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Last Updated: 12/18/17

Informed Consent

Secondary research uses of existing biospecimens and identifiable private information are exempt from human subject regulatory requirements, including informed consent, under certain circumstances, such as when the biospecimens and/or information are publicly available. In addition, Institutional Review Boards (IRB's) may waive consent for minimal risk research on existing specimens if the criteria stipulated in the federal regulations have been met. However, for certain research involving high throughput sequencing technologies, particularly whole genome or whole exome sequencing, there is emerging consensus that informed consent from participants should be obtained due to the elevated risk of re-identification.1

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. Consent for the collection, storage and research use of tissue should be explicit when patients undergo surgery or biopsy, and should explain the scientific rationale for research with excised biospecimens.

The Final Rule endorses the use of a broad consent model for collecting research tissue from patients for long-term storage and future approved research uses that are not precisely known or specified at the time of collection. The National Cancer Institute has developed consent and patient information templates that aim to describe in clear and concise language what it means to participate in research involving biospecimens, including potential privacy risks, and also the concept of a research biorepository. The following resources may be helpful:

Footnotes

  1. http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf