Print Edition - Informed Consent for Clinical Trials: A Regulatory Reference Guide

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August 2012
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What can go wrong with informed consent documents? Plenty ...

  • Lack of proper signatures and dates
  • Non-English speakers signing English consent documents
  • Lack of signatures from legally authorized representatives
  • Forged signatures
  • Consent obtained from subjects who lacked the capacity to give consent
  • Inadequate disclosure of risks associated with a trial protocol
  • Consent forms used without IRB approval

Want us to go on? We could.

Is your informed consent process effective and compliant with FDA and OHRP? If you hesitated for even a moment, kindly accept this invitation to preview — at no risk — Informed Consent for Clinical Trials: A Regulatory Reference Guide.

This brand new guide has been completely updated and includes the following essential references:

Part One – FDA Guidance Documents

  • A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators
  • Questions and Answers on Informed Consent Elements - New
  • Exception from Informed Consent Requirements for Emergency Research - New
  • IDE Informed Consent
  • In Vitro Diagnostic Device Studies - Frequently Asked Questions - New
  • Leftover Human Specimens that are Not Individually Identifiable
  • Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
  • INDs: Review of Informed Consent Documents - New
  • INDs: Exception from Informed Consent Requirements for Emergency Research

Part Two – OHRP Documents

  • Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators - New
  • Informed Consent FAQs - New
  • Informed Consent Checklist - Basic and Additional Elements
  • OHRP Tips on Informed Consent - New
  • Guidance on Exculpatory Language in Informed Consent - New
  • Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e)
  • Compliance Oversight Activities: Determinations of Noncompliance
  • Informed Consent—Legally Effective and Prospectively Obtained
  • Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued - New
  • Informed Consent Requirements in Emergency Research
  • Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
  • Human Subject Regulations Decision Charts

The Challenge of Informed Consent …
Even in routine health care procedures, explaining risks and benefits of any treatment – and obtaining the patient’s consent —is often difficult.  But the complexities of explaining risks and benefits of participating in a clinical trial are daunting.

With this 300+ page guide, you will never again wonder if your informed consent process meets federal standards.  Don’t roll the dice and ‘hope’ you will get this right … the stakes are too high.  Make SURE you know, exactly, what’s required to the letter.

The cost is only about $1.00 per page.  Where else can you buy insurance like this that could save you thousands upon thousands in money, time and even worse … lost data or reputation?

Don’t risk it. 

Get Multi-user Access With The Electronic Books Library.
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