Why is IRB review needed?
Federal Regulations (Code of Federal Regulations, chapter 45, Section 46.11 6) require that all proposals for research involving human subjects be submitted for prior review to the Institutional Review Board (IRB). The United States Department of Health and Human Services (HHS) requires all researchers conducting human- subjects research to provide prospective subjects with informed consent. An exception to the informed-consent rule may be obtained if: (i) the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or (ii) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normal required outside of the research context.
Related Questions
- The Scientific Review of Human Research Protocol form is needed to submit my protocol to the IRB. Why is this form needed and how many signatures are required?
- Assuming IRB approval is needed for all participating design schools and there be a review time after the development of the first public user survey?
- Why is IRB review needed?
