Informed Consent Form Checklist
With few exceptions, all human subjects research typically requires informed consent. An Informed Consent form should be directly addressed to the potential research participants in accessible language. The following components should be included:
- Statements regarding the research study: an explanation of the purposes of the research, how the data will be used, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.
- Statement regarding risks: a description of any reasonably foreseeable risks or discomforts to the subject.
- For research involving more than minimal risk, an explanation of any compensation, and an explanation of any available medical treatment or counseling if harm or discomfort occurs, and where further information may be obtained.
- 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 research-related harm to the subjects.
- Statement regarding benefits: a description of any benefits to the subject or to others that may reasonably be expected from the research.
- If relevant, a statement regarding alternative treatments or activities: a disclosure of any appropriate alternative procedures, courses of treatment, or other activity that might be advantageous to the subject.
- Statement regarding confidentiality: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (How the data and the findings will be used).
- Statement regarding voluntary participation, selective or partial participation, discontinuation procedures, and absence of penalty: a statement that participation is voluntary, that refusal to participate in whole or in part will involve no loss of benefits or penalty to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without loss of benefits or penalty to which the subject is otherwise entitled.
- For research involving minors, parental or legal guardian permission is required. Therefore, the primary audience for such an Informed Consent form is likely the parent or legal guardian, rather than the participating child. For studies involving older children, the form should include signature lines for both child and parent (or legal guardian).