14 
o problems with the Guidelines; 
o what things are taking large amounts of time; 
o what things are taking inappropriate amounts of time; 
o in what areas do IBCs disagree with the RAC with 
regard to containment for a particular experiment; 
o in what ways are the Guidelines too stringent or too relaxed; 
o how frequently does the IBC meet; and 
o does the IBC have other responsibilities at the institution. 
She said approximately 250 questionnaires were mailed. ORDA received 45 
responses, a low response, but probably an indication of an absence of 
problems at the IBC level. Dr. Nightingale said few of the respondees 
feel overburdened. Most IBCs deal only with recombinant DNA issues. 
Those feeling they have a heavy workload (such as the Harvard University 
IBC) do not wish to assume any additional biosafety tasks. Other IBCs 
feel they could expand. 
Dr. Nightingale said the Schering Corporation IBC suggested that a system 
be implemented by RAC and/or ORDA to audit IBC functions to ensure that 
they are ope rating in accordance with the Guidelines. 
The IBC of the State University of New York at Albany requested that all 
experiments, including exempt experiments, be registered; the IBC argued 
that it is impossible otherwise to know if the decision by the principal 
investigator that his experiment was exempt was correct. 
Seme IBCs wrote it wold be helpful to have "a guide to the Guidelines" 
even though they felt the Guidelines were now easier to understand, easier 
to follow, and on the whole quite satisfactory. This guide might be a 
subject index, an investigator use packet, or an expanded table of contents 
Dr. Nightingale said some letters from IBC chairpersons suggested clarifica 
tions in the Guidelines. For example, Section III-C should be clarified to 
specify when registration documents are to be filed. While the title of 
Section III-C indicates that notice must be filed simultaneously with 
initiation of experiments, the text does not. Dr. Nightingale moved that 
the language of the first paragraph of Section III-C be amended to indicate 
when the registration document should be filed with the EBC. By a vote of 
twenty in favor, none opposed, and one abstention, the RAC recommended 
that the language of Section III-C be clarified at the next printing of 
the Guidelines. 
[ 99 ] 
