Greene onto the IRB and look forward to working with her.
Moriam Olanrewaju, PharmD
Moriam Olanrewaju, PharmD (she/her) has joined the Rutgers IRB as an expedited reviewer. Dr. Olanrewaju is a non-Rutgers Clinical & Board-Certified Sterile Compounding Pharmacist (BCSCP) who has comprehensive years of practice in Clinical Infusion Pharmacy, retail, hospital, long-term care and medication therapy management. We welcome Dr. Olanrewaju onto the IRB and look forward to working with her.
| | |
Interested in Becoming an IRB Member | |
|
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?
Please read more information online about IRB Membership or by contacting our Training and Communications Manager, Michelle Watkinson, CIP.
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 Claribel Vega @claribel.vega@rutgers.edu or Angela Cartmell-McGlynn if interested.
| |
|
Dillon Reitemeyer joined the Rutgers IRB office as an IRB Administrator. He is currently a PhD student in Social Work at Rutgers University where his research interests include healthcare and employment policy, clinical assessment and diagnosis, and disability. Dillon Reitmeyer obtained his Master’s degree in Social Work from Rutgers University in 2020 and his Bachelor’s in Philosophy from Rutgers University in 2016. Prior to his role as an IRB Administrator, he was a graduate research assistant at the Boggs Center on Developmental Disabilities and a social work field intern at the Center for Adult Autism Services at Rutgers University.
| | |
|
Karen Benjamin joined the Rutgers IRB office as a new IRB Administrator. Prior to Rutgers, Karen has held positions with several NJ non-profits as well as with UMDNJ School of Public Health. She has worked in the areas of maternal and child health, early childhood development, child abuse prevention, tobacco control, community coalitions and systems building. Her experience includes all aspects of health education program planning and implementation, and her passion is working with mission-driven teams to ensure outcomes that improve the wellbeing of individuals and communities. Karen enjoys spending time with family, being in her garden and trying to reduce her carbon footprint. She earned her MPH from UMDNJ and her BS in Public Health from Stockton University.
| |
|
Stephanie Hios joined the Rutgers IRB office as a new IRB Administrator. Stephanie began her career in an administrative role supporting local government leadership at the Borough of Paramus, NJ. Following that, she started working at Children’s Aid and Family Services (CAFS) where she remained for the last eight years in various roles of increasing responsibility. She worked on the development of programs to support individuals with special needs including the opening of community residences, a day habilitation program, and multiple in-home services for children.
Her most recent role as Director of Training and Quality Systems at CAFS included the creation and implementation of training initiatives, cross departmental collaboration for all quality systems, as well as new housing development.
Stephanie earned her Bachelor’s Degree in Psychology from Ramapo College and her Master’s Degree in Educational Leadership from Montclair State University. She currently lives in New Jersey with her husband, Athan, who she married in October 2021.
| | |
|
Website Revisions
CIRTification. The Rutgers Human Subjects Protection Program (HSPP) IRB is pleased to offer CIRTification educational training as an alternative option for research involving community partners. For more information, please see our website, CIRTification Training | Rutgers Research.
What is CIRTification? The CIRTification is a program developed by Dr. Emily Anderson at the Center of Clinical and Translational Sciences (the University of Illinois at Chicago) to provide the core research ethics in lay language. CIRTification is a free, web-based human research protections training program tailored specifically to the needs and roles of community research partners. The program is offered in English and in Spanish. The CIRTification program is a 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.
Who can take CIRTification? The CIRTification program is only for individuals from community organizations who are working with Rutgers faculty, staff, or students on human subjects research.
Who cannot take CIRTification? CIRTification training will not be available to Rutgers faculty, staff, and students; instead Rutgers faculty, staff and students are required to complete the Rutgers CITI training. For more information about CITI training requirements of Rutgers faculty, staff, and students engaged in human subjects research, please see: https://research.rutgers.edu/researcher-support/research-compliance/research-integrity/collaborative-institutional-training.
Any other Information The community-based partners cannot have access to Protected Health Information (PHI) associated with or derived from a healthcare service event (I.e., from treatment, payment, operations or from medical records). Community-based partners cannot be associated with an institution that has its own Human Subjects Training requirements. For more information, please see our website, CIRTification Training | Rutgers Research.
| | |
AAHRPP Accreditation Updates | |
|
The Rutgers University has just completed the AAHRPP on-site visit for the evaluation of the HSPP/IRB program! A special thanks to everyone who provided their assistance, guidance and expertise in this process.
Rutgers University is currently awaiting the report from AAHRPP for the next steps. Stay Tuned!
]=
| |
|
Requirements for Posting the Protocol and Statistical Analysis Plan to ClinicalTrials.gov
The study Protocol and Statistical Analysis Plan (SAP) (often included in the protocol) must be posted to ClinicalTrials.gov along with basic results information for certain clinical trials.
Q: WHICH trials must post the Protocol and SAP?
A: Studies required to have the Protocol and SAP posted as part of results reporting include:
-
Applicable Clinical Trials (ACTs) with a Primary Completion Date on or after January 18, 2017.
-
NIH-funded clinical trials (including behavioral, phase 1, and early device feasibility interventions) for which the study started and the grant application was submitted to NIH on or after January 18th, 2017.
Q: WHEN must the Protocol and SAP be posted?
A: At the time of results reporting, no later than 12 months after the Primary Completion Date.
- The Primary Completion Date is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Usually, the last participant's last study visit.
- To protect your research and ensure that the correct version is posted, do not post the Protocol or SAP before reporting results.
Q: WHAT version of my Protocol and SAP should I post, and what do they need to include?
A. Post the most recent IRB approved version at the time of results reporting.
- They can be the same document: the SAP is often included in the protocol.
