Compliance with The NIH Guidelines for Research Involving Recombinant
DNA Molecules
Notice Number:NOT-OD-04-067
Key Dates Release Date: September 14, 2004
Issued by National Institutes of Heath (NIH), (http://www.nih.gov)
Office of Biotechnology Activities (OBA), (http://oba.od.nih.gov/oba/index.html)
The NIH Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines) stipulate biosafety and containment measures for
recombinant DNA research. Furthermore, they outline essential ethical
principles and key safety reporting requirements for human gene
transfer research.
Investigators and institutions are reminded that they must adhere to
the NIH Guidelines when they perform research involving recombinant DNA
molecules 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. A fully indexed and easily navigated version of
the NIH Guidelines can be accessed at:
http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
Institutional Biosafety Committees - Institutions subject to the NIH
Guidelines must establish an Institutional Biosafety Committee (IBC)
for the review of recombinant DNA research. Each institution must
register the IBC with the NIH Office of Biotechnology Activities (OBA).
Furthermore, membership updates must be filed annually with OBA.
Unless exempted from the NIH Guidelines, experiments involving
recombinant DNA must at a minimum be registered with the IBC, and
certain types of experiments require IBC review and approval prior to
initiation (including, but not limited to, all human gene transfer
studies). More information on the NIH Guidelines and IBCs, including
the registration and annual reporting requirements, can
be found at: http://oba.od.nih.gov/rdna_ibc/ibc.html
Requirements for human gene transfer trials - Investigators conducting
human gene transfer research at, or sponsored by, an institution that
receives NIH support for recombinant DNA research must comply with
Appendix M of the NIH Guidelines. Appendix M outlines points to
consider in the design and submission of these protocols to OBA. Under
Appendix M, investigators conducting trials subject to the NIH
Guidelines must register their protocols with OBA and provide certain
information about the trials for review by the NIH and, possibly, the
NIH Recombinant DNA Advisory Committee. Once a trial is initiated,
further information must be submitted to NIH, including reports of
serious adverse events (SAEs). Investigators must report in an
expedited manner those SAEs 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. More information about Appendix M requirements can be
found in Frequently Asked Questions at:
http://oba.od.nih.gov/rdna/rdna_faq_list.html
Investigators are encouraged to report adverse events using the NIH
Genetic Modification Clinical Research Information System (GeMCRIS).
This system provides an online reporting format enabling the creation
of reports that can be submitted electronically to the NIH and that can
be conveyed to the FDA and the institutional oversight committees that
may need to review them (see below). More about using GeMCRIS for on-
line reporting can be found at:
http://oba.od.nih.gov/rdna/adverse_event_oba.html
Investigators and administrators are encouraged to contact OBA with any
questions they may have concerning 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
