INFORMED CONSENT
DEFINATION
• Informed consent is an ethical and legal
requirement for research involving human
participants. It is the process where a participant is
informed about all aspects of the trial, which are
important for the participant to make a decision and
after studying all aspects of the trial the participant
voluntarily confirms his or her willingness to
participate in a particular clinical trial and
significance of the research for advancement of
medical knowledge and social welfare.
CONCEPT
• The concept of informed consent is embedded in the
principles of Nuremberg Code, The Declaration of
Helsinki and The Belmont Report. Informed consent
is an inevitable requirement prior to every research
involving human being as subjects for study.
Basic Elements for Written Informed
Consent Documents.
• A statement that the study involves research;
• An explanation of the purpose of research and
the expected duration of the subject's
participation.
• A description of the procedures to be followed
and identification of any procedures that are
experimental.
• A description of any foreseeable risks or
discomforts to the subject, an estimate of their
likelihood and a description of what steps will be
taken to prevent or minimize them.
• A description of any benefits to the subject or to
others that may reasonably be expected from
the research. Monetary compensation is not a
benefit.
• A disclosure of any appropriate alternative
procedures or courses of treatment that might
be advantageous to the subject.
• A statement describing to what extent records will
be kept confidential, including a description of who
may have access to research records.
• For research involving more than minimal risk, an
explanation and description of any compensation
and any medical treatments that are available if
research subjects are injured; where further
information may be obtained and whom to contact
in the event of a research-related injury.
• Information on the amount of
remuneration/compensation, if any, that will be
provided to subjects.
• An explanation of whom to contact for
answers to pertinent questions about the
research and the research subject's rights
(include the clinical centre's patient
representative and telephone number).
• A statement that participation is voluntary and
that refusal to participate or discontinuing
participation at any time will involve no
penalty or loss of benefits to which the subject
is otherwise entitled.
Challenges in Informed Consent Process.
• Language Barriers: It is assumed that the
individual who signs the consent form does so
with full understanding of what is stated on
the consent form.
• Religious Influence: The informed consent
process is designed to give every participant
the liberty to decide whether to accept or
refuse the recommended medical treatment.
• False Expectations: Even when there are no
language barriers or religious impediments to
hinder the communication relationship
between researcher and participant,
misunderstanding can still occur due to
participants false expectations of the
experiment outcome.
• Patient Perceptions: Most patients believe
that, trials will put extra burden on them. They
assume that the conventional treatment is best
and they are afraid of the unknown side-effects
of new treatment.
• Children: Where research involves children
(under the age of 18) consent/permission has
to be obtained from parents. If the child is
above 7 years of age then “child assent” is also
mandatory.
• Vulnerable People and Groups: Vulnerable
groups include the person who is absolutely or
relatively incapable of protecting their
interests. Obtaining informed consent is critical
when working with them, specifically with
some groups like people with learning
disabilities.
