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INFORMED CONSENT

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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 ... – PowerPoint PPT presentation

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Title: INFORMED CONSENT


1
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

2
Why Informed Consent ?
3
Research Done The Wrong Way IThe 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

4
Research Done The Wrong Way IINazi 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

5
Informed Consent in Human ResearchThe Origins
  • Before the 20th century, guidelines required
    physicians need to adhere to acceptable medical
    standards
  • Issue of patients agreement to the research
    never discussed
  • Most requirements arose after the Nuremberg
    trials

6
Informed Consent in Human ResearchThe 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

7
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

8
Biomedical Research in HumansGuidelines for
Informed Consent
  • The Nuremberg Code, 1947
  • The Declaration of Helsinki, 1964 (2000)
  • The Belmont Report, 1979
  • ICH GCP, 1997
  • ICMR Guidelines, 2000

9
The Nuremberg CodeWhat 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

10
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

11
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

12
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

13
The Declaration of Helsinki andInformed 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

14
The Declaration of Helsinki andInformed 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

15
The Declaration of Helsinki andInformed 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

16
The Belmont ReportWhat 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

17
The Belmont Report and Informed Consent
  • Identifies three elements of the process
  • Information
  • Comprehension
  • Voluntariness

18
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 subjects
    capacities
  • Investigators must ascertain comprehension
  • Special provisions immaturity, mental
    disability
  • Voluntariness
  • There must be no coercion or undue influence

19
ICMR GuidelinesWhat 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

20
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)

21
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

22
Various terms
Informed Consent
  • 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

23
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


24
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
25
Information in informed consent
  • Provided in writing
  • The informed consent form
  • Discussed with the subject
  • Consent must be in a language the subject
    understands

26
Counseling
  • Who does the counseling.?
  • Clinical InvestigatorPreferably a senior who has
    experience or at least trained in counseling .

27
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

28
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

29
Study procedures
  • What is subjects 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

30
  • 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 /
  • subjects legally acceptable representative to
    waive
  • any legal rights or release investigator /
    sponsor
  • /institution from liability for negligence
  • Circumstances for termination of subjects
  • participation by investigator

31
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, LiV
32
  • 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

33
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
34
SUMMARY-INFORMED CONSENT
  • Moral, not just legal requirement
  • Comprehensibility essential
  • Cultural influences
  • Support information helpful
  • Pre-testing
  • Free of coercion

35
  • Format of informed consent form for subjects
    participating in clinical trial
  • Study Title
  • Study Number
  • Subject Initials ___________ Subjects Name
    ____________
  • Date of births / age ________
  • Please initial
  • box (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
  • Sponsors 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.

36
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
Signatorys Name Signature of the
Investigator Date Study Investigators Nam
e Signature of the witness Date
37
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)
  • Research Ethics Training Curriculum R.Rivera,
  • D. Borasky, R. Rice, Family Health
    International, 2001.
  • http//www.fhi.org
  • Designing Clinical Research An Epidemiologic
    Approach
  • Ed Stephen, B Hulley, Steven R. Cummings
    Williams
  • Wilkins, Batlimore

38
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.

39
Our Experience contd
  • Insurance
  • Dosage of drugs, expiry dates of drugs.
  • Compensation amount.
  • ICF Different languages.
  • ADVERSE EVENTS .
  • Diet

40

Thank you
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