APRIL 27-28-MIMJTES OF MEETING 
4 
Dr. Red ford asked whether adequate public notice has been given for the 
proposed revisions of the virus and plant sections of the Guidelines. 
Dr. Fredrickson noted that a report of the U.S. - EMBO meeting had been 
published in the Federal Register . Ihe proceedings of the Falmouth 
meeting will be published in the Journal of Infectious Diseases . In 
addition, the Minutes of this meeting will also be printed and made 
available to the public. Dr. Fredrickson indicated that in its review 
the RAC may recommend alterations of specific sections in the Guidelines. 
Dr. Fredrickson described other changes in the roles and responsibilities 
section of the Guidelines. The revised Guidelines would extend to all 
reccmb inant DNA research at institutions receiving NIH funds for recombinant 
DMA research. He indicated that more responsibility for compliance and 
monitoring would be delegated to the local level. All Chairmen of IBC's 
will be invited to attend an NIH-sponsored briefing at which these new 
responsibilities would be explained. The shift in the locus of responsibility 
would include the following conditions: an explicit single set of standards 
for the conduct of the research, necessary competence within the IBCs , a 
clear understanding that sanctions would be imposed for non-compliance, 
post-hoc review of all IBC actions by ORDA, and mandated public participation 
on the IBCs. Dr. Fredrickson also stated that there would be a compliance 
section with penalties for violation of the Guidelines that could extend to 
cessation of all grant support. 
Dr. Fredrickson then discussed the need to permit voluntary registration 
of non-NIH recombinant DNA projects, particularly in the absence of 
legislation. He asked the RAC to consider the question and decide upon 
their willingness to review industrial projects. He noted that they 
must keep in mind penalties for the unauthorized release of proprietary 
information. Dr. Kutter asked about IBC responsibilities in the event 
of non- compliance, particularly where there were repeated violations. 
Dr. Fredrickson replied that these situations will have to be considered 
on a case-by-case basis. Dr. Red ford asked how it would be possible to 
check on the activities of IBCs. Dr. Fredrickson indicated that there 
will be no NIH inspection force and that legislation, if passed, would 
give such responsibility to another agency. NIH will monitor membership 
of IBCs and aid in self- regulation. A related issue was raised by 
Dr. Susan Wright who expressed concern that the shift of approval authority 
to the IBC was a major change in the review procedure. She asked whether 
there would be a further public hearing on this proposal. Dr. Fredrickson 
replied that a public hearing was under consideration (note added after 
meeting: a public meeting under the auspices of the Secretary will be 
held September 15, 1978). In response to a question about interagency 
cooperation. Dr. Fredrickson replied that these changes only applied to 
NIH, but he hoped that other agencies would accept them as well. 
At the conclusion of the discussion Dr. Fredrickson noted that this 
would be Dr. Stetten's last meeting as Chairman of the RAC, and compli- 
mented him for his service in that capacity since the first meeting of 
the RAC in February 1975. 
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