INFORMED CONSENT
Dr. I. Manorama Thomas
B.Sc. (Hons.), MBBS; M.S; F.A.M.S.
Emeritus Professor, St. Johns Medical College,
Chairperson Independent Ethics Committee, Bangalore
Why Informed Consent ?
Research Done The Wrong Way – I
The Tuskeegee Syphilis Study *
Longest non-therapeutic experiment on human beings in medical
history: The progress of untreated syphilis (1932-72).
 399 poor African-American sharecroppers in rural Macon County,
Alabama, USA.


The men were told they were being treated for “bad blood”.

Even after penicillin was discovered and found to be a miracle cure, the
men were not treated or even told what they had.

US government officials went to extreme lengths to insure that they
received no therapy from any source.

Presidential apology, May 1997
* Tuskegee Syphilis Study Legacy Committee Final Report of May 20, 1996
Research Done The Wrong Way – II
Nazi Prisoner Research During World War II
Objectives of various trials:
– Effect of cold, heat, chemicals on men, women and children
– “Time to death” testing in response to stressors in healthy
“volunteers”
– Organ transplant experiments on healthy “volunteers”
 Any information given (some?) is irrelevant because prisoners were forced
to participate
 Outcome:
– 23 German scientists taken to court, 7 acquitted, 9 imprisoned, 7
given death sentence
– Nuremberg Code of 1947

Informed Consent in Human Research
The Origins
Before the 20th century, guidelines required
physician’s need to adhere to acceptable
medical standards
 Issue of patient’s agreement to the research
never discussed
 Most requirements arose after the Nuremberg
trials

Informed Consent in Human Research
The Origins

Emerges from the ethical principle of Respect for
Persons
– Individuals be treated as capable of taking decisions
for themselves (“autonomy”)
– Those with diminished autonomy be protected
What is informed consent?
Informed consent is a PROCESS
 Involves

– Providing all relevant information to the volunteer/
patient
– The patient/ volunteer understanding the information
provided
– Voluntarily agreeing to participate

A basic right
Biomedical Research in Humans
Guidelines for Informed Consent
The Nuremberg Code, 1947
 The Declaration of Helsinki, 1964 (2000)
 The Belmont Report, 1979
 ICH GCP, 1997
 ICMR Guidelines, 2000

The Nuremberg Code
What is it?
A set of 10 principles on research involving
humans
 Developed after the horrors of Nazi experiments
on humans became public
 Published in 1947

The Nuremberg Code and
Informed Consent

The voluntary consent of the human subject is
absolutely essential
– Person must have legal capacity to consent
– Should have “sufficient knowledge and
comprehension” to make an “understanding and
enlightened decision”
– Must be able to exercise “free power of choice”
The Nuremberg Code and
Informed Consent

Inform the subject of
–
–
–
–

The nature, duration and purpose
The method and means
All inconveniences and hazards
Possible effects on health
There should be no force, fraud, deceit, duress,
coercion
The Declaration of Helsinki
What is it?
A statement of ethical principles on research
involving humans
 Published by the World Medical Association
 Developed from the Nuremberg Code
 Made by physicians
 First adopted at Helsinki in 1964

The Declaration of Helsinki and
Informed Consent

Subjects must be
– Volunteers
– Informed participants
Consent be obtained, preferably in writing
 If subject in a dependent relationship with the
physician, consent be obtained by an
independent physician

The Declaration of Helsinki and
Informed Consent

Consent from legally acceptable representative
required if subject:
– Minor
– Incapable of giving consent
• Physical or mental disability

If subject is a minor, assent be taken, where
possible
The Declaration of Helsinki and
Informed Consent

When consent not possible prior to participation
in research
– Approved by the “review committee”
– Consent must be obtained as soon as possible from
the subject or a legally acceptable representative
The Belmont Report
What is it?
Ethical principles and guidelines for protecting humans
in clinical research
 Developed by a commission set up in the US in the
aftermath of the Tuskeegee Study becoming public
 Published in 1979

The Belmont Report and
Informed Consent

Identifies three elements of the process
– Information
– Comprehension
– Voluntariness
The Belmont Report and
Informed Consent

Information
– All information be provided
– Conditions under which information provided also important
(rapid/ disorganized manner?)

Comprehension
– Adapt presentation of information to subject’s capacities
– Investigators must ascertain comprehension
– Special provisions – immaturity, mental disability

Voluntariness
– There must be no coercion or undue influence
ICMR Guidelines
What are they?

