Participants Informed Consent Form Guidelines for
Low Reading Comprehension and Minor Subjects
1. Informed consent for minors required for subject and for subject's
parent/guardian.
a. Parent or guardian informed consent form to be submitted for ALL
subjects less than 18 years of age.
b. Minor subject's informed consent form written on the comprehension
level of the minors who are subjects.
i. Must be comprehensible either when read by subjects or read
to subjects (see 2.1 & 1.2.2 for reading comprehension
stipulations).
ii. Exempt minors - babies or those whose oral comprehension
level is too low to understand the form do not sign a consent
form. The parent or guardian signed consent form is sufficient.
2. Informed consent form for illiterate or low-reading comprehension subjects.
a. Submit the consent form that will be read verbatim to subjects who are
either illiterate or have 3
rd
grade or lower reading comprehension level.
b. The scripted consent form must be comprehensible to subjects who hear
it and include:
i. A statement of the purpose of the research.
ii. An explanation of all aspects of the research that might
reasonably be expected to influence subject's willingness
to participate including any possible negative
consequences of participation.
iii. An explanation of all other aspects of the research about which
the subject may inquire.
iv. A statement that the subject may withdraw from the research
at any time without penalty.
v. The researcher's name and his/her contact phone number
and, if a student researcher, the major professor's or
instructor's name and phone number.
vi. A place for subjects signature and, if subject uses a mark, a
place for the signatures of two witnesses not affiliated with
the research.
