What Is Informed Consent?
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. It is a fundamental mechanism to ensure respect for persons through provisions of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that it 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 subject's future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.
The process of obtaining and documenting informed consent must comply with the requirements of 45 CFR 46.116 and 45.CFR 45.117.
Types of Consent Forms
Short Form Consent and Oral Presentation: The oral presentation must be accompanied by a short consent form unless this requirement is waived. The short consent form and oral presentation are appropriate when procedures are simple or the research involves minimal risk. Minimal risk is ultimately determined by the HSPRC, but generally means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The oral presentation, used with a short consent form, must cover the same elements of informed consent as those required in the long form. If an oral presentation is planned, include the content of the presentation in your application. The oral presentation must be witnessed each time it is read to a group of subjects. The date and signature of the auditor witness and of the person explaining the study is needed on the oral presentation form. The auditor witness shall sign both the short consent form and the oral presentation form. Provide subjects with a copy of the oral presentation and a copy of the short consent form.
Long Form Consent: The long consent form is required when studies have a longitudinal perspective and require the subjects' ongoing participation or if the research procedures are complex and difficult to understand or involve more than minimal risk. Consecutively number the pages in the lower left corner. Denote total number of pages (e.g., page 1 of 6). Provide a space in the lower right corner for the subject to initial each page. Provide a copy to the subject or the subject’s legally authorized representative.
Sample Consent Long Form
Waiver of Consent Forms: At the request of the investigator, the IRB may waive the requirement to obtain a signed consent form for some or all subjects if it finds either:
- That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required when performed outside of the research context.
In cases in which the consent form requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
For more information, see Tips on Informed Consent