Regulatory Information

Federal Resources

Office of Human Research Protections (OHRP)

The federal oversight agency used by the IRB for guidance and with which TCNJ is registered and has a Federalwide Assurance (FWA).

• Federalwide Assurance (FWA)
• Title 45 CFR 46: Protection of Human Subjects
• Expedited Review Categories
• Policies & Assurances, by Topic
• Decision Charts
  • To determine (1) if it is research; (2) if it is eligible for exemtion; (3) – (7) which exemption; (8) if it can be expedited; (9) if continuing review can be expedited; (10) if Informed Consent can be waived; (11) if documentation of Informed Consent can be waived.

Belmont Report

Ethical Principles and Guidelines for the Protection of Human Subjects of Research by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979).

Health Insurance Portability and Accountability Act (HIPAA)

National standards to protect the privacy of personal health information – from the U.S. Department of Health and Human Services, Office for Civil Rights.

National Science Foundation (NSF)

• Grant Proposal Guide
• Grant Policy Manual
• FAQs on Proposal Preparation and Award Administration
• NSF Merit Review (1999)

National Institutes of Health (NIH)

• NIH Office of Human Subjects Research
• NIH On-Line Education Module
• Grants and Funding Opportunities
• NIH Guide
• Grants Policy Statement

Food and Drug Administration (FDA)

• Informed Consent
• FDA Information Sheets