Regulatory & Compliance Support
Regulatory Knowledge & Support
Regulatory Knowledge and Support offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. We bring unique expertise to benefit the entire research team, from research coordinators to Principal Investigators. We can provide knowledgeable guidance and advice with local and federal regulations, and facilitate early engagement and education for stakeholders for the timely and complete submission of necessary applications. This includes help with guidance on IND and IDE’s along with protocol review.
Link to Regulatory Support: https://njacts.rbhs.rutgers.edu/investigator-resources/regulatory/
Scientific Review Board
The Rutgers Health Scientific Review Board supports investigator-initiated studies by reviewing non-oncology protocols to assess proper statistical design, enrollment goals, feasibility (including adequate research staffing, competing trials, funding, resources, and departmental support) to help accelerate IRB approval and to help ensure study success.
The Scientific Review Board (SRB) ensures that the scientific question being asked within a protocol is relevant and that the design of the protocol is appropriate to answer that question.
For information on the Rutgers Health Scientific Review Board (SRB) please visit: https://njacts.rbhs.rutgers.edu/investigator-resources/regulatory/scientific-review-board/
If your study meets the following criteria for SRB review, please click on this link to submit to the SRB for review: https://redcap.rutgers.edu/surveys/?s=C8E4XE4A9KNN4AAX
Criteria for SRB Review:
All of the following criteria must be met for SRB review:
- Principal Investigator is a Rutgers Health faculty member outside of CINJ
- Rutgers Health investigator-initiated protocol (i.e., not sponsored by industry or an NIH consortium)
- Study entails obtaining consent of study participants
Rutgers IRB
An Institutional Review Board (IRB) ensures the protection of the rights and welfare of human research subjects based on the rules and regulations of the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) by approving, requiring modifications in, or disapproving Human Subject Research projects.
Link to IRB and HRPP services: https://research.rutgers.edu/faculty-staff/compliance/human-research-protection
IRB Draft Services
DRAFT Services (formerly known as Pre-Review Service) stands for “Document Revision And Feedback Team”. The mission of the DRAFT Service is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. It is highly recommended that the DRAFT Service is used by investigators prior to submitting new studies or substantial modifications to existing studies in eIRB.
Link to IRB Draft Services: https://research.rutgers.edu/faculty-staff/compliance/human-research-protection/draft-services
Biosafety Program
The Rutgers Biosafety Program in the Department of Environmental Health and Safety (REHS) is responsible for overseeing research performed with: recombinant and synthetic genetic material, pathogenic microorganisms (affecting humans, plants and animals), select agents and toxins, human material and human cell lines, transgenic plants and transgenic animals
IATA Training
IATA training is required before shipping Dangerous Goods and other regulated materials. If any transport will involve the need to transfer materials through city streets or in a personal vehicle, REHS must be contacted beforehand, as there may be additional trainings and requirements. Rutgers personnel are not permitted to transport certain materials in vehicles (e.g., Category A Infectious Substances). Please contact biosafety@rutgers.edu for more details.
Link: https://ipo.rutgers.edu/rehs/shipping-biological-material
eReg
As part of the overall mission to improve the efficiency and quality of the clinical trials conducted at Rutgers Health, the Rutgers Health Chancellor’s Office and NJACTS have invested in eReg, an electronic regulatory filing system.
Link: https://njacts.rbhs.rutgers.edu/clinical-trials-office/solutions/ereg/