HSPP/IRB Bulletin
March 28, 2022
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From the Office of Human Research Protections (OHRP)
OHRP’s new Informational Resource Flyer includes a QR code allowing anyone with smartphone access to a free online library of trusted resources about research and research participation. Print, display, and distribute this flyer at any research center for the benefit of prospective research participants! Find the flyer here together with other informational materials (in English and Spanish) that you may wish to print and provide for potential research participants! These resources are free and you do not need permission to distribute them.
OHRP launched two interactive training programs on considerations for reviewing and designing research involving human participants. OHRP created these programs to enable investigators and IRB reviewers to be cognizant of the importance of diversity, inclusion, and risk minimization in research participation. Click here to access OHRP's other scenarios.
Pending Implementation of a Human Subjects Training Program known as CIRTification
The rollout of CIRTification at Rutgers will begin soon. Additional details about roll-out will be included in future Bulletin newsletters. The CIRTification program provides research ethics training alternative for individuals in community organizations, with limited understanding of conducting human research and protecting potential research participants. This option provides training that focuses on establishing the skills in community partners to conduct human subject research effectively and safely in their communities.
CIRTification training will not be available to Rutgers faculty, staff, and students; instead Rutgers faculty, staff and students are required to complete the CITI training. The CIRTification program is only for individuals from community organizations who are working with Rutgers faculty, staff, or students on human subjects research. The community-based partners cannot have access to Protected Health Information (PHI) and they cannot be associated with an institution that has its own Human Subjects Training requirements.
Pre-Review Process for Full Board Studies
The Pre-Review Process for Full Board Studies Standard Operating Procedures were finalized and are effective immediately.
The process is being expanded to include studies reviewed by the Full Board when the study is either tabled or revisions are requested with subcommittee re-review.
The new process will include the following:
- A mandatory pre-review/consultation by the Pre-Review Team for studies the full board determines are tabled and require full board re-review.
- An optional pre-review/consultation by the Pre-Review Team for studies the full board determines can be re-reviewed by an IRB subcommittee.
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Jeffery Backstrand, PhD
Jeffery Backstrand, PhD, is a professor emeritus who retired from Rutgers University in 2020. Dr. Backstrand is a specialist in quantitative research methods and has considerable knowledge and experience in the areas of public health nutrition and nutritional epidemiology. His knowledge and expertise have made him an integral member of the Rutgers IRB.
In 2017, prior to his retirement, Dr. Backstrand became a member of the IRB when a colleague and friend had become ill and Dr. Backstrand agreed to take his place as a favor. Through his membership with the IRB, Dr. Backstrand gained a larger picture of research at Rutgers, engaged with people from a range of academic backgrounds, and applied his expertise in public health and the social sciences to support ethical research at Rutgers.
Dr. Backstrand has found his participation in the IRB an important part of the structure of his retired life under COVID, while providing a bit of structure to his life and ongoing university service as Professor Emeritus.
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
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?
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Jeralyn Pierre
I’m excited to join the HSPP team and ready to jump in and provide assistance and guidance with our research community in the conduct of human subject regulations with the goal to become a subject matter expert in the AAHRPP process. My background comes from office and project management administration in the construction and engineering fields where I became accomplished in supporting project teams and client service professionals who excelled in driving tasks to completion and inspiring success through innovative strategies and ideas. I assisted as a project administrator where I was responsible for contract completion, creating subcontracts and vendor agreements, creating the project work breakdown structure, setting up project invoice templates, submitting monthly invoices and quarterly and/or monthly reporting documents per the contract, and any other support requested from the Project Manager, Office Principal, VP’s, or anyone from the Accounting, HR, or IT departments. One new initiative that I was able to add while being there was an invoice tracking sheet that provided a synopsis of the project history to help with project transfers. Moving forward, I’m glad to be working within a successful department and learning this new process as the team is in transition!
Let's get Accredited!
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Brenda Griffin
My name is Brenda Griffin and I have recently joined The Office of Research Regulatory Affairs as the New Coordinator of Administrative Services. I bring over 20 years of administrative experience, most of those years here at Rutgers. I recently just came over from Rutgers School of Social Work. Prior to the UMDNJ merger with Rutgers University in 2013, I began working at the University of Medicine and Dentistry of New Jersey as a Data Control Clerk in the Technical Assistance Center in 2004. I worked closely with Training and Consultation Specialists, State Screening Centers, Directors, and Coordinators to ensure screeners met annual proficiency standards. In addition, I worked at the Graduate School of Biomedical Sciences, Division of Child Behavioral Health Services, and University Hospital in Patient Care Services where I functioned as a Management Assistant and reported directly to the Vice President of Patient Care Services on a Special Project which focused on decreasing the use of Inpatient Restraints. I graduated from The Cittone Institute with a 4.0 GPA in Medical Office Administration.
I'm looking forward to working with you all.
