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HSPP/IRB Bulletin
August 31, 2022
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This Fall, the IRB will be launching two interactive tools on Qualtrics to assist Principal Investigators with their submissions to the IRB.
The first is a comprehensive decision tool that makes recommendations on which Rutgers templates to use and what level of review (Non-human subjects, Exempt, Expedited, Full Board) your IRB submission may qualify for.
The second tool provides guidance to aid investigators in understanding the level of involvement a non-Rutgers site has in research. This tool asks a series of questions to help determine if an external site is engaged in research and provides recommendations on next steps when preparing a submission to the Rutgers IRB.
QA/QI Team
Human Subject Protection Program (HSPP) Quality Assurance Team regularly conducts the following two types of Post Approval Monitoring (PAM) Reviews:
· Routine PAM Review: conducted as a quality assurance activity and randomly chosen, to ensure that human research studies are conducted according to ethical, regulatory requirements and the IRB approved protocol.
· For-Cause PAM Review: based upon a complaint, a concern or an IRB required review to ensure that the study is being conducted according to ethical, regulatory requirements and the IRB approved protocol.
However, the HSPP Quality Assurance Team is also available to consult with investigators and study staff, upon request, for the following additional services:
· Investigator Initiated: Researchers may request us to meet with the study team on study start-up
· Sponsor/Investigator Responsibilities: We can assist when the Principal Investigator is both the Sponsor and Investigator of his/her study. This is when he/she is required to meet all the responsibilities normally assigned to the sponsor.
· External Audits: Assist Investigators in Audit Preparation of an external inspection, e.g., FDA, sponsor, etc.
· Self-Monitoring Studies: Advise researchers on how to self-monitor their research. Provide PIs with tools to effectively train research team members in human research and related activities. To assist our researchers, we have developed numerous guides and tools to help organize and monitor research.
Whom to Contact
Barbara LoDico, Quality Improvement Senior Analyst
Barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
Smithk6@research.rutgers.edu
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Clarie O'Connell, DrPH
Dr. Claire O’Connell, DrPH, is an Associate Professor in the Physician Assistant Program and Director of Didactic Education within the Rutgers School of Health Professions. Dr. O’Connell received her doctorate in public health from Rutgers School of Public Health. Dr. O’Connell has been active in the research community herself, publishing in peer reviewed journals and academic textbooks.
Dr. O’Connell has been an IRB member since 2003. She initially engaged with the IRB for her own research. After a couple of successful applications for small research projects, she was approached by the IRB Director at the time to join the NB/Piscataway IRB. Since joining the IRB , Dr. O’Connell reports that the experience has provided her with great insight into research protocols, subject safety, collegiality, and the interplay between academia and clinical medicine. Dr. O’Connell enjoys working with a diverse group of peers and reviewing a variety of research protocols. Dr. O’Connell’s perspective as a non-MD clinician is essential to many of the reviews our IRB conducts.
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John Worobey, PhD
Dr. John Worobey, PhD, is a Professor Emeritus of Nutritional Sciences who retired from Rutgers University in 2022. Dr. Worobey had a 37(and a-half) year career at Rutgers, where he was initially hired to teach child development but transitioned into conducting research on nutrition and behavior in infancy. Dr. Worobey received his doctorate from The Pennsylvania State University. Through Dr. Worobey’s own research initiatives, he has published on topics such as preventing obesity in infants, influences on the development of food preferences, feeding practices of mother’s, and so much more.
Dr. Worobey has been an IRB member since 2017. He initially joined the Rutgers University IRB at the invitation of a former IRB member to fill in for her when she was to go on sabbatical. Dr. Worobey saw the invitation as an opportunity to be part of a committee that provides vital service at Rutgers. Since joining the IRB, Dr. Worobey has enjoyed getting a first look at what constitutes the latest research and learning about advances in medicine. Dr. Worobey’s knowledge and experience in the field of nutrition contributes to the vast knowledge of our diverse IRB. The IRB appreciates his dedication.
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Anthony Lemaire, MD
Dr. Anthony Lemaire, MD, is an Associate Professor in the Department of Surgery at the Rutgers Robert Wood Johnson Medical School. Dr. Lemaire earned a bachelor’s degree from Columbia University and his medical degree from Yale Medical School. Dr. Lemaire also completed a fellowship in Cardiology at Duke Medical Center. His career and research interests are in the fields of adult cardiac surgery, coronary artery bypass grafts (CABG), minimally invasive valvular surgery, heart transplant and left ventricular assist device placement, and aortic surgery.
