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Compliance with the NIH Guidelines for
Research Involving Recombinant DNA Molecules
Release Date: May 28, 2002
Notice: NOT-OD-02-052
National Institutes of Heath
Office of Biotechnology Activities
http://www4.od.nih.gov/oba/
Investigators and institutions are reminded that they must adhere to
the NIH Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines) when they perform research that is conducted at or
sponsored by an entity receiving any NIH support for recombinant DNA
research. Therefore, even privately funded projects employing
recombinant DNA must adhere to the NIH Guidelines if they are being
carried out at, or funded by, an organization that has any NIH
contracts, grants, or other support for this kind of research.
Adherence to the NIH Guidelines is mandatory and important because they
stipulate biosafety and containment measures for recombinant DNA
research. Furthermore, they delineate critical ethical principles and
outline key safety reporting requirements for human gene transfer
research. A fully indexed, hyperlinked copy of the NIH Guidelines can
be viewed on line or downloaded at:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
Reporting safety information from human trials - Investigators
conducting human gene transfer research supported by an entity, or
conducted at facilities coming under the NIH Guidelines, must comply
with Appendix M of that document. Appendix M outlines points to
consider in the design and submission of these protocols to OBA.
Reporting serious adverse events and other safety information is a key
aspect of compliance with that Appendix. The scope and timing of
safety reports to the NIH were recently modified to be harmonized with
those of the FDA, and now the same information can be reported to both
agencies on the same schedule. Investigators conducting human gene
transfer research subject to the NIH Guidelines must report in an
expedited manner those serious adverse events that are unexpected and
possibly associated with the gene transfer product. These reports
should be sent to OBA within 15 calendar days of sponsor notification,
unless the event was life-threatening or fatal, in which case, it
should be reported within 7 calendar days. All other serious adverse
events should be reported on an annual basis. More information about
these requirements can be found at:
http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255842.
In addition, a sample format for reporting these events can be found
at: http://www4.od.nih.gov/oba/rac/AER_template.rtf.
Soon, these events will be reportable on-line.
Institutional Biosafety Committees - Institutions subject to the NIH
Guidelines must establish an Institutional Biosafety Committee (IBC)
for the review of recombinant DNA research. The institution must
register the IBC with the NIH Office of Biotechnology Activities (OBA).
Furthermore, membership updates must be filed annually with OBA.
Certain types of experiments, including all human gene transfer
studies, require prior IBC review and approval. More information on
IBCs, including the registration and annual reporting requirements,
can
be found at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm.
Investigators and administrators are encouraged to contact OBA with
any
questions they may have about these and other requirements. Questions
can be directed to:
Allan C. Shipp
Director of Outreach
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 750, MSC 7985
Bethesda, Maryland 20892
301-435-2152
Email: oba@od.nih.gov
Also, readers may wish to subscribe to OBA's listserv to stay apprised
of developments in this arena. Send the message "subscribe oba_news"
to listserv@list.nih.gov.
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