header1

Guidelines for the Preparation of Informed Consent Forms

Guidelines for the Preparation of Informed Consent Forms

The Department of Health and Human Services requires all researchers conducting human subjects research to provide prospective subjects with informed consent. The rationale for informed consent is spelled out in the Belmont Report, while the current federal requirements governing informed consent are given in the Code of Federal Regulations, Chapter 45, Section 46.116. These federal requirements apply to all human subject research projects whether or not they are federally funded.

In most cases, federal regulations require written informed consent. The consent form should be written in clear, everyday language that prospective volunteers can easily understand. Ordinary language should replace technical terms. The Code of Federal Regulations furthermore explicitly states that the consent form may not employ "any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence" (45 CFR 46.116).