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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.

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Presentation on theme: "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."— Presentation transcript:

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 – 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

4 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

5 Informed Consent in Human Research The Origins Before the 20 th 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

6 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

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 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

9 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

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 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

14 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

15 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

16 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

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 subject’s capacities –Investigators must ascertain comprehension –Special provisions – immaturity, mental disability Voluntariness –There must be no coercion or undue influence

19 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

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 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 Informed Consent

23 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 WHAT IS INFORMED CONSENT ?

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 Investigator—Preferably a senior who has experience or at least trained in counseling.

27 PROCESS OF INFORMED CONSENT Nature of research project Timing Before screening 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 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

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 / 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

31 Clear, simple, non technical Sufficient time to make decision Give written information Translations written / verbal Thumb impressions allowed All signatures should be dated Any questions, further information whom to ask rights of research subject, AEs Language ljy, Li”V

32 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 Confidentiality, privacy adverse consequences of information eg. psychiatric illness, sexual preferences, substance abuse, to employers, insurance, legal authorities, HIV stigma

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 :___________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.

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 : Signatory’sName Signature of the Investigator :Date StudyInvestigator’sName Signature of the witness Date

37 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 Resource Material

38 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

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

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