Dr. Lemaire has been an IRB member since 2013. He initially joined the Rutgers University IRB to assist with the interpretation of studies organized by surgeons. Since joining the IRB, Dr. Lemaire has enjoyed learning about new subject matter through review and evaluation of studies. Dr. Lemaire’s knowledge and experience in the field of surgery make him an essential part of the IRB.
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Lauren Healy, BS, RLAT
Lauren Healy, BS, RLAT (she/her) has joined the Rutgers IRB as an expedited reviewer. Ms. Healy is a Senior Scientist (IACUC Specialist) at Bristol Myers Squibb, Lawrenceville, NJ. For the past 16 years, Ms. Healy has a regulatory compliance background related to animal care and use. Ms. Healy also has experience in clinical research as a Clinical Research Coordinator. She is excited to begin this new journey, in the parallel ethics committee, for review of research involving human subjects. We welcome Ms. Healy onto the IRB and look forward to working with her.
Francis Barchi, PhD, M.B.E.
Francis Barchi, PhD, M.B.E. (she/her) has joined the Rutgers IRB as an expedited reviewer. Dr. Barchi is an Associate Professor in the Edward J. Bloustein School of Public Policy and a core member of the Rutgers Global Health Institute. Dr. Barchi’s work focuses on ethical issues in global health as well as the individual, household, and community factors that influence women’s and girls’ health and well-being in sub-Saharan Africa. Her research interests in Africa include violence against women and children, sexual and reproductive health, capacity-building in research ethics education in low- and middle-income countries, and ethical issues in international research. A committed educator, Dr. Barchi teaches at the undergraduate, graduate, and post-graduate levels both at Rutgers and internationally, using case-based and active learning techniques to teach global health, health & human rights, and biomedical ethics. We welcome Dr. Barchi onto the IRB and look forward to working with her.
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Interested in Becoming an IRB Member | |
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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.
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AAHRPP Accreditation Updates | |
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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 form AAHRPP for the next steps. Stay Tuned!
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Requirements for Posting Consent Forms to ClinicalTrials.gov
The Revised Common Rule (45 CFR 46) requires that an informed consent form must be posted on a public federal website, such as ClinicalTrials.gov, for any clinical trial conducted or supported by a federal department or agency (such as NIH).
Q: WHICH trials must post consent forms?
A: Clinical Trials, funded or conducted by a Common Rule department or agency, that were either IRB approved on or after January 21 2019 OR voluntarily transitioned to the Revised Common Rule requirements.
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Common Rule departments and agencies include our federal funders (such as NIH, VAORD, etc.)
- Clinical Trial means "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 the interventions on biomedical or behavioral health-related outcomes."
Q: WHEN must the consent form be posted?
A: After recruitment closes, and no later than 60 days after the last study visit by any subject.
Q: WHAT version of my consent form should I post?
A. Any version that was actually used to consent at least one subject.
- No need to update versions or post multiple versions of your consent form.
- NEVER post signed consent forms, or consent forms containing identifiable patient health information.
Q: WHO posts the consent form?
A: For investigator-initiated trials at Rutgers, the Principal Investigator is responsible for posting the consent form. This can be delegated to study team members with access to the ClinicalTrials.gov record.
Q: HOW do I post a consent form to my ClinicalTrials.gov record?
A: You will need to convert your ICF document 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.
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Single IRB Draft Guidance Open for Public Comment
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OHRP is announcing the availability of a draft guidance document for public comment titled ‘‘Use of a Single Institutional Review Board for Cooperative Research.’’ Notice of that draft guidance is included in the July 1, 2022 issue of the Federal Register (87 FR 39534), which can be accessed here.
This draft guidance has a public comment period of 60 days, closing on August 30, 2022. See the Federal Register Notice or the OHRP website here for details regarding how to submit public comment.
CIRB Stakeholders
There are two additional CIRB-approved 2018 Common Rule Short Form consents (Tetum and Ukrainian) now available on CTSU’s website under Resources.
Sites can use these approved short forms for any study approved by the CIRB if:
- There is no eligibility restriction in the protocol based on language that would prohibit enrollment of the participant;
- The Signatory Institution’s policies permit the use of short form consents;
- These policies have been reported to the CIRB on either the Annual Signatory Institution Worksheet or the Annual PI Worksheet.
