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U.S. National Institutes of Health
Last Updated: 03/05/10

Informed Consent

Institutional Review Boards (IRB’s) may waive consent for minimal risk research on existing specimens provided that the criteria stipulated in the federal regulations 45CFR46 have been met. For specimens that do not already exist, there is an emerging consensus that informed consent should be obtained for research use of identifiable specimens collected during routine medical care. Most believe that the consent for the collection, storage and research use of tissue should be explicit and separate from the routine surgical consent. The National Cancer Institute, together with the National Action Plan on Breast Cancer (NAPBC), developed and tested a model informed consent document and an accompanying patient information sheet to request consent for future unspecified research use of specimens collected during routine medical care. These documents can be downloaded in HTML or PDF format and modified as appropriate for use by research institutions collecting specimens for research purposes. The PDF version can be viewed using Adobe Acrobat Reader.