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HRPP/IRB Bulletin
November 30, 2022
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Upcoming Changes to HRPP
- In an effort to update our terminology and move away from the term "subjects" (who are really participants, after all!), we will be working to rebrand our Human Subjects Protection Program (HSPP) to Human Research Protection Program (HRPP). Accordingly, you will see this minor change over the next weeks and months in all areas, from staff email signatures to website pages, guidance documents, and the like.
Upcoming Changes to the eIRB system for Committee Members
- Our electronic submission system, eIRB, has been updated for changes to the Committee member "Submit Designated Review" activity area to now include regulatory-required checklists (e.g., research involving children as subjects) instead of these being separate documents to be completed and uploaded per each submission. In addition, the Submit Designated Review activity will include a new area for the review of Reportable Events: Unanticipated Programs (UAPs).
- All individual COI-management plans are available in eIRB for currently active studies. Specifically, COI management plans are now present in the attachments section of the eIRB record for that study. All IRB committee members will need to regularly to view the status of COI disclosures in the eIRB system to complete their review(s). HSPP IRB Staff will provide updates at IRB meetings and through email communications.
NIH 2023 Data Management and Sharing Policy
The NIH 2023 Data Management and Sharing Policy is effective January 25, 2023. For information on this policy, please see https://libguides.asu.edu/NIH-2023-DMS. Please note that Rutgers IRB will be updating our submission system, eIRB, where necessary to meet the NIH policy requirements.
Upcoming IRB Tool Launches
The IRB will be launching two interactive tools this coming winter.
The IRB Review Type and Template Recommendation Tool is a Qualtrics-based tool developed by the Rutgers IRB.
- This tool asks a series of questions to provide investigators with recommendations on which protocol and consent templates to use based on the type of research indicated.
- This tool also provides insights into the level of IRB Review that the study may qualify for ---- a determination of Non-Human Subjects Research, Exempt research, Expedited research, or Full Board Greater Than Minimal Risk Research.
- Finally, this tool provides information on which consent waivers may be applicable --- Waiver of Consent, Waiver of Documentation of Consent, and/or Waiver of HIPAA Authorization. The recommendations and insights are summarized upon completing the Qualtrics Form.
The Engagement in Research Tool is another Qualtrics-based tool. This tool has been adapted and modified from a tool initially developed by The Ohio State University IRB in 2019. In the Rutgers version of this tool, a series of questions is asked to help investigators determine whether or not a collaborating external (non-Rutgers) site is considered to be “engaged in research.”
Upon completion of the Qualtrics Form, guidance and recommendations are provided on how to proceed with including the external site in a Rutgers IRB submission.
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Do you have eCOI+ questions? or Need help with your disclosure forms?
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ed time only" or "only 7 remaining"! | | |
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IRB Wedding
A huge congratulations to IRB Vice Chair Dr. Richard Drachtman. His son Craig Drachtman and beautiful bride Blaine Schoen are newlywed.
IRB Accolades
Please take a look at the Research Ethics publication co-authored by our very own HRPP's Swapnali Chaudhari! Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight. Swapnali and her co-authors represent a great group of esteemed colleagues in the field. Congratulations to Swapnali Chaudhari on being a tough leader and for this significant contribution to the field of human research protections.
https://journals.sagepub.com/doi/10.1177/17470161221138028
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Sebestian Acevedo
Sebastian Acevedo is a current MD/MPH student at both Rutgers New Jersey Medical School and the Rutgers School of Public Health. Mr. Acevedo received his undergraduate degree from Rutgers University, New Brunswick. He is deeply interested in pursuing a career as a physician scientist.
Mr. Acevedo became a member of the IRB in 2022 and reports that his membership offers him the opportunity to learn how to both review and write comprehensive IRB protocols. Mr. Acevedo reports that his experience with the IRB has increased his technical knowledge on implementing institutionally sanctioned research proposals. As a member of the IRB, Mr. Acevedo is enjoying learning about the exciting new projects that are happening around the university.
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Kristen Gilmore Powell, PhD
Kristen Gilmore Powell, PhD is an Associate Research Professor and Associate Director of the Center for Prevention Science within the School of Social Work. She is also Director of the Northeast and Caribbean Prevention Technology Transfer Center. Her scholarship is focused on building the capacity of community-based organizations to mobilize, intervene, create systemic change, and, consequently, overcome social problems through effective prevention approaches within an empowerment framework. Dr. Powell has been conducting research and evaluation on topics relevant to prevention science, environmental strategies, empowerment theory, sustainability, and health disparities for close to 15 years.
