Informed consent is the culmination of a process wherein the researcher explains the research activity and the implications of participation. The informed consent document should be written in language that is understood by the subject. Of primary concern is that the subject fully understands the nature of the research and how his/her rights will be protected. A significant component of individual rights is the protection of the subject’s privacy. The federal government and UNC Pembroke require these minimum components in any informed consent document. This is a very important part of the IRB process at UNC Pembroke.

REQUIRED ELEMENTS OF CONSENT (21 CFR 50. 25)

• 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 of the procedures to be followed, and identification of any procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the subject or to others, which may reasonably be expected from the research.
• A disclosure of appropriate alternative procedures or courses of treatment, if any that might be advantageous to the subject.
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatment are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights and whom to contact in the event of a research-related injury to the subject.
• A statement that the subject can contact the IRB chair if answers to pertinent questions or concerns about injury remain unanswered.
• A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Click here for a Sample Informed Consent