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    NIH Guidelines

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    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. (来源: 来宝网 )



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