13 
Dr. Mascxi said that accountability and respcxisibility, in the ethical, 
moral, and legal sense, rest ultimately with the institution and the prin- 
cipal investigator. R^ulatory guidelines will not stop the person vAxj 
is dishonest or malicious or careless. He agreed with the observation 
that a "piecemeal" erosion of the Guidelines was occurring. He suggested 
that piecemeal erosion if it continues too Icwig without reexamination of 
the basic premises, can result in a loss of respect for the institution 
promulgating an eventually empty statement. He endorsed the Baltimore- 
Campbell proposal and moved that a RAC subcommittee be established with 
the specific mandate of evaluating that proposal and reporting back to 
the RAC on the implementation process. Dr. Bems seconded the moticxi. 
Dr. Qottesman preferred that the RAC subocmmittee not be tied to the 
Baltimore-Canpbell proposal per se but that it ccxisider many cptions in 
a reevaluation of the need for c^iaiges in procedures, penalties, and ccxi- 
tainment levels of the Guidelines. Dr. Novick agreed with Dr. Gottesman. 
He moved that a subcommittee be instituted to review the Guidelines with 
respect to both general ocxitainment levels and the proposal to convert the 
Guidelines to a voluntary code. Dr. Gottesman seconded the motion. 
Dr. Williams suggested Dr. Novick' s motion be amended to direct the subcom- 
mittee to examine the Baltimore-Campbell proposal during its deliberations. 
Dr. Harris, with Dr. Nightingale, offered the following substitute motion; 
"That RAC recommend to the Director, NIH, that a study group 
conprised of RAC members, and any others he so directs or 
appoints, be constituted to review the current regulations. 
Such review to include but not be limited to: (a) the present 
need for the Guidelines in their existing form and procedures, 
as opposed to a voluntary standard of practice, (b) tiie continued 
applicability of the present Guidelines to reccmbinant ENA 
technology, (c) the currently recommended levels of ccxitainment, 
(d) current processes and procedures impeding or facilitating 
research and/or industrial ^plication, and (e) mechanisms for 
soliciting public input. Such study group to report to the 
RAC and the Director, NIH, its finding, conclusions and recom- 
mendations for RAC review and reocmmendation." 
Dr. Nightingale said that the mechanisms for soliciting public cotrent 
were to include processes beyond publication in the Federal Register . 
Dr. Goldstein asked if Dr. Harris' proposal vould relieve RAC of responsi- 
bility for the reevaluation of the Guidelines. Dr. Harris replied that 
the initiative would remain with the RAC, but that the NIH Director might 
wish to expand the review group to include non-RAC members. Ilie working 
group would report to RAC, which would then offer recommendations to the 
Director. Dr. Goldstein suggested the language be amended to indicate 
clearly that the working group is a RAC subcommittee. Dr. Harris agreed 
and substituted the following sentence: 
[102] 
