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HRPP/IRB Bulletin
October 31, 2023
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New Registration Process for eIRB Workshops | |
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The Rutgers Human Research Protection Program (HRPP) and Institutional Review Board is pleased to announce that registration for eIRB Virtual Training Workshops is now completed directly via the Research Course Registration System (CRS). CRS provides each registrant with an instantaneous email confirmation along with the session’s Zoom link and calendar event invite.
eIRB workshops are offered monthly. The CRS portal has workshops from October 2023 to March 2024, with additional 2024 dates forthcoming. These workshops are designed to provide a step-by-step tutorial on using the electronic submission system known as eIRB and offer a Q&A session. They are open to all Rutgers faculty, staff, and students.
To obtain session dates/times and register for a workshop, please visit the Research Course Registration System.
Registration is required to secure your spot, and you'll receive the Zoom meeting link from the CRS system.
For more information, please visit “eIRB Workshops” under HRPP/IRB Educational Resources.
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Virtual Institutional Review Board (IRB) Office Hours
When:
- Every Tuesday from 1 – 1:30 pm
- Every Thursday, 10 – 10:30 am (except Thanksgiving, 11/23/23)
Where: All Office Hour Sessions are virtual via Zoom.
What is offered?
Please join DRAFT Service's office hours if you have a question on process, design, best practices, regulations, policies, or need help in the development of a document.
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Each individual consultation is limited to ~10 minutes.
- All attendees joining the Office Hours Waiting Room during the designated times on Tuesdays and Thursdays will have their questions addressed.
What to expect:
- When you join the Office Hours Zoom, you will be placed into the waiting room. Wait times vary, and investigators are seen on a first come, first served basis.
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When you are moved from the waiting room to the main room, we will ask if there are any other members of your team attending the office hours. If so, we will make sure that you are grouped together. Please note, your spot in the queue will be reserved once all members have logged onto Zoom.
- When a DRAFT member is available, you will be assigned to a breakout room to begin your 10 minute consultation.
The mission of DRAFT (Document Revision And Feedback Team) Services is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices.
Click here for the full process of submitting to the DRAFT Services team.
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Welcome to the HRPP/IRB Team! | | |
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Sara McConnell, BS joined the HRPP/IRB as an IRB Administrator in October 2023. She has a B.A. in Linguistics from the University of Maryland, College Park, and a B.S. in Computer Science from University of Maryland, University College.
Her previous position was as a Faculty Research Assistant at the University of Maryland, where she spent many years working with the IRB as a researcher. She helped conduct research on the effects of nerve stimulation on language learning. She also helped curate data sets for the testing and evaluation of AI systems.
In her free time, Sara can be found crocheting and hanging out with her dog Zelda.
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Megan Ringel, PhD joined the HRPP/IRB as an IRB Administrator in Fall 2023. Born and raised in the NJ/PA area before spending her college and professional years in the southwest, Megan developed a keen interest in social psychology and went on to earn her bachelor’s degree in psychology from Arizona State University, followed by a Ph.D. in Psychological Science from the University of California, Irvine.
As a graduate student, she discovered that she enjoyed teaching as much as research. This led to her spending the last three years as an assistant professor at St. Edward’s University in Austin, TX, where she also served as a member of the university’s IRB committee.
Megan is passionate about research and trending scientific issues related to research ethics and high-quality methodological practices. She looks forward to bringing her research and teaching background to a new role that will allow her to support vital research initiatives at Rutgers.
Outside of work, Megan and her husband (Charles) are excited to be in NJ and experience “leaf-peeping” this fall, while also lamenting how late they will now have to stay up to watch the west coast NBA games.
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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 contact our Training and Communications Manager, Michelle Watkinson, CIP.
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Holly Polakiewicz, MSW (she/hers) is from the Rutgers NJ-STEP program and is serving as a Prisoner Representative member. Hollis is a Licensed Social Worker (LSW) with a professional background in volunteer management, trauma-informed care, and education (adult basic education, GED preparation, and prison education). We welcome Ms. Polakiewicz to the IRB and look forward to working with her.
Madhu Mohan, DMD (she/hers) is an Assistant Professor at the Rutgers School of Dental Medicine's Pediatric Dentistry and Community Health department and is the Program Director of the Pediatric Dentistry Postgraduate Program. Dr. Mohan has expertise in pediatric dentistry, clinical research, and lab-based research with dental materials. We welcome Dr. Mohan to the IRB and look forward to working with her.
Pinki Bhatt, MD (she/hers) is an Assistant Professor in the Division of Infectious Disease within the Department of Internal Medicine at Rutgers - Robert Wood Johnson Medical School. Dr. Bhatt has expertise in Clinical Trials and in research with immunocompromised patients. We welcome Dr. Bhatt to the IRB and look forward to working with her.
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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 or Angela Cartmell-McGlynn if interested.
