assignment # 3

The basic elements of an informed consent are those required information that must be provided to the subject:

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 products which 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 which 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 and that notes the possibility that external regulatory agencies, such as the Food and Drug Administration, may inspect the records.
6) For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7) 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 the informed consent should also be provided 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.

ref: http://www.rgs.uci.edu/ora/rp/hrpp/requiredelements.htm