INFORMED CONSENT:
The process in
Latin America
Rodrigo Xavier
PRA International
DIA 10th Latin
American
Congress of Clinical
Research
October 20th 2013
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2
Why Latin America?
•
Languages: Spanish, Portuguese ... AND English
– Although regulatory agencies do not accept english documents, investigator and
sites are often able to communicate in English if necessary.
– Translations: Spanish with the exception of Brazil (Portuguese)
– Even if in spanish, there are wordings differences (local review)
•
Demographics: Population concentrated in big cities
– High subject/site proportion
•
Geography: 2 hemispheres
– seasonal diseases intercalate
•
Capabilities: Investigators and sites
•
Capable investigators and sites deliver trustworthy results
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Why Latin America? (continued)
•
Be carefull!!!
– Although Latin America is a promising region for clinical trials, certain cautions
should be taken when preparing one of the most important documents for ethical,
regulatory, and mainly the patient’s review.
•
Timelines:
– The ICF is the document that has the highest requirements rate from ethical and
regulatory (when applicable) packages from Latin America  highest source of
delays in the ethical/competent review process.
•
Cultural differences:
– Plain ICF translations usually do not generate documents that are acceptable for
Latin American patients/ethical/regulatory agencies. Patient knowledge is usually
oversetimated requiring the document wording to be thoroughly reviewed locally.
Also, each country has it´s own peculiarities which will require a “different” ICF to
be created for each of the countries.
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Why Latin America? (continued)
•
General overview:
– Too many regulations and specific requirements per country
– Sometimes the experience tells us more that the regulations
– Provide a general idea of the most important topics from an ICF when brought to
Latin American countries.
– Comparative way
•
Countries:
– Argentina, Brazil, Chile, Colombia, Mexico and Peru.
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Language and Regulations (continued)
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Spanish
Portuguese
Spanish
Spanish
Spanish
Spanish
Norms (MoH):
No 57 - 2001
(Annex 1)
Resolutions:
No 8430/1993
No 2378/2008
Regulations:
Regulation of the
General Law of
Health Pertaining to
Clinical Research –
1986 (chapters II to
V)
Regulations:
Regulation of
Clinical Trials 2006 (INS) Title II,
Title III/ chapter II &
Annex 8
Dispositions:
No 6677/10
Resolutions:
No 251/97
No 466/12
Resolution:
No 1480/2011
Laws:
No 25326
- MoJ
Drug Information Association
Resolutions (ISP):
No 4607 - 2001
Law (MoH):
No 20120
(art.11) – 2006
www.diahome.org
Laws:
General law of
health – 2003 (art.
100 &103)
Manuals:
Operating Manual
for Clinical Trials
RJN 419-2007-JOPD/INS
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Ethical and Competent Authorities
ARGENTINA
Ethics Committee
(local or central);
National Direction
of Personal Data
Protection
(DNPDP)
BRAZIL
Committee for
Ethics in Research
(CEP);
National
Commission for
Ethics in Research
(CONEP)
CHILE
COLOMBIA
Ethics and
Scientific
Evaluation
Committees
(CEC)
Independent Ethics
Committee
Public Institute of
Health (ISP)
Food and Drug
Vigilance Institute
(INVIMA)
MEXICO
PERU
Institutional Ethics
Commissions
Institutional or
external ethics
committee
Health Secretariat
of Federal
Commission for the
Protection Against
Sanitary Risks
(COFEPRIS)
National Institute of
Health (INS)
Institutional Ethics
Committee (CEI)
MoJ
(confidentiality
section only)
National
Administration of
Drugs, Food and
Medical Technology
(A.N.M.A.T.)
National Health
Surveillance
Agency (ANVISA)
- Does not require
review of the
consent form.
Depending on
jurisdiction, other
CAs (provincial
CEC, MoH)
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Bringing ICFs to LA requirements:
•
General and standard modifications in ICFs when brought to Latin American
countries.
–
–
–
–
–
–
–
–
–
Wording
Patient Information and Confidentiality
Medical Assitance
Access to Medication
Compensation
Contraception Methods
Signatures
Special Populations
Sample Storage
Drug Information Association
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Wording
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Your condition may
improve, but may
also get worse
(Coercion).
Your condition may
improve, but may
also get worse
(Coercion).
