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HSP Module 2: Informed Consent
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TOC
HSP Module 2: Informed Consent
General Guidance - Protocol Design
Consent Process
The Involvement of Third Parties in the Consent Process
Readability of the Consent Form
Translation of Consent Forms
Sections of the Consent Form
Overview
Guiding Ethical Principles and Explanation
Specific Guidance on Special Issues
Waiver of Informed Consent Under FDA Regulations
Waiver of Documentation of Informed Consent Under the Common Rule
Waiver of Informed Consent or Elements of Consent Under the Common Rule
Obtaining Informed Consent With Incomplete Disclosure or Deception
Consent for research involving collection and storage of tissues or data:
Consent for research involving collection and storage of tissue or data
Consent for Research Involving Collection and Storage of Tissue or Data
Consent for Research Involving Collection and Storage of Tissues or Data
Consent for Community Research
Applicable Regulations or Guidance
Additional Resources and Links
Conducting the study
Maintaining Consent Forms and Records
The Ongoing Process of Consent
Ongoing Care for Subjects Who Withdraw From a Study or Subjects Who Are Withdrawn by the Investigator
Disclosing New Information to Participants
Post Study
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