DAIDS SCORE Manual
Informed Consent of Participants
Version 3.0 – 10 June 2024 Page 9 of 21
• Corroborate that the participant’s consent was voluntary, and the consent
process was adequate.
• Ensure the informed consent information was accurately explained, and the
person obtaining informed consent/PI/IoR addressed the participant’s questions
satisfactorily.
While applicable rules may permit CRSs to use the procedures described above to
recruit and consent participants who do not speak any of the languages spoken by the
site staff, CRSs should consider how they will communicate with these participants
throughout the clinical research. Particularly for studies that carry more than minimal
risk, CRSs should plan how they will address future communications, e.g.: when
adverse events (AEs) require oral or written communication and an interpreter is not
available (occurs over the weekend).
Consenting Illiterate Individuals
CRSs may consent and enroll individuals who speak and understand the language used
for the consenting process (including ICFs) but do not read and write this language.
These individuals may participate in clinical research by consenting orally and either
“making a mark” or by adding a fingerprint/thumbprint on the ICF, as long as these
methods of consent meet applicable local laws and regulations, CRS Consent SOPs,
and institutional policies and procedures. In the participant’s research record, CRSs
must indicate why there is no participant signature, how they communicated with the
potential participant, and how the potential participant communicated agreement to
participate in the clinical research (e.g., participant used a thumbprint on the ICF). An
impartial witness must participate in the entire consent process, sign/date the consent
document, and add the participant's name and date in the ICF’s “participant” fields.
To ensure a complete understanding, CRSs may implement a process to assess
participant literacy, as needed. CRS must obtain required approvals before using
specific tools to assess participant literacy.
Consenting Populations Requiring Additional Protections
CRSs with adequate, established provisions (45 CFR part 46 subparts B, C, and D as
well as 21 CFR part 50 subpart D) may consider consenting potential participants that
require additional protections during the consent process, such as pregnant women,
fetuses and neonates, or participants that are vulnerable to coercion or undue influence.
Vulnerable populations may include minors; prisoners; wards; individuals with impaired
decision-making capacity; ethnic minorities; members of a group with a hierarchical
structure; individuals with incurable diseases; individuals in nursing homes; refugees;
individuals in emergency situations; lesbian, gay, bisexual, transgender and
queer/questioning (LGBTQ) populations; individuals from minority religious groups;