Informed consent must be obtained from research subjects depending on the level of HSR review determined by the chair of the HSRC and must address the basic elements listed below. If required, the informed consent form must be signed by each subject or the subject’s legally authorized representative before participation in the research. If the subject is under the age of 18, the consent form must also be signed by a parent or legal guardian. A copy of the written consent shall be provided to the person signing the form.
(In most cases of Exempt level reviews, no informed consent form will be required, but this will be determined based on the review of individual proposals.)
The Basic Elements of Informed Consent
- 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 which are experimental
- A description of any foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any medical treatments or counseling are available if injury or distress occurs and, if so, what they consist of, or where further information may be obtained
- An explanation of who to contact for answers to pertinent questions about the research and research subjects’ rights, and who to contact in the event of a research-related injury to the subject
- 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
In addition, where appropriate, one or more of the following elements shall be provided to the subject:
- 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
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
- Any additional costs to the subject that may result from participation in the research
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
- 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
- The approximate number of subjects involved in the study