• Cover Letter
• Executive Summary
• Analysis and Proposed Actions Regarding The National Bioethics Advisory Commission (NBAC) Report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
  • Introduction
  • General Comments
  • Discussion of Terms Used in Report
  • Specific Issues of Note
  • Future Considerations
  • Comments on Specific Recommendations
    • Recommendations Regarding Interpretation of the Existing Federal Regulations
    • Recommendations Regarding Special Concerns About the Use of Unlinked Samples
    • Recommendations Regarding Requirements for Investigators Using Coded or Identified Samples
    • Recommendations Regarding Obtaining Informed Consent
    • Recommendations Regarding the Criteria for Waiver of Consent
    • Recommendations Regarding Reporting Research Results to Subjects
    • Recommendations Regarding the Considerations of Potential Harm to Others
    • Recommendations Regarding the Publication and Dissemination of Research Results
    • Recommendations Regarding Professional Education and Responsibilities
    • Recommendations Regarding the Use of Medical Records in Research on Human Biological Materials
• Appendix

Printable (PDF) version of the report

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National Bioethics Advisory Commission Publications