February 2024 SOCRA Source Journal - Journal - Page 44
TABLE 4:
PREREQUISITES FOR VALID INFORMED CONSENT
Disclosure: Provide complete and understandable information about the following:
• The study’s purpose, duration, and potential risks or benefits
• The study’s possible other consequences
Understanding: Full understanding of all information
Authenticity: Judgement consistent with the patient’s personal values
• Non-control:
• Ability to decide without coercion, manipulation, or other undue influences
Capacity: Ability to oversee the consequences of their participation
Intentionality: Intention to participate in the research study
Adequate Time: Provide sufficient time to decide whether to participate
Table 4 highlights the
prerequisites for valid informed
consent. For example, the
informed consent form must
be concise, readable, accurate,
and understandable. The
process must disclose all
relevant information, including
the proposed intervention
and its associated risks and
benefits and their relative
likelihood. Regulatory oversight
is significantly more restrictive
for research involving children.
45 CFR 46, Subpart D provides
special protections for children
involved in research.
Children are not autonomous;
however, they still have a right
to participate in research.
They should be encouraged
to participate in the decisionmaking process about research.
Assent should be child-focused
and written at the child’s level
of understanding. It should
44
be rigid enough to provide
protection and show respect for
the children and flexible enough
to allow for the varied cognitive
and emotional levels of the
potential participants.
There should be a reasonable
assurance that children and
their parents will not experience
coercive pressure to participate
or to continue to participate in
the project. Procedures must
be in place to ensure that
participants provide assent or
consent to participation if they
are capable of doing so.
The determination of decisionmaking capacity should
be based not only on the
child’s developmental level
of maturity, but also on their
personal wishes. The federal
regulations allow IRBs to
determine which children
are capable of assenting to
research participation, “taking
SOCRA SOURCE © May 2023
into account the ages, maturity,
and psychological state of the
child.” In general, at the age
of 7, children may be capable
of providing a simple assent
or capable of refusing to
participate in research. At age
14, children become capable
of the more sophisticated
level of cognition required for
participation in the informed
consent process.
It is necessary to improve
comprehension and assess
potential participants’
understanding of the study: its
purpose, procedures, eligibility
requirements, compensation,
and so forth. Researchers must
check whether the prospective
participants have any questions.
The language in the assent or
informed consent document
must be clear and discourage
unrealistic expectations.
Researchers must thoroughly
review the assent or informed