Your condition may
improve, but may
also get worse
(Coercion).
Your condition may
improve, but may
also get worse
(Coercion).
Your condition may
improve, but may
also get worse
(Coercion).
Your condition may
improve, but may
also get worse
(Coercion).
Explanation on
Randomization;
Placebo;
Explanation on
Randomization;
Placebo;
Explanation on
Randomization;
Placebo;
Explanation on
Randomization;
Placebo;
Explanation on
Randomization;
Placebo;
Explanation on
Randomization;
Placebo;
Volumes in
comparison with
tablespoons, and
cups.
Volumes in
comparison with
tablespoons, and
cups.
Volumes in
comparison with
tablespoons, and
cups.
Volumes in
comparison with
tablespoons, and
cups.
Volumes in
comparison with
tablespoons, and
cups.
Volumes in
comparison with
tablespoons, and
cups.
Words may acquire
different meaning
Words may acquire
different meaning
(SUBJECT and
DRUGS)
Words may acquire
different meaning
Words may acquire
different meaning
Words may acquire
different meaning
Words may acquire
different meaning
Tables, Charts,
checkboxes, %.
Tables, Charts,
checkboxes, %.
Tables, Charts,
checkboxes, %.
Tables, Charts,
checkboxes, %.
Tables, Charts,
checkboxes, %.
Tables, Charts,
checkboxes, %.
Drug Information Association
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9
Patient Information and Confidentiality
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Strict
confidentiality. How
it will be stored,
who will have
access, why is
necessary, and
how long.
Guarantee of
confidentiality with
process
explanation.
Reference the
local law (No
25326)
Patient access to
the tests results (if
requested)
Reference to the
local law should be
used (No 19.628)
Patient access to
the tests results (if
requested)
Drug Information Association
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Medical Assitance
ARGENTINA
BRAZIL
CHILE
COLOMBIA
Medical and Non
Medical Expenses
Medical and Non
Medical Expenses
“Full Assistance”
Medical and Non
Medical Expenses
Medical and Non
Medical Expenses
Information about
an insurance
company
contracted for the
study
Also, it needs to be
clear that expenses
for suspected
abnormality related
to the study
medication during
and after the
pregnancy should
be covered
Information about
an insurance
company
contracted for the
study
Information about
an insurance
company
contracted for the
study
Limiting words
should be avoided
when possible.
Limiting words
should be avoided
when possible.
Drug Information Association
MEXICO
Medical and Non
Medical Expenses
PERU
Medical and Non
Medical Expenses
Information about
an insurance
company
contracted for the
study
Limiting words
should be avoided
when possible.
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Access to Medication
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Participants who
require continued
treatment at the
end of the study
shall have access
to the intervention
that has been
beneficial or to an
alternative
intervention or
other appropriate
benefits approved
by the IEC, for the
time established by
the latter or until
access is
guaranteed by
other means
Access to study
medication/
procedure must be
guaranteed to the
patient if deemed to
be benefiting him,
for as long as it
benefits him as per
investigator /
physician judgment
and prescription.
Not clearly stated in
regultations
Not clearly stated in
regultations
All necessary care
should be provided
to avoid any issues
related to the
withdrawall of the
medication
Participants who
require continued
treatment at the
end of the study
shall have access
to the intervention
that has been
beneficial or to an
alternative
intervention or
other appropriate
benefits approved
by the IEC, for the
time established by
the latter or until
access is
guaranteed by
other means
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Compensation
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Patient cannot be
paid for his
participation in the
trial.
Patient cannot be
paid for his
participation in the
trial.
Patient cannot be
paid for his
participation in the
trial.
Patient cannot be
paid for his
participation in the
trial.
Patient cannot be
paid for his
participation in the
trial.
Patient cannot be
paid for his
participation in the
trial.
Reimbursement or
previous
compensation for
any patient´s study
cost
Reimbursement or
previous
compensation for
any patient´s study
cost
Reimbursement or
previous
compensation for
any patient´s study
cost
Reimbursement or
previous
compensation for
any patient´s study
cost
Reimbursement or
previous
compensation for
any patient´s study
cost
Reimbursement or
previous
compensation for
any patient´s study
cost
Avoid using
conditionals in
sentences.
Compensation may
applicable for
Bioequivalence and
phase I studies.
