All Primary Investigators (PIs) must be faculty or staff at The College of New Jersey. While we encourage students to conduct research, students are not allowed serve as the PI on proposals submitted to the IRB. Students do have access to the iMedris system and may complete IRB applications, but the faculty sponsor must be the designated PI and is the only person able to hit the final submit button.
The list below represents federal agencies websites or documents that contain policies, explain specific provisions, and provide links to resources for that agency.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) REGULATIONS
- Policy for the Protection of Human Research Subjects, 45 CFR Part 46
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, 45 CFR Parts 160 & 164 (subparts A & E)
- Federalwide Assurance (FWA) for the Protection of Human Subjects – outlines general terms of commitment for institutions to comply with requirements 45 CFR Part 46, maintained by the HHS Office of Human Research Protections (OHRP)
FOOD AND DRUG ADMINISTRATION (FDA) REGULATIONS
- Protection of Human Subjects, 21 CFR Part 50
- Institutional Review Boards, 21 CFR Part 56
- Investigational New Drugs (INDs), 21 CFR Part 312
- Investigational Device Exemption (IDE), 21 CFR Part 812
- Electronic Records, Electronic Signatures, 21 CFR Part 11
DEPARTMENT OF DEFENSE (DOD) REGULATIONS
DEPARTMENT OF EDUCATION
DEPARTMENT OF JUSTICE
DEPARTMENT OF VETERANS AFFAIRS
FEDERAL CERTIFICATE OF CONFIDENTIALITY
The human subject protections codified in the CFR are founded on the ethical guidelines outlined in the:
Belmont Report(link is external) (HHS website)
Declaration of Helsinki(link is external) (World Medical Association)
TCNJ investigators conducting human subjects research are expected to be familiar with the Belmont Report principles through training.