IRB (Institutional Review Board) in the U.S. and Ethics Committees in the European Union are responsible for reviewing and approving/rejecting Research Protocols submitted by investigators.
Following the publication of the Belmont Report in 1978, universities, hospitals, and organizations that receive funding from the U.S. government are required to have their Research Protocols approved by an external panel of research experts, an IRB (Institutional Review Board). Likewise, researchers from the European Union need to have their work reviewed and approved by an Ethics Committee.
IRB and Ethics Committees are charged with the responsibility to ensure (1) Respect for Persons; (2) Beneficence/Nonmaleficence; (3) Justice.
|Respect for Persons/Autonomy||Treat people with respect. Acknowledge others’ rights to hold unique values and beliefs. Protect people with diminished autonomy. Protect people’s identity.|
|Beneficence/Nonmaleficence||Do no harm. Help subjects. Compensate subjects, if possible, for their time and expertise. Produce work for the good of society.|
|Justice||Treat people equitably. Distribute benefits/burdens equally.|
Academic disciplines, organizations, and professional associations require researchers who engage in human subjects research to have their research plans reviewed by an IRB or Ethics Committee prior to its implementation. Subsequently, throughout the conduct of the study, the IRB or Ethics Committee oversees the conduct of the study.
Not all research with human subjects requires IRB/Ethics Committee Review. Some categories of research are Exempt or Expedited from a full review. Investigators should check with their IRB Board or Ethics Committee to discern whether their study is exempt or expedited–or requires a full review.