Informed consent: Definition & elements

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Informed consent: Definition & elements

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Informed consent: Definition & elements

  1. 1. Informed Consent Form Dr. Ghiath Alahmad
  2. 2. What is “Consent?” Defined as permission, approval, or assent Touching a person without consent constitutes a battery, and putting a person in fear of being touched without consent is assault.
  3. 3. What is “INFORMED Consent”? Consent given by the patient based on knowledge of the procedure to be performed, including its risks and benefits, as well as alternatives to the proposed treatment.
  4. 4. Purpose of Consent Respect Subject’s Will .. Understand nature of research Be informed of purpose, risks, and benefits, and alternative therapies Make a Voluntary Decision about Participation
  5. 5. “Informative” Informed Consent What you need to know about informed consent. What you need to do to create an “informative” Informed Consent Form.
  6. 6. Types of Consent Expressed consent =either oral or written consent by the patient to undergo a specific procedure or treatment. Implied consent =inferred from the circumstances. It is rarely documented and is relied upon for care or treatment that is routine and does not involve significant risk.
  7. 7. Types of Consent Expressed consent =either oral or written consent by the patient to undergo a specific procedure or treatment. Implied consent =inferred from the circumstances. It is rarely documented and is relied upon for care or treatment that is routine and does not involve significant risk.
  8. 8. Types of Consent Expressed consent =either oral or written consent by the patient to undergo a specific procedure or treatment. Implied consent =inferred from the circumstances. It is rarely documented and is relied upon for care or treatment that is routine and does not involve significant risk.
  9. 9. REQUIRMENTS
  10. 10. REQUIRMENTS
  11. 11. Voluntariness REQUIRMENTS
  12. 12. Voluntariness Disclosure REQUIRMENTS
  13. 13. Voluntariness Disclosure Understanding REQUIRMENTS
  14. 14. Voluntariness Disclosure Competence Understanding REQUIRMENTS
  15. 15. Voluntariness Disclosure Competence UnderstandingREQUIRMENTS
  16. 16. 1 & 4: Competence and Voluntariness Competence = the ability to perform a certain task. The task at hand is to make a decision that reflects your values and assessment of likely outcomes Values Assessment Ability Task Competence
  17. 17. Force & Excessive influence Competence Invalid Consent 1 & 4: Competence and Voluntariness
  18. 18. Respecting persons Autonomy  Informed Consent Autonomy is self-governance Respecting their right of self-determination Getting their consent for medical treatment Protecting their Ability Competencyinformed understanding
  19. 19. Evaluating Decision-Making Capacity Ability to understand Ability to evaluate Ability to communicate
  20. 20. Competence ? Proxy Voluntary inpatient mental health services Convulsive treatment Psychosurgery Abortion Neglect of the patient through the omission of care primarily intended to provide for the comfort of the patient
  21. 21. The research presents no greater than minimal risk to the child The permission of the child’s parents or guardians The assent of the child
  22. 22. Children and Informed Consent 18 17 16 15 14 13 12 11 10 9 8 7 6 5 For children under 7 years of age, it is an informal process Children 7 – 11 years of age, assent is verbally obtained and documented in the research records Minors 12 – 17 years of age, should be given the opportunity to document their assent on an IRB approved assent form Assent Consent
  23. 23. General guidelines of what information is required for informed consent The nature of the procedure The risks of the procedure The alternatives to the procedure The expected benefits of the procedure The probable outcome 2 & 3: Disclosure and Understanding
  24. 24. No Understanding = No Consent 2 & 3: Disclosure and Understanding Informed Consent = Shared Decision-Making
  25. 25. Elements of Informed Consent
  26. 26. Basic Elements Benefits Contact Purposes Risks Alternative Confidentiality Compensation Voluntary
  27. 27. termination costs be provided Number Additional Elements Unexpected Risks Consequences of Withdrawal
  28. 28. BASIC Elements
  29. 29. The 8 Mandatory Elements of Informed Consent A statement that the study involves research, an explanation of the purposes of the research Description of the procedures Identification of any procedures which are experimental Duration
  30. 30. A description of any reasonably foreseeable risks or discomforts to the subject. Risks & Discomforts The 8 Mandatory Elements of Informed Consent
  31. 31. A description of any benefits to the subject or to others which may reasonably be expected from the research. Benefits Self Other s The 8 Mandatory Elements of Informed Consent
  32. 32. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. Alternative treatments The 8 Mandatory Elements of Informed Consent
  33. 33. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Confidentiality The 8 Mandatory Elements of Informed Consent
  34. 34. For research involving more than minimal risk: •an explanation as to whether any compensation •and an explanation as to whether any medical treatments are available if injury occurs and, •if so, what they consist of, or where further information may be obtained. Compensation Including Treatments The 8 Mandatory Elements of Informed Consent
  35. 35. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research-related injury to the subject. Contacts The 8 Mandatory Elements of Informed Consent
  36. 36. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Voluntary The 8 Mandatory Elements of Informed Consent
  37. 37. Additional Elements When Appropriate
  38. 38. Additional Elements, When Appropriate A statement that the particular treatment or procedure may involve risks to the subject (or embryo or fetus, if the subject is or may become pregnant) which are currently unexpected. Unexpected Risks
  39. 39. Estimated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent. Termination Additional Elements, When Appropriate
  40. 40. Any additional costs to the subject that may result from participation in the research Additional costs Additional Elements, When Appropriate
  41. 41. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject Consequences of withdraw Additional Elements, When Appropriate
  42. 42. A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject. New findings Additional Elements, When Appropriate
  43. 43. The approximate number of subjects involved in the study. Number of subjects Additional Elements, When Appropriate

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