Informed Consent

Elements of Informed Consent:

(1) Purpose of Research:

A statement that the study involves research

An explanation of the purposes of the research

Expected duration of the subject's participation

A description of the procedures to be followed

Probability of random assignment to each treatment

Identification of any procedures that are experimental

(2) Risks and Discomforts:

A description of any reasonably foreseeable risks or

discomforts to the subject

(3) Benefits:

A description of any benefits to the subject or to others,

which may reasonably be expected from the research

(4) Alternatives:

A disclosure of appropriate alternative procedures or

courses of treatment, if any, that might be advantageous

to the subject

(5) Confidentiality:

A statement describing the extent, if any, to which

confidentiality of records identifying the subject will be

maintained and, if relevant, that other agencies might

inspect the records

(6) Compensation for Injury:

For research involving more than minimal risk, an explanation

as to whether any compensation and an explanation as to

whether any medical treatments are available if injury occurs

and, if so, what they consist of, or where further information

may be obtained

(7) Research Questions:

An explanation of whom to contact for answers to pertinent

questions about the research and research subjects' rights,

and whom to contact in the event of a research-related injury

to the subject

(8) Voluntary Participation:

A statement that participation is voluntary, 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

Additional Elements of Informed Consent (When Appropriate):

(1) 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.

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

(3) Any additional costs to the subject that may result from participation in the research.

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

(5) 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.

(6) The approximate number of subjects involved in the study.