What question did this study set out to answer?

To address emerging ethical, legal, and epidemiologic concerns regarding informed consent requirements for genetic research involving stored human tissue samples.

April 10, 1996JAMA

Informed Consent for Genetic Research-Reply

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ECEllen Wright ClaytonVanderbilt University Medical Center

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Implication

Consensus report clarifies informed consent requirements for stored tissue research, highlighting institutional review board waiver criteria.

Key Points

To address emerging ethical, legal, and epidemiologic concerns regarding informed consent requirements for genetic research involving stored human tissue samples.
Convened an expert multidisciplinary working group organized with the Centers for Disease Control and Prevention.
Evaluated federal regulatory frameworks governing institutional review board oversight of research involving identifiable biological specimens.
Federal regulations mandate institutional review board review for all research protocols that utilize identifiable tissue samples, regardless of whether the study focuses on genetics.
Investigators are required to obtain informed consent from identifiable individuals unless the institutional review board establishes that all four federal regulatory criteria for waiving or limiting consent are fulfilled.

Cite This Study

Ellen Wright Clayton (1996) studied this question.

synapsesocial.com/papers/6a163702f9004307dec1fb76 https://doi.org/10.1001/jama.1996.03530380027021

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Implication

Consensus report clarifies informed consent requirements for stored tissue research, highlighting institutional review board waiver criteria.

Informed Consent for Genetic Research-Reply

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Informed Consent for Genetic Research-Reply

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