HSPP/IRB Bulletin
December 17, 2021
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FDA Audit
- The FDA conducted an audit on the IRB Office from December 6-9, 2021. The routine review was based upon the regulatory criteria for approval.
- They reviewed a total of 6 IRB approved studies from the Newark and New Brunswick Campuses, the HSPP SOP's, and attended a full board meeting.
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At the audit close-out visit, the inspector stated "as an IRB office, Rutgers IRB meets the ‘gold standard' and we are thrilled to inform you the IRB office passed with no findings/observations reported". The overall process over this past week once again reassured that the current procedures in place ensures compliance with the federal regulations and maintains adequate documentation.
Regulatory Updates
From COGR: Report Offers Universities Big Data Research Tips (Inside Higher Ed)
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A new report examining how big data research is pursued in academic contexts was released Tuesday by Ithaka S+R, a non-profit organization focused on helping the academic community use digital technologies to advance research and teaching. The findings of the report, “Big Data Infrastructure at the Crossroads: Support Needs and Challenges for Universities,” were drawn from a partnership with librarians at more than 20 colleges and universities who conducted interviews with more than 200 faculty working across a variety of disciplines.
Human Subjects Research Information & Events (Click on Links):
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From COGR: Consent Waiver for Low-Risk Studies Moves Toward FDA
From PRIM&R
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Rutgers Pre-Review Services |
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Last month's HSPP bulletin highlighted the Rutgers Pre-Review Process for Investigators; what Pre-Review is, how it works, how to submit, etc. This month will focus on what Pre-Review Is Not.
What Pre-Review Is Not
Pre-Review is not a guarantee of IRB approval
- individual IRB members (who are faculty familiar with a variety of research) may have additional comments during the review process after you submit your protocol through eIRB
Pre-Review is not a replacement for
- Human Subjects Protection Training
- Using/following the IRB templates
- Editing and proof-reading the submission documents for inconsistencies and completeness before submission
- Faculty Advisor mentoring and review of the documents prior to submission
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Jorge Serrador, PhD
Jorge Serrador, Ph.D., is an Associate Professor for the Department Of Pharmacology, Physiology, and Neuroscience at Rutgers New Jersey Medical School. In addition to his role with Rutgers, Dr. Serrador has an active research program examining how brain blood flow regulation and the balance system interact. His team’s latest work is developing a novel neuromodulation device to improve balance and gait in older individuals to reduce fall risk. Dr. Serrador has received funding from NASA, NIH, and the DoD to understand how impaired brain blood flow might contribute to cognitive problems and loss of consciousness.
Dr. Serrador became a member of the IRB because he always believed in the importance of ethical and safe human research. As a human physiologist, he felt that it was important to contribute his perspective to the IRB to help ensure research is of the highest quality. Dr. Serrador is committed to providing mentorship to others. As a vice-chair, he is able to help younger members of the IRB learn and grow in their IRB roles. He also enjoys helping educate the students on the importance of the IRB and helping them to develop as human researchers. Dr. Serrador brings a wealth of knowledge and experience to his role as vice-chair, and the IRB appreciates his contribution
New Board Members
- James Galt, MLS (he/him/his) has joined the Rutgers IRB as an expedited reviewer. Mr. Galt is a Curriculum Development/Instructional Design Specialist at the Rutgers Robert Wood Johnson Library of the Health Sciences & Rutgers Robert Wood Johnson Medical School Graduate Medical Education. We welcome Mr. Galt onto the IRB and look forward to working with him.
- Tracy Davis, Ph.D. (she/her/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Davis has two undergraduate degrees and a master's degree from the University of South Florida and a Doctoral degree from the University of Kentucky. She holds a certificate in Applied Statistics from the University of Kentucky. Dr. Davis joined Rutgers University in the Fall of 2013. She is a full-time faculty member in the Interdisciplinary Studies department in the School of Health Professions where she is the Aging Track Coordinator for the aging track in the undergraduate and graduate degree programs. In addition to teaching, she is involved in numerous research projects. Much of her research focuses on HIV prevention among older adults and disability among those living with HIV. We welcome Dr. Davis onto the IRB and look forward to working with her.
- Lauren Feldman, Ph.D. (she/her/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Feldman studies media effects in political and science contexts, and her recent research emphasizes three primary areas of interest: climate change communication, partisan media and misinformation, and comedy and social change. She teaches courses on entertainment and politics, media effects, media and climate change, and quantitative research methods. We welcome Dr. Feldman onto the IRB and look forward to working with her.