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Save the Date - November 8th and 9th | |
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The Rutgers Office for Research and Montclair State University are collaborating for this year's annual Black Lives Matter in Research Virtual Symposium.
The theme for this year is "Transforming the Health Research Landscape for Justice and Equity."
When: November 8th and 9th from 12 – 4 pm each day
What to Expect: Esteemed keynote speakers, Dr. David S. Kountz from Hackensack Meridian Health and Dr. Ndidiamaka Amutah-Onukagha from Tufts University, and informative panel discussions.
More Info: Please join us on the event group page on LinkedIn for up-to-date information on this event..
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Have you visited the revised Human Research Protection Program (HRPP) | Rutgers Research website?
Recent Website Revisions
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DRAFT Services are available to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. Make sure to take advantage in their pre-review services and virtual office hour sessions.
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Reliance: Our Single IRB Submission Guidance can assist you in the preparation of submitting an eIRB application when Rutgers is serving as the IRB of Record for an external site for non-Exempt research. This guidance went into effect on October 1, 2023.
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AAHRPP Accreditation Updates | |
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Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Learn more.
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All Things ClinicalTrials.gov | |
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ClinicalTrials.gov Tip: Entering Outcome Measure Time Frames
One of the most common sources of Quality Control comments that cause ClinicalTrials.gov records to be rejected is the Outcome Measure Time Frame field. The requirements for Outcome Measure Time Frames can be summed up as:
- Outcome Measure Time Frames need to be specific
- Unless you are measuring a value of change over time, Time Frames for Primary Outcome Measures must have only one time point.
Let’s explore further.
Outcome Measure Time Frames need to be specific.
The Outcome Measure Time Frame is the specific time point or window (e.g. Week 6) when you will be collecting the outcome measure data for each participant. It is not the overall duration of the study.
Vague Time Frames (e.g. “during study visit”) will be rejected. If you have a large visit window, or you are collecting a time-to-event outcome measure, such as “days until progression”, use “About [AVERAGE TIME POINT]” or “Up to [MAXIMUM TIME POINT]” to describe your Time Frame.
Examples:
Acceptable Time Frames
- Baseline
- Week 6
- Up to 10 minutes
- Hospital admission to discharge (about 5 days)
Unacceptable Time Frames
- Visit 1
- Post-intervention
- End of Study
- During Hospitalization
Time Frames for Primary Outcome Measures must have only one time point, or must be assessing a change between 2 time points.
Unless you are measuring a value of change over time, Time Frames for Primary Outcome Measures must have only one time point per outcome measure, or the record will be rejected. This can be a frustrating requirement, but it can be easily addressed.
Option 1: Not assessing a change (most common)
If you are NOT measuring and reporting a value of change between two time points for your outcome measure, write your outcome measure, and then use the “Copy Outcome” button to duplicate it for each time point. Just don’t forget to update the title and time frame for each one!
Examples:
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Outcome 1: Number of Participants Fully Vaccinated at Baseline [Time Frame: Baseline]
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Outcome 2: Number of Participants Fully Vaccinated at Month 2 [Time Frame: Month 2]
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Outcome 3: Number of Participants Fully Vaccinated at Month 4 [Time Frame: Month 4]
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Outcome 4: Number of Participants Fully Vaccinated at Month 6 [Time Frame: Month 6]
Option 2: Assessing and reporting a change between 2 time points
If you ARE assessing a change between two time points, simply include both time points in the Time Frame, and add “Change In…” to the Title.
Examples:
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Title: “Change in Minutes of Physical Activity” [Time Frame: Baseline, Week 6]
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Title: “Change in Visual Analog Scale Pain Scores” [Time Frame: Baseline (immediately prior to surgery), Month 6]
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Title: “Change in A1c Levels” [Time Frame: Baseline, Day 10]
For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
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Join the Human Research Protections Program (HRPP) Reliance Workshop on Thursday, November 16, 2023 from 12:00 pm-1:00 pm!
The session will focus on understanding the IRB Reliance Mechanisms. Researchers, faculty and students are invited to learn more about our streamlined reliance processes for Single IRB (sIRB) and Administrative Review submissions to the IRB.
Please register to attend the one-hour Reliance Workshop.
Please contact us at irbrelianceteam@research.rutgers.edu with any questions.
Availability During Virtual IRB Office Hours
The Reliance Team is excited to announce that we are available during Virtual IRB Office Hours during select Tuesday sessions.
We are joining Virtual Office Hours on the following dates:
- Tuesday, November 7th
- Tuesday, November 14th
- Tuesday, November 21st
- Tuesday, November 28th
If you'd like to connect with us on one of these select dates, please join using the general Office Hours Zoom Link | Passcode: 133269. When you join, please let us know that you'd like to meet with the Reliance Team so that you can be placed appropriately for consultation.
