INFORMED CONSENT

The purpose of informed consent is to help investigators protect research participants by informing them about the nature of the research, including the procedures to be followed and any associated risks or benefits to participation. In compliance with federal regulations, the IRB carefully reviews informed consent documents.

There are several useful informed consent templates that investigators should use as a model when writing their documents. However, the IRB strongly believes that participants’ rights are best protected when investigators determine the appropriate tone, language, and format of the consent form based on what they believe will best convey study information that is accurate and understandable to their participants.

Bottom line: use templates but tailor them so that they’re appropriate, informative, and understandable to your research subjects.

Regulations require that certain basic elements be included in informed consent. As a general rule, the following points should be considered when writing an informed consent:

Include the basic required consent elements specified by the federal regulations.
Use simple language. We suggest that it be written at no more than an 8th-grade reading level.
Avoid technical and legal terms.

For certain minimal risk studies, the use of a “study information sheet” may be more appropriate than collecting written signatures of participants on a standard informed consent document. Please contact the IRB Administrator to learn more about when the use of an information sheet is appropriate.

Visit the IRB Forms & Templates page for templates and sample documents.

A minor (child) is a person who has not attained the legal age of adulthood, which is eighteen in the state of Ohio*. A minor can assent but cannot legally consent to treatments or procedures involved in research.

Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research. The IRB must determine for each study whether all or some of the children are capable of assenting to participation. Federal regulations do not require that assent be sought from children starting at a specific age; therefore, determination by the IRB will be made based on such factors as the nature of the research and the age, maturity, status, and psychological state of the child participants. Note that the basic consent elements required for an adult consent are not required to be included in a child assent.

Assent for children should be written using simple language the child can understand. Generally, the IRB suggests the following types of assent be used based on a child’s reading ability:

Oral Script: A simple oral script can be read to young children that are not proficient at reading but are still capable of giving assent.

Written Assent: A written and signed assent form can be given to older children/minors that are proficient readers and capable of comprehending concepts such as a research study, voluntary participation, benefits and risks, etc.

NOTE: The JCU IRB hesitates to specify an exact age range where an oral script versus a written and signed assent is appropriate. In some instances, assent cannot be obtained (e.g. babies and toddlers) and only parental permission is necessary. Each situation and child is different and therefore the JCU IRB in conjunction with the principal investigator will make the appropriate determination on a case-by-case basis.

*In the United States, the legal age of adulthood is a matter of state and local law. Please see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children-research/index.htmlfor more information about research with children.

The Institutional Review Board

INFORMED CONSENT