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Home » Store » Books » Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide
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Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide
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Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care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
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