Basic Elements of Informed Consent
In seeking informed consent the following information shall be provided to each subject
or the legally authorized representative:
(1) 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 that are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be
expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any,
that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained;
(6) 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) 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) A statement that participation is voluntary, refusal to participate will involve
no penalty or loss of benefits to which the subject is otherwise entitled, and the
subject may discontinue participation at any time without penalty or loss of benefits
to which the subject is otherwise entitled; and
(9) One of the following statements about any research that involves the collection of
identifiable private information or identifiable biospecimens:
(i) A statement that identifiers might be removed from the identifiable private information
or identifiable biospecimens and that, after such removal, the information or biospecimens
could be used for future research studies or distributed to another investigator for
future research studies without additional informed consent from the subject or the
legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject's information or biospecimens collected as part of the
research, even if identifiers are removed, will not be used or distributed for future
research studies.
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