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Contraception methods
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
Not clearly stated in
regultations
Not clearly stated in
regultations
PERU
Description of the
mechanisms of
prevention and
protection of
pregnancy;
Description of the
mechanisms of
prevention and
protection of
pregnancy;
Description of the
mechanisms of
prevention and
protection of
pregnancy;
Abstinence may
not be allowed as
a contraceptive
method by some
Ecs.
Abstinence, sexual
and religious
orientations must
be respected.
Double Barrier
contraceptive
method is required.
Double Barrier
contraceptive
method is required.
(Catholic sites –
contraceptive)
(Catholic sites –
contraceptive)
Coverage of the
agreed
contraception
method between
investigator and
patient.
Coverage of the
agreed
contraception
method between
investigator and
patient.
Extends to female
Partners
Extends to female
Partners
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Description of the
mechanisms of
prevention and
protection of
pregnancy;
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Signatures
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Patient / Legal
Representative and
person responsivle
for consent.
Patient / Legal
Representative and
person responsivle
for consent.
Patient / Legal
Representative and
person responsivle
for consent.
Patient / Legal
Representative and
person responsivle
for consent.
Patient / Legal
Representative and
person responsivle
for consent.
Patient / Legal
Representative and
person responsivle
for consent.
Witness if
applicable
Impartial witness
Impartial witness
and Signature of
hospital director
(or delegates) is
required;
2 Impartial
witnesses (along
with relationship)
Witness if
applicable
Witness if
applicable
All pages must be
initialized by
PIs or Sis obtaining
signatures
PIs or Sis obtaining
signatures
PIs or Sis obtaining
signatures
PIs or Sis obtaining
signatures
1 Original to site
and 1 ORIGINAL to
the patient
1 Original to site
and 1 ORIGINAL to
the patient
1 Original to site
and 1 Copy to the
patient
1 Original to site
and 1 Copy to the
patient
Drug Information Association
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PIs or Sis obtaining
signatures
1 Original to site
and 1 ORIGINAL to
the patient
1 Original to site
and 1 Copy to the
patient
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Special Populations
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
PERU
Will require
signature from one
parent (shared
responsability), but
both signatures is
advisable or legal
representative
Will require
signature from one
parent (shared
responsability), but
both signatures is
advisable or legal
representative
Will require
signature from one
parent (shared
responsability), but
both signatures is
advisable or legal
representative
Will require
signature from both
parents (widowers
and etc), or legal
representative
Will require
signature from both
parents (widowers
and etc), or legal
representative
Will require
signature from both
parents (widowers
and etc), or legal
representative
Birth Certificate for
minors
Birth Certificate for
minors
Birth Certificate for
minors
Birth Certificate for
minors
Birth Certificate for
minors
No docs reqiored –
usually an ID from
parents
Assent Forms
when applicable
Assent Forms
when applicable
Assent Forms
when applicable
Assent Forms
when applicable
Assent Forms
when applicable
Assent Forms
when applicable
Signature of
impartial witness
(after verbal
assent) if subject/
legal rep is/are not
able to read
Drug Information Association
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Two witnesses
signatures required
(mandatory in all
cases);
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Sample Storage
ARGENTINA
BRAZIL
CHILE
COLOMBIA
MEXICO
Final destination of
the exported
samples, where will
they be stored,
duration of the
storage, and when
will the samples will
be destroyed.
Final destination of
the exported
samples, where will
they be stored,
duration of the
storage, and when
will the samples will
be destroyed.
Not clearly stated in
regultations
Not clearly stated in
regultations
Not clearly stated in
regultations
A clarification that
the samples will be
used for the
purposes described
in the Consent and
not for future use.
Sample storage if
necessary should
be stated in the
ICF. In case of
future use, further
descriptions are
necessary (441).
PK and PG –
recommended to
be apart from main
ICF
PK and PG –
recommended to
be apart from main
ICF
Drug Information Association
PERU
Sample storage if
necessary should
be stated in the
ICF. In case of
future use, further
descriptions are
necessary.
PK and PG –
recommended to
be apart from main
ICF
PK and PG –
recommended to
be apart from main
ICF
www.diahome.org
PK and PG –
recommended to
be apart from main
ICF
PK and PG –
recommended to
be apart from main
ICF
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That´s it!!!
• Thank you for your time.
• Questions:
– [email protected]
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