Regulations & Guidance

The Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) oversee the operations of the IRB. 

The Office of Human Research (OHR) is your primary point of contact for questions pertaining to regulation, guidance, and GW policies relating to human subjects research. 

Federal Regulations

U.S. Department of Health & Human Services (HHS), Office for Human Research Protections (OHRP)

• 45 CFR 46- Protection of Human Subjects
• HHS: Expedited Review Categories

U.S. Food and Drug Administration (FDA)

• 21 CFR 50 - Protection of Human Subjects
• 21 CFR 56 - Institutional Review Boards (IRB)

Federal Guidelines

National Institutes of Health (NIH)

• Inclusion of Women and Minorities in Research
• Inclusion of Children in Research
• Research Involving Individuals with Questionable Capacity to Consent
• ClinicalTrials.gov

Office for Civil Rights (OCR)

• HIPAA - Health Information Privacy for Research
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

Ethical Codes

• Belmont Report
• World Medical Association Declaration of Helsinki

Guidance in Research

• "CABLES" Guidance on assessing risks in research
• Principal Investigator Considerations for Student Research
• International Compilation of Human Research Protections
• OHR Guidance for International Research
• CTSI-CN Virtual Organizer 
• Investigational New Drug (IND) Guidance for investigators seeking an IND 
• Data Security Guidance on data security measures from the GW Office of Compliance and Privacy 

Decision Charts

The following Decision Charts have been developed by the Office for Human Research Protections (OHRP) to assist investigators in determining the review category that best suits their research.

Chart 1- Does your research involve human subjects?

Chart 2- Research involving human subjects eligible for exemption?

Chart 3- Research involving educational settings-exempt?

Chart 4- Research involving tests, surveys, interviews, public behavior- eligible for exemption?

Chart 5- Existing data documents and specimens- eligible for exemption?

Chart 6- Public benefit or service program- eligible for exemption?

Chart 7- Food and taste acceptance studies- exemption apply?

Chart 8- Is your study eligible for expedited review?

Chart 9- Can your continuing renewal review be expedited?

Chart 10- Can your study waive or alter informed consent elements?

Chart 11- Can the documentation of informed consent be waived?