Regulatory Resources
Regulatory Knowledge and Support Services
Let our team navigate you through the regulatory process for successful a research project.
Office of Research Compliance
The Office of Research Compliance (ORC) supports and promotes ethical research practices at Stony Brook University. The ORC and the SBU research community partner together to ensure compliance with federal, state, and local laws and regulations as well as University policies.
Responsible Conduct of Research
SBU ensures compliance with appropriate formal training requirements for the responsible conduct of research and scholarship as part of our commitment to a culture of integrity.
Resources, Training, and Policy
Human Subjects Research
All research projects with human subjects must be reviewed and approved, or receive an exempt determination, by an Institutional Review Board (IRB) prior to beginning the research.
Decision Tool: Am I Doing Human Subjects Research?
Review HHS regulations for the protection of human subjects: 45 CFR 46
Overview and Submission Guidelines of Human Subjects Research at Stony Brook University
Regulatory Documentation
All SBU investigators doing research involving human subjects must maintain a Regulatory Binder and a Research Participant record.
Exception: Pharmaceutical industry-funded/initiated studies have their own specific documentation requirements which must be followed.
Go to section 17.11 of the SBU Human Subjects SOP for a complete list.
NIH has also published a helpful Regulatory Binder checklist for download
External IRBs and Reliance Agreements
Stony Brook has existing Master Reliance Agreements with the following external IRBs:
Learn more about reliance agreements
Florence eBinders
Florence eBinders allows research teams to digitize all study binder documentation and workflows. Launched in our Cancer Center in 2022, it can be used by study teams for federally-funded or investigator-initiated studies for free, or on industry-funded trials for a fee. Provides remote access for start-up, monitoring and source data review for your sponsors. Contact Melanie Keister, to request an account. Access training modules here.
FDA Clinical Trial Guidance Documents
These guidance documents represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection.
Genomic data sharing / sample banking
Research that generates or uses genetic information may create special risks to human subjects. NIH GDS Policy allows for “broad and responsible sharing of genomic research data” via submission of data into a NIH-designated data repository.
Review the Genomic Data Sharing policies in section 17.12 of the SBU Human Subjects SOP
Laboratory Animal Research
SBU’s Institutional Animal Care and Use Committee (IACUC) is devoted to assuring the finest care and most humane use of our experimental animals, and must review animal research projects.
Radioactive Drug Metabolism Research
The Radioactive Drug Research Committee (RDRC) reviews human research protocols involving radioactive drugs that are without a New Drug Application (NDA) filed with the FDA, or an Investigational New Drug (IND) application.
Recombinant / Synthetic nucleic acid molecules
The Institutional Biosafety Committee (IBC) reviews and oversees recombinant and/or synthetic nucleic acid molecule research, and research involving biohazardous material.
Stem Cells
The Stem Cell Research Oversight (SCRO) Committee provides reviews and oversight of all issues related to the derivation and research use of embryos and stem cells at Stony Brook University.