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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
Overview
Overview
Ethical Principles and Guidelines
Overview
Principles
Principles
Principles
Principles
Respect for Persons
Beneficence
Categories of Vulnerability – Specific Vulnerable Populations
General Guidance - Protocol Design
Protocol Design - Provisions for Data and Safety Monitoring
Protocol Design - Responsibility for Data and Safety Monitoring
Protocol Design - Establishing Criteria for Terminating or Re-Examining a Protocol
General Guidance - Conducting the Study
Conducting the Study - Identifying and Reporting Adverse and Unexpected Events - Social-Behavioral Research
Conducting the Study - Identifying and Reporting Adverse and Unexpected Events - Biomedical Research
Conducting the Study - Renewal of Approval for Protocols, Monitoring, and Postapproval Auditing of Research Protocols
Conducting the Study - Terminating a Study Because of Safety Concerns, Demonstrated Effectiveness of Intervention, or Futility of Continuing
General Guidance - Post-Study
General Guidance - Protocol Design
Protocol Design - Inclusion and Exclusion Criteria
Protocol Design - Vulnerable Subjects
Protocol Design - Recruitment
General Guidance - Conducting the Study
Conducting the Study - Retention of subjects
Conducting the Study - Equitable Selection of Subjects When There Is Overwhelming Subject Interest
General Guidance - Post Study
Guidance
Protocol Design - Identification and Quantification of Research Risk
Protocol Design - Minimization of Risk
Assessment of Benefits
Protocol Design - Assessment of the Risk-Benefit Relationship
General Guidance - Conducting the Study
General Guidance - Post-Study
Guidance
Conducting the Study - Protecting Subjects and Others From Harm
Conducting the study - Receiving a Subpoena
Conducting the Study - Responding to Breaches of Confidentiality
Conducting the Study - Responding to Media Inquiries
General Guidance - Conducting the Study
General Guidance - Post-Study
General Guidance - Protocol Design
Protocol Design - Obtaining Informed Consent From Potential Subjects
Protocol Design - Securing Private Information
Guiding Ethical Principles and Explanation
Acceptable Risk With Vulnerable Subjects
Justice
Specific Guidance
Screening Subjects for Attributes of “Non-Health”
Recruitment with Advertisements, Flyers, Posters, Brochures
Recruitment Using the Internet
Clinical Trial Registries
Recruitment With Targeted Letters
Recruitment by Phone
In-Person Recruitment
Specific Guidance
Placebo-Controlled Trials
Use of a Less-Effective Comparator When Conducting Clinical Trials in Developing Countries (copied in large part from Council for International Organizations of Medical Sciences)
Conducting Studies During Early Phases of Testing Non-Validated Drugs, Devices, or Interventions
Specific Guidance on Special Issues
Specific Guidance on Special Issues Certificates of Confidentiality
Specific Guidance on Special Issues Privacy During Recruitment
Specific Guidance on Special Issues Confidentiality with Mailed Questionnaires
Specific Guidance on Special Issues Privacy and Confidentiality Issues When Conducting Genetic Research and Research With Stored Biological Samples
Specific Guidance on Special Issues
Data and Safety Monitoring Committees
Audits and Data Monitoring by Federal Agencies
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
Regulations
Regulations
Applicable Regulations - HIPAA
Applicable Regulations Common Rule and FDA Regulations
Applicable Regulations State and Miscellaneous Regulations
Regulations
Regulations
Resolving Conflicts Between Ethical Principles
Unanticipated Encounters With Vulnerable Subjects
Additional Resources and Links
Additional Resources and Links
Applicable Regulations or Guidance
Development of Ethical Codes for Research
Resources
Resources
Resources
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
The Importance of Conducting Research Ethically
Additional Resources and Links
Post Study
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
Welcome to Quiz Mode
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