Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide

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Informed Consent for Clinical Trials 2017
A Regulatory Reference Guide

On January 19, 2018, revisions to the Protection of Human Subjects Regulations, known as the Common Rule, will go into effect. If you conduct clinical research under the jurisdiction of the FDA or one of 15 other federal agencies, you need to know exactly what that means, especially regarding one of the thorniest issues you face — informed consent.

FDAnews’ new edition of Informed Consent for Clinical Trials helps you understand all the changes that are coming and gives you all the resources you need to comply with informed consent rules — all in one place. In addition to the text of the new Common Rule, here’s what you’ll find in the 2017 guide:

Part One – FDA Guidance Documents

  • IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects — NEW
  • Use of Electronic Informed Consent — NEW
  • A Guide to Informed Consent — Information Sheet
  • Questions and Answers on Informed Consent Elements
  • Exception from Informed Consent Requirements for Emergency Research
  • Guidance for Informed Consent for IDEs
  • ICH E6(R2) Good Clinical Practice — NEW
  • In Vitro Diagnostic Device Studies — Frequently Asked Questions
  • Leftover Human Specimens that are Not Individually Identifiable
  • Exceptions from Informed Consent Requirements for Emergency Research
  • Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
  • INDs: Review of Informed Consent Documents
  • INDs: Exception from Informed Consent Requirements for Emergency Research

Part Two – Office of Human Research Protection Documents

  • Informed Consent FAQs
  • Informed Consent Checklist — Basic and Additional Elements
  • OHRP Tips on Informed Consent
  • Minimal Risk Informed Consent Models — NEW
  • Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
  • Guidance on Exculpatory Language in Informed Consent
  • Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e)
  • Informed Consent — Legally Effective and Prospectively Obtained
  • Considerations in Transferring a Previously Approved Research Project to a New IRB or Research Institution
  • Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued
  • Informed Consent Requirements in Emergency Research
  • Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
  • Human Subject Regulations Decision Charts — UPDATED

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Who Will Benefit

  • Site managers
  • Trial sponsors
  • Principle investigators
  • CROs

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