Components of Informed Consent 

The consent form must include: 

A statement that the study involves research, a readily understood explanation of the purpose(s) of the research and the expected duration of the subject’s participation, a simple description of the procedures to be followed, identification of any procedures which are experimental, and if deception will be involved. If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the conclusion of the subject’s participation an explanation will be provided. 

A description of any reasonably foreseeable risks or discomforts to the subject. These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience. 

A description of any benefits to the subject or to others which may reasonably be expected from the research (if no direct benefit, this should be stated). 

A statement concerning costs or compensation to the subject, if any. 

An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject. Phone numbers should be provided. 

Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained. 

A statement that participation is voluntary, that refusal to participate will involve no penalty of 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.

June, 1998