Guidelines and Documentation Requirements for Research Involving Human and Animal Subjects

ATP Proposal Preparation Kit, February 2004

Advanced Technology Program
Guidelines and Documentation
Requirements for
Research Involving
Human and Animal Subjects

2003 - 2004

View entire Guidelines and Documentation in PDF format.

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I. Research Involving Human Subjects [View PDF.]

A. Introduction
B. Assurance of Compliance
C. Protected Classes
D. Clinical Trials
E. Human Subjects in Foreign Countries
F. Transplantation of Fetal Tissue
G. Research Involving Embryos and Embryonic Stem Cells
H. Research Exempt From the Regulations
I. Required Documentation
J. Contact Information
K. Definitions

II. Research Involving Vertebrate Animals [View PDF.]

A. Introduction
B. IACUC Review and Compliance
C. Animal Study Protocols
D. Required Documentation
E. Contact Information
F. Definitions

Appendices

Appendix 1: Applicable Authorities [View PDF.]
Appendix 2: Human Subjects Determination Checklist [View PDF.]
Appendix 3: Request for an Exemption From 15 C.F.R. Part 27 for Research Involving Human Subjects in Information Technology, Manufacturing, or Imaging Studies [View PDF.]
Appendix 4: Request for an Exemption From 15 C.F.R. Part 27 for Research Involving Human Subjects in Biological Studies [View PDF.]
Appendix 5: Submission Timeline for Required Documentation-Human Subjects [View PDF.]
Appendix 6: Submission Timeline for Required Documentation-Vertebrate Animals [View PDF.]

Return to Helpful Resources or refer to the ATP Proposal Preparation Kit.

Date created: February 3, 2004
Last updated: February 13, 2004

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