Attachment II - Page 2 
PROPOSED TEXT 
I . Issues Covered by the Department of Elealth and Human Services (DHHS) 
Regulations for Research Involving Human Subjects 
The points in this section are specific applications of the general DHHS 
guidelines for approval of research by Institutional Review Boards (IRBs) 
and for informed consent (45 CFR §46.111 and 46.116). The general guidelines 
are quoted in each subsections. 
A. Research Design, Risks and Benefits 
The pertinent section of the DHHS regulations reads as follows: 
"In order to approve research covered by these regulations the IRB 
shall determine that all of the following requirements are satisfied: 
"(1) Risks to subjects are minimized: 
"(i) By using procedures vhich are consistent with sound research 
design and which do not unnecessarily expose subjects to 
risk, and 
"(ii) vvhenever appropriate, by using procedures already being 
performed on the subjects for diagnostic or treatment 
purposes. 
"(2) Risks to subjects are reasonable in relation to anticipated 
benefits, if any, to subjects, and the importance of the knowl- 
edge that may reasonably be expected to result. In evaluating 
[ 110 ] 
