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Good Clinical Practice (GCP)

in Clinical Research
Food And Drug Administration

ICH GCP for Clinical Research investigators

Presentation Outline

Practice vs. Research


clinical

research vs. clinical trial


therapeutic vs. non-therapeutic research

GCP: Introduction and Principles


Basic GCP Applications for Investigators
Ethical

Principles in Clinical Research


Informed Consent Process: Introduction

Research vs. Practice

Practice refers to interventions that are


designed solely to enhance the well-being of
an individual patient or client, and that have a
reasonable expectation of success.
standard

interventions scientifically proven and

accepted

The purpose of medical or behavioral practice


is to provide diagnosis, preventive treatment or
therapy to particular individual.
BELMONT REPORT

Research vs. Practice (2)

Research designates an activity


designed to test a hypothesis, permits
conclusions to be drawn, and thereby to
develop or contribute to generalizable
knowledge
expressed

for example in theories, principles,


and statements or relationships) that can be
corroborated by scientific observation and
inference.
BELMONT REPORT

Research vs. Practice (3)

Research is usually described in a formal


protocol that sets forth an objective, and
a set of procedures designed to reach the
objective.

BELMONT REPORT

Research vs. Practice (4)

Research represents a systematic


investigation (formal), including research
development, testing, evaluation, that is
designed to develop or contribute
generalizable knowledge.
methodology

Practice gains more flexibilities compared


with research

RESEARH vs. PRACTICE

Question

GENERALIZABLE KNOWLEDGE

Hypothesis

Established
Intervention

Objectives
RESEARCH

PRACTICE

Design

Similar
Conditions

Trial
Conclusion
UNMET MEDICAL NEEDS

[rationale and background]

Clinical Research

research that either directly involves a


particular person or group of people or uses
materials derived from humans such as
behaviors

or samples of the tissues, that can be


linked to a particular living person (identifiable
tissue or bio-specimens)

Declaration of Helsinki 2013

ethical principles for medical research


involving humans subjects, including
research on identifiable human materials
and data

Clinical Research [2]:


categories
[1] Patient-oriented research: involves a
particular person or group of people or
uses of materials from humans
studies

of mechanisms of human disease;


studies of therapies or interventions for
diseases;
clinical trials; and
studies to develop new technology related to
diseases

Clinical Research [3] ]:


categories
[2] Epidemiological and behavior studies:..
examining the distribution of diseases, the
factors that affect health, and how people
make health-related decisions
[3] Outcomes and health services
research: seeking to identify the most
effective and most efficient interventions,
treatments, and services

Clinical Trials

one type of clinical research that involves


a researcher or researchers who directly
observes a person or people, and/or who
collect data to answer a scientific or
medical question about the safety or
potential benefit of an intervention such
as medication, device, teaching concept,
training method or behavioral change

Clinical Trials[2]

a prospective biomedical or behavioral


research study of human subjects that is
designed to answer specific questions
about biomedical or behavioral
interventions (drugs, treatments, devices,
or new ways of using known drugs,
treatments, or devices) [US NIH]

Clinical Trials[3]

a controlled study involving human subjects that


is designed to prospectively evaluate the safety
and effectiveness of new drugs or devices or of
behavioral interventions [US DHHS, IRB
Handbook]

a systematic investigation, including research


development, testing, and evaluation that is
designed to develop or contribute to
generalizable knowledge [US CFR Title 46 Part
102]

Clinical trial [4]

any investigation in human subjects intended to


discover or verify the clinical, pharmacological, a
nd/or other pharmacodynamic effects of an inve
stigational product(s), and/or to identify any ad
verse reactions to an investigational product(s),
and/or to study absorption, distribution, metaboli
sm, and excretion of an investigational product(s
) with the object of ascertaining its safety and
/or efficacy. The terms clinical trial and clinic
al study are deemed synonymous. [ICH GCP]

