It is important to remember that informed consent is a process – not a piece of paper. Since subjects retain the right to withdraw from a study, consent is an ongoing process. It starts well before any forms are signed and continues until participation is complete.
The consent process involves meeting with a potential subject, determining whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation with that subject. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.
If consent is to be informed, the subjects must genuinely understand the study. Hence, researchers should strive to convey information to subjects, not merely disclose it to them. Subjects should be able to demonstrate their understanding of the procedures, risks, and benefits of the study in which they are agreeing to participate.
Once a subject understands a study and expresses a willingness to participate, researchers must document the subject’s consent with a consent form. A signature certifies the subject’s willingness to participate, though a signed form is not equivalent to assuring that the subject has understood the research. Including a date with the signature avoids confusion about whether the subject began to participate before giving consent. A copy of the signed consent form must be provided to each subject.
The federal regulations allow for a waiver of documentation of consent if (1) the only record linking the subject and research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality or (2) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. A consent form must be provided to potential subjects, however a signature is not required.
Sample Informed Consent – Confidential Research (subjects 18 or older)
Sample Informed Consent – Anonymous Research
Children and Adolescents as Research Subjects
Written parent/guardian permission is required for all studies involving children under the age of 18. Parent/guardian permission is documented in a form similar to a consent form for an adult subject, but tailored to invite “your child” to participate rather than “you.” Once parent/guardian permission has been obtained, the agreement of the child is required. The child’s agreement is documented with an “assent form,” a child-friendly document that outlines the essential information about the research.
All children between 8 and 17 years old should receive an opportunity to assent; most children 8 years old or older have the cognitive and emotional maturity to understand a research project and to decide whether they want to participate in it. Some children under the age of 8 may also be capable of granting and withholding assent.
Researchers should draft a form (or a verbal script) that is age-appropriate, study-specific, and considers the typical child’s experience and level of understanding. The form (or verbal script) should:
* state why the study is being conducted;
* describe what will happen and for how long or how often;
* state that the decision to participate belongs to the child, and that refusal or withdrawal is “okay;”
* explain if participation will hurt and, if so, for how long and how often;
* describe the child’s other choices, if any;
* describe any good things that might happen;
* mention any compensation for participating; and
* ask for questions.
Illustrations can be helpful and the document should be no longer that one page if possible.
Sample Parent/Guardian Permission
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