Elements of Consent

The consent form, in most behavioral research, should serve as "a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research"(45CFR46§ ll.116(a)5(i). The required elements include:

• 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, in language understandable by a layperson, of what the subjects will do as participants in the study (e.g., reports of personal information or experiences, complete of self-assessments, making judgments, solving memory problems, reporting their opinions), including identification of any procedures that are novel or untested
• Contact information for the investigator(s)
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject that may reasonably be expected from the research
• A description of the use of information and data collected
• A description of how confidentiality of records identifying the subject will be maintained; participants should be told if identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies
• 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
• 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.
• A means to indicate understanding and acceptance of the conditions of consent

In some cases, additional elements of consent are required, such the consequences of a subject’s decision to withdraw from the research, procedures for orderly termination of participation by the subject or investigator, and any additional costs to the subject that may result from participant. Consent cannot, however, include exculpatory language asking the participant to waive any of his or her rights or statements of release of the researcher from liability.

The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). OHRP also has a tips sheet for informed consent available at http://www.hhs.gov/ohrp/policy/ictips.html.