Informed Consent

Investigators are reminded that information given to the subject or the representative shall be in language understandable to the subject or the representative. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, as well as a witness. A copy shall be given to the person signing the form. The basic elements of a consent form include:

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 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;

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. Persons 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. The consent document should provide the name of a specific person and the telephone number to contact for answers to questions about: 1) the research subjects' rights; 2) a research related injury; and 3) the research study itself. It is as important for the subject to know why an individual should be contacted as it is for the subject to know whom to contact. The person(s) named for questions about research subjects' rights should NOT be the primary investigator (as this may tend to inhibit subjects from reporting concerns and discovering possible problems). If a student is conducting the research, please include the faculty member who is mentoring the research project as the contact person to answer questions #2 and #3 above. Please also include the IRB Chairperson to answer question #1 above.

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.

Additional Elements of Consent Form

When applicable, one or more of the following elements of information shall also be provided to each subject:

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; and

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