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Informed Consent

The Department of Health and Human Services and UH policies require investigators to obtain legally effective informed consent of study subject—or the subject’s legally authorized representative—before involving the subjects as participants in human subject research. Without it, no subject may be involved in research.

Informed consent is the voluntary choice of an individual to participate in research based on an accurate understanding of its purposes, procedures, risks, benefits, alternatives and any other factors that may affect a person’s decision to participate. Read more about Informed Consent.

Is Informed Consent Required?
Under certain circumstances, informed consent as a requirement may be waived by the Committees for the Protection of Human Subjects. 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.

The Consent Process
Obtaining informed consent is not simply obtaining a signature on a consent form: 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. The consent form formalizes the agreement to participate and should be designed to document the process.

View a sample confidential research consent form for subjects 18 years of age and older.
View a sample anonymous research consent form.

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.

Once a subject understands a study and expresses a willingness to participate, researchers must document the subject’s consent with a consent form. The 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.

Children and Adolescents as Research Subjects
Written parent/guardian permission is required for all studies involving subjects under 18 years of age.  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”. If parent/guardian permission is obtained, then the researcher also must request permission from the child. The child’s agreement to participate is documented with an “assent form,” a child-friendly document that outlines essential information about the research.

View a sample Parent/Guardian Permission form.
View a sample Assent to Participate in a Research Study form (children 17 years and younger).

All children 8- to 17-years of age should receive an opportunity to assent. Most children 8-years-old and older have the cognitive and emotional maturity to understand a research project and to decide whether they want to participate. Some children under the age of 8 also may be capable of granting or 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.

The document should be no longer that one page, if possible. Illustrations can be helpful.

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Page last modified: 08/02/2012