What is informed consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when you learn the facts about the research study.
You can request the research staff assist you with the "informed consent form" that goes over these facts so you can decide whether you want to take part in the research study. These facts include details about the research study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.
Informed Consent Elements
The regulations require that the following information must be conveyed to each subject:
- 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 reasonably 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 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;
- 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; and
- 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.
The consent form may also describe additional information, such as:
- 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; and
- the approximate number of subjects involved in the study.
- You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction.
- You should never feel rushed or pressured to make a decision.
- Being part of a research study is completely voluntary. You are free to decline to participate for any reason.
- You may also stop participating at any time or refuse to answer any individual questions.
- Signing a consent form does not waive any of your legal rights or alter your ability to stop participating at a later time.
- Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled.
- In some studies, it will be impossible to withdraw data already collected about you. The consent form will state if your data can or cannot be removed.
Do you have a question, concern or complaint about your involvement in a research study or your rights as a research participant? Contact the IRB Administrator:
- Email: ORSIRB@orau.org
- Phone: 865-574-4359