Informed consent


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Informed Consent in Clinical Researches

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  • We do not have national guidelines
  • Take the time at the initial discussion Test subject comprehensionYou sholuld consider contiinuingcoprehension at everthy time you/...Discuss new information that may impact a subject’s willingness to continue study participation (i.e., new known risks, benefits, alternatives, changes in study design, etc.)Remind subject of study goals and objectives this will improve subject compliance with the protocol and improve retention of subjects
  • Free choice from the start and at any time “u can withdraw”
  • Free choice from the start and at any time “u can withdraw”
  • Free choice from the start and at any time “u can withdraw”
  • Free choice from the start and at any time “u can withdraw”
  • Informed consent

    1. 1. Informed Consent
    2. 2. Outline: 1. What is Informed Consent 2. Ethical basis: Why? 3.The consent process. 4. What is required to obtain a valid Informed Consent? 5. Elements of informed consent. 5. Special situations 6. Conclusions
    3. 3. Informed consent is ??Processor aDocumenta
    4. 4. Consent is a continuous process, not a one-time event. A document. useful information for subjects names and contact information reminder about study procedures
    5. 5. Facts  Researchers need the person to enroll.  Research can do harm.  Protocols may require specific procedures that may not be the best alternative.  Researchers may be blinded to potential alternatives.  Therapeutic misconception of research subjects.
    6. 6. •Applies the ethical principle: respect for persons. •Facilitates trust in the research enterprise. Informed consent
    7. 7. It is no longer an option. It is now a must under the current guidelines & regulations
    8. 8. The Consent process: Information provided Information understood Decision made Comprehension monitored and maintained
    9. 9. The Process of Consent:  Choose the right environment and location to obtain consent.  Involve multiple health care personnel as necessary.  Include family members in the process as warranted.  Ensure that the subject or Legally Authorized Representative is competent.
    10. 10. The Process of Consent: (cont’d)  Ensure the subject or LAR has sufficient understanding.  Continue the process of consent throughout the study.
    12. 12. The Plan 1. Identify obstacles to participation in study and ways to overcome obstacles 2. Identify words subject may not understand 3. Compile “Frequently Asked Question” list 4. Decide who will do consent discussion 5. Decide where consent discussion will be held 6. Provide adequate time to explain study to subject 7. Provide adequate time for subject to read and consider and for questions to be answered
    13. 13. Consent Process Plan .1Identify the obstacles to subject participation and ways to overcome the obstacles TRANSPORTATION FAMILY WORK
    14. 14. Obstacles to Participation How Obstacles Will Be Resolved Generic Obstacles 1 1 2 2 3 3 Study Specific Obstacles 1 1 2 2 3 3
    15. 15. Consent Process Plan 2. Identify words subject may not understand in ICF Placebo “a small animal like an amoeba” IRB / IEC “a committee that reviews your medical records to see if you should be institutionalized” Double blind “Means being blind in both eyes”
    16. 16. “Double Blinded Placebo Controlled study to measure the efficacy of XXXXXX” How can you translate it to Arabic ? XXXXX
    17. 17. Consent Process Plan 3. Compile list of questions the subjects may ask about the study and appropriate responses
    18. 18. Consent Process Plan 4. Decide who will conduct consent discussion  Investigator may obtain consent  Investigator may delegate responsibility to a knowledgeable person.  Investigator is ultimately responsible for assuring informed consent has been appropriately obtained
    19. 19. Consent Process Plan 5. Decide where consent discussion will be held  Conduct in a quiet area  Subject should have adequate uninterrupted time  Easy access to a study doctor  Provide space for family members or friends to be present during the consent discussion
    20. 20. Consent Process Plan 6. Provide adequate time to explain the study and study procedures to the subject  Create a visual description when possible to foster understanding  Use patient education tools / brochures to assist in discussion  Explain the responsibilities of study participation
    21. 21. Consent Process Plan 7. Provide adequate time for subject to read and consider - No undue influence or coercion - Allow subject to take consent home to discuss with families or friends 8. Provide time for questions to be answered
    22. 22. Consent Process Plan -“How frequently will you need to come to the clinic during the study?” -“When can you decide if you want to discontinue from the study?” -“What medications must you avoid while in the study?” 9. Use open-ended questions to assess if subject has received adequate information to make an informed decision
    23. 23. Consent Process Plan 10. Avoid closed-ended questions  “Do you understand?”  “Do you have any questions?”
