Dr. Donald S. Fredrickson 
12 January, 1978 
Page 2 
While there were many other valid recommendations made to you con- 
cerning the proposed revisions, they are present in the record of the 
meeting and I shall not restate them in this letter. There are, however, 
some specific points I would like to make regarding the section on Roles 
and Responsibilities in the Proposed Revised Guidelines; some of these 
I included in my statement to you during the meeting and others have come 
to mind since that time. 
In the section describing the roles and responsibilities of the 
principal investigator (Section IV A. (v) ) , I feel the Guidelines should 
be more specific in delineating exactly what the investigator must do to 
secure approval for his proposed research. If he must submit his draft 
of a Memorandum of Understanding and Agreement to the NIH Office of 
Recombinant DNA Activities, the Guidelines should include a statement to 
this effect and go further to define what information comprises an 
acceptable MUA (perhaps the latter statement could be included as either 
a footnote or an appendix) . 
Also, the Guidelines should inform the investigator of the vehicle 
by which the ORDA will either affirm or deny his request; will a tele- 
phone conversation be sufficient or must he await a formal letter or a 
revised notice of his grant award or continuance before initiating any 
recombinant DNA experiments? While these may seem to be rather picky 
recommendations, misunderstandings have occurred regarding this matter 
and I believe specific procedures must be described in the Guidelines. 
Likewise, in regard to institutional roles and responsibilities 
(Section IV B.), the role of the institutional biohazards committee in 
authorizing an MUA before submitting it to the ORDA is not at all clear. 
Does the institutional biohazards committee have this responsibility 
and, if so, what specific procedures must be followed? The Guidelines 
should answer these questions. 
Footnote 9 of the Proposed Revised Guidelines raises the possibility 
of establishing an area biohazards committee. Is it conceivable that 
both an institutional committee and an area committee could be monitoring 
the activities of the same investigator, resulting in a potential con- 
flict of jurisdiction? Perhaps the intent of this footnote could be 
clarified. 
I hope that you will find these comments useful. I am impressed 
by the overall direction of change in the proposed revisions and am 
looking forward to further reduction of stringency in the Guidelines as 
may be warranted by accumulation of new risk assessment information. 
Sincerely 
Jon S. Beaty ^ 
Member, OSU Biohazards Committee 
cc: Dr. Waclaw Szybalski 
[Appendix A — 211] 