Ethical guidelines for research involving humans
– “Ethical Guidelines for Biomedical Research on
Human Subjects”

Published by the Indian Council of Medical
Research in 2000
ICMR Guidelines and
Informed Consent





Participation must be voluntary
Participants must be “fully apprised of the research”
The investigator must obtain informed consent
– Responsibilities and information that must be
provided
Assent be obtained, where possible, for minors
Requirement for consent can be waived by an ethics
committee if risk is minimal (e.g. collecting data from
subjects’ records)
Summary

Guidelines require
– All relevant information be provided to subjects
– Ascertaining they understand what their participation
means for them
– Voluntary consent
– Protecting vulnerable subjects with additional
safeguards
Informed Consent
Various terms

Patient Information Sheet
– Provides only the information

Informed Consent Form
– Used to document consent

Both integrated in to one document
called the informed consent form
WHAT IS INFORMED CONSENT ?
Informed consent is … “consent given by a
competent individual who
• has received the necessary information
• has adequately understood the information
• after considering the information, has arrived
at a decision without having been subjected
to coercion, undue influence or inducement,
or intimidation”.
CIOMS International Ethical Guidelines
INFORMED CONSENT AS A PROCESS
Informed consent is a communication process :
• between the researcher and the participant
• starts before the research is initiated
• continues throughout the duration of the study
FHI, Research Ethics Training Curriculum
Information in informed consent

Provided in writing
– The informed consent form
Discussed with the subject
 Consent must be in a language the
subject understands

Counseling
Who does the counseling.?
 Clinical Investigator—Preferably a
senior who has experience or at
least trained in counseling .

PROCESS OF INFORMED CONSENT
Timing
Before screening
Nature of research project
• Explicitly state that it is research
• How subjects will be recruited
• Purpose / aim of research
• Investigators’ names & affiliations
What must a subject know?
Treatments

Trial treatment(s)
– Treatments
• Investigational product and placebo
• Investigational product and active
comparator
• Investigational product in different doses
– Probability for random assignment of
treatments
• “flipping a coin”/ “drawing a card”
• What chance that the subject would be
assigned to a particular treatment
– “equal chance”
Study procedures
•
What is subject’s involvement
•
Duration of study
•
Explain about sample collections (not just names
of tests)
•
Procedures which are research / experimental
•
If treatment, how different from conventional
•
Randomization / blinding
•
No. of subjects in study
Potential risks : Benefits
• Medical, social, psychological, economic
• Probability, magnitude
Participation
• Voluntary
• Can withdraw
• No penalty, no loss of benefits
No coercion
No statement / information that causes subject /
subject’s legally acceptable representative to waive
any legal rights or release investigator / sponsor
/institution from liability for negligence
Circumstances for termination of subject’s
participation by investigator
Any questions, further information
whom to ask rights of research subject, AEs
Language
• Clear, simple, non technical
• Sufficient time to make decision
• Give written information
• Translations written / verbal
• Thumb impressions allowed
• All signatures should be dated
ljy, Li”V
Confidentiality, privacy
adverse consequences of information eg. psychiatric
illness, sexual preferences, substance abuse,
to employers, insurance, legal authorities, HIV stigma
Monitor / auditor/IRB/IEC/ regulatory authority
have direct access to records without violating
confidentiality to extent permitted & subject
authorizes such access by signing consent
Publication, identity will remain confidential
WAIVER OF INFORMED CONSENT
• Minimal risk
• Rights and welfare of participants protected
• Research not possible without a waiver
• Appropriate information provided
FHI, Research Ethics Training Curriculum
SUMMARY-INFORMED CONSENT
• Moral, not just legal requirement
• Comprehensibility essential
• Cultural influences
• Support information helpful
• Pre-testing
• Free of coercion
Format of informed consent form for subjects participating in clinical trial
Study Title:
Study Number :
Subject Initials :___________
Date of births / age ________
Subject’s Name :____________
Please initial
box
1.
2.
3.
(Subject)
I confirm that I have read and understood the information sheet date
[
for the above study and have had the opportunity to ask questions
I understand that my participation in the study is voluntary and that I
[
am free to withdraw at any time, without giving any reason, without my
medical care or legal rights being affected.
I understand that the Sponsor of the clinical trial, others working on the [
Sponsor’s behalf, the Ethics Committee and the regulatory authorities will
not need my permission to look at my health records both in respects of
the current study and any further research that may be conducted in relation
to it, even if I withdraw from the trial. I agree to this access. However, I
understand that my identity will not be revealed in any information
released to third parties or published.
]
]
]
4. I agree not to restrict the use of any data or results that arise from this study [
provided such a use is only for scientific purpose(s)
5. I agree to take part in the above study
[
Signature (or Thumb impression) of the Subject/Legally acceptable
Representative :_______________
Date :
Signatory’s
Name
Signature of the Investigator :
Date
Study
Investigator’s
Name
Signature of the witness
Date
]
]
Resource Material
1. Ethical guidelines for Biomedical Research on Human
Subjects, Indian Council of Medical Research (ICMR)
New Delhi 2000
2. The Gazette of India Extraordinary Part II Section 3(I)
3. Research Ethics Training Curriculum R.Rivera,
D. Borasky, R. Rice, Family Health International, 2001.
http://www.fhi.org
4. Designing Clinical Research An Epidemiologic Approach
Ed Stephen, B Hulley, Steven R. Cummings Williams &
Wilkins, Batlimore
Our Experience
What IEC/IRBs should look for:
 Inspect facility in C.R.Os/
Hospitals/otherplaces, especially,
Space, ICU facilities, No. of beds,
whether bunker beds, Food-Hygiene
,Recreation &Toilet Facilities.
 DCGI permission.

Our Experience contd
Insurance
 Dosage of drugs, expiry dates of drugs.
 Compensation amount.
 ICF Different languages.
 ADVERSE EVENTS .
 Diet

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Guidelines on Informed Consent