M.J. Welsh and A.E. Smith, RAC Application 
B. Results of local IRB and IBC deliberations and recommen dations that pertain to vour 
protocol. 
Appendix 3 
C. A one-paee scientific abstract of the protocol. 
Appendix 4 
D. A one-page description of the proposed experiment in nontechnical language . 
Appendix 5 
E. Curricula vitae for key professional personnel . 
Appendix 6 
F. An indication of other federal agencies to which the protocol is being submitted for 
review. 
The protocol will be submitted to the Food and Drug Administration. 
G. Any other material which vou believe will aid in the review. 
IV. REPORTING REQUIREMENTS 
A. S erious adverse effects of treatment should be reported immediately to both the local 
IRB and the NIH Office for Protection from Research Risks and a written report 
should be filed with both groups. A copy of the report should also be forwarded to the 
NIH Office of Recombinant DNA Activities (ORDA). 
We will conform to these requirements. 
B. Reports regarding the general progress of patients should be filed with both your local 
IRB and ORDA within six months of the commencement of the experiment and at six- 
month intervals thereafter. These twice-vearlv reports should continue for a 
sufficient period of time to allow observation of all major effects. In the event of a 
patient's death, a summary of the special post mortem studies and statement of the 
cause of death should be submitted to the IRB and ORDA. if available. 
We will conform to these requirements. 
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Recombinant DNA Research, Volume 16 
