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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 whether to participate in the research study.  If subjects cannot give informed consent, it must be obtained from their legal representatives.  For example, when subjects are minors (under 18) or when they are mentally incapacitated, 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 8^th grade level) in a manner understandable to subjects, using language that is non-technical so participants can fully understand the implications of participating in the research project. 

The forms must first be modified with information about the specific project. Keep in mind that the form will be read and agreed to by the subject; thus, the pronoun “I" refers to the subject, not the researcher. A copy of the modified form must be included with the Approval Request. Note that during research, 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 non-English-speaking people, and it is anticipated that the consent interviews are likely to be conducted in a language other than English, the consent document must be provided to subjects in the appropriate language.  The PI should first submit the consent document in English for HSRRC review and approval.   Once approved, the PI will be asked to submit the document to the HSRRC-IRB in the appropriate language, and have a professional who is fluent in both languages verify for the HSRRC that the two documents are equivalent in language.

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