United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-07-15 article Notices D09002ee1c7f91411 D09002ee1c7f914bd United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors." The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. 79 FR 41291 https://www.govinfo.gov/app/details/FR-2014-07-15/2014-16492 2014-16492 fr15jy14-87 4164-01-P Docket No. FDA-2006-D-0031 https://www.govinfo.gov/app/details/FR-2014-07-15/2014-16492 https://www.govinfo.gov/content/pkg/FR-2014-07-15/html/2014-16492.htm https://www.govinfo.gov/content/pkg/FR-2014-07-15/pdf/2014-16492.pdf 2 p. 41291 41292 79 FR 41291 Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability; Federal Register Vol. 79, Issue NOTICE 2014-16492 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2006-D-0031 4164-01-P 2014-16492 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors." The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.

Although comments on any guidance can be submitted at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a comment on this draft guidance before it begins work on the final version of the guidance, electronic or written comments on the draft guidance should be submitted by September 15, 2014. Marsha Melvin, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave, Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov. Guidance: Informed Consent Information Sheets , marsha.melvin@fda.hhs.gov http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm http://www.regulations.gov www.hhs.gov/ohrp/humansubjects/anprm2011page.html Vol. 79, no. 135 Office of the Federal Register, National Archives and Records Administration 2014-07-15 continuing daily deposited born digital 329 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-07-15 P0b002ee1898299b1 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr15jy14 https://www.govinfo.gov/app/details/FR-2014-07-15 https://www.govinfo.gov/content/pkg/FR-2014-07-15/pdf/FR-2014-07-15.pdf https://www.govinfo.gov/content/pkg/FR-2014-07-15/xml/FR-2014-07-15.xml fdlp 41085 41403 DGPO 2014-07-15 2024-06-02 FR-2014-07-15 machine generated eng FR FR-2014-07-15 79 135