1. Informed Consent Ghaiath M. A. Hussein MBBS, MHSc. (Bioethics) Research Ethics Workshop, Medani (Dec., 08)

2. 12/13/20152 INFORMED CONSENT  “EVERY INDIVIDUAL HAS THE RIGHT TO KNOW WHAT RISKS ARE INVOLVED IN UNDERGOING OR FOREGONIG MEDICAL TREATMENT (research) AND CONCOMMITTANT RIGHT TO MAKE MEANINGFUL DECISIONS BASES ON A FULL UNDERSTANDING OF THOSE RISKS ….. JUDICIAL ATTEMPT TO REDRESS THE INEQUALITIES OF DOCTOR-PATIENT RELATIONSHIP.” HOLLIS v. DOW CORNING, 1995

3. Definition:  "autonomous authorization of a medical intervention … by individual patients/participants" (Beauchamp and Faden, 2004)  It's the practical expression of patient's autonomy, and the respect for him/her personality GhaiathResearch Ethics Workshop Dec., 08.3

4. Components of FIC: 1."Disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. 2."Capacity" refers to the patient's ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen. 3."Voluntariness" refers to the patient's right to come to a decision freely, without force, coercion or manipulation. GhaiathResearch Ethics Workshop Dec., 08.4

5. Exceptions to individually-given consent (from Hebert P. Doing Right)  Waiver by patient (do what you think best!)  Incompetence (consent given by SDM)  Emergency  “ therapeutic privilege ” (if disclosure would do harm than good to the patient)- less acceptable GhaiathResearch Ethics Workshop Dec., 08.5

6. FORMS OF CONSENT  Normally, should be provided by participants themselves.  Deferred consent is where the subject is entered into a research study and consent is gained from surrogates after a specified period of time for continuation of the subject ’ s inclusion in the trial.  Prospective informed consent represents an attempt to canvass support in advance from a population considered at risk of developing a serious illness.  Surrogate consent (SDM): ideally a substituted judgment made by a person responsible for health care decision-making for a particular patient under the relevant legislation GhaiathResearch Ethics Workshop Dec., 08.6

7. Practical challenges to a "Fully Informed Consent"  Diagnostic uncertainty  Complexity of medical information  Linguistic and cultural differences  Overworked health personnel  Paternalistic approach in doctor- patient relationship in developing countries, including Sudan. GhaiathResearch Ethics Workshop Dec., 08.7

8. Disclosure VOLUNTARINESSCapacity

9. 1. Disclosure  This refers to the process during which physicians provide information about the proposed research to the participant. GhaiathResearch Ethics Workshop Dec., 08.9

10. 10 Eight Required Elements [45 CFR 46.116(a) & 21 CFR 50.25] 1.Statement that study is research and information on purposes / duration / procedures / experimental procedures 2.Reasonably foreseeable risks or discomforts 3.Reasonably expected benefits 4.Alternative procedures 5.How confidentiality will be maintained

11. 11 Eight Required Elements [45 CFR 46.116(a) & 21 CFR 50.25] 6.Information on compensation for injuries (unless minimal risk) 7.Contact persons for information on research, injury, subject’s rights 8.Voluntary participation, no penalty or loss of benefits for refusal or withdrawal

12. 12 Six Additional Elements 1.Statement that there may be risks which are unforeseeable 2.Under what circumstances investigator could terminate subject’s participation 3.Additional costs to subjects 4.Consequences of subject’s withdrawal from research 5.Statement that will be told of new findings 6.Approximate number of subjects in study

13. 13 Informed Consent Document and Risks to Subjects  Adverse events vs. unanticipated problems  A risk or problem is unanticipated if it is not in the protocol or consent document  Risks discussed in the protocol should be included in the consent document  Questions raised as a result of an unanticipated risk: Does the informed consent form need to be amended? Do previously enrolled subjects need to be re- consented? Does a report need to be made to REC?

