Informed Consent

Ghaiath M. A. Hussein
MBBS, 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
interventionby individual
patients/participants" (Beauchamp and Faden, 2004)
It's the practical expression of
patient's/participants 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/participants
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, Dec. 08.
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 subjects 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, Dec. 08.
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.
Ghaiath Research Ethics, Dec. 08.
Ghaiath Research Ethics, Dec. 08.
1. Disclosure
This refers to the process during which
researchers provide information about the
proposed research to the participant.
Ghaiath Research Ethics, Dec. 08.
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
Ghaiath Research Ethics, Dec. 08.
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, subjects rights
3.Voluntary participation, no penalty or loss of
benefits for refusal or withdrawal
Ghaiath Research Ethics, Dec. 08.
Six Additional Elements
1. Statement that there may be risks which are
unforeseeable
2. Under what circumstances investigator could terminate
subjects participation
3. Additional costs to subjects
4. Consequences of subjects withdrawal from research
5. Statement that will be told of new findings
6. Approximate number of subjects in study
Ghaiath Research Ethics, Dec. 08.
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?
Ghaiath Research Ethics, Dec. 08.
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 research
o Waiver or alteration will not adversely affect the
rights and welfare of the subjects
o Research could not practicably be carried out
without the waiver or alteration
o Subjects will be provided with additional pertinent
information
Ghaiath Research Ethics, Dec. 08.
Documentation of Informed Consent
Written consent document
Language understandable to the subject or
the subjects Legally Authorized
Representative (LAR)
Signed by subject or subjects LAR
Copy SHALL be given to subject
Opportunity to read before signing
Ghaiath Research Ethics, Dec. 08.
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 Research Ethics, Dec. 08.
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 Research Ethics, Dec. 08.
3. Voluntariness:
refers to a participants 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, Dec. 08.
Ghaiath
VOLUNTARINESS
FREE OF UNDUE INFLUENCE
PERSUATION: APPEALS TO REASON
MANIPULATION
COERCISION: EXPLICIT OR IMPLICIT
THREATS
FORCE: RESTRAINT OR SEDATION
Research Ethics, Dec. 08.
Ghaiath
MANIPULATION
DISTORTION OF FACTS OR OMISSION
NON-COERCIVE ALTERNATION
OFCHOICES
UNDUE FINANCIAL PAYMENT
UNDUE INFLUENCE, GOVERNMENT
FUNDING ONLY AT GRADE 8 FOR HPV
Research Ethics, Dec. 08.
Ghaiath
CIRCUMSTANTIAL INFLUENCE
EXTERNAL: TIMING AND THE PERSON
GIVING INFORMATION
DOCTOR AND PATIENT IN RESEARCH
TRIAL CASES
THERAPEUTIC PRIVILEGE
Research Ethics, Dec. 08.
Ghaiath Research Ethics, Dec. 08.
C. Confidentiality
The duty to respect the patients/research
participant confidence that the
researcher/doctor will not disclose the
information s/he received as part of research
of health care.
Ghaiath Research Ethics, Dec. 08.
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
Ghaiath Research Ethics, Dec. 08.
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.
Ghaiath Research Ethics, Dec. 08.
DISCUSSION Q & A
Now try your own consent form
Ghaiath Research Ethics, Dec. 08.
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
Ghaiath Research Ethics, Dec. 08.