Informed Consent Guidance and template

Basic elements of Informed Consent Form (ICF)

The following points are the basic elements of the ICF and must be present in any ICF:

·           A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

·           A description of any reasonably foreseeable risks or discomforts to the subject.

·           A description of any benefits to the subject or to others which may reasonably be expected from the research.

·           A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

·           A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the regulatory bodies for which the study is submitted may inspect the records.

·           For research involving more than minimal risk, an explanation as to whether any compensation and whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

·           An explanation of whom to contact for answers to any related questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

·           A statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled has been specified by the Informed Consent Form.

·           Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

-A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable.

- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

- Any additional costs to the subject that may result from participation in the research.

- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

- The approximate number of subject involved in the study.

- Others as requested by the local regulatory authorities, and as proposed by the IRB committee.