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HRPP/IRB Newsletter
July 2024
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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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Conversion of Paper-based IRB Protocols to eIRB+ | |
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The deadline for converting paper-based IRB protocols (e.g., protocols approved outside of the eIRB+ system) is August 30, 2024.
HRPP Compliance: Please note that any study that is not converted to the eIRB+ system by the August 30, 2024 deadline will be considered inactive and closed by the Human Research Protection Program (HRPP).
Once a paper study is closed by the HRPP, no research-related activity can continue without a new eIRB+ submission. Closed paper submissions cannot be reactivated.
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Get to Know the eIRB+ Application Types! | |
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Over the next few months, we will feature a different eIRB+ application. First in our series is the eIRB+ application for secondary data analysis only.
The application you have been waiting for is here, an application specifically geared toward human subjects research involving secondary data analysis only. Have you seen the new eIRB+ application for research projects involving secondary data analysis only?
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What is secondary data?
Secondary data are data that were originally collected by someone else or originally collected for different purposes. In other words, whenever you conduct research using data that already exists or will be collected by someone for non-research purposes, you are conducting secondary research with data.
When should this application be used?
This application should only be used when your research does not create/analyze new information. It should be used when your research is analyzing data created by other research or originally created for non-research purposes.
Can you give me some examples?
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Examples of data created originally for non-research purposes include, but are not limited to, clinical care, education, employment, benefits, and the like.
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Examples of data created by other research includes, but is not limited to, research data created by a researcher at another institution, research data created by you for another research projects, national survey data, and the like.
May I use this application for research involving secondary use of biospecimens?
No. You should not use this application when your research involves secondary use of biospecimens. If your research involves secondary use of biospecimens you should use the application titled “Research Protocol Study (minimal risk) - Expedited/Exempt”. Secondary use of biospecimens are biospecimens that were collected originally by someone else or originally collected for different purposes. In other words, whenever you conduct research using biospecimens that already exists or will be collected by someone for non-research purposes (left over samples collected as part of clinical care), you are conducting secondary research with biospecimens.
Learn more about the Secondary Data Analysis Only eIRB+ application.
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eIRB+ PDF Quick Guides for each of the eIRB+ initial submission types are available.
These step-by-step Quick Guides provide overviews, screenshots, and tips for the eIRB+ application.
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Consult with HRPP/IRB Subject Matter Experts! | |
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The mission of the Document Review and Feedback Team (DRAFT) is to improve IRB submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices through pre-reviews and consultations.
Learn more about DRAFT.
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The IRB Reliance Team provides subject matter expertise and consultations on the IRB requirements for collaborative research.
These subject matter experts are adept at assisting study teams with navigating IRB requirements for engaging in multi-institutional research.
Learn more about Reliance.
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Workshop and Training Opportunities | |
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Attend a virtual eIRB+ Workshop to learn more about the updates to our submission platform and business processes.
eIRB+ Workshop sessions offer a comprehensive walkthrough of updated features, step-by-step application tutorials, and an opportunity to address any questions you may have.
Open to all Rutgers faculty, staff, and students, our sessions have already attracted over 540 registrants across 60 sessions!
Register now on the Course Registration System to secure your spot in upcoming training sessions. Multiple sessions will be available weekly throughout each month/semester.
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New IRB Committee Member Spotlight | |
Rutgers IRB is excited to announce that the following individuals have joined the Institutional Review Board as members: | |
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Jenna Camacho, MHA, B-PHIL, CHP is a Healthcare Administration Specialist at RWJBH, and her expertise is in Healthcare Compliance.
Modupe Coker, PhD, BDS, MPH is an Assistant Professor at RSDM, and her expertise in Oral Biology and Dental Medicine.
Christie Lyn Costanza, MPH, BSN is the Associate Director of Clinical Research Operations at New Jersey Medical School. Her expertise is in Community Engagement with Health Education along with Infectious Diseases (i.e., Hepatitis B & C, COVID, HPV, HIV+), Vaccine Research (i.e., Shingles, COVID, flu), Clinical Research Nursing & Management, and Research Repositories.
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Kabilan Gounder, PhD, M.Phil, MSc. is an Assistant Professor of Oral Biology at Rutgers School of Dental Medicine (RSDM). His expertise is in Oral Biology, Oral Diseases, and Dental Medicine.
Mary Beth Russell, PhD, MA, RN (RWJBH) is the Senior Vice President at the Center for Professional Development Innovation, Research & The Institute for Nursing Excellence. Her expertise is in Nursing, Professional Development, and Educational Leadership & Interprofessional Collaboration in Healthcare.
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We welcome each new member onto the Rutgers IRB. The IRB looks forward to working with our new members to ensure the protection of individuals participating in research and fostering the ethical conduct of human subjects research. | |
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Can AI Replace Human Research Participants? These Scientists See Risk (Scientific American). In science, studying human experiences typically requires time, money and—of course—human participants. But as large language models such as OpenAI’s GPT-4 have grown more sophisticated, some in the research community have been steadily warming to the idea that artificial intelligence could replace human participants in some scientific studies.
The U.S. wants to change how researchers get access to a huge trove of health data. Many don’t like the idea (Science). Health researchers are urging the U.S. government to rethink a plan that would require them to use an in-house government system, and pay substantially more, to access a massive trove of data assembled by federal programs that support medical care for some 140 million people. Ahead of a May 15 deadline to provide comment, researchers are highlighting concerns with the proposed policy change by the U.S. Centers for Medicare and Medicaid Services (CMS). Academic researchers have long used data CMS has exported to their universities to produce peer-reviewed studies, including some that have led to changes in policy.
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