The general requirements of a consent form relate to type of Stationery, and appropriate Identification, Style, Readability, Length, Format, and Exculpatory Language.
Additionally, federal regulation requires that the consent form contain specific elements. To increase consent form readability and clarity, the consent form should be written to include the appropriate elements of consent in the same sequences. All consent forms for non-Exempt research should include these elements: Title of the Research Study, Invitation to Participate, Basis for Subject Selection, Purpose of the Study, Explanation of Procedures, Potential Risks and Discomforts , Potential Benefits to the Subject, Potential Benefits to Society, Assurance of Confidentiality, Rights of Research Subjects, Voluntary Participation and Withdrawal, Documentation of Informed Consent, and Identification of Investigators.
Consent forms for Exempt research should include these elements as necessary. Some non-Exempt research may warrant additional elements to include Alternatives to Participation, Financial Obligations, Compensation for Participation, In Case of Emergency Contact Procedure, and Emergency Care and Compensation in Case of Injury.
If the research is classified as minimal risk or greater, each element should be identified by the listed subheading in bold type. Use of a subheading increases readability and helps the prospective subject focus attention on each element of consent. Subheadings, however, are not required for Exempt research or research classified as less than minimal risk because in general this research is less complex. It is acceptable if researchers use subheadings to increase the readability of the consent form.