NIH Guidance on Informed Consent
For Gene Transfer Research
Introduction to Guidance
Communication about the Study to Potential Participants
Special Considerations for Informed Consent
Conflicts of Interest
Comprehensibility
Time for Decision Making
Assent
Consent Form
General Requirements of Human Subjects Research
Purpose
Procedures
Alternatives
Voluntary Participation
Potential Benefits
Possible Risks, Discomforts, & Side Effects
Costs
Specific Requirements of Gene Transfer Research
Reproductive Considerations
Long-term Follow-up
Request for Autopsy
Interest of the Media and Others in the Research
Privacy and Confidentiality
Additional Resources
Table of Contents
Appendix
Title
Appendix M-III
Introduction to Guidance
Important Note
Appendix M-III-A
Communication about the Study to Potential Participants
Main Points
Tools and Background Materials
Special Considerations for Informed Consent
Appendix M-III-A-1
Conflicts of Interest
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-A-2
Comprehensibility
Main Points
Tools and Background Materials
Appendix M-III-A-3
Time for Decision Making
Main Points
Sample Language
Appendix M-III-A-4
Assent
Main Points
Tools and Background Materials
Appendix M-III-B
Consent Form
Main Points
Tools and Background Materials
General Requirements of Human Subjects Research
Appendix M-III-B-1
Purpose
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-B-1-a
Procedures
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-B-1-b
Alternatives
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-B-1-c
Voluntary Participation
Main Points
Sample Language
Appendix M-III-B-1-d
Potential Benefits
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-B-1-e
Possible Risks, Discomforts, & Side Effects
Main Points
Sample Language
Appendix M-III-B-1-f
Costs
Main Points
Sample Language
Specific Requirements of Gene Transfer Research
Appendix M-III-B-2-a
Reproductive Considerations
Main Points
Sample Language
Tools and Background Materials
Appendix M-III-B-2-b
Long-term Follow-up
Main Points
Sample Language
Appendix M-III-B-2-c
Request for Autopsy
Main Points
Sample Language
Appendix M-III-B-2-d
Interest of the Media and Others in the Research
Appendix M-IV
Privacy and Confidentiality
Main Points
Sample Language
Tools and Background Materials
Additional Resources
Articles
Bibliographies
Books
Brochures
Glossaries
Government Guidelines and Regulations