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Informed consent is an important step in ensuring that research subjects/participants are treated ethically. Subjects must have enough information to make an informed decision about whether to participate in a research study. If subjects cannot give informed consent, it must be obtained from their legal representatives. For example, when subjects are minors (under 18 years of age) or have an intellectual disability, consent from a legal representative (such as a parent or legal guardian) is required. 

Assent:  In addition to obtaining parental consent for minors, children (those under 18) should be asked to provide assent, or agreement, to participate in research, whenever they are capable of doing so. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent. Usually, children who are age seven and older are asked to provide verbal assent or, in some cases, sign an assent form, which is stated or written in language appropriate to the ages and conditions of research subjects. Researchers are required to document in their records that child assent, oral or written, was obtained.

Consent documents should be clearly written in plain English (usually at the 8th grade level) in a manner that is easily interpretable by subjects, using language that is non-technical, so that participants can fully understand the implications of participating in the research project. 

Consent/assent forms must be modified with information about the specific project. They should be written in simple language that describes the study and includes all the sections that appear in our consent form template, as these are required by the federal regulations. It is recommended that researchers assume a lack of familiarity with their field, including jargon, acronyms, theories, and methods, even if these might seem readily apparent to the researchers. Forms should be written as if the researcher were talking to the subjects, describing the study, what they will be asked to do, and what will happen to their data afterwards. A copy of the modified form must be included when submitting the Approval Request. Note that during recruitment, all forms must be completed in duplicate; the subject retains one copy and the other is retained by the researcher.

Note: In order to meet the requirements of 45 CFR 46.116, the consent document must be in language understandable to the subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. However, when the majority of anticipated study subjects are not fluent speakers/readers of English, and it is anticipated that the consent interviews will likely be conducted in a language other than English, the consent document must be provided to subjects in the appropriate language. The researcher should first submit the consent document in English for HSRRC review and approval. Once approved, the researcher will be asked to submit the document to the HSRRC-IRB in the appropriate language, with certification from a professional who is fluent in both languages who has verified for the HSRRC that the non-English version is a faithful translation of the approved English version of the document(s).

When research will take place in a setting where approval for data collection would be appropriate (e.g. in a school or at a private business), the HSRRC-IRB may require the submission of a signed site approval form (see below). 

For more information on consent and disclosure requirements, see the Code of Federal Regulations: Title 45, Part 46—Protection of Human Subjects.

(All links below link to Word documents.)
 

For...	Required Form	To be Signed by:
all subjects	Informed Consent Form	subjects (or their parent and legal guardian
minors (children)	Child Assent Form (age 7-12)  Adolescent Assent Form (age 13-17)	child/teen subjects
off-campus data collection	Site Approval Form	appropriate location administrator