INFORMED CONSENTPrinciples, Practice, and legal challenges by Dr.T.V.Rao MD

1. INFORMED CONSENT
Principles, Practice, and
legal challenges
DR.T.V.RAO MD
Chairman
Azeezia Ethics Committee
Azeezia Medical College
Kollam , Kerala

2. AZEEZIA ETHICKS COMMITTEE
Azeezia Medical College
Kollam

3. We all started practicing after

4. Why Doctors need ethics

5. 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 cannot be tampered

6. Components of an Acceptable
Informed Consent
Decision-Making Capacity
Complete Disclosure
Understanding
Authorization
6

7. 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

8. Understanding Informed Consent
• Millions of volunteers participate in
government- and industry-sponsored clinical
trials each year. Prior to agreeing to
participate, every volunteer has the right to
know and understand what will happen during
a clinical trial. This is called informed
consent and it is a process that can help you
decide whether or not participating in a trial is
right for you

9. Research Done The Wrong Way – II
Nazi Prisoner Research During World War
• 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

10. 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

11. 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

12. 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)

13. The participant should know well
• When any one gives written
consent to participate in a clinical
trial, they are acknowledging
that they understand and
accept all aspects of the
research study—including any
risks or benefits involved.

14. Physician has a Ethical obligation
• The physician has an ethical obligation to help
the patient make choices from among the
therapeutic alternatives consistent with good
medical practice. Informed consent is a basic
policy in both ethics and law that physicians
must honor, unless the patient is unconscious
or otherwise incapable of consenting and
harm from failure to treat is imminent

15. A Step wise approach in
communication of Information
• Physicians need not communicate all
information at one time, but should
assess the amount of information
that patients are capable of receiving
at a given time and present the
remainder when appropriate

16. The Role of the Physician is
important
• Physicians themselves, rather than a
representative, nurse, or other related health
care professional, are the best choice to speak
to the patient about informed consent. In
discussing the matter with the patient, the
physician should cover:
• The patient's diagnosis, if it is known.
• The nature and purpose of the proposed
treatment or procedure.

17. Pros and Cons in Communication
• The benefits and the risks of that proposed
treatment or procedure.
• The alternatives to the proposed treatment or
procedure.
• Alternatives should be discussed regardless of
their cost and regardless of whether they will
likely be covered by the patient's health
insurance.
• .
• .
• -

18. Consent form should include
• The form will have information specifically about
the procedure. Generally speaking, a to Your
surname, given names, date of birth, sex and
other details
• Whether or not an interpreter is required
• An explanation of your condition, in plain
language
• An explanation of the procedure, in plain
language
• General risks of anaesthesia, which may be
included in a separate form

19. Obtaining Consent from Incompetent
Individuals and Minors
• In most cases, a mentally disabled person has an
appointed guardian authorized to make medical
decisions, informed consent, for that individual.
Medical providers need to make sure that when they
obtain informed consent for incompetent individuals,
they have obtained it from the correct person or
persons.
• In most situations, parents can give informed
consent for treatment for their minor children.
• -

20. What Signature means ?
• However, informed consent is not
strictly about signing a document. It
is a process that involves ongoing
conversations between the research
staff and you before, and even after,
you decide to become a study
volunteer.

21. A open discussion avoids legal
litigations
• To begin, the research staff is
obligated to discuss all the pertinent
information about the trial—its
purpose, the procedures involved,
the potential risks and benefits—
with you. It is your responsibility to
ask questions if there is something
you do not understand.

22. ALL RESEARCHERS MUST
EXPALIN BEFORE THE RESEARCH
COMITTE

23. About the clinical trial
must explain before the Ethical Committee
• That is the main purpose of the study?
• Why is this study important to me?
• What are the chances that this drug will work?
• What kinds of risks are involved?
• How much of my time will this take?
• Does the study involve a placebo or a
treatment already on the market?

24. • 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
Study procedures

25. 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 subje
subject’s legally acceptable representative t
any legal rights or release investigator / spon
/institution from liability for negligence
Circumstances for termination of subject’s
participation by investigator

26. SUMMARY-INFORMED CONSENT
• Moral, not just legal requirement
• Comprehensibility essential
• Cultural influences
• Support information helpful
• Pre-testing
• Free of coercion

27. Format of informed consent form for subjects participating in clinical trial
Study Title:
Study Number :
Subject Initials :___________ Subject’s Name :____________
Date of births / age ________
Please initial
box (Subject)
1. I confirm that I have read and understood the information sheet date [ ]
for the above study and have had the opportunity to ask questions
2. 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.
3. 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.

28. 28
Was this initial interaction with
the patient approached
appropriately?
Would you have done
anything differently?

29. EMERGING CHALLENGES TO
RESEARCHERS
• Who will review information
collected about me during the trial?
• What happens if I decide to quit the
study?
• Can the investigator take me out of
the study even if I want to
continue?

30. 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

31. Reference and Adopted from
Dr. I. Manorama Thomas
Emeritus Professor, St. Johns Medical
College,
Chairperson Independent Ethics Committee,
Bangalore
From Google page.

32. Ethics for long term success