Clinical Trial

Clinical Research

Where generalizable knowledge


comes from

Data Quality vs. Data


Integrity

Data Quality vs. Integrity

Quality: a measure of the ability of a product,


process, or service to satisfy stated or implied
needs
Data Quality: the essential characteristics of
each piece of data, in particular, quality data
should include:
accurate;
legible;
complete

and contemporaneous (recorded at the time


activity occurs;
original;
attributable to the person who generated the data

Data Quality vs. Integrity

Data Integrity: the soundness of the body of


the data as a whole, in particular, the body of
data should be 1credible, 2internally
consistent, and 3verifiable

Both quality and integrity are essential for


data to be relied upon for regulatory decisionmaking

Good Clinical Practice (GCP)


in Clinical Research
Suchart Chongprasert, Ph.D.
Food and Drug Administration
ICH GCP for Investigators, 31 July 2013, Chaingmai

[1]

[2]

Special attentions paid on

Human subjects are protected


Rights;
Safety;
Well being

Clinical trial data are credible


for regulatory decision;
for scientific use to
improve interventions

GCP significance
..randomized controlled clinical trials form the
foundation for evidence-based medicine, but
such research can be relied upon only if it is
conducted according to principles and standards
collectively referred to as Good Clinical
Practice (GCP)

Source: WHO Handbook for GCP: Guidance for Implementation

International Conference
on Harmonization GCP

Clinical trial
...any investigation in human subjects intended to
discover or verify the clinical, pharmacological, and/or
other pharmacodynamic effects of an investigational pr
oduct(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption,
distribution, metabolism, and excretion of an investigat
ional product(s) with the object of ascertaining its safet
y and/or efficacy. The terms clinical trial and clinical
study are deemed synonymous.
ICH GCP [1.12]

Clinical Trial

investigation/research in humans
using pharmaceutical products
investigational

phase or approved one

the objective is to discover or verify


clinical / pharmacological / pharmacodynamic

effects
absorption/ distribution / metabolism / excretion

so as to ascertain the safety and efficacy of


investigational products

What is ICH GCP


. international ethical and scientific quality
standard for the designing, conducting, recor
ding, performing, monitoring, auditing, reporti
ng a clinical trial that involves human particip
ation...
ICH GCP: Introduction

ICH GCP

quality system being used in a clinical trial


from the beginning to the end
quality

standard

encompassing both
[1]

scientific, and
[2] ethical aspects

Why GCP
. compliance with this guideline assures the
public that the rights, safety, and well-being of
trial subjects are protected, and that trial data ar
e credible .

ICH GCP : Introduction

Importance is given to

Human subjects are protected


Rights
Safety,
Well being

Clinical trial data are credible


for regulatory decision
for scientific use to
improve interventions

ICH GCP - Objective


.to provide a unified standard for European
Union, United States, and Japan to facilitate mu
tual acceptance clinical data by regulatory auth
orities in the three jurisdictions
no

repetition of quality clinical trials conducted


previously in any of these regions
ensuring the quality for the protection of humans
as well as the quality and integrity of clinical data

ICH GCP - Development


...developed with the consideration of the current GCP
of the EU, Japan, US as well as Australia, Canada,
the Nordic Countries, and the WHO.
combined

together principles and guidelines


implemented in advanced countries or organization
promoting global acceptance of clinical data
generated
ICH GCP: Introduction

Applicability
When to apply the ICH GCP?
.should follow when generating clinical data
that are intended to be submitted to
regulatory authorities in the three regions.
support

a regulatory decision for marketing


authorization of pharmaceutical products

ICH GCP: Introduction

other applicabilities
.. the principles established in this

guideline can also be used for other clini


cal investigations that may affect safety
and well-being of trial subjects.
can

be applied to broader than a clinical trial

considerations
..some principles of GCP may not apply to all

types of research on human subjects;


consideration of these principles is strongly
encouraged wherever applicable as a means of
ensuring the ethical, methodologically sound
and accurate conduct of human subjects
research..

