This document discusses the importance and history of informed consent in clinical research. It provides definitions of informed consent from international guidelines and outlines the key principles of voluntary participation, comprehension, and disclosure of information. The summary also highlights some notable events that shaped standards of informed consent, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, and controversies like the Tuskegee Syphilis Study. Required components of informed consent forms are listed from ICMR guidelines in India.

1. Rajmeet Singh
Assistant Professor,
Department of
Pharmacology

2. Why Informed consent ?
Every individual has the right
to ‘Bodily integrity’
2

3. “A process by which a subject voluntarily
confirms his or her willingness to participate
in a participate in a particular trial, after
having been having been informed of all
aspects of the trial trial that are relevant to
the subject’s decision to decision to
participate.
Informed consent is documented by means of
a means of a written, signed and dated
informed informed consent form.”
Informed Consent - definition
3
InternationalConference on Harmonization
E6 -GoodClinicalPractice

4. Goal
“The goal of the informed consent process is to
provide people with sufficient information so
they can make informed choices about whether
to begin or continue participation in clinical
research.”
5

5. HISTORICAL BACKGROUND OF INFORMED
CONSENT
1891- Prussian Minister of Interior,tuberculin
For the treatment of tuberculosis must not be
used against a person’s will.
1898- Dr. Albert Neisser was fined by the Royal
disciplinary court of Prussia for not
Seeking patient’s consent forhis experimental
studies of vaccination for Syphilis.
1907- Sir William Osler endorsed the necessity
Of informed consentinmedicalresearch.
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6. Declaration of Helsinki, 1964
• A set of ethical principles regarding human
experimentation developed for the medical
community by the World Medical Association
• Originally adopted in June 1964 in Helsinki,
Finland,
• Since it has undergone six revisions (the most
recent at the General Assembly in October 2008)
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7. DoH…cont.
7
The Declaration developed the ten principles first
stated in the Nuremberg Code, and tied them to the
Declaration of Geneva (1948), a statement of
physician's ethical duties
The Declaration more specifically addressed
clinical research, reflecting changes
from the term 'Human Experimentation' used in the
Nuremberg Code.
Relaxation of the conditions of
consent, now research was allowed without
consent where a proxy consent, such as a legal
guardian, was available.

8. Tuskegee Syphilis Study
8
• Tuskegee study of untreated syphilis in Negro male began
in 1932 in Tuskegee, Alabama by PHS (Public Health
Service)
• Study purpose – to observe progression of disease in black
male (To compare result with OSLO study)
• In 1940s penicillin became a standard treatment
for Syphilis
• Still Penicillin was withheld from the patients

9. Tuskegee Syphilis Study…THE END
End of Experiment-
• 28 men died directly formsyphilis
• 100 dead of related complications
• 40 wives infected
• 19 children - congenital syphilis
On May 16, 1997, President Bill Clinton formally
apologised.
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10. National Research Act (1974)
10
• Congress mandated the establishment of
Institutional Review Boards (IRBs) to review all
federally funded human research
• Created the National Commission for the
Protection of Human Subjects of
Biomedical and Behavioural
Research.
• One of the Commission’s statements was “The
Belmont Report: Ethical Principles and Guidelines
for the Protection of Human Subjects of
Research’’

11. The Belmont Report
• Issued on 30 September, 1978 and published in the
Federal Register on 18 April, 1979
• Objective - “to provide an analytical framework
that will guide the resolution of ethical
problems arising from research involving human
subjects.”
• The Belmont Report is presented in three discussion
topics:
 Boundaries between practice and
research,
 Basic ethical principles
 Applications 11

12. Boundaries Between Practice and
Research
12
• Practice - interventions intended to solely improve
the health condition of the patient. The goal of
practice is to provide a diagnosis,
preventive treatment, or therapy that will enhance
the patient’s wellness.
• Research - activities designed to develop or
contribute to the general body of knowledge which
includes theories, principles, and relationships.
• Subjects must clearly know which study activities
are standard practice and which are research.

