Consent Process for Legally Blind Research Participants
Version date: April 11, 2007
If subjects who cannot read the consent materials due to blindness, or the subject's legally authorized representative (LAR) is legally blind, the following is the consent process is recommended:
- Have an impartial witness observe the consent process, such as a subject advocate or someone not affiliated with the research team. Family members are not recommended to serve as witnesses.
- The consent and HIPAA authorization forms should be presented to potential subjects orally and the potential subject provided with an audiotape or videotape of the process.
- If potential subjects have access to equipment that can read the consent document for them, providing sufficient time for them to review the consent document independently of the research team.
- As would be expected for any consent process, ensure sufficient time is allowed for questions to be asked by the potential subjects, subject's representative, and research team to ensure that the consent process was clear and effective.
- The consent and HIPAA documents should include a statement that the forms were read to the subject by a member of the research team designated to obtain informed consent.
- The subject signs and dates the consent form, if capable of doing so. In the case that informed consent is being obtained from the subject's LAR, the LAR will instead sign and date the form.
- The witness signs and dates the consent form. A statement should precede the witness' signature that attests that the consent information was accurately explained and that the subject apparently understood the information, and the informed consent was given freely.
- The person obtaining consent signs and dates the consent and HIPAA forms.
- Signed copies of the consent and HIPAA forms are provided to the subject or subject's LAR.
- As would be expected for any consent process, it is the investigator's responsibility to judge the subject's comprehension of the consent information including the understanding the participation is voluntary and that that subject has the right to withdraw at any time during the study. If the investigator doubts the subject's consent comprehension, he or she should not enroll the subject in the study.