Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999

Informed Consent for Clinical Trials 2017
A Regulatory Reference Guide

In 2017, FDA published final changes to the Protection of Human Subjects Regulations, known as the Common Rule. 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  • Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care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

Order Your Copy Today

PDF Edition


Available Format

PDF Edition — $377

Who Will Benefit

  • Site managers
  • Trial sponsors
  • Principle investigators
  • CROs

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.