NOTICE PERTINENT TO THE APRIL 2002 REVISIONS OF THE
NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT
DNA MOLECULES (NIH GUIDELINES)
ROLES AND RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR (PI)
Under the amendment to Section IV-B-7, which was published in the Federal Register on November 19, 2001 (66 FR 57970, specifically: 57975) and became effective on December 19, 2001, a PI may delegate the reporting responsibilities set forth in Appendix M-I-C, Reporting Requirements, to another party, with written notification of the delegation to OBA. A letter from each PI indicating to whom they have delegated the reporting requirements set forth in Appendix M-I-C must be on file with OBA. This delegation of reporting responsibility may, if appropriate, be extended to include the material submitted under Appendix M-I-A, Requirements for Protocol Submission, of the NIH Guidelines. To that end, a letter from the PI should be submitted to OBA, either directly by the investigator or as part of the material submitted under Appendix M-I-A.
Summary of Amendments [Major Actions]
Page 10 Section I-E: Additions to General Definitions. New sections -- I-E-8, I-E-9,
I-E-10
Page 36 Appendix B-I [Lines 5-8]: New – General definition of an E. coli strain as a RG1 agent
Page 97-98 Appendix M-I-C-3: Annual Reports. New – (Harmonized submission requirements)
Page 98 Appendix M-I-C-4: Safety Reporting. New appendix – (Harmonized reporting requirements)
Page 99 Appendix M-I-C-5: Confidentiality. New appendix
Page 99 Appendix M-I-D: Safety Assessment. New appendix
Page 106 Appendix M-IV: Privacy; deleted “…and Confidentiality” from heading; clarification of protection measures.
Effective June 24, 1994, Published in Federal Register, July 5, 1994 (59 FR 34496)
Amendment Effective July 28, 1994, Federal Register, August 5, 1994 (59 FR 40170)
Amendment Effective April 17, 1995, Federal Register, April 27, 1995 (60 FR 20726)
Amendment Effective December 14, 1995, Federal Register, January 19, 1996 (61 FR 1482)
Amendment Effective March 1, 1996, Federal Register, March 12, 1996 (61 FR 10004)
Amendment Effective January 23, 1997, Federal Register, January 31, 1997 (62 FR 4782)
Amendment Effective September 30, 1997, Federal Register, October 14, 1997 (62 FR 53335)
Amendment Effective October 20, 1997, Federal Register, October 29, 1997 (62 FR 56196)
Amendment Effective October 22, 1997, Federal Register, October 31, 1997 (62 FR 59032)
Amendment Effective February 4, 1998, Federal Register, February 17, 1998 (63 FR 8052)
Amendment Effective April 30, 1998, Federal Register, May 11, 1998 (63 FR 26018)
Amendment Effective April 29, 1999, Federal Register, May 11, 1999 (64 FR 25361)
Amendment Effective October 2, 2000, Federal Register, October 10, 2000 (65 FR 60328)
Amendment Effective December 28, 2000 Federal Register, January 5, 2001 (66 FR 1146)
Amendment Effective December 11, 2001 Federal Register, December 11, 2001 (66 FR 64051)
Amendment Effective December 19, 2001 Federal Register, November 19, 2001 (66 FR 57970)
Amendment Effective January 10, 2002 Federal Register, December 11, 2001 (66 FR 64052)
Amendment Effective January 24, 2002 Federal Register, November 19, 2001 (66 FR 57970)
NIH GUIDELINES FOR RESEARCH
INVOLVING RECOMBINANT
DNA MOLECULES
(NIH GUIDELINES)
April 2002
Visit the OBA Web site at:
http://www4.od.nih.gov/oba
For current information on Guidelines, Protocols, Principal Investigators, Meetings,
and information about upcoming Gene Therapy Policy Conferences
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
These NIH Guidelines supersede all earlier versions and shall be in effect until further notice.
