Informed Consent
Process
Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties, both the subject, whose autonomy is respected, and the investigator, who otherwise faces legal hazards.
One of the most common mistakes made by researchers is a failure to write a clear understandable consent form.
The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference. (OHRP Policy and Guidance)
Documentation
Informed consent must 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. A copy shall be given to the person signing the form.
Required information
The regulations require that the following information must be conveyed to each subject: 45 FR 46.116(a)
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;
1. a description of any reasonably foreseeable risks or discomforts to the subject;
2. a description of any benefits to the subject or to others which may reasonably be expected from the research;
3. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
4. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
5. 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;
6. 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 7. 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 are described at 45 CFR 46.116(b)
All of the following information pertaining to children and research comes directly from OHRP Policy and Guidance. http://answers.hhs.gov/ohrp/categories/1570
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