Source: WHO Handbook for GCP: Guidance for Implementation

Applications of GCP

studies of a physiological, biochemical, or


pathological process, or of a specific intervention

controlled studies of diagnostic, preventive or


therapeutic measures

studies designed to determine the consequence


for individuals and communities of specific
preventive or therapeutic measures
Source: WHO Handbook for GCP: Guidance for Implementation

Applications of GCP [2]

studies concerning human health-related


behavior in a variety of circumstances
and environments

studies that employ either observation or


physical, chemical, or psychological
intervention
may

generate records or make use of existing


records containing biomedical or other information
about individuals who may or may not be identifiable
from the records or information

GCP Implementation:
Shared Responsibilities

ICH GCP: STRUCTURE & CONTENT


Glossary
Principles of ICH GCP
IRB/IEC
Investigator
Sponsor

Clinical Trial Protocol


Investigators Brochure (IB)
Essential Documents for the
conduct of Clinical Trials

Standard
arrangement

Personnel

Documents

Fundamental Concepts of ICH G CP

ICH GCP Principles


[1] ethical principles established in the
Declaration of Helsinki (updated 2013)
[2] favorable risk and benefits ratio at the
beginning and continuing of a clinical trial
[3] rights, safety, and well-being of trial subjects
most important consideration, and precede the
interests of science and society
[4] nonclinical and clinical data (if any) available
to support the proposed trial

ICH GCP Principles [2]


[5] trial scientifically sound and written in a clear
protocol
[6] protocol receives prior approval from IEC/IRB
[7] medial care and medical decision made be
responsible by qualified physicians or dentists
[8] investigator and staff qualified by education,
training, and experience
[9] freely informed consent obtained from
individual subject prior to his/her participation

ICH GCP Principles [3]


[10] clinical trial information be managed in a way
that allows accurate reporting, interpretation,
and verification
[11] confidentiality of trial subjects
[12] investigational product manufactured,
handles, and stored according to GMP
[13] QA system and procedures implemented
throughout the trial

Advantages of GCP
importance

is given to (1) the protection of human


subjects and (2) the quality and integrity of clinical da
ta

clear

assignment of key individuals involving in a


clinical trial i.e., investigator, EC, sponsor

standardized

glossary of terms

standardized

elements of informed consent

standardized

IRB/IEC membership

emphasize

on principles, de-emphasize on how to

Limitations of GCP

very high standards to be applied in for the Thai


context (in general);

subject to easy deviation;

require intensive resources to implement;

sponsor QA

may not be practical in a resource-poor setting;

require adequate resources and investment in a


regulatory authority

Ethics in Clinical
Research and
Independent Ethics
Committee
Suchart Chongprasert,
Ph.D.
Food and Drug
Administration
ICH GCP for
Investigators, 16 December 2013,

Presentation Outline
Morality vs. Ethics
Basic Ethical Principles in Clinical
Research

RBJ

Principles

Practical Applications
Independent Ethics Committee (IEC) /
Institutional Review board (IRB)

Clinical trials should be conducted in


accordance with the ethical principles that
have their origin in the Declaration of
Helsinki, and that are consistent with GCP
and the applicable regulatory requirements

ICH GCP Principle 1

Research involving humans should be


scientifically sound and conducted in
accordance with the basic ethical
principles, which have their origin in the
Declaration of Helsinki.
Three basic ethical principles of equal
importance, namely respect for person,
beneficence, and justice permeate all GCP
principles.
WHO GCP Principle 1

the two more important things needed for


ethical clinical research i.e., informed
consent and virtuous investigators.

summarized from Dr. Henry Beechers Article

Basic Ethical Principles

Respect for person


Autonomy

(independence)

Beneficence and [non-maleficence]


maximizing

benefit; minimizing harms;


do no harm

Justice
distributive

justice

Respect for Person


Respect for person requires that subjects, to
the degree that they are capable, be given
opportunities to choose what shall or shall
not happen to them.