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AAHRPP Accreditation Updates |
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Rutgers was notified that the AAHRPP Step 1 application was accepted. Congratulations to everyone, it was a major team effort. Step 2 in the application process was submitted on February14th and is currently under review.
For more information, please contact Swapnali Chaudhari and Malica Dock.
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When a Principal Investigator leaves Rutgers,
what happens to their ClinicalTrials.gov record?
ClinicalTrials.gov records need to be resolved before a Principal Investigator (PI) leaves their position at Rutgers. If records are left unresolved, it puts the University at risk for noncompliance, and burdens other researchers and study team members with the tasks of tracking down the unreported data or contacting the P.I. at their new position.
If a P.I. is leaving Rutgers, they can resolve their records in one of three ways:
1. The P.I. can resolve and "close" any outstanding records for completed studies, by verifying that the study status and enrollment have been updated and that any required results have been submitted.
2. The P.I. can ask that the record be transferred to a new P.I. if the study will continue at Rutgers after they are gone.
3. In certain situations, the P.I. can take the record with them to their new institution, if they will be continuing the study there.
For help to assist with all three options, or to check if you have any study records with outstanding tasks, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu .
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Quality Assurance/Quality Improvement |
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The Humans Subject Protection Quality Assurance Team’s commitment to compliance includes the development of educational initiatives and appropriate oversight and monitoring, to assist research faculty at Rutgers, the State University of New Jersey.
The Quality assurance team will continue to utilize the HSPP QA/QI tool kit items to assess institutional compliance with Federal Regulations, State Laws, and Institutional Policy.
Quality assurance review of the Institutional Review Board Meetings will be accomplished by utilizing the IRB Minutes Checklist (HRP-431).
This initiative is scheduled to begin June 2022. This QA review will occur monthly to assess compliance of the Institutional Review Board with required regulations.
The HSPP Analysts will prepare a formal quarterly report in 2022 on the findings and observations of Institutional Review Board monthly meeting quality assurance reviews to be shared with HSPP leadership, staff, and IRB Committee members.
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NIH Single IRB Updates
For nonexempt human subjects research using a single protocol at multiple U.S. sites, you must identify a single institutional review board (sIRB) of record that will conduct the ethical review of your protocol, as required by NIH’s Single IRB Policy for Multi-Site Research. Foreign sites and research training (T) awards are not subject to the sIRB policy, nor are other domestic sites at which sIRB review is prohibited by a federal, tribal, or state law, regulation, or policy. As made clear in the August 23, 2021 Guide notice, you are not required to submit a plan describing the use of an sIRB at the time of the grant application submission. NOT-OD-21-174: Reminder of Guidance on Requirement for NIH Single Institutional Review Board (IRB) Plan
The revised NIH Grants Policy Statement (NIHGPS, rev. 12/17/2021) represents an update to the April 2021 version and is applicable to all NIH grants and cooperative agreements beginning on or after October 1, 2021. Significant Changes Table_NIHGPS 2021_APRIL.pdf
HSPP Single IRB/Commercial IRB Website Updates
The SMART IRB Learning Center badge is now available on the HSPP Website. This badge (i.e., link) includes videos and resources to help investigators and the study team successfully navigate single IRB review arrangements utilizing SMART IRB. The badge can be found on the HSPP Website: External IRBs | Rutgers Research
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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.
- Wednesday, March 30, 2022, at 11:30 am
- Wednesday, April 4, 2022, at 11:30 am
- Wednesday, April 20, 2022, at 2:30 pm
- Wednesday, May 4, 2022, at 2:30 pm
- Tuesday, May 10, 2022 at 11:30 am
- Wednesday, June 1, 2022 at 11:30 am
- Wednesday, June 8, 2022 at 2:30 pm
From COGR News Digest
Two senators asked the Office of Science and Technology Policy to help make federally-funded research free (Government Executive). Two senators launched an effort to create policy that supports public-access for federal research programs focusing on equity, sustainable development and strategic technological development. In a letter sent to the director of the White House’s Office of Science and Technology Policy, Sens. Ron Wyden, D-Ore., and Edward Markey, D-Mass, requested free public access to research publications in an effort to further scientific understanding, as well as make taxpayer-funded endeavors accessible to members of the public.
The Role of Research at Universities: Why It Matters (Forbes) There are many “core elements” to the mission of a great university. Teaching would seem the most obvious, but for those outside of the university, “research” (taken to include scientific research, scholarship more broadly, as well as creative activity) may be the least well understood. This creates misunderstanding of how universities invest resources, especially those deriving from undergraduate tuition and state (or other public) support, and the misperception that those resources are being diverted away from what is believed should be the core (and sole) focus, teaching. This has led to a loss of trust, confidence, and willingness to continue to invest or otherwise support (especially our public) universities. https://www.forbes.com/sites/davidrosowsky/2022/03/02/the-role-of-research-at-universities-why-it-matters/?sh=31f999a16bd5
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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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Implementation of a Human Subjects Training Program known as CIRTification.
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