Office of Human Research Protection

Definition

The Office of Human Research Protection (OHRP) is a U.S. government agency responsible for ensuring the ethical conduct and protection of human subjects in research. OHRP provides guidance, oversight, and education to institutions conducting research involving human participants.

5 Must Know Facts For Your Next Test

1. OHRP enforces regulations outlined in the Department of Health and Human Services (HHS) Common Rule.
2. It requires Institutional Review Boards (IRBs) to review and approve research studies involving human subjects.
3. OHRP monitors compliance with ethical standards through routine audits and investigations.
4. Institutions must have a Federalwide Assurance (FWA) approved by OHRP before engaging in federally funded research involving human subjects.
5. OHRP provides educational resources to researchers on topics like informed consent, data privacy, and risk minimization.

Review Questions

• What role does OHRP play in the protection of human research subjects?
• Why is an Institutional Review Board (IRB) necessary according to OHRP guidelines?
• What is a Federalwide Assurance (FWA) and why is it important for institutions conducting federally funded research?

Related terms

Institutional Review Board (IRB): A committee that reviews and approves research involving human subjects to ensure ethical standards are met.

Common Rule: A set of federal regulations for ethical standards in the protection of human subjects in research.

Informed Consent: The process of providing potential research participants with comprehensive information about a study so they can make an informed decision about their participation.