IRB Consent Process

A major component of any proposal is the method by which the researchers will obtain voluntary and informed consent from subjects. Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand.

  1. In seeking informed consent the following information should be provided to the subject:
    1. A statement that the study involves research, an explanation of the purposes of the research and who will be conducting the research, 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 (again, these may be emotional or psychological or social or financial in addition to physical risks);
    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 description of how the 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 (usually the investigators), research subjects' rights (usually the IRB Administrator), and whom to contact in the event of a research-related injury to the subject (usually the IRB Administrator);
    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.
  2. When appropriate, one or more of the following elements should also be provided to each subject:
    1. A statement that a particular treatment or procedure may involve risks to the subject (or 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.

Copies of signed consent forms must be retained for three years after completion of the research and must be available for IRB review if necessary.

IRB Cooperative Research Verification
The revised Common Rule [45 CFR 46.115(b)] allows for U.S. institutions engaged in cooperative research to rely upon approval from a single IRB. Each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with policy. One institution will be responsible for submission to appropriate IRB and maintenance of IRB records for the cooperative research. If you are engaged in a cooperative research project that has obtained IRB permission from another institution’s IRB, you are required to submit the IRB Cooperative Research Verification form in addition to the cover sheet only to the MSUM IRB via IRBNet.

Developing consent forms and consent
Assent
Consent special circumstances
Audiotaping, videotaping and photographing subjects
Research using electronic methods