Updates to Reliance Documents
Exciting News! The former reliance documents (i.e., HRP 1812A/B, HRP 830 and HRP 811 forms) have been completely redesigned to be reduce the amount of document(s) required to establish a reliance agreement. Three forms have been condensed into ONE document referenced as the “Relying Site Local Context.”
The “Relying Site Local Context” are available for download in the “External IRB” tab.
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All Things Quality Assurance & Evaluation | |
The Quality Assurance and Evaluation (QA&E) Team continues its series on the seven most common pitfalls identified during Post Approval Monitoring (PAM) Reviews.
The May issue of the HRPP/IRB Bulletin introduced our series, "7 Ways to Help Prevent Common Non-Compliance Issues" and listed seven common compliance pitfalls:
- Assess Your Research Plan Feasibility
- Data Collection Forms and Checklists
- Standard Operating Procedures (SOPs)
- Resource Availability
- Training
- Documentation
- Reporting
If you missed any of the previous articles in this series, please visit the Newsletter section of our website (Net ID required to access).
#5: Training
One of the most common findings during both Routine and Directed (For Cause) PAM Reviews is that the research team altered or did not adhere to the IRB-approved study protocol in some way. This often includes protocol changes, changes to the consent document(s), additions to or omissions to data collection forms and other study instruments made prior to IRB approval.
Protocol adherence refers to the accurate following of all aspects of a protocol. It involves appropriate execution of the study procedures, correct documentation, and punctual reporting, all in alignment with the instructions laid out in the protocol.
Adherence to IRB approved documents cannot be overstated. It is instrumental in ensuring participant safety, data validity, and overall success of the study. The protocol delineates procedures to minimize risks. Non-adherence could expose participants to unnecessary risks.
Examples of Protocol Non-Adherence:
- Using an outdated consent form or a consent form without an IRB stamp.
- Altering wording of any kind within an IRB Approved consent form, questionnaire(s), survey(s), etc. without obtaining IRB approval.
- Changes to the participant eligibility criteria or recruitment process.
- Study procedures being completed by staff who are not qualified/approved to do so.
- Over-enrollment of the number of IRB approved participants.
Ways to Avoid Protocol Non-Adherence: Staff Training
The PI is responsible for ensuring that staff are adequately trained before delegating any study-specific duties/tasks to study team members. All staff need to be aware of the tasks that they are assigned to perform, and principal investigators (PIs) must ensure that staff are properly qualified and trained to perform the tasks assigned. Given the significant impact of protocol adherence, it’s essential to devise strategies to ensure it is maintained throughout the study.
Study Staff Should Have Comprehensive Training Regarding:
- Management of patient files and study logs
- Subject recruitment procedures and follow-up
- IRB submissions
- Timely reporting of any protocol deviations/violations, as well as any reportable events.
For assistance please contact:
Andrea Dragan, Quality Assurance and Evaluation Director
andrea.dragan@rutgers.edu
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.
For more information, please visit “eIRB Workshops” under HRPP/IRB Educational Resources.
To obtain session dates/times and register for a workshop, please visit the Research Course Registration System.
Education Item
NIH Seeking Comment on Draft Resource Informed Consent for Research Using Digital Health Technologies. NIH is requesting information on the utility and useability of sample language and accompanying considerations developed for use in informed consent documents for digital health technologies utilized in research. Digital health technologies are increasingly being deployed in biomedical and behavioral research, leading to enhanced scientific discovery and improved health outcomes. Incorporating such technologies into traditional research frameworks may pose new considerations when developing and reviewing informed consent documents for research studies. Research institutions, funders, and researchers have a shared responsibility to ensure that the unique potential benefits and risks from use of digital health technologies in research are effectively communicated in a clear and concise manner, to aide participants in making an informed choice regarding whether to take part in a research study. To assist in this effort, NIH has worked to develop sample language and points to consider, intended for voluntary use by investigators and Institutional Review Boards (IRB) when developing and reviewing informed consent for research studies involving digital health technologies.
Request for Information (RFI) Best Practices for Sharing NIH Supported Research Software. NIH is soliciting input on best practices for openly sharing research software including source code, algorithms, scripts, computational workflows, and executables that were created during the research process or for a research purpose. This RFI will inform and frame the National Institutes of Health’s (NIH) guidance regarding development, refactoring, implementation, and sharing of NIH-supported research software.
FDA, CDC And Other Federal Agencies Discuss Marijuana Research Barriers, State Legalization Models And CBD Regulations At National Academies Meeting (Marijuana Moment). Representatives of multiple federal agencies participated in a National Academies of Sciences, Engineering and Medicine (NASEM) meeting on Friday for a wide-ranging discussion about cannabis policy, with experts sharing their perspective on issues such as marijuana research barriers under prohibition, efforts to create a regulated pathway for CBD, state initiatives to promote social equity and more.
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