Consent Process for Low Literacy and Physically Disabled Participants

Overview

This guidance provides information on methods to be used when obtaining the informed consent of human subjects who have low literacy or a physical disability that prevents them from being able to sign a consent document.

Low literacy participants must not be confused with non-English speaking subjects who are able to read and write in a language other than English.

Physically disabled participants must not be confused with participants who have a cognitive or decisional impairment. Separate guidance on participants who have a cognitive or decisional impairment that causes diminished capacity to understand the risks and benefits of participation and to autonomously provide informed consent.

Definitions

Low literacy: when an individual can speak and understand English but cannot read and write

Physically Disabled: when an individual can understand and comprehend spoken English, but is physically unable to talk or write

Unbiased witness: an individual who is not a study team member or a family member of the participant who will be physically present during the consent process to observe the process and sign consent forms

Low Literacy Participants

A person who speaks and understands English, but cannot read and write is considered to have a low level of literacy. Low literacy individuals can be enrolled in a study by "making their mark" on the consent document instead of providing their signature.

The following steps should be taken when enrolling low literacy participants:

  • An unbiased witness must observe the consent process. The witness cannot be a study team member or a family member of the participant.
  • A study team member who is approved to obtain consent should present the consent materials to the potential participant orally. For details on who can obtain consent please see Obtaining Consent.
  • Consider using a video or audio recording of the consent discussion as part of the documentation of informed consent
  • Sufficient time should be allowed for participants’ questions and concerns to be satisfactorily addressed prior to obtaining informed consent
  • If the participant verbally agrees to participate in the study, the subject should mark an “X” on the consent signature line or their fingerprint can be captured on the consent signature line
  • The witness signs and dates the consent form. By doing so the witness attests that the consent information was accurately explained, that the subject apparently understood the information, and informed consent was given freely.
  • The study team member obtaining consent signs and dates the consent form
  • The Participant receives a copy of the consent form.
    • If the study is FDA regulated, the participant must receive a signed copy of the consent form.
  • The Study team retains a signed/dated copy of the consent form for study records
  • The study team should document the names of all the individuals who were present for the consent process and any procedures the study team used to enhance the participant’s comprehension, in the research record.

    Item 4.12 of the OSIRIS application must thoroughly describe the above consent process

Physically Disabled

A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means.

The following steps should be taken when enrolling physically disabled participants who are cognitively competent:

  • An unbiased witness must observe the consent process. The witness cannot be a study team member or a family member of the participant.
  • A study team member who is approved to obtain consent should present the consent materials to the potential participant. This can be done in a written format or orally. For details on who can obtain consent please see Obtaining Consent.
  • Sufficient time should be allowed for participants’ questions and concerns to be satisfactorily addressed prior to obtaining informed consent
  • If the participant agrees to participate in the study, they should indicate their agreement in a predefined manner such as blinking of the eyes or raising an arm.
  • The witness signs and dates the consent form. By doing so the witness attests that the consent information was accurately explained and that the subject apparently understood the information and informed consent was given freely.
  • The study team member obtaining consent signs and dates the consent form
  • The Participant receives a copy of the consent form.
    •  If the study is FDA regulated, the participant must receive a signed copy of the consent form.
  • The Study team retains a signed/dated copy of the consent form for study records
  • The study team member obtaining consent must document the names of all the individuals who were present for the consent process, the method used to communicate with the participant and the specific means by which the participant communicated agreement to participate, in the research record.

Item 4.12 of the OSIRIS application must thoroughly describe the above consent process

 

version 4.26.2016