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://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

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://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm  
In addition, a sample format for reporting these events can be found 
at:  http://oba.od.nih.gov/oba/rac/Adverse_Event_Template.pdf
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://oba.od.nih.gov/rdna_ibc/ibc.html

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: [email protected]

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 [email protected]

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