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 Form
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 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.
Online Survey Cover Letter
When a participant is asked to complete an online survey, the IRB may grant a waiver of signed consent due to the impracticality of obtaining the participant's signature. The consent document must appear as the first page of the online survey, contain a statement regarding collection of Internet Protocol addresses, and contain participation agreement statements at the bottom of the consent document.
Parental Consent Form
This document is used to obtain signed consent for minor children to participate in research studies. The parent or legally authorized representative (LAR) giving consent must sign two copies of the document, one of which is to be kept by the parent or LAR and the other by the investigator.
Assent Forms for Minors
Studies involving participants under the age of 18 require that researchers obtain both parental or LAR consent in addition to obtaining assent from minors when the IRB determines that a child is capable of providing assent. One of the following methods must be used in obtaining child assent:
Use a parental consent document that also includes a child assent statementWhen using the combined-document method, the assent statement should be written in age-appropriate language, addressing what the child is being asked to do and the rights of the child not to take part in the study. The parental consent section of the document should contain a signature line for the parent or legally authorized representative (LAR), and the assent section of the document should contain a line on which the child signs. A sample of this type of document is provided below.
Use a parental consent document and separate child assent documentWhen a separate assent document is utilized, the researcher should ensure that the name of the consenting parent appears on the assent that is signed by the minor (as surnames may differ). The links below provide samples of assent written in age-appropriate language.
Researchers are required to obtain parental permission prior to obtaining child assent, and minors are not required to take part in a study for which a parent has given consent. All questions regarding use of assent should be directed to firstname.lastname@example.org or to the IRB Administrator at (678) 797-2268.