FDA Exculpatory Language in Informed Consent

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Draft — Not for Implementation Guidance on Exculpatory Language in Informed Consent This draft guidance, when finalized, will represent the Office for Human Research Protections’ (OHRP’s) and the Food and Drug Administration’s (FDA’s) current thinking on this topic. This guidance does not create or confer any rights for or on any person and does not operate to bind OHRP, FDA or the public. OHRP and FDA guidance should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP and FDA guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR part 46 or the Food and Drug Administration regulations at 21 CFR parts 50 and 56. The use of the word should in OHRP and FDA guidance means that something is recommended or suggested, but not required. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the OHRP or FDA staff responsible for 1

implementing this guidance. I. INTRODUCTION This draft guidance has been prepared jointly by the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This document applies to non-exempt human subject research conducted or supported by the Department of Health and Human Services (HHS) and is intended for clinical investigators, institutional review boards, and funding agencies that may be responsible for review or oversight of human subject research conducted or supported by HHS. This document also applies to human subject research regulated by FDA and is intended for clinical investigators, sponsors, and institutional review boards conducting or reviewing such research. This document provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent. The document includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory. When finalized, this document will supersede OHRP’s November 15, 1996, guidance entitled, “‘Exculpatory Language’ in Informed Consent” and question number 52 in FDA’s January 1998 guidance entitled, “Institutional Review Boards Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.” OHRP’s and FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe OHRP’s and FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. II. DISCUSSION 1

Contact information for both OHRP and FDA can be found in Section III of this guidance.

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