- Sebastian Acevedo (he/him/his) has joined the Rutgers IRB as an expedited reviewer. Mr. Acevedo is a NJMS medical student with canvasing along with Community-Based Research (Qual. & Quan. Research Methods) experience. We welcome Mr. Acevedo onto the IRB and look forward to working with him.
- Daniella Colombo (she/her/hers) has joined the Rutgers IRB as an expedited reviewer. Ms. Colombo is a NJMS bi-lingual medical student (Fluent in Spanish) with previous research experience in Spanish-Speakers and children populations. We welcome Ms. Colombo onto the IRB and look forward to working with her.
- Nandini Mishra (she/her/hers) has joined the Rutgers IRB as an expedited reviewer. Ms. Mishra is a NJMS medical student who has experience in conducting reading programs for non-English speaking Populations with certification in Biliteracy for French. Ms. Mishra has Crisis Counselor Certification through Crisis Text Line. We welcome Ms. Mishra onto the IRB and look forward to working with her.
New Departmental Approvers
- Dr. Hao Lui (CINJ's Biostatistics Shared Resource & Department of Biostatistics and Epidemiology, School of Public Health)
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Drs. Mary Beth Russell & Nancy Holecek (RWJ Barnabus Health)
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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The FDA has taken action to enforce the FDAAA801 law on clinical trials results reporting on ClinicalTrials.gov since April 2021. JAMA Viewpoint published Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements on November 12, 2021, that researchers from Yale, and Columbia, Universities Allied for Essential Medicines (UAEM) used a Freedom of Information Request to discover the following:
58 Preliminary Notice of Noncompliance Letters were sent by FDA since 2013
- 57 for Results
- 1 for Registration
- 32 to drug makers
- 0 to Federal Agencies
90% reported to ClinicalTrials.gov (median = 3 weeks)
On November 21, 2021, UAEM released the full text of all 58 Preliminary Notice of Noncompliance Letters. Other entities such as STAT and RAPS picked up the story and are requesting FDA for comments.
While several Rutgers investigators are working closely with institutional ClinicalTrials.gov Administrator Rebecca Chen to complete their overdue results reporting responsibility, there were no Rutgers investigators named on any of the above reports.
We deeply appreciate all the support and effort from investigators and the senior management and will continue working with the Rutgers research community to keep up with the good work.
Should you have any questions/ concerns regarding this compliance matter, please reach out to Rebecca Chen and/ or the HSPP Office ClinicalTrials.gov Support.
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Quality Assurance/Quality Improvement |
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How to Request Single Patient Expanded Access
- When a physician wants to submit a Single Patient Expanded Access request to obtain an unapproved investigational drug for an individual patient, he or she must first ensure that the manufacturer is willing to provide the investigational drug for expanded access use. In an emergency situation, the request to use an unapproved investigational drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone.
- In a non-emergency situation, a written request (IND) for individual patient use of an investigational drug must be submitted to the FDA. The investigational drug may be shipped and treatment of the patient may begin 30 days after the application is received by FDA or earlier if notified by the FDA that treatment may proceed. These non-emergency requests are known as individual patient INDs, or single patient expanded access requests.
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It is important for Institutional Review Boards to request a review of all documents submitted to the FDA and to encourage investigators to be clear on who submitted the application and who holds the Investigational New Drug Approval.
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Upcoming changes in January 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.
The SMART IRB Learning Center for Investigators and Study teams found in the provided link, https://smartirb.org/study-teams/, includes videos and companion resources that are designed to help investigators and study teams successfully plan for and navigate single IRB review arrangements for their studies. These packages contain a suite of resources to help in preparing NIH grant applications that require a single IRB review and to ensure investigators understand and can fulfill their responsibilities related to single IRB arrangements.
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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.
- 1/10/2022 at 11:30 am
- 1/12/2022 at 2:30 pm
- 2/07/2022 at 11:30 am
- 2/09/2022 at 2:30 pm
- 2/17/2022 at 11:30 am
- 2/22/2022 at 2:30 pm
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In the works:
- Coming Soon: Additional Revisions to Protocol & Consent Templates to be more inclusive (i.e., Updating forms for the appropriate LGBTQIA+ population language).
- Revisions to International Guidance
- IRB Orientation Workshops
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