Belmont Report

Respect for Person

People should be treated as an


autonomous agent
subject

autonomy

Subjects with diminished autonomy need


special protection
vulnerable

subjects

Respect for Person

autonomous agent means individuals


who are able to make their own decision
regarding their goal and the process to
achieve such goals
focus

paid on choice and opinion of each


autonomous individual upon ones
determination
right to self-determination

People with Diminished


Autonomy
Individuals whose willingness to volunteer in
a clinical trial may be unduly influenced
by the expectation, whether justified or
not, of benefits associated with
participation or of a retaliatory response
from senior members of a hierarchy in
case of refusal to participate

People with Diminished


Autonomy (2)
Examples are members of a group with a
hierarchical structure such as medical,
pharmaceutical, and nursing students,
subordinate hospital and laboratory
personnel, employees of pharmaceutical
industry, members of the arm forces, and
persons kept in detention.

People with Diminished


Autonomy (3)
Other vulnerable subjects include patients
with incurable diseases, persons in
nursing home, unemployed or
impoverished persons, refugees, minors,
and those incapable of giving own consent

special safeguard measures

additional safeguards to protect the rights,


safety, and well-being of subjects with
diminished autonomy
special

justification to the ethics committee


that research could not be carried out equally
well with less vulnerable subjects
seeking permission of a legal guardian or
other legally authorized representatives
impartial witness
monitoring the conduct of the study

Respect for Person


right for self-determination;
humans dignity;
informed consent;
vulnerable subjects;
privacy and confidentiality

Beneficence
moral obligation to maximize the benefits
and to minimize harm
requiring that

risks

of research be reasonable in the light of


the expected benefits
research design be sound
instigators be competent both to conduct the
research and to safeguard the welfare of the
subjects

Before a trial is initiated, foreseeable risks


and inconveniences should be weighed
against the anticipated benefits for the
individual trial subject and society. A trial
should be initiated and continued only if
the anticipated benefits justify the risks

ICH GCP 2.2

Clinical trials should be scientifically sound


and described in clear detailed protocol

ICH GCP 2.5

The medical care given to, and medical


decision made on behalf of, subjects
should always be the responsibility of a
qualified physician or, when appropriate,
of a dentist

ICH GCP 2.7

Beneficence

in addition to maximizing benefits and


minimizing risks or harm

beneficence sometimes expressed as a


separate principle of non-maleficence
(do no harm)

Risks and benefits of research may affect


the individual subjects and society at
large (or special groups of subjects in
society). In balancing these different
elements, the risks and benefits affecting
the immediate research subjects will
normally carry special weight.
Belmont Report

The rights, safety, and well-being of


the trial subjects are the most important
considerations, and should prevail over
the interests of science and society.

ICH GCP 2.3

Justice

distributive justice
who

bears the burden/risk of research


who takes benefits

giving rise to moral requirements that


there be fair procedures and outcomes in
the selection of trial subjects

Justice [2]

justice in the selection of research


subjects requires attention in two respects
individual
social

equity requires that no group or class of


persons should bear more than its fair
share of the burdens of participation in
research

Justice [3]

Subject should be drawn from qualifying


population in the general geographic area
of the trial without regard to race, ethnicity,
economic status, or gender unless there is
a sound scientific reason to do otherwise

CIOMS Guideline 12

Practical Applications

Informed consent [Respect for Person]


informed

Risk/benefit assessment [Beneficence]


favorable

decision making
ratio

Selection of trial subjects [Justice]


fair

and equitable procedures and outcomes

Suitability of Informed Consent

sufficiency of information given;


basic

minimum elements

understanding;
understood

consent

voluntariness;
freely

given without undue influence

Remember!