A Short Forms Q & A is available on the CIRB Website.
Standard Operating Procedures
These standard operating procedures establish the workflow process when Rutgers University IRB serves as the IRB of Record for a Multi-Site Study or Collaborative Study and when Rutgers University cedes review to an external IRB of Record.
Rutgers University serving as the IRB of Record: HRP-893 - SOP - RU As IRB of Record 7.1.20.docx (live.com)
Rutgers University ceding review to an external IRB of Record: hrp-892_-_sop_-_external_irbs_7.7.20.docx (live.com)
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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.
Upcoming eIRB Workshops (all dates available online):
- Wednesday, September 7, 2022 at 11:30 am
- Wednesday, September 14, 2022 at 2:30 pm
- Monday, September 19, 2022 at 11:30 am
- Tuesday, September 27, 2022 at 12:45 pm
Human Subjects Research Webinar:
Office of Human Research Protections (OHRP) is offering a free, live exploratory workshop on "Beyond Altruism – Exploring Payment for Research Participation" on Thursday, September 15th,2022. All are welcome to attend (no advanced registration is required). OHRP is excited to announce this year’s Exploratory Workshop on Thursday, September 15. This free live-streamed one-day workshop will explore the role of paying people for their participation in research, as well as practical challenges and considerations for how payments should be made. Session one will include a variety of unique participant perspectives regarding payment for research participation. Session two will cover practical challenges and implementations of the financial aspects of research participation. Event panelists include many distinguished experts in the field of bioethics and research ethics, including Emily Largent, Jill Fisher, Luke Gelinas, Celia Fisher, David Borasky, and many others! To learn more, please click here! CIP credits available.
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):
NIH Privacy Certificates Shield Reproductive Research Post-Roe (Bloomberg Law) Reproductive health researchers shouldn’t have to turn over their data to law enforcement in states with post-Roe abortion bans thanks to a federal statute—although legal experts caution it’s an added layer of protection and not a guarantee. A program known as certificates of confidentiality protects identifiable, sensitive research data from the legal process, making the data inadmissible as evidence unless the participant agrees to its disclosure. The program is written into the Public Health Service Act. https://news.bloomberglaw.com/pharma-and-life-sciences/nih-privacy-certificates-shield-reproductive-research-post-roe?context=search&index=1
State ‘Personhood’ Laws Threaten Embryonic Stem Cell Research (Bloomberg Law) Biomedical scientists using embryonic stem cells or fetal tissue could find their studies at risk in conservative states aiming to redefine personhood after the US Supreme Court’s rollback of abortion rights. These states would give embryos and fetuses the same rights as people. A provision in Georgia’s new abortion law includes embryos, once there’s a detectable heartbeat, which is at about six weeks, and fetuses in population counts. The laws primarily are intended to focus on abortions, but they have downstream consequences on a range of issues, including biomedical research. https://news.bloomberglaw.com/pharma-and-life-sciences/state-personhood-laws-threaten-embryonic-stem-cell-research?context=search&index=5
Bipartisan Bill Introduced to Designate Funding for Clinical Trials on the Efficacy of State-Licensed Medical Cannabis Products. The legislation authorizes the Director of the National Institutes of Health to designate “institutions of higher education as Centers for Excellence in Cannabis Research for the purpose of interdisciplinary research related to cannabis and other biomedical, behavioral, and social issues related to cannabis.” This research will explicitly include clinical investigations assessing “the safety and efficacy of cannabis in providing therapeutic benefits for certain priority diseases or conditions” as well as studies evaluating “the relative risk of cannabis as compared to alcohol and tobacco,” among other purposes. https://norml.org/news/2022/08/04/congress-bipartisan-bill-introduced-to-designate-funding-for-clinical-trials-on-the-efficacy-of-state-licensed-medical-cannabis-products/.
As U.S. declares public health emergency, science leaders ask publishers for access to monkeypox research (Science) Just hours before the United States declared monkeypox a national public health emergency today, the White House Office of Science and Technology Policy (OSTP) and science leaders from around the world called on scientific publishers to immediately make any monkeypox-related research and data published by their journals freely available to help contain the spread of the virus. https://www.science.org/content/article/science-leaders-ask-publishers-access-monkeypox-research
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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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