    24. 24. Consent Process Plan 11. An important step towards successful and ethical clinical research
    25. 25. When should Informed Consent be obtained?  Obtain consent after approval by Sponsor and IRB / EC.  Obtain consent prior to initiation of any clinical procedures that are performed solely for purpose of determining eligibility for research
    26. 26. DateSubject or Legally Acceptable Representative Person Conducting Review of Consent Date DateWitness Who can sign the Consent Form? Impartial Witness
    27. 27. Documentation of Informed Consent Process  Check that contact information is complete on ICFs given to subject  Provide subject with one of the copies of the signed and dated ICF  File the original signed and dated ICF in the subject file  Document study participation in medical records of subject
    28. 28. Construction of a complete and readable consent form can be a difficult task even in the 21st century
    29. 29. What is required to obtain a valid informed consent?
    30. 30. All studies must have informed consent prospectively obtained from each research subject (or LAR).  All types.  Level of risk.  Unless REC waives.
    31. 31.  Approved by the REC.  Signed by the subject or LAR.  A copy must be given to the person signing the form. Informed consent must be documented using a written consent form .
    32. 32. A good consent form:  Complete information  Accurate information  In compliance with regulations and guidelines  Short simple sentences  Simple understandable language  Culturally sensitive language
    33. 33. Elements of informed consent Essential Additional
    34. 34. Voluntary participation Contact information Compensation Confidentiality Alternatives Benefits Risks Purpose Essential
    35. 35. Additional elements:  Statement that there may be risks which are unforeseeable  Withdrawal criteria  Additional costs to subjects  Consequences of subject’s withdrawal from research  Statement that will be told of new findings  Approximate number of subjects in study
    36. 36. No single model represents a Blue-Print for all countries
    37. 37. Common Findings:  Too long consent form  Too complicated language, Section describing what procedures  Not all the objectives mentioned in the protocol are mentioned in the consent form  Alternative are not mentioned.
    38. 38. Common Findings:  Procedures do not accurately describe all relevant issues – for example: How many times for blood samples to be withdrawn?  Benefits of the research are over-stated  Risks are not complete.
    39. 39. To be adequate an informed consent requires that : Subject Autonomous Decision making capacity
    40. 40. Children Pregnant women Mentally ill Prisoners Minorities… Vulnerable groups:
    41. 41. Children’s assent To use children in research, you must first obtain the permission of the parent(s) and then obtain assent from the child.
    42. 42. Waiver of informed consent  Waiving Documentation of Consent.  Waiving Some elements of Consent.  Waiving All of the elements of Consent.
    43. 43. Waiver of consent Uncommon and exceptional
    44. 44. All studies Must have a consent form or a waiver of consent.
    45. 45. More than Minimal Risk? yes Will waiving adversely affect subjects` rights? yes No Practical to do research without waiver? No Information will be provided later” if appropriate” yes No yesNo No waiving No waiving No waiving No waivingREC approve Waiver
    46. 46. Proper informed consent: Disclosure Understanding Voluntariness
    47. 47. Proper informed consent: Disclosure Understanding Voluntariness What to tell How to tell Circumstances
    48. 48. Proper informed consent: Disclosure Understanding Voluntariness Challenges?? How to assess Therapeutic misconception/ randomization
    49. 49. Proper informed consent: Disclosure Understanding Voluntariness Free choice No coercion No undue inducement Affected by:  Power relation  Restricted choices  Illness  Incentives
    50. 50. Challenges regarding informed consent Four main challenges: Illiteracy Culture,traditions and religion Stored biological samples Child assent
    51. 51. Informed consent and illiteracy  In one of the clinical trials an old illiterate villager told the researchers: “I understood all what you said and I agree to participate in this trial but I used not to sign any paper”  What should the researchers do??
    52. 52. Culture, traditions and religion + Stored biological samples Local Research Ethics regulations and LAW are required
    53. 53. Children  Every routine intervention that is undertaken on the child requires consent from the parents.  If the child is able to understand some aspects of the research study, then his or her “assent” must be obtained in addition to the parents’ permission.
