Types of Informed Consent
A researcher may not involve a human subject in research that is covered by the federal guidelines unless the legally effective informed consent of the subject or the subject's legally authorized representative (LAR) has been obtained. Consent documents must contain sufficient information, written in language easily understood by the intended audience, that provides an opportunity for the subject or LAR to consider whether to take part in a research study and that minimizes possible coercion or undue influence. One or more of the following types of consent documents should be used in research studies that include human subjects.
To ensure that all mandatory elements of informed consent are addressed, researchers are encouraged to review the Consent Checklist.
Signed consent of all participants is required unless a waiver of signed consent is granted by the IRB. The researcher must provide the participant with two copies of the consent document to be signed. One signed copy is kept by the participant and the other copy by the investigator.
Cover Letter - No Signature
Cover letters are used when a signed consent form is either not needed or would, by its use, compromise the anonymity of participants. The IRB may grant a waiver of signed consent when it is determined that a cover letter is acceptable.
Participants under the age of 18 are unable to provide informed consent to participate in research. Assent is a form of consent that is to be used in such cases when research involves participants under the age of 18. “Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. Researchers should consider age appropriateness of the language and terminology used and create assent forms accordingly.
Parental Permission Guidance
For participants under the age of 18, adequate provisions should be made for soliciting the permission of the parent(s) or legal guardian(s). The regulations define “permission” as the “agreement of parent(s) or guardian to the participation of their child or ward in research.”
The term “parent” means a “child's biological or adoptive parent.” The term “guardian” means “an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.” Parental permission should be documented in a manner similar to that used to document informed consent.