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BIO Submits Comments on Informed Consent Guidance

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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.&rdquo; BIO shares FDA&rsquo;s commitment to enhancing communication with, and thereby the protection of, human research subjects.</p>

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” BIO shares FDA’s commitment to enhancing communication with, and thereby the protection of, human research subjects.

BIO believes that clearly and effectively communicating with potential research volunteers is essential to their protection, and as such, BIO greatly appreciates the Agency’s work to publish the Draft Guidance. In general, BIO finds the Draft Guidance very well-written, informative, and comprehensive. There are several aspects of the Draft Guidance for which BIO offers additional considerations or requests clarification and/or revision.