Table of Contents

National Institute of Health - Office of Biotechnology Activities

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

General Requirements of Human Subjects Research

Voluntary Participation

Potential Benefits

Possible Risks, Discomforts, & Side Effects

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