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1 Responsibilities of the Institution. Health 
2 Monitoring. Institutions are only required to determine 
3 the necessity of doing health monitoring, not to actually 
4 do it. There is nothing in the guidelines that requires 
5 medical monitoring, data collection, maintenance of 
6 records, or, for that matter, good experiments designed 
7 to determine if anything is happening with recombinant 
g DNA organisms inside human bodies. 
9 Very little study has been done on the epidem- 
10 iology of recombinants in humans, and although we have 
11 heard repeatedly that no one has been injured in this 
12 kind of research, they are still saying that about 
13 commercial nuclear reactors. 
14 It is important to note that the most dangerous 
15 kinds of experiments have not been done. Almost all the 
16 work has been executed with safer recombinants. 
17 Recommendations. Make mandatory requirements 
10 for data collection and record keeping in a unified manner, 
19 obviously allowing for easier accumulation and analysis. 
20 Carry out an assessment in a year or two to 
21 see if the centralized collection of this data is required. 
22 Institutional Biohazard Committees. The NIH 
23 has delegated considerable authority to the IBC's to allow 
24 research to proceed prior to NIH approval on changes in 
25 PI through P 3 protocols. This policy will lead to confusion 
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