The College of New Jersey

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Policies & Procedures

Investigators may not initiate any research involving humans until they have received notification of IRB approval and have agreed to comply with all contingencies made in connection with that approval.

TCNJ IRB Policies and Procedures Manual


Restrictions

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.


Federal Regulations

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

FOOD AND DRUG ADMINISTRATION (FDA) REGULATIONS

DEPARTMENT OF DEFENSE (DOD) REGULATIONS

DEPARTMENT OF EDUCATION

DEPARTMENT OF JUSTICE

DEPARTMENT OF VETERANS AFFAIRS

FEDERAL CERTIFICATE OF CONFIDENTIALITY

STATE REGULATIONS

Ethical Guidance

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.

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