federal_register: 2011-22883

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-22883 Guidance on Exculpatory Language in Informed Consent, Draft Notice The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, "Guidance on Exculpatory Language in Informed Consent." The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP's November 15, 1996 guidance document entitled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." The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS or regulated by FDA. 2011-09-07 2011 9 https://www.federalregister.gov/documents/2011/09/07/2011-22883/guidance-on-exculpatory-language-in-informed-consent-draft https://www.govinfo.gov/content/pkg/FR-2011-09-07/pdf/2011-22883.pdf Health and Human Services Department 221 The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, "Guidance on Exculpatory Language in Informed...  

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