TABLE OF CONTENTS
SECTION I. SCOPE OF THE NIH GUIDELINES
Section I-A. Purpose
Section I-B. Definition of Recombinant DNA Molecules
Section I-C. General Applicability
Section I-D. Compliance with the NIH Guidelines
Section I-E. General Definitions
SECTION II. SAFETY CONSIDERATIONS
Section II-A. Risk Assessment
Section II-A-1. Risk Groups
Section II-A-2. Criteria for Risk Groups
Section II-A-3. Comprehensive Risk Assessment
Section II-B. Containment
SECTION III. EXPERIMENTS COVERED BY THE NIH GUIDELINES
Section III-A. Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and NIH Director Approval Before Initiation
Section III-A-1. Major Actions under the NIH Guidelines
Section III-B. Experiments That Require NIH/OBA and IBC Approval Before Initiation
Section III-B-1. Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram Body Weight
Section III-C. Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before Research Participant Enrollment
Section III-C-1. Experiments Involving the Deliberate Transfer of Recombinant DNA, or DNA or RNA Derived from Recombinant DNA, into One or More Human Research Participants
Section III-D. Experiments that Require IBC Approval Before Initiation
Section III-D-1. Experiments Using Risk Group (RG) 2, RG 3, RG 4, or Restricted Agents as Host-Vector Systems
Section III-D-2. Experiments in Which DNA From RG 2, RG 3, RG 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
Section III-D-3. Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
Section III-D-4. Experiments Involving Whole Animals
Section III-D-5. Experiments Involving Whole Plants
Section III-D-6. Experiments Involving More than 10 Liters of Culture
Section III-E. Experiments that Require IBC Notice Simultaneous with Initiation
Section III-E-1. Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus
Section III-E-2. Experiments Involving Whole Plants
Section III-E-3. Experiments Involving Transgenic Rodents
Section III-F. Exempt Experiments
SECTION IV. ROLES AND RESPONSIBILITIES
Section IV-A. Policy
Section IV-B. Responsibilities of the Institution
Section IV-B-1. General Information
Section IV-B-2. Institutional Biosafety Committee (IBC)
Section IV-B-2-a. Membership and Procedures
Section IV-B-2-b. Functions
Section IV-B-3. Biological Safety Officer (BSO)
Section IV-B-4. Plant, Plant Pathogen, or Plant Pest Containment Expert
Section IV-B-5. Animal Containment Expert
Section IV-B-6. Human Gene Therapy Expertise
Section IV-B-7. Principal Investigator (PI)
Section IV-B-7-a. General Responsibilities
Section IV-B-7-b. Information to Be Submitted by the PI to NIH OBA
Section IV-B-7-c. Submissions by the PI to the IBC
Section IV-B-7-d. Responsibilities of the PI Prior to Initiating Research
Section IV-B-7-e. Responsibilities of the PI During the Conduct of the Research
Section IV-C. Responsibilities of the National Institutes of Health (NIH)
Section IV-C-1. NIH Director
Section IV-C-1-a. General Responsibilities
Section IV-C-1-b. Specific Responsibilities
Section IV-C-1-b-(1). Major Actions
Section IV-C-1-b-(2). Minor Actions
Section IV-C-2. Recombinant DNA Advisory Committee (RAC)
Section IV-C-3. Office of Biotechnology Activities (OBA)
Section IV-C-4. Other NIH Components
Section IV-D. Voluntary Compliance
Section IV-D-1. Basic Policy - Voluntary Compliance
Section IV-D-2. Institutional Biosafety Committee Approval - Voluntary Compliance
Section IV-D-3. Certification of Host-Vector Systems - Voluntary Compliance
Section IV-D-4. Requests for Exemptions and Approvals - Voluntary Compliance
Section IV-D-5. Protection of Proprietary Data - Voluntary Compliance
Section IV-D-5-a. General
Section IV-D-5-b. Pre-submission Review
SECTION V. FOOTNOTES AND REFERENCES OF SECTIONS I THROUGH IV
APPENDIX A. EXEMPTIONS UNDER SECTION III-F-5--SUBLISTS OF NATURAL EXCHANGERS
Appendix A-I. Sublist A
Appendix A-II. Sublist B
Appendix A-III. Sublist C
Appendix A-IV. Sublist D
Appendix A-V. Sublist E
Appendix A-VI.
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