Informed Consent
 Informed Consent

 Definitions

 Process
 Special situations

 Elements of informed consent

 Retention
Definition of Informed Consent: ICH
GCP 1.28
 A process by which a subject voluntarily
confirms his or her willingness to participate
in a particular trial, after having been
informed of all aspects of the trial that are
relevant to the subject’s decision to
participate

 Informed consent is documented by means

of a written, signed, and dated informed
consent form

 Cornerstone of ethical conduct in clinical

research
Informed Consent of Trial Subjects
 In obtaining and documenting
informed consent, the
investigator should comply with
the applicable regulatory
requirements and adhere to GCP
and to the ethical principles that
have their origin in the
Declaration of Helsinki
Informed Consent Document
 Prior to the beginning of a trial,
the investigator must obtain from
the IRB/IEC written
approval/favorable opinion of the
written informed consent form and
any other written information to
be provided to subject

 Revisions will also need re-

approval and re-consenting
 Informed Consent Process
 Intention is to transmit study information from
investigator to subject/legal representative

 Assumes subject clearly understands

• Risks

• Alternative treatments

• Benefits
• Their obligations as a subject
• The study involves research

 Reading and signing a consent does not assure

comprehension
 Problems
 Not being done Vs not done correctly
 The timing of the consent may not
be correct
 Proper signatures are not always
obtained
 Consent form is poorly written
 There are missing required elements.
 Informed Consent Process
 Subject is to be treated as an
autonomous agent

 Subject must be allowed to make a

voluntary decision without coercion
 Consent must be obtained prior to any
study related procedures
 Consent should not contain any language
waiving the subject’s legal rights
 Informed Consent Process
 Giving subject adequate information
 Providing an opportunity for subject to consider
options
 Answering questions

 Ensuring comprehension

 Obtaining voluntary agreement

 Supplying ongoing information

 Documenting subject’s agreement to participate
 Informed Consent Process

 Consent form must be approved by the

IRB/IEC

 Investigator is ultimately responsible for

obtaining consent
 Informed Consent Process
 All oral and written information must
be understandable to the subject
• Language in which subject is fluent
• Medical terms versus lay terms

 Subject is to be provided a copy of the

consent document
 If amended, consent needs to be re-
approved and re-signed by all ongoing
subjects
 Special Situations

 Trials which have no anticipated

direct clinical benefit to the
subject should be conducted in
subjects who can personally give
consent and who can sign and
date the written informed
consent form
 Special Situations

 Trials which have no anticipated

direct clinical benefit may be
conducted in subjects with consent of
a legally acceptable representative
provided
• The objectives of the trial cannot be met
by means of a trial in subjects who can
give informed consent personally

• The risk to the subjects is low

 Special Situations

 The negative impact is minimal

 The trial is not prohibited by law

 The IRB/IEC has given written

approval/favorable opinion of
the trial
 Special Situations
 In an emergency situation when prior
consent of the subject is not possible
• The consent of a legally acceptable
representative should be requested if one
is available

• If a legally acceptable representative is

not available, the subject can still be
enrolled if it is to the subject’s best
clinical interest
 Special Situations
 When subjects can only be included in
a trial with the consent of a
representative (e.g., minors, or
persons with severe dementia)
• The subject should be informed about the
trial to the extent of his/her
understanding

• If capable, the subject should sign and

date the informed consent form
 Special Situations
 Subject or representative is
unable to read
• An impartial witness should be
present during the entire informed
consent discussion

• After the subject has orally

consented the subject and/or
representative should sign and date
the consent form if they are capable
 Special Situations

Impartial witness signs attesting that

all trial information was clearly
explained to the
subject/representative
 Elements of Informed Consent
Form
 The trial involves research
 Purpose of the trial
 Possibility of random assignment
 Trial procedures that will be necessary
 Experimental aspects of the trial
 Possible risks
 Reasonably expected benefits
 Alternative procedures
 Elements of Informed Consent
Form
 Available compensation in the event of injury

 Payment, if any, to the subject for

participation in the trial
 Anticipated expenses, if any
 State that the subject’s involvement in the
trial is voluntary and the subject may
withdraw at any time
 The persons who will be granted direct
access to the subject’s medical information
 Elements of Informed Consent
Form
 The identification of the individual
subjects will be kept confidential

 The subject and/or representative will

be informed when any new
information becomes available
 A person to contact for further
information on the trial and in the
event of an emergency
 Reasons why the subject may be
terminated from the trial
 Elements of Informed Consent
Form
 Expected duration of the trial

 Approximate number of subjects that

will be included in the trial
 Subject agrees that the data collected
will be reported and transferred as
part of trial analysis
 The subject will not be uniquely
identified and their data will be used
even if subject withdraws
 Document Retention
 A master copy of each version of the
informed consent form should be filed along
with its approval with the trial documents

 The signed completed informed consent

forms should be filed with the subject’s trial
file or medical records, as appropriate

 According to ICH, all trial documents must

be retained 2 years after the last approval of
a marketing application
 The consent process
 Have someone read the consent form.
 Presenter summarizes important
points.
 Ask if there are questions.
 Never convince a subject to
participate.
 Ask the subjects questions to assess
comprehension.
 Give adequate time
 Schedule Y appendix V
 Checklist for Subject’s informed
comnsent documents
 Essential elements
 Additional elements

 Format of informed consent form

for subjects participating in a
clinical trial