    54. 54. Child Assent  What ages? 7 years – 14 years – 16 years – 18 years – 19 years – less than 21 years???  Written vs oral  What information should be given?
    55. 55. Willowbrook Studies  From 1966 to 1969, hepatitis studies were carried out at the Willowbrook State School, a NY institution for mentally defective persons.  These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease.
    56. 56.  The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts from stools of infected individuals, and later subjects received injections of more purified virus preparations.
    57. 57. Willowbrook Studies  Investigators defended the deliberate injections of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to get infected under carefully controlled research conditions.
    58. 58. The investigators also defended the study by stating that: They obtained parental consent The children would receive a subclinical infection followed by immunity to the particular hepatitis virus. The study had extreme value in understanding an important disease that would lead to a vaccine.
    59. 59. Willowbrook Studies  During the course of these studies, Willowbrook closed its doors to new patients, but because the research program had its own space, it was able to admit new patients.  Subsequently, parents were able to gain admission for their children only if they agreed to have their children enrolled in the study.
    60. 60. Consent Letter ???  Dear_______________:  We are studying the possibility of preventing epidemics of hepatitis on a new principle. Virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow. This may give the children immunity against this disease for life. We should like to give your child this new form of prevention with the hope that it will afford protection.  Permission form is enclosed for your consideration. If you wish to have your child given the benefit of this new preventative, will you so signify by signing the form.  Sincerely, H. H. Berman, MD We should like to give your child this new form of prevention with the hope that it will afford protection. If you wish to have your child given the benefit of this new preventative, ……
    61. 61. Case 1  An investigator interviews a potential research subject, explaining the purpose of the study, the foreseeable risks, etc. The subject smiles at the investigator and says, “I am a simple man and I don’t understand all this medical stuff and I don’t think I ever will. But if you believe I should let you do research on me, I will.”  Would it be ethical to enroll that person into the study?
    62. 62. Case 2  A post graduate student was asked by his professor to participate in the control group of the professor’s clinical trial.  Is It Ethical to recruit the student?  What should the student do?
    63. 63. Case # 3  An investigator would like to measure cytokines levels in bronchoalveolar lavage fluid from patients with suspected lung cancer lesions.  He has a colleague who does bronchoscopies on such patients and he asks this colleague if he could obtain an extra 15 cc of lavage fluid from these patients when they undergo bronchoscopy to diagnose the etiology of their lung masses.
    64. 64.  Should informed consent be waived for the obtainment of the additional 15cc of lavage fluid?
    65. 65. Case # 4  An oncologist-investigator is conducting a chemotherapy clinical trial and is actively enrolling patients. Within his clinical practice, at the request of the families, he does not tell many of his patients their cancer diagnosis. Non- disclosure of diagnosis also occurs even if the patients receive chemotherapy.  Based on this culture related factor, he requests from the REC permission to enroll cancer patients in his chemotherapy trials without telling them their cancer diagnosis. He is concerned that a requirement to reveal such information will hinder enrollment.  Should the REC grant a waiver of consent?
    66. 66. Case # 5  An investigator is recruited to do a Phase 4 study for a drug company that aims to collect data on side effects of a recently approved drug for hypertension.  She will obtain data from the patients she sees in her private clinic.
    67. 67. Case #5 Cont.  The data she sends to the drug company will not contain any identifying information  Could informed consent be waived for this study?
    68. 68. Case # 6  An investigator is recruiting patients for a clinical trial and he has discovered that his subjects are taking the informed consent document to their private physicians, who are persuading the subjects to withdraw from the clinical trial. The subjects are told that the trial is too risky and unethical.  Hence, the investigator tells the REC that he will no longer give his subjects the consent document. He states that the larger number of dropouts is ruining the statistical power of the clinical trial.  Should the REC agree with the investigator?
    69. 69. Cases on Informed Consent  An investigator wants to do a retrospective medical record review of patients admitted to the hospital during the last five years. All data will be recorded anonymously.  Should a waiver of informed consent be granted?
    70. 70. BOTTOM LINE The ultimate responsibility for protection of the rights and welfare of research subjects rests with the principal investigator. Obtainment of valid informed consent is an important part of that protection.
    71. 71. Honesty builds Trust
    72. 72. 76