HSPP/IRB Bulletin
November 23, 2021
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HSPP Website Updates
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Regulatory Updates:
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NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research (NOT-OD-22-001). The National Institutes of Health (NIH) is informing the research community of its implementation of a provision in the 2018 Requirements for the Federal Policy for the Protection of Human Subjects (“the revised Common Rule”) under which public health surveillance activities may be deemed not to be research for the purposes of the regulation (45 CFR 46.102(I)(2)). For more information, visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-001.html
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New Departmental Approvers:
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The following people have completed training and have been included online under the IRB's eIRB Departmental Approvers Listing :
- Dr. Carlos Pato (NJMS/RWJ Psychiatry)
- Dr. Keith Stowell (UBHC)
- Dr. Keith Cook (NJMS Podiatry)
- Dr. Noa'a Shimoni (NJMS-Family Medicine)
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New Items under Consideration and/or Revision:
- Coming Soon -Additional Revisions to Protocol & Consent Templates to be more inclusive (i.e., Updating forms for the appropriate LGBTQIA+ population language).
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Rutgers Non-Human Research Self-Certification Tool (HRP-310b) |
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Did you know that the Rutgers Human Subject Protection Program Website has a Self-Certification Tool that researchers can use to determine if their project meets the criteria for Non-Human Subjects Research?
This tool asks a series of questions about the proposed project activities and based on the Principal Investigators Responses, issues a Non-Human Subject Self-Certification Certificate that the Investigator can print, or directs the PI to contact the IRB for assistance.
Cautions:
The self-certification is for internal Rutgers-use only (i.e., self-certifications cannot be used for grant submissions).
Investigators should not use the Self-Certification Tool if any of the following applies to the project:
- Federally funded research
- Biospecimens
- FDA-Regulated Drugs, Devices, Or Biologics
- Stem Cells
- Research involving Formal Agreements Between Institutions to Obtain or Use data (data use agreement)
- International Sites, Subjects, or Data
- Studies involving Undergraduate Principal Investigators
Instead, they should submit their project to the Rutgers IRB using eIRB.
Please note:
- IRB Staff do not have access to nor review what has been submitted in this self-certification online form.
- A Non-Human Research Self-Certification, rather than an official Rutgers IRB Non-Human Research (NHR) Determination, may not satisfy requirements imposed by other organizations/institutions, sponsors, or professional journals.
If the Self-Certification is not accepted and the PI needs an Official Rutgers IRB Non-Human Research Determination they should submit a request for a determination of Non-Human Subjects Research in eIRB.
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Patricia Dalton, JD
Patricia Dalton, JD, is the Director of Research Policy for Rutgers New Jersey Medical School. Patricia handles a wide range of matters in her role with NJMS including helping the research community with their understanding of research-related regulations and the law, often working closely with the Office of General Counsel and Compliance. Patricia also assists in the drafting and negotiation of agreements for the School’s Clinical Affairs team and Graduate Medical Education program. Her commitment to the law and research education has made her an integral member of the Rutgers IRB.
In the early 2000s, as the University attorney assigned primarily to negotiate clinical research agreements, Patricia became interested in the role of the IRB. Wanting to learn more about human subject protection, Patricia attended an IRB meeting as a guest. That encounter with the IRB brought Patricia new insights into the world of clinical research. With mentorship from the former New Brunswick Board chair Dr. Mary Swigar and former IRB director(s) Donna Hoagland and Paul Papagni, Patricia increased her proficiency in matters related to the University’s research community.
At present, Patricia serves as a vice-chair of the IRB. She reports that her service to the institution continues to provide her with the opportunity to engage with the research community in a meaningful way. Patricia reports knowing of no better way to learn and stay informed about human subject research and how it may be improved and flourish at our research sites than to serve as an IRB member.
Interested in being featured in an upcoming issue of this bulletin?
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eIRB System Announcements |
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Stay tuned for updates to the eIRB System! |
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AAHRPP Accreditation Updates |
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ClinicalTrials.gov Modernization, an effort launched in August 2019 by the National Library of Medicine (NLM), aims to ensure that ClinicalTrials.gov continues to be a trusted and valued premier public health resource that provides maximum value to the public and serves its mission well into the future. This multi-year initiative aims to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. The modernization approach involves three key activities: stakeholder engagement, product development, and technical infrastructure enhancements.
The webinar ClinicalTrials.gov Modernization Beta Preview, delivered by Rebecca Williams, PharmD, MPH, Acting Director of ClinicalTrials.gov on October 10th, 2021, provides an update on modernization efforts and information on the launch of beta ClinicalTrials.gov. The first beta release has user-focused features with multiple updated designs and will be accessible to its users by end of 2021.
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Quality Assurance/Quality Improvement |
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A Comparison of Auditing Biomedical and Social-Behavioral Human Subjects Research
While there are some similarities in the conduct of Biomedical and Social-Behavioral Human Subjects Research, there are also many differences: applicable regulations and guidelines, institutional policies, standard research practices, background/makeup of research teams, and more.
As such, the approach to auditing these protocols must be distinct and depends on the type of research being conducted. Auditors must take into account subject populations, types of interventions, levels of research experience, and common research tools, among other things. A nuanced approach tailored by the appropriate considerations can affect factors such as Principal Investigator cooperation, comprehensiveness of the audit review, and duration of the audit process.
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Effective January 1, 2022, the submission process at Rutgers IRB (Institutional Review Board) for Advarra submissions will be revised. All Advarra submissions must be submitted directly to the Rutgers IRB office for a preliminary review. |
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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.
- 11/9/2021 at 11 am
- 11/18/2021 at 2:30 pm
- 12/7/2021 at 11 am
- 12/16/2021 at 2:30 pm
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In the works:
- Additional Revisions to Protocol & Consent Templates to be more inclusive
- IRB Orientation Workshops
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