Informed Consent

         No investigator may involve a human being as a subject in research supported by federal funds unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that give the prospective subject or his representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

        The information that is given to the subject or representative must be in language understandable to the subject or representative. No informed consent may include language by which the subject or representative waives any of the subject’s legal rights or releases the investigator, the sponsor, or the institution or its agents from liability for negligence.

 Information to be Provided to Subjects

In seeking informed consent, the investigator shall provide the following information.

• 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 that are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of the benefits to the subject or to others that may reasonably be expected from the research.
• A disclosure of appropriate alternative procedures of 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 or medical treatment is available if injury occurs, and where further information may be obtained.
• An explanation of whom to contact for answers to questions about the research and the subject’s rights, or 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.

When appropriate, one or more of the following elements of information shall also be provided to each subject or representative.

1. A statement that research could involve risks to the subject (or an embryo if the subject is pregnant) that are presently unforeseeable.
2. Anticipated circumstances under which the investigator may terminate a subject’s participation without regard to the subject’s consent.
3. Any additional cost 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, that may affect the subject’s willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved in the study.

        The IRB may waive some or all of the requirements for informed consent if the research could not practicably be carried out without the waiver, provided that (1) the research is designed to evaluate public benefit or service programs, procedures for obtaining benefits under those programs, possible changes in those programs, or possible changes in methods or levels of payment under those programs; or (2) the research involves minimal risk, the waiver will not adversely affect the rights of subjects, and the subjects will be provided with additional pertinent information after participation, as appropriate.

 Documentation of Informed Consent

        Informed consent shall be documented by the use of a written consent form approved by the institutional review board and signed by the subject or his representative. A copy of the form shall be given to the person signing it.

        The consent form may embody all the elements of informed consent required by the preceding section, or a short form may be used stating that the required information has been presented orally to the subject or his representative. When a short form is used there must be a witness to the oral presentation. In addition, a written summary of the information to be presented orally must have been approved by the institutional review board. The subject or his representative need sign only the information presented. The person actually obtaining consent shall also sign a copy of the summary. A copy of the summary of information and a copy of the short consent form shall be given to the subject or his representative. 

Click here for a sample consent form.

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