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SELF-SURVEILLANCE AND REPORTING

Each investigator and each department head in signing the committee decision report affirm their respective pledges: the investigator (1) to follow faithfully the protocol spelled out in his application (with amendments, if any are recommended by the committee), (2) to report promptly any departure from protocol or untoward occurrences to his department head, and (3) to modify or terminate his investigation at the decision of the department head or committee; the department head, (1) to share in the responsibility for the conduct of the investigation, (2) to consult with the review committee regarding any significant departure from protocol or the occurrence of any untoward developments, specifically, permanent disability or death, and (3) to respond to the annual request for reports of work in progress, correcting any deficiencies of supervision as they become obvious. The committee reserves the right to terminate the experiment at any time if by majority vote it decides that the risks of further experimentation are prohibitive. In the event of such an occurrence, the Director of the Office of Sponsored Programs will so notify the sponsoring agency.