The three ethical principles are originally


derived from the Western culture

In applying these principles, please take


into account local norms, cultures, and
traditions as appropriate

Consult IEC, if needed

Ethics Committee

A trial should be conducted in compliance with


the protocol that has received prior institution
al review board (IRB) /independent ethics co
mmittee (IEC) approval or/favorable opinion.

ICH GCP Principle 2.5

A trial should be conducted in compliance with the


protocol that has received prior IRB/IEC
approval/favorable opinion.

ICH GCP Principle [2.6]

Institutional Review Board


An independent body constituted of medical,
scientific, and non-scientific members whose
responsibility is to ensure the protection of
rights [1], safety [2], and well-being [3] of human
subjects involved in a trial by, among other
things, reviewing, approving, and providing
continuing review of trial protocol and
amendment (s) and of the methods and
material to be used in obtaining and
documenting informed consent of the trial
subjects
ICH GCP [1.31]

Independent Ethics Committee


An independent body (a review board or a committee,
institutional, regional, national or supranational)
constituted of medical professionals and non-medical
members whose responsibility is to ensure the
protection of the rights [1], safety [2], and well-being [3] of
human subjects involved in a trial, and to provide
public assurance of that protection by, among other
things, reviewing and approving / providing favorable
opinion on, the trial protocol, the suitability of the
investigator(s), facilities, and the methods and
material to be used in obtaining informed consent of
the trial subjects
ICH GCP [1.27]

IRB/IEC
Institutional

Review Board (IRB) used in the US

Independent

Ethics Committee (IEC) used in

Europe
deem
in

synonymous

Thailand, both are used interchangeably


ERC, REC

IRB/IEC
independent

board / committee (free of any undue


influence to perform their task and make the
decision)

exist

in several levels depending on situations e.g.,


institutional (CU, MU) , national (MOPH), regional
(EU), or supranational

members

with medical and non-medical professions

responsible

for protection of human subjects in a


trial (rights, safety, and well being)

84

IRB/IEC

assuring the public of their achieved


responsibilities by performing the following
tasks
reviewing and approving the trial protocol;
suitability of the investigator and the team
(through most update CVs);
adequate facilities to conduct the trial;
methods and materials to be used in obtaining
informed consent
o etc.

85

IRB/IEC

86

interface between the investigator and the


subjects

possessing a formal authority for the approval


of the trial and/or suspending/terminating the
trial based upon the applicable laws and
regulations

Why IEC Review?

required independent review of a research


protocol
o one of the criteria for determining if the
conduct of a clinical trial is ethical

protection of subjects

ensure safety and well being of subjects

Declaration of Helsinki !!
87

Policy

88

IRB/IEC constituting and operating in


accordance with the ICH GCP

written approval received prior to initiating the


trial

if no constituted / appropriate IEC, use an


independent IEC such as MOPH IEC

IEC Composition
3.2.1 consist of a reasonable number of
members, who collectively have the
qualifications and experiences to review
and evaluate the science[1], medical[2]
aspects, and ethics[3] of the proposed trial

89

If it is not scientifically valid, it is unethical

Preparation and Submission

90

investigator needs to

obtain confirmation of IEC members present


and occupation

inform IEC of any payments to subjects and


advertisements, if any

obtain a list of IEC members

Documents for Submission


Informed
Consent/Patient
Information Sheet

protocol and
amendments

Investigators
Brochure/drug
information

EC
submission

any
advertisements

Diary cards

payment
schedule

Roles of Investigator

interface between sponsor and ethics


committee

satisfies documentation requirements

updates ethics committee as required


safety

progress;
safety, SAEs;
progress report, etc.
93

Roles of Investigator [2]


Investigator

must
not be involved in the approval process
not

influence / apply pressure to committee


members

communicate

with the IEC in an appropriate


manner (e.g., respect for their decision, appeal
the decision with supportive new scientific
evidence for the protocol etc.)

