Informed consent: Definition & elements

1. Informed Consent Form
Dr. Ghiath
Alahmad

2. 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.

3. 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.

4. 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

5. “Informative” Informed Consent
What you need to know about informed
consent.
What you need to do to create an
“informative” Informed Consent Form.

6. 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.

7. 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.

8. 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.

9. REQUIRMENTS

10. REQUIRMENTS

11. Voluntariness
REQUIRMENTS

12. Voluntariness Disclosure
REQUIRMENTS

13. Voluntariness Disclosure
Understanding
REQUIRMENTS

14. Voluntariness Disclosure
Competence Understanding
REQUIRMENTS

15. Voluntariness
Disclosure
Competence UnderstandingREQUIRMENTS

16. 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

17. Force &
Excessive
influence
Competence
Invalid
Consent
1 & 4: Competence and Voluntariness

18. Respecting persons
Autonomy  Informed Consent
Autonomy is self-governance
Respecting their right of self-determination
Getting their consent for medical treatment
Protecting their Ability
Competencyinformed
understanding

19. Evaluating Decision-Making Capacity
Ability to understand
Ability to evaluate
Ability to communicate

20. Competence
? Proxy
Voluntary inpatient mental health services
Convulsive treatment
Psychosurgery
Abortion
Neglect of the patient through the omission of care primarily
intended to provide for the comfort of the patient

21. 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

22. Children and Informed Consent
18
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
Assent
Consent

23. 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
2 & 3: Disclosure and Understanding

24. No Understanding = No Consent
2 & 3: Disclosure and Understanding
Informed Consent = Shared Decision-Making

25. Elements of Informed Consent

26. Basic Elements
Benefits
Contact
Purposes Risks
Alternative Confidentiality Compensation
Voluntary

27. termination costs
be provided Number
Additional Elements
Unexpected
Risks
Consequences
of Withdrawal

28. BASIC Elements

29. 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

30. A description of any reasonably
foreseeable risks or discomforts to the
subject.
Risks
&
Discomforts
The 8 Mandatory Elements of Informed Consent

31. A description of any benefits to the subject or to
others which may reasonably be expected from
the research.
Benefits
Self Other
s
The 8 Mandatory Elements of Informed Consent

32. 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

33. 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

34. 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

35. 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

36. 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

37. Additional Elements
When Appropriate

38. 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

39. 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

40. Any additional costs to the subject that may result from
participation in the research
Additional
costs
Additional Elements, When Appropriate

41. 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

42. 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

43. The approximate number of subjects involved in the study.
Number of
subjects
Additional Elements, When Appropriate