Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (OGCP) Marsha Melvin at [email protected], (CDER) Kristen Miller at 301-796-0762, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800, or (CDRH) Sheila Brown at 301-796-6563 (CDRH). U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health July 2014 Contains Nonbinding Recommendations Draft – Not for Implementation Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Additional copies are available from: Office of Good Clinical Practice Office of Special Medical Programs, Office of Medical Products and Tobacco Food and Drug Administration 10903 New Hampshire Avenue WO32-5103 Silver Spring, MD 20993 (Tel) (301) 796-8340 http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulations andDraftGuidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration July 2014 Contains Nonbinding Recommendations Draft – Not for Implementation TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. SUMMARY OF THE CONSENT PROCESS ............................................................... 2 III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION .................... 3 A. General Requirements for Informed Consent ............................................................... 3 1. Exceptions to Informed Consent ..................................................................................... 4 2. Coercion and Undue Influence ........................................................................................ 4 3. Language Understandable to the Subject or the Representative ................................. 5 4. Exculpatory Language ..................................................................................................... 5 B. Basic Elements of Informed Consent .............................................................................. 6 1. Description of Clinical Investigation ............................................................................... 6 2. Risks and Discomforts ...................................................................................................... 8 3 Benefits ............................................................................................................................... 9 4. Alternative Procedures or Treatments ........................................................................... 9 5. Confidentiality ................................................................................................................. 10 6. Compensation and Medical Treatments in Event of Injury ....................................... 11 7. Contacts ........................................................................................................................... 12 8. Voluntary Participation.................................................................................................. 12 C. Additional Elements of Informed Consent ................................................................... 13 1. Unforeseeable Risks ........................................................................................................ 13 2. Involuntary Termination of Subject’s Participation ................................................... 13 3. Additional Costs to Subject ............................................................................................ 14 4. Consequences of Subject’s Decision to Withdraw ....................................................... 15 5. Providing Significant New Findings to Subjects .......................................................... 15 6. Number of Subjects......................................................................................................... 16 D. Element of Informed Consent for Applicable Clinical Trials ..................................... 16 E. Documentation of Informed Consent ............................................................................ 16 1. Requirement for Written Documentation of Informed Consent ................................ 16 2. Alternative Methods of Obtaining Informed Consent ................................................ 17 3. Requirement for Dating Consent Form ........................................................................ 18 4. Forms for Documentation of Informed Consent ......................................................... 19 a. Long Form ................................................................................................................. 19 b. Short Form ................................................................................................................ 19 IV. RESPONSIBILITIES FOR INFORMED CONSENT ................................................ 20 A. The IRB ............................................................................................................................ 20 1. Review of All Informed Consent Materials .................................................................. 20 a. Adequacy and Appropriateness of Wording ......................................................... 22 b. Use of Standardized Language ................................................................................ 22 2. Review of the Consent Process ....................................................................................... 23 3. IRB Review Procedures .................................................................................................. 24 4. Identification of Revised Consent Forms ...................................................................... 24 B. The Clinical Investigator ................................................................................................ 24 1. Delegation of Consent Interview.................................................................................... 25 2. Financial Relationships and Interests ........................................................................... 26 Contains Nonbinding Recommendations Draft – Not for Implementation C. The Sponsor ..................................................................................................................... 26 1. Considerations for Multicenter Clinical Investigations .............................................. 27 D. The FDA ........................................................................................................................... 27 1. Investigational New Drugs and Biologics ..................................................................... 27 2. Investigational Medical Devices ..................................................................................... 28 V. ADDITIONAL CONSIDERATIONS ........................................................................... 29 A. Review of Patient Records.............................................................................................. 29 B. Non-English Speaking Subjects ..................................................................................... 30 C. Subjects with Low Literacy and Numeracy ................................................................. 34 D. Physically Challenged Subjects ..................................................................................... 34 E. Impaired Consent Capacity ........................................................................................... 35 F. Children as Subjects ....................................................................................................... 36 G. Subject Participation in More Than One Clinical Investigation ................................ 39 H. Suspension/Termination of a Study ............................................................................. 40 I. Data Retention upon the Withdrawal of Subjects ....................................................... 41 K. Reporting Aggregate Results of the Clinical Investigation ......................................... 41 Contains Nonbinding Recommendations Draft – Not for Implementation Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors1 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or Agency’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call