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Informed Consent

Ghaiath M. A. HusseinMBBS, MHSc. (Bioethics)

Ghaiath

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

Research Ethics, Dec. 08.

Definition:• "autonomous authorization of a medical

intervention…by individual patients/participants" (Beauchamp and Faden, 2004)

• It's the practical expression of patient's/participant’s autonomy, and the respect for his/her personality

Ghaiath Research Ethics, Dec. 08.

Components of FIC:1."Disclosure" refers to the provision of relevant

information by the clinician (researcher) and its comprehension by the patient (participant).

2."Capacity" refers to the patient's/participant’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.


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


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

(researcher-participant) relationship in developing countries.


1. Disclosure• This refers to the process during which

researchers provide information about the proposed research to the participant.


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 discomforts3.Reasonably expected benefits4.Alternative procedures5.How confidentiality will be maintained


Eight Required Elements[45 CFR 46.116(a) & 21 CFR 50.25]

1.Information on compensation for injuries (unless minimal risk)

2.Contact persons for information on research, injury, subject’s rights

3.Voluntary participation, no penalty or loss of benefits for refusal or withdrawal


Six Additional Elements1. Statement that there may be risks which are

unforeseeable2. Under what circumstances investigator could terminate

subject’s participation3. 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


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:

o Does the informed consent form need to be amended?o Do previously enrolled subjects need to be re-consented?o Does a report need to be made to REC?


Waiver of Informed Consent(not permitted in FDA-regulated studies)

• REC must find and document that four (4) criteria have been satisfied: o Minimal risk researcho Waiver or alteration will not adversely affect the

rights and welfare of the subjectso Research could not practicably be carried out

without the waiver or alterationo Subjects will be provided with additional pertinent

information


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)


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.


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

VOLUNTARINESS• FREE OF UNDUE INFLUENCE• PERSUATION: APPEALS TO REASON• MANIPULATION• COERCISION: EXPLICIT OR IMPLICIT

THREATS• FORCE: RESTRAINT OR SEDATION


Ghaiath

MANIPULATION• DISTORTION OF FACTS OR OMISSION• NON-COERCIVE ALTERNATION

OFCHOICES• UNDUE FINANCIAL PAYMENT• UNDUE INFLUENCE, GOVERNMENT

FUNDING ONLY AT GRADE 8 FOR HPV


Ghaiath

CIRCUMSTANTIAL INFLUENCE• EXTERNAL: TIMING AND THE PERSON

GIVING INFORMATION• DOCTOR AND PATIENT IN RESEARCH

TRIAL CASES• THERAPEUTIC PRIVILEGE



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.


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

publicationTo each of the previous conditions, there

are ethically-acceptable exceptions


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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