informed consent: definition & elements

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