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.