informed consent: definition & elements
DESCRIPTION
Informed consent: Definition & elementsTRANSCRIPT
Informed Consent Form
Dr. Ghiath Alahmad
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.
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.
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
“Informative” Informed Consent
What you need to know about informed consent.
What you need to do to create an “informative” Informed Consent Form.
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.
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.
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.
REQUIRMENTS
REQUIRMENTS
Voluntariness
REQUIRMENTS
Voluntariness Disclosure
REQUIRMENTS
Voluntariness Disclosure
UnderstandingREQUIRMENTS
Voluntariness Disclosure
Competence UnderstandingREQUIRMENTS
VoluntarinessDisclosure
Competence UnderstandingREQUIRMENTS
REQUIRMENTS: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
Force & Excessive influence
Competence
Invalid Consent
REQUIRMENTS:1 & 4: Competence and Voluntariness
Respecting persons
Autonomy Informed ConsentAutonomy is self-governance
Respecting their right of self-determination Getting their consent for medical treatment
Protecting their Ability
Competency
informed
understanding
Evaluating Decision-Making Capacity
Ability to understand
Ability to evaluate
Ability to communicate
Competence? Proxy
Voluntary inpatient mental health servicesConvulsive treatmentPsychosurgeryAbortionNeglect of the patient through the omission of care primarily intended to provide for the comfort of the patient
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
Children and Informed Consent18
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
As
se
nt
Consent
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
REQUIRMENTS: 2 & 3: Disclosure and Understanding
No Understanding = No Consent
REQUIRMENTS: 2 & 3: Disclosure and Understanding
Informed Consent = Shared Decision-Making
Elements of Informed Consent
Basic Elements
Benefits
Contact
Purposes Risks
Alternative Confidentiality
Compensation
Voluntary
termination costs
be provided Number
Additional Elements UnexpectedRisks
Consequences of Withdrawal
BASIC Elements
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
A description of any reasonably foreseeable risks or discomforts to the subject.
Risks&
Discomforts
The 8 Mandatory Elements of Informed Consent
A description of any benefits to the subject or to others which may reasonably be expected from the research.
Benefits
Self Others
The 8 Mandatory Elements of Informed Consent
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
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
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
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
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
Additional ElementsWhen Appropriate
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
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
Any additional costs to the subject that may result from participation in the research
Additional costs
Additional Elements, When Appropriate
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
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
The approximate number of subjects involved in the study.
Number of subjects
Additional Elements, When Appropriate