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  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 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 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 subject’s 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. 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

  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 Investigator—Preferably 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 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

  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. 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

  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 :___________ Subject’s 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 [ ] • 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’s Name Signature of the Investigator : Date Study Investigator’s Name 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. • • 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. Insurance Dosage of drugs, expiry dates of drugs. Compensation amount. ICF Different languages. ADVERSE EVENTS . Diet Our Experience contd

  40. Thank you