94

IRB/EC Decision
unconditional

approval

documented

in writing

be

signed and dated by Chairman / Secretariat

approval

letter bears full the protocol number and


title and/or version

Note: a trial must not be begun prior to receiving


the IEC approval letter !!
95

Summary

96

independent review is mandatory in biomedical


research, including a clinical trial

competent IRB/IEC fulfills the requirement of


the Declaration of Helsinki, ICH GCP, and
applicable regulations

investigator should ensure that the trial protocol


is reviewed and approved by a competent
ethics committee

Summary [2]

investigator should obtain an EC approval letter


before commencing the trial

investigator should ensure a regular contact with


the EC in case of new information, amendments,
progress report, or safety update etc.

Informed Consent Process


Suchart Chongprasert, Ph.D.
Food and Drug Administration
ICH GCP for Clinical Research investigators, 31July 2013, Chiangmai

Presentation Outline
What does it means?
Basic Elements of Informed Consent
Certain Important Aspect of Informed
Consent
Exercise

Freely given informed consent should be


obtained from every subject prior to
clinical trial participation

ICH GCP Principle [2.9]

each potential subject must be adequately


informed of the aims, methods, anticipated
benefits and potentials hazards of the study
and the discomforts it may entail.
the physician should obtain the subjects
freely given informed consent, preferably in
writing.
Declaration of Helsinki

A process1 by which a subject voluntarily2


confirms his or her willingness to
participate in a particular trial, after having
been informed3 of all aspects4 of the trial
that are relevant to the subjects decision5
to participate. Informed consent is
documented by means of a written6
signed7 and dated8 informed consent form.

ICH 1.28

Informed consent
..an ongoing
a form
2
aprocess,
subjectnot
voluntarily
for just signing

A process by which
confirms his or her willingness to
participate in a particular trial, after
having been informed3 of all aspects4 of
the trial that are relevant to the subjects
decision5 to participate. Informed consent
is documented by means of a written6
signed7 and dated8 informed consent
form.

Informed consent
no coerce
or use
A process1 by which a subject
voluntarily
undue influence
confirms his or her willingness to
participate in a particular trial, after
having been informed3 of all aspects4 of
the trial that are relevant to the subjects
decision5 to participate. Informed consent
is documented by means of a written6
signed7 and dated8 informed consent
form.

Informed consent
A process1 by which a subject voluntarily2
confirms his or her willingness to
participate in a particular trial, after having
been informed3 of all aspects4 of the trial
that are relevant to the subjects
decision5 to participate. Informed consent
is documented by means of a written6
thoroughly about
7
8
signed and dated informed consent
the trial e.g.,
form.
purpose, benefits,
payment etc.

Informed consent
A process1 by which a subject voluntarily2
subjects autonomy
confirms his or her to
willingness
to
make their own
participate in a particular
trial, after having
judgment
been informed3 of all aspects4 of the trial
that are relevant to the subjects
decision5 to participate. Informed consent
is documented by means of a written6
signed7 and dated8 informed consent
form.

Informed consent
A process1 by which a subject voluntarily2
confirms his or her.acceptable
willingnessway
to
participate in a particular
after having
under thetrial,
ICH GCP
context 4 of the trial
been informed3 of all aspects
that are relevant to the subjects decision 5
to participate. Informed consent is
documented by means of a written6
signed7 and dated8 informed consent
form.

