Informed Consent Checklist

Institutional Review Board

Requiredelements of consent

The consent form must be written in language that is appropriate for, and understandable by, the subject population - for standard subject populations, language should be no higher than the 8th grade level
A statement that the study involves research

The purpose of the research

The expected duration of participation
A description of the research procedures
A description of all the reasonably foreseeable risks and discomforts
A description of all the reasonably expected benefits, either to the subject, or to society if the subject will not directly benefit. If the subject will not directly benefit from the study, a statement must be made to that effect
Specific and precise information on confidentiality measures, and how the subjects’ identities will be protected
A contact number for questions about the research (investigator’s telephone number, including area code)
A contact number if subjects feel their rights have been violated (telephone number of the IRB [919.515.4514] or [919-515-7515]
The consent form may not include any exculpatory language through which the subject is made to waive, or appear to waive, any of his/her legal rights, or which releases the investigator or institution from liability.
It must contain a statement that participation is voluntary, refusal to participate involves no penalty or loss of benefits to which the subject is entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits
Elements to be contained in consentif appropriate
Consequences of a subject’s decision to withdraw early from a study
Any additional costs to the subject from the research study
Anticipated circumstances under which the subject’s involvement in the study may be ended by the investigator without the subject’s consent
Under a separate heading called “Compensation,” it must list the compensatory provisions of the study
The total number of subjects expected to be enrolled in the study
Mostly medically related elements, but sometimes applicable to social research as well
A statement that significant new findings that may affect a subject’s willingness to continue participation will be provided to the subject
A statement that some procedures of the study may result in risks that are currently unforeseeable
Alternative treatments that are available to the subject outside of the research
A description of procedures for handling payment for a study-related injury (If the possibility of injury from the study exists, an emergency, 24-hour contact number must be included as well)