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Informed Consent
Ghaiath M. A. HusseinMBBS, MHSc. (Bioethics)
Research Ethics Workshop, Medani (Dec., 08)
04/21/23 2
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
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
Ghaiath Research Ethics Workshop Dec., 08. 3
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.
Ghaiath Research Ethics Workshop Dec., 08. 4
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
Ghaiath Research Ethics Workshop Dec., 08. 5
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
Ghaiath Research Ethics Workshop Dec., 08. 6
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.
Ghaiath Research Ethics Workshop Dec., 08. 7
Disclosure
VOLUNTARINESSCapacity
1. Disclosure
This refers to the process during which physicians provide information about the proposed research to the participant.
Ghaiath Research Ethics Workshop Dec., 08. 9
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 benefits4. Alternative procedures5. How confidentiality will be maintained
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
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 subjects4. Consequences of subject’s withdrawal from
research5. Statement that will be told of new findings6. Approximate number of subjects in study
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
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
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
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)
Ghaiath Ethics of Pt. Safety, July 08. 16
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.
Ghaiath Ethics of Pt. Safety, July 08. 17
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
Ghaiath Research Ethics Workshop Dec., 08. 18
04/21/23 19
VOLUNTARINESS
FREE OF UNDUE INFLUENCE PERSUATION: APPEALS TO REASON MANIPULATION COERCISION: EXPLICIT OR IMPLICIT
THREATS FORCE: RESTRAINT OR SEDATION
04/21/23 20
MANIPULATION DISTORTION OF FACTS OR OMISSION NON-COERCIVE ALTERNATION
OFCHOICES UNDUE FINANCIAL PAYMENT UNDUE INFLUENCE, GOVERNMENT
FUNDING ONLY AT GRADE 8 FOR HPV
04/21/23 21
CIRCUMSTANTIAL INFLUENCE
EXTERNAL: TIMING AND THE PERSON GIVING INFORMATION
DOCTOR AND PATIENT IN RESEARCH TRIAL CASES
THERAPEUTIC PRIVILEGE
Ghaiath Ethics 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.
Ghaiath Ethics 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, To each of the previous conditions, there are ethically-acceptable there are ethically-acceptable
exceptions exceptions
Ghaiath Ethics 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.
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.
DISCUSSION… Q & A
Now try your own consent form…
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
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