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)
April 2002
Visit the OBA Web site at:
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-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