Rutgers Office for Research Simplifies the Faculty Experience with New Resources for IRB Reviews
A new concierge pre-review service along with other tools are now available for all faculty to use in expediting the IRB approval process and turnaround time
The Office for Research has recently launched a new Human Research Protection Program (HRPP)/ Institutional Review Board (IRB) Pre-Review Service to facilitate a complete submission of human subject studies for investigators prior to submitting new studies or substantial modifications to existing studies in the electronic Institutional Review Board system.
The idea was first envisioned by leaders of the IRB and José Miguel Román, JD, DMin, vice president, Research Administration.
“At the start of the COVID-19 pandemic, there were many COVID-related protocols that needed review,” said Román. Given the urgency, the protocols needed to be reviewed as efficiently and as quickly as possible. Leaders in the IRB envisioned a concierge service where principal investigators could reach out to expert members and have their submissions reviewed, receive feedback, and make changes to enhance and strengthen their research proposal in record time. “After having instituted the pre-review process, the turnaround time for COVID-related protocols went from 45 to 8 calendar days, allowing Rutgers University to become a national leader in response to the pandemic,” he added.
The optional pre-review process begins when the IRB receives a request for pre-review, or a pre-review is recommended by HRPP/IRB Staff. Investigators requesting or being recommended for pre-review must follow the Pre-Review Instructions for Researchers. The process ends when the investigator has been notified by the pre-review team that the overview is complete, provided with instructions to address the comments/suggestions as they deem applicable, and submit the revised study/modification documents in the eIRB system.
In addition to the pre-review process, the team also revitalized the onboarding, orientation and mentoring for new IRB team members, ensuring all have a strong understanding of the highly specialized regulatory framework for review of clinical and behavioral research at Rutgers. The team uses a new centralized work management tool that can help organize all the moving parts of onboarding new team members.
“The team offers daily and weekly interactive sessions with experienced senior HRPP team members providing hands-on learning opportunities,” said Hila Berger, MPH, CHC, CIP, assistant vice president for Research Regulatory Affairs. “We have established an internal mentorship program, where new team members are paired with experienced team members to provide ongoing support and guidance. By implementing these changes, we are confident that our new IRB team members will be well-prepared to effectively review and approve research studies,” she continued.
The team is also developing several other resources that aid in the IRB submission process. The first is the IRB Review Type and Template Recommendation Tool, a Qualtrics-based tool developed by Jason Lin, senior IRB manager, and team that 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. Once live, this tool will provide 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 will provide 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 second resource, 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. Once live, the Rutgers version of this tool, will ask a series of questions to help investigators determine whether 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.
The third resource is the Non-Human Research Self-Certification Tool another resource that provides support to Rutgers investigators when determining if a project is human research requiring IRB review. This tool asks a series of questions about the proposed project activities and, based on responses, issues a self-certification or directs faculty to contact the IRB for assistance.
Thanks in large part to the work on the HRPP/IRB team members the pre-review process and these other resources played a role in the recent AAHRPP accreditation that was awarded to Rutgers University. Rey Panettieri, Jr, MD, vice chancellor for translational medicine and science at Rutgers Biomedical and Health Sciences, professor in the Department of Medicine at Robert Wood Johnson Medical School, and director of the Rutgers Institute for Translational Medicine and Science commented on the achievement saying, “The AAHRPP accreditation represents a new chapter in Rutgers’s attainment of excellence in Regulatory Affairs. This is an elite designation that recognizes an outstanding commitment to safety and vigilance in clinical research.”
When asked what he sees as the largest benefit to faculty overall regarding these improvements, Román said, “these new processes and tools provide an opportunity for faculty to ask questions, learn, grow, and evolve. The pre-review process specifically is a valuable learning experience and a critical process that creates relationships between faculty and IRB staff providing faculty the opportunity to vet and review their protocols and get feedback to strengthen their proposals."