An IRB member since 2016, Dr. Powell initially joined the IRB by way of an invitation from a colleague who was cycling off the committee. Dr. Powell welcomed the opportunity and has enjoyed providing service to the research community. Dr. Powell reports that it is great to work with colleagues coming from all over the university. She finds her work with the IRB helpful to her own research and reports that her involvement with the IRB sharpens her own research protocols.
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Jaclyn Brancato, DO
Jaclyn Brancato, DO (she/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Brancato is a non-Rutgers Board-certified and licensed Internal Medicine Physician at Summit Health. Dr. Brancato has experience with various populations with various health needs including Spanish-speaking individuals. We welcome Dr. Brancato onto the IRB and look forward to working with her.
Jeremy Reimann, MSPH, BS
Jeremy Reimann, MSPH, BS (he/his) has joined the Rutgers IRB as an expedited reviewer. Mr. Reimann is a non-Rutgers Senior Clinical Trials Project Manager and has experience in Industry-sponsored Clinical Trials and is working on Clinical Research with INDs. We welcome Mr. Reimann onto the IRB and look forward to working with him.
Robrecht van der Wel, PhD
Robrecht van der Wel, PhD (he/his) has re-joined the Rutgers IRB as an experienced expedited reviewer. Dr. van der Wel is the Department Chair and an Associate Professor of Psychology (Rutgers-Camden). Dr. van der Wel teaches various courses including Cognitive Processes, Experimental Psychology, The Psychology of Human Action, and Statistics for the Behavioral Sciences. His research aims include elucidating how we use our action systems in support of psychological processes. These processes include cognitions underlying action planning and coordination in individual contexts, as well as social cognitive processes that come into play when we perceive, plan, and coordinate with others around us. We welcome back Dr. van der Wel onto the IRB and look forward to working with him.
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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 HRPP/IRB Bulletin
Please contact Claribel Vega @claribel.vega@rutgers.edu or Angela Cartmell-McGlynn if interested.
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Lakecia Ravenell
Lakecia Ravenell joined the Rutgers IRB office as a Coordinator of Administrative Services. Prior to her role as a Coordinator of Administrative Services, she worked as a Court Services Officer for the Superior Court of New Jersey. Her background experience includes working in the investigative and compliance field. She obtained her Master’s degree in Criminal Justice Administration in 2012 and her Bachelor’s degree in Criminal Justice with a minor in Urban Studies in 2010 from Saint Peter’s University. She is very excited for the new journey at Rutgers University.
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AAHRPP Accreditation Updates | |
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The Rutgers University has just submitted their improvement plan and is currently awaiting the counsel's review.
Stay Tuned!
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NIH Is Implementing Requirement to Post Study Results to ClinicalTrials.gov in Response to HHS OIG Report
Originally, it was reported by eight member institutions of the national Clinical Trials Registration and Results Reporting Taskforce that NIH has issued possible non-compliance letters to their investigators requesting results reporting for their NIH-funded research studies. Since the October HSPP/IRB Bulletin, over thirty member institutions have reported that investigators from their institutions have received these letters.
A redacted version of this letter from NIH can be viewed here.
NIH’s action appears to be an implemented procedure in response to the recent HHS OIG Report: The National Institutes of Health Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements that came out August 2022. See Report in Brief or Full Report.
In written comments, NIH concurred with the OIG recommendations and described actions it has taken or plans to take in response. NIH indicated that it is implementing activities that will enhance NIH’s ability to take compliance actions against responsible parties that are late in submitting trial results or do not submit results. In addition, NIH stated that it has implemented significant improvements related to working with responsible parties to understand the challenges they face in submitting their results to ClinicalTrials.gov and that it has implemented procedures to address these challenges. Check out Appendix B of the Full Report for NIH’s comments, and NIH Policy Statement on Dissemination of NIH-funded Clinical Trial Information .
For assistance completing results reporting responsibilities or if you have any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
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A Proposed Rule by the Food and Drug Administration
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The Food and Drug Administration (FDA or we) is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. This proposed rule would establish an IRB recordkeeping requirement that would be harmonized, to the extent practicable and consistent with statutory provisions, with the revised Common Rule's IRB recordkeeping requirement for research overseen by an IRB that is not operated by the institution where the study is conducted.