- Documents must include the Official Title of the study, NCT number (if available), and version date on the first page.
- You may redact personally identifiable information (e.g., names, addresses), as well as trade secret and confidential commercial information.
- The SAP should include: how data are analyzed; what specific statistical methods are used for each analysis, and how adjustments are made for testing multiple variables. If some analysis methods require critical assumptions, the written description should allow data users to understand how those assumptions were verified.
Q: WHO posts the Protocol and SAP?
A: For investigator-initiated trials at Rutgers, the Principal Investigator is responsible for posting the Protocol and SAP. This can be delegated to study team members with access to the ClinicalTrials.gov record.
Q: HOW do I post the protocol and SAP to my ClinicalTrials.gov record?
A: You will need to convert your document(s) to a PDF/A format, and then upload it to your ClinicalTrials.gov study record.
For assistance, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu. We are always happy to help you with your ClinicalTrials.gov questions.
| |
|
Single IRB and External IRB
| | |
|
It is common for investigators from two or more institutions to partner to conduct human subjects research or be involved in multi-site research studies. To conserve resources, enhance and streamline the Institutional Review Board (IRB) review process when such collaborations occur, regulations allow institutions to “enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort” (45 CFR 46.114). In other words, regulations allow research partners to agree to rely on a single IRB for review and approval of their non-Exempt study.
Rutgers has established 96 Reliance Agreements from July 2021-July 2022 with Princeton University, Columbia University, Centers for Disease Control, Hackensack Medical Center, University of North Carolina, Northwestern University and many more!
For more details regarding Single IRB and External IRB please navigate to the following link: External IRBs | Rutgers Research
Rutgers IRB Fees
The Rutgers IRB Fee Schedules can be found on the HSPP Website in the provided link: IRB Fees | Rutgers Research. This content is subject to change.
| |
Quality Assurance/Quality Improvement | |
|
For all Post Approval Monitoring (PAM) Directed (For Cause) and PAM Routine Reviews all Quality Assurance Analysts have now added the following to our QA/QI review preparation:
Review of Principal Investigator’s background, including, CV, CITI, verification the PI is NOT included on the FDA/HSS Debarment List, and if the PI has any FDA Warning Letters issued (FDA Form 483).
The addition of the preparatory PAM review in reference to the FDA/HSS Debarment List will be listed in every Final Audit Report as an attachment. Please note, every Directed (For Cause) Audit Report is presented to the IRB Executive Committee and sent directly to the Principal Investigator.
For assistance please contact:
Barbara LoDico, Quality Improvement Senior Analyst
Barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
Smithk6@research.rutgers.edu
| |
Education and Training Opportunities | |
|
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.
Upcoming eIRB Workshops (all dates available online):
-
Thursday, October 13th at 12:45 pm
-
Monday, October 17th at 11:30 am
- Wednesday, October 26th at 2:30 pm
-
Wednesday, November 2nd at 2:30 pm
-
Tuesday, November 8th at 12:45 pm
Education Items
(some articles might require subscription access)
The articles below highlight the importance of Belmont Report's Ethical Principles of Respect for Persons (operationalized by informed consent), Beneficence (operationalized by minimalization of harms while increasing benefits) and Justice (which is meant to promote equitable representation in research in terms of fairly distributing the risks and benefits of research):
Research Protection Rules Standardized Under FDA Proposals (1) (Bloomberg Law) Clinical researchers whose studies fall under both HHS and FDA jurisdictions will have a more consistent set of standards for protecting their study volunteers under a pair of proposed rules released Tuesday. The Food and Drug Administration released two proposed rules Tuesday that aim to iron out inconsistencies between the agency’s human subject protection regulations (21 CFR 50; 21 CFR 56; 21 CFR 812) and Health and Human Services Department regulations known as the Common Rule (45 CFR 46). https://news.bloomberglaw.com/pharma-and-life-sciences/research-protection-rules-standardized-under-fda-proposals?context=search&index=5
Data on Number of Research Project Grants per Principal Investigator (NIH Open Mike) Earlier this year, we posted a blog about inequalities in Research Project Grant (RPG) support for extramural principal investigators (PIs). The blog was based on a paper we published in which we showed, among other things, that well-funded PIs not only were supported by more money but also by a larger number of distinct grants. Over 80% of the PIs in the top centile (top 1%) of funding were supported by two or more grants, compared to only 33% of the PIs in the bottom 99%. https://nexus.od.nih.gov/all/2022/09/26/data-on-number-of-research-project-grants-per-principal-investigator/
Who’ll Pay for Public Access to Federally Funded Research? (Inside Higher Ed) The White House painted an incomplete economic picture of its new policy for free, immediate access to research produced with federal grants. Will publishers adapt their business models to comply, or will scholars be on the hook? https://www.insidehighered.com/news/2022/09/12/wholl-pay-public-access-federally-funded-research See also:
Public access is not equal access (Science, Editorial)
https://www.science.org/doi/10.1126/science.ade8028
Sharing: Protecting Privacy When Sharing Human Research Participant Data (NOT-OD-22-213) This information is not intended to provide a guide for compliance with regulatory requirements nor is it establishing binding rules for NIH awardees, but instead provides a set of principles, best practices, and points to consider for creating a robust framework for protecting the privacy of research participants when sharing data. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-213.html
Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data (NOT-OD-22-214) This Supplemental Information to the NIH Policy for Data Management and Sharing (DMS Policy) describes considerations and best practices for the responsible and respectful management and sharing of AI/AN participant data under the DMS Policy. This Supplemental Information was developed in response to Tribal Nations’ input received through Tribal Consultation and public comments from AI/AN organizations and community members, researchers, institutions, data providers and users, research participants, infrastructure developers, and others to further promote culturally respectful and effective research partnerships.
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-214.html
| | | | | |