13. Application of Belmont Principles:
Applications of these principles to conduct
research requirescareful consideration of
A.Informed consent
B.Risks benefit assessment
C.Selection of subjects of research
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14. Belmont Report : Informed Consent
14
1. Research subjects are told every thing about the
study, including risks.
2. The information must be easy to understand.
3. Research subjects who agree to participate must
do so voluntarily, they must not be pressurized or
swayed into it.

15. INFORMED CONSENT PROCESS
INFORMATION
COMPREHENSION VOLUNTARINESS
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16. Conceptual framework – informed consent
process
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17. Difficulties With Informed Consent
Problems Physicians
may face
a.Use of technical language
b.Uncertainties intrinsic to
all medical information
c.Worried about harming
or alarming the patient
d.Hurried and pressed by
multiple duties
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Problems Patients
may face:
a. Limited knowledge
b. May be inattentive
or
distracted
c. Overcome by fear
and anxiety
d. Selective hearing
because of denial,
fear, or
preoccupation with
illness

18. ICMR Guidelines
• Ethical guidelines for research involving
humans
“Ethical Guidelines for Biomedical Research on Human
Subjects”
• Published by the Indian Council of Medical
Research in 2000
• Revised version - 2006
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19. Required components of ICF (ICMR
guideline, 2006)
1. Nature and purpose of study stating it as research
2. Duration of participation with number of participants
3. Procedures to be followed
4. Investigations, if any, to be performed
5. Foreseeable risks and discomforts adequately described and
whether project involves more than minimal risk
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20. Components of ICF…..cont.
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1. No loss of benefits on withdrawal
2. Benefit sharing in the event of commercialization
3. Contact details of PI or local PI/Co-PI in multicentric
studies for asking more information
4. Contact details of Chairman of the IEC for appeal
against violation of rights
5. Voluntary participation

21. Components of ICF…..cont.
21
If test for genetics and HIV is to be done,
counselling for consent for testing must be given
as per national guidelines
Storage period of biological sample and related data
with choice offered to participant regarding
future use of sample, refusal for storage and
receipt of its results

22. Obligations of investigators
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1. Communicate to prospective participants
2. Exclude unjustified deception, undue
influence and intimidation.
3. Seek consent only after the prospective participant is
adequately informed
4. Obtain a signed form as an
evidence of informed consent (written
informed consent) preferably witnessed by a person not
related to the trial.

23. Obligations of investigators
5. Take surrogate consent from the authorized
relative or legal custodian
6. Fresh informed consent of participant
wherever applicable
7. If participant loses consciousness or competence to
consent during the research period ( AD /
Psychiatric conditions) surrogate
consent may be taken from LAR
8. Assurance for continuation of existing benefits
even after withdrawal of consent 32

24. Fresh or Re-consent
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1. Availability of new information which would
necessitate deviation of protocol.
2. When a research participant regains consciousness
from unconscious state
3. When long term follow-up or study extension is
planned later.
4. When there is change in treatment modality,
procedures, site visits.
5. Before publication if there is possibility of
disclosure of identity ( data, photograph etc.)

25. Waiver of consent
1. When it is impractical to conduct research since
confidentiality of personally identifiable information has to
be maintained throughout research.
e.g. study on disease burden of HIV/AIDS.
2.Emergency situations, when surrogate consent unavailable
3.Research on anonymised biological samples from
deceased individuals, left over samples, cell lines etc.
4. Research on publicly available information, documents,
records, works, performances, reviews etc.
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26. Assent
• ‘Assent’ means a child's affirmative agreement to
participate
in research.
• “All paediatric participants should be
informed to the the fullest extent possible
about the study in a language
language and in terms that they are able to
understand.” – Schedule Y
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27. Community consent
• Communityconsent is generally obtained
through a process of dialogue with the
community leadership.
• Agreement from the community leadership is
obtained prior to, but does not replace, the
consent and/or assent of individual participants.
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28. Drug Trials & India
Recently, a PIL submitted to the SC suggested that big
pharmaceuticals including GlaxoSmithKline and MSD –
had tested two HPV vaccines
( gardasil and cervarix) on
almost 24,000 tribal girls in Andhra Pradesh and Gujarat
without proper consent.
‘Poor, sick, desperate. What more could Big Pharma ask in
Indian drug trials?’
- Anjana Ahuja, 2006
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