Statement of 
THE COMMITTEE ON LABORATORY-CREATED BIOHAZARDS 
We have considered the pending "Revised NIH Guidelines for Recombinant 
DNA Research" (DHEW Publication (NIH) 77-99., Summer 1977). We have every 
reason to believe that the Recombinant DNA Molecule Program Advisory 
Committee has functioned conscientiously and effectively and that the gen- 
eral thrust of the recommendations is appropriate. We will not attempt to 
either add to or subtract from the cogency. of their specific recommendations. 
We have, however, certain comments which we believe deserve consider- 
ation -with respect to the Guidelines as they have operated and will continue 
to operate after this revision cycle. We put these comments in the form of 
suggestions for the Advisory Committee and for the Director of the National 
Institutes of Health and his staff as they seek to implement and adjust the 
Guidelines to fit advancing knowledge. 
1. Time of Revision Action : We are concerned by the long delay 
between the time the revisions are. proposed t>y the Advisory Committee and 
the time they are approved by the Director of?the NIH. There have also 
been long delays in the certification of approved host-vector systems. 
While we are aware of the requirements for ample review and comment , we 
suggest that careful review of the process may eliminate unnecessary delays. 
Several other suggestions noted below may contribute to the improvement of 
this process, but we particularly urge that the process be reviewed as a 
whole for the purpose of reducing the time required for a revisory action 
(perhaps 90 days) . 
2. Institutional Biohazards Committees : A key to the success of the 
self-regulatcry concept of the Guidelines is the effective operation of the 
Institutional Biohazards Committees.. . We urge that a study of the operations 
of these committees be instituted as soon as possible. Particular attention 
should be given to the standards established by the committees for institu- 
tional approval of research, the composition of the committees, the breadth 
of jurisdiction of the committees within their respective institutions and 
their "clout" in administrative terms, and the costs and funding of the 
operation of the committees. Consideration should also be given to mechan- 
isms for sharing experiences among the several committees and to special 
grants to cover their expenses. Too often such costs must compete at. a 
disadvantage for restricted local administrative budgets. 
3. Continuing Reassessment and Revision : The consensus of our Committee 
is that a continuing reassessment and revision of the Guidelines could be 
expedited and made more comprehensive by the establishment of ad hoc panels 
of experts charged with periodic examination and review of specific scien- 
tific issues related to recombinant DNA research, as well as to problems 
of the administration and implementation of the Guidelines. The panels 
would report to the Advisory Committee for a second-level review prior to 
submission to the Director of the NIH. 
[Appendix A — 124] 
