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)

U.S. Food and Drug Administration (FDA)

Federal Guidelines

National Institutes of Health (NIH)

Office for Civil Rights (OCR)

Ethical Codes

Guidance in Research

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?