14. 14 Waiver of Informed Consent (not permitted in FDA-regulated studies)  REC must find and document that four (4) criteria have been satisfied: Minimal risk research Waiver or alteration will not adversely affect the rights and welfare of the subjects Research could not practicably be carried out without the waiver or alteration Subjects will be provided with additional pertinent information

15. 15 Documentation of Informed Consent  Written consent document  Language understandable to the subject or the subject’s Legally Authorized Representative (LAR)  Signed by subject or subject’s LAR  Copy SHALL be given to subject  Opportunity to read before signing

16. Principles for providing information to the participant:  make it clear; avoid jargon  use language appropriate to the patient's level of understanding in a language of their fluency  pause and observe patients for their reactions  invite questions from the patient and check for understanding  invite the patient to share fears, concerns, hopes and expectations  watch for patients' emotional response: verbal and non-verbal  show empathy and compassion  summarize the imparted information  provide contact information (and other resources) GhaiathEthics of Pt. Safety, July 08.16

17. 2. Capacity:  refers to the presence of a group/set of functional abilities a person needs to possess in order to make a specific decisions (Griso and Applebaum, 1998). These include:  To UNDERSTAND the relevant information  To APPRECIATE the relatively foreseeable consequences of the various available options available. GhaiathEthics of Pt. Safety, July 08.17

18. 3. Voluntariness:  refers to a participant’s right to make participation decisions free of any undue influence. Influences include:  Physical restraint or sedation  Coercion involves the use of explicit or implicit threat to ensure that the treatment is accepted  Manipulation involves the deliberate distortion or omission of information in an attempt to induce the patient to accept a treatment GhaiathResearch Ethics Workshop Dec., 08.18

19. 12/13/201519 VOLUNTARINESS  FREE OF UNDUE INFLUENCE  PERSUATION: APPEALS TO REASON  MANIPULATION  COERCISION: EXPLICIT OR IMPLICIT THREATS  FORCE: RESTRAINT OR SEDATION

20. 12/13/201520 MANIPULATION  DISTORTION OF FACTS OR OMISSION  NON-COERCIVE ALTERNATION OFCHOICES  UNDUE FINANCIAL PAYMENT  UNDUE INFLUENCE, GOVERNMENT FUNDING ONLY AT GRADE 8 FOR HPV

21. 12/13/201521 CIRCUMSTANTIAL INFLUENCE  EXTERNAL: TIMING AND THE PERSON GIVING INFORMATION  DOCTOR AND PATIENT IN RESEARCH TRIAL CASES  THERAPEUTIC PRIVILEGE

22. GhaiathEthics of Pt. Safety, July 08.22 C. C. Confidentiality  The duty to respect the patient ’ s/research participant confidence that the researcher/doctor will not disclose the information s/he received as part of research of health care.

23. GhaiathEthics of Pt. Safety, July 08.23 Measures to respect confidentiality  Avoid identifiable data  Encode the collected data  Limit access to data  Keep in password-protected PC  Destroy the original copies after analysis, or publication To each of the previous conditions, there are ethically- acceptable exceptions

24. GhaiathEthics of Pt. Safety, July 08.24 Case  Dr. B, a psychiatrist in private practice, is approached by a pharmaceutical company to assist with a clinical trial to test the efficiency of a new drug in the treatment of acute psychosis.  The study will enroll acutely psychotic patients with no history of psychosis (or of treatment with antipsychotic drugs) through physicians' clinics and emergency departments.

25. Case …cont.  Patients enrolled in the study will be randomly assigned to receive the new medication or a placebo and will remain in the hospital for eight weeks.  During this time, they will not be permitted to receive antipsychotic medication other than the study drug.  Informed consent will be obtained from each participant or proxy. Patients may be withdrawn from the study if their medical condition worsens substantially.

26. DISCUSSION… Q & A Now try your own consent form…

27. References  Presentations on Informed Consent by:  Dya Eldin Mohammed Elsayed, MD  WALLACE LIANG  Office for the Protection of Research Subjects (OPRS)  Case from Cambridge Textbook of Bioethics