Additional elements in ICD

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Additional elements, which may be required in an ICD

a. Statement of foreseeable circumstances under which the Subject’s participation may be terminated by the investigator without the Subject’s consent.

b. Additional costs to the Subject that may result from participation in the study.

c. The consequences of a Subject’s decision to withdraw from the research and procedures for orderly termination of participation by Subject.

d. Statement that the Subject or Subject’s representative will be notified in a timely manner if significant new findings develop during the course of the research which may affect the Subject’s willingness to continue participation will be provided.

e. A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or fetus, if the Subject is or may become pregnant), which are currently unforeseeable

f. Approximate number of Subjects enrolled in the study

(Source: Schedule Y of Drugs and cosmetics (II Amendment) rules, 2005 Ministry of Health and Family welfare (Department of health) Govt. of India)