The Proposed Rule published document can be found in the link provided.
https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research
The public comment period ends on 11/28/2022.
Rutgers IRB Fees
The updated 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.
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Quality Assurance/Quality Improvement | |
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Mysteries of Post Approval Monitoring (PAM)
One of the ways HRPP’s Quality Assurance Team assures commitment to compliance is by conducting various Quality Assurance and Quality Improvement projects. Often these QA/QI projects are conducted internally, within our own HRPP/IRB office.
When we perform an internal QA/QI project we collect data on our own processes, evaluate that data, then develop strategies that will help us improve our program in some capacity. It may be a change a specific practice, a process, or in a service we may be able to provide. The outcome is to assess how we conduct work and make improvements that will benefit the research community and participants.
The Quality Assurance Team is in the process of completing an internal QA/QI initiative that began over the summer of 2022 of our own IRB Meetings Minutes for all the IRB Boards. Our findings and observations of the IRB’s monthly meetings will be shared with HRPP leadership and IRB Committee members.
In addition, we are also currently conducting a QA/QI project on how Reportable Events, including but not limited to, Unanticipated Problems, Adverse Events, Protocol Deviations and Protocol Violations. We are assessing how these are being submitted in the eIRB system, as well as, how they are reviewed and if the determinations being made per Institutional Policy and in accordance with Federal Regulations.
For assistance please contact:
Barbara LoDico, Quality Improvement Senior Analyst
Barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
Smithk6@research.rutgers.edu
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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):
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Wednesday, December 7th at 2:30 pm
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Monday December 12th at 11:30am
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Monday, January 9th at 11:30am
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Tuesday, January 10th at 2:30pm
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Wednesday January 18th at 11:30am
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Monday January 30th at 11:30am
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):
LinkedIn Ran Social Experiments on 20 Million Users Over Five Years (PRIM&R) A study that looked back at those tests found that relatively weak social connections were more helpful in finding jobs than stronger social ties. According to PRIM&R, "The other ethical concern around this study was the lack of informed consent. During these experiments, it’s unknown whether users understood that they were a part of the study, consequently subjecting themselves to unknown effects on their job opportunities. LinkedIn defends that it acted within the user agreement, privacy policy, and member settings. The privacy policy states that LinkedIn can use members’ data for research purposes. While this may be the case, it begs the question whether language buried in a privacy policy that is seldom read constitutes truly informed consent. In the end, the lack of clear communication and transparency left many unaware of their involvement".
https://www.nytimes.com/2022/09/24/business/linkedin-social-experiments.html; https://cdn.fs.pathlms.com/9DyiUjaETmyJDdGb3LWP
NIH to Seek Input on Wider Access to Taxpayer-Funded Research (Bloomberg Law) The NIH will solicit in the next few months suggestions for improving the dissemination of taxpayer-funded research to the public, the agency’s acting science policy head said. “NIH already has a Public Access Policy, but what can we do better? How can we make it better? And who can help us?” Lyric Jorgenson, the National Institutes of Health’s acting associate director for science policy, asked Tuesday at the American Association for the Advancement of Science’s science and technology policy forum. The forthcoming call for recommendations stems from a White House initiative announced in August to broaden the reach of government-funded research. https://news.bloomberglaw.com/pharma-and-life-sciences/nih-to-seek-input-on-wider-access-to-taxpayer-funding-research?context=search&index=2
COVID research is free to access — but for how long? (Nature) At the beginning of the COVID-19 pandemic, scientific journals rushed to make related research free to read — temporarily, at least. …Now the pandemic is in its third year, and reports are circulating that the end of free-to-access COVID-19 research is nigh. If so, that would suggest publishers have decided that the COVID-19 emergency is over before world health authorities have. But is that the case? https://www.nature.com/articles/d41586-022-03418-9
A Plea for Making Virus Research Safer (New York Times, Guest Essay) Viruses far more devastating than the coronavirus that causes Covid-19 have plagued humankind. Smallpox, for example, killed up to 30 percent of people it infected. Thanks to science, it’s now a plague of the past, with the last natural infection occurring in 1977. I am a virologist who studies how mutations enable viruses to escape antibodies, resist drugs and bind to cells. I know virology has done much to advance public health. But a few aspects of modern virology can be a double-edged sword, and we need to promote beneficial, lifesaving research without creating new risks in the lab. https://www.nytimes.com/2022/10/30/opinion/virology-safety.html
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