No statutory authority. Applicable, revised regulations were issued by the National Institutes of Health on May 7, 1986 (51 FR 16958).
The original guidelines for research involving recombinant DNA molecules were published December 11, 1978 (43 FR 60108) and revised as cited above. The purpose is to specify practices for constructing and handling recombinant DNA molecules and organisms and viruses containing recombinant DNA molecules.
The Guidelines are applicable to all recombinant DNA research within the United States or its territories which is conducted at or sponsored by an institution that receives any support for recombinant DNA research from the National Institutes of Health. The regulations are specifically applicable to research funded by agencies (public or private) external to the NIH if the institution receives NIH funds for related research. NSF, for example, has incorporated the NIH Guidelines in their regulations. There is a flow-down requirement to subrecipients.
Institutions are responsible for insuring that recombinant DNA activities comply with the Guidelines. To do this, institutions must:
a) establish and implement policies that provide for the safe conduct of recombinant DNA research that comply with the NIH guidelines;
b) establish an institutional biosafety committee (IBC) that:
i) has at least five members selected because they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA activities; at least two members shall not be affiliated with the institution
ii) reviews and approves all recombinant DNA research not in the exempt category
iii) keeps minutes of activities and makes them available to the public upon request; and
c) report to NIH on the identity of committee members, including a statement of their relative
background to allow assessment of their capabilities to review recombinant DNA research.
Recombinant DNA requirements require approval in advance of initiation of the experiment. In some instances, approval must be secured from the institutional biosafety committee (IBC), and, in others, from the IBC and the Recombinant DNA Advisory Committee of NIH (RAC). Notification to either body must include:
a) the source(s) of DNA;
b) the nature of the inserted DNA sequences;
c) the hosts and vectors to be used;
d) a statement of whether a deliberate attempt will be made to obtain expression of a foreign gene;
e) containment conditions specified in the Guidelines themselves.
Four categories of experiments are exempt from the review and approval requirements:
a) those that are not in organisms or viruses;
b) those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source;
c) those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well established physiological means; and
d) certain specified recombinant DNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes.
Sanctions for Non-Compliance
Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for recombinant DNA projects and of NIH funds for other recombinant DNA projects at the institution; or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.
Minimum Compliance Action
Establish a five-person committee charged with the requirements to review all research involving the use of recombinant DNA molecules.