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 — the 2012 edition of  … Informed Consent for Clinical Trials: A Regulatory Reference Guide.

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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. 

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Informed Consent for Clinical Trials: A Regulatory Reference Guide is offered by FDAnews in print or PDF format for $377 each.

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