ATTACHMENT 3 MEMORANDUM Use of Human Volunteers in Medical Research, Principles, Policies and Rules of the Office of The Surgeon General (To be used as far as applicable as a non-mandatory guide for (ILLEGIBLE) and conducting contract research). 1. The voluntary consent of the human subject is essential, means that the person concerned: a. Should have legal capacity to give consent. b. Should be so situated as to be able to exercise the power of choice, without intervention of force, of deceit, duress, over-reaching, or other form of constraint or coercion. c. Should have sufficient knowledge and understanding of the experiment to enable him to make an enligtened decision, on the basis of explanation given to him as specified below. d. Should state his consent in writing, signed in the presence of at least one witness who shall attest to such signature in writing. 2. Each invididual who initiates, directs or engages in experiment has a personal duty and responsibility for ascertaining the quality of the volunteer's consent. 3. Before the acceptance of consent of the volunteer, he be given adequate explanation. He should be informed of the (ILLEGIBLE) duration, and purpose of the experiment; the method and means it is to be conducted; all inconveniences and hazards reasonably expected and the effects upon his health or person which may come from his participation in the experiment. 4. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other means of study, random and unnecessary in nature. 5. The number of volunteers used must be kept at a minimum consistent with the requirement of a fruitful experiment for the society. 6. In order that the anticipated results will justify the experiment, it (the experiment) should be designed and based on results of animal experimentation and a knowledge of the nature of the disease or other problem under study. 1 7. The experiment should be so conducted as to avoid all necessary physical and mental suffering and injury. 8. No experiment should be conducted where there is a reason to believe that dealth or disability injury will occur. 9. The degree of risk to the volunteer should never (ILLEGIBLE) determined by the humanitarian importance of the problem to (ILLEGIBLE) by the experiment. 10. The experiment should be conducted only by scientifically qualified persons (including an adequately trained physician) who shall be required to exercise the highest degree of skill and (ILLEGIBLE) throughout the experiment. Competent consultants should be (ILLEGIBLE) able on short notice in this connection. 11. Adequate preparations should be made and adequate (ILLEGIBLE) provided to protect the experimental subject against (ILLEGIBLE) note possibility of injury, disability of death. This include hospitalization and medical treatment as may be required. 12. The human volunteer subject should be at liberty to bring the experiment to an end if he feels that it is impossible to continue under the test. 13. The scientist or physician in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and (ILLEGIBLE) judgement required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experiment subject. 14. Established policy prohibits the use of prisioners (ILLEGIBLE) in human experimentation. They will not be used under any circumstances. 15. Agents used in research must have the following (ILLEGIBLE) characteristics: a. Controllable lothality b. No serious chronicity anticipated c. Effective therapy available d. Adequate background of animal experimentation.