Informed consent
Desirable informed consent
o adequate information disclosed
o language suitable to the recipient
o
o
o

not too technical


avoid a non-mother language
remember that the readers are not scientific
expert/ethics committee members

Methods for Documenting


Informed Consent

written informed consent


In

accordance with ICH GCP

oral witnessed consents


no

documented evidence
beyond the scope of ICH GCP

Elements of IC (ICH GCP)


1. involve research;
2. research purpose;
3. choice of treatments, including
randomization;
4. trial procedures, including invasive ones;
5. subjects responsibilities;
6. trial aspects that are experimental;
7. foreseeable risks/inconvenience

Elements of IC [2]
8. anticipated benefits, if not any, inform as well;
9. treatment alternative if not willing to
participate and related risks/benefit;
10. compensation/treatment in case of trialrelated injury;
11. prorated payment, if any;
12. expected expenses, if any, for participating;

Elements of IC [3]
13. voluntary statement;
14. statement for direct access by monitor,
auditor, IEC/IRB, authority upon signing the
consent form;
15. confidentiality of the subjects private info.
kept;
16. be informed timely available new
information affecting the willingness to
continue in the trial;

Elements of IC [4]
17. contact person for more information or
in case of injury;
18. circumstances for withdrawal/
termination;
19. expected duration;
20. approximate number of trial subjects
(local vs. global)

Important Considerations

consent must be informed;


careful

about the uninformed informed consent


ensure subjects understanding (understood consent)

subjects given ample time;


all questions answered to the subject's
satisfaction;
no undue pressure/influence;
language clearly understood by the subjects
recommended

not higher than grade 8

Important Considerations [2]

no language causing the subjects or the


legally acceptable representatives to
waive their legal rights;
IC

not a legal contract / agreement

ICF personally signed and dated by the


subject and the person obtaining the ICF;
a copy of ICF given to subject prior to
participation;

Suitability Considerations for IC

informed and [ understood ] consent;


respect

for subjects right to self-determination


(autonomy)

disclose sufficient information;


all

aspects about the trial

suitable for subjects capacity (normal vs.


diminished);
age;
educational

status;

sex;
culture,

geosocial factors etc.

Suitability Considerations for IC [2]

voluntariness; and

practicality
amount

of the given info. vs. time for


consideration in reality

short form??

depending

on investigators explanation

Importantly!

In principle, obtaining informed consent in


a clinical research is a must

Waiving of informed consent is an


exception which should be well-justified
and received prior approval from IEC/IRB
before implementation

IC Exercise

Practical Considerations
Q: Who should obtain informed consent ?
A: In general, the investigator or authorized
person obtains the informed consent.
According to the Helsinki Declaration, the
physician who treats the potential subject
should not obtain the consent by
him/herself, instead other physician who
understands the protocol well does. Avoid
doctor/patient dependent relationship.

Practical Considerations
Q: Obtaining informed consent in children /
minor ?
A: For children with legal incompetence
(i.e., age <20 yrs), but able to give assent
to the research protocol, an assent form
should be obtained besides parents
informed consent
[assent: affirmative agreement to participate
in the trial]

Practical Considerations
Q: When to conduct the trial in relation to
the time to obtain the informed consent ?
A: The study cannot start prior to
receiving a written informed consent from
the subjects. Also, an unconditional
written ethics committees approval letter
must be obtained before beginning the
trial.

Practical Considerations
Q: Informed consent in a clinical
pharmacology trials (PK, phase I study)?
(i.e., non therapeutic trial)
A: Should be conducted in the subjects who
can give informed consent by themselves
by personally signing and dating on the
form.

Practical Considerations
Q: When should the informed consent be
amended ?
A: When new information that may affect
the safety and well being of the subject
becomes available, and it may affect the
subjects decision to continue
participating in the trial.

Practical Considerations
Q: How long should it take to obtain the
informed consent?
A: Depending on the situation. Remember that
informed consent is an ongoing process, not
finished upon the signature of the subject.
Specifically, how long it takes until the subject
signs and date on the form is what the
investigator needs to know. Exact time cannot
be established, but the investigator needs to
achieve efficient project management and
obligation under the GCP on obtaining informed
consent.

Summary
o

Informed consent is a continuing process


to confirm subject's voluntary willingness to
participate in the trial.

Informed consent should be obtained from


each patient prior to enrolling the subject
into the trial.

Childrens assent form is required in most


clinical trials involving children (below
majority age) participation