Transcript Informed Consent

Informed Consent
Retha Britz
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Retha Britz Copyright 2013 All
rights reserved for this
presentation
A Refresher
What is ethics?
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How we ought to behave [regardless of legislative
requirements] Study of the concepts involved in
practical reasoning - “good” vs “bad” & “right” vs
“wrong
Reasons for the behaviour
Moral principles
Research ethics?
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Same in order to protect research pts from being
“used as a means to the researcher’s end” i.e.
Informed Consent (IC)
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For research with/on humans, IC is a
ethical cornerstone
Required by all guidance documents
and legislation (incl SA Constitution,
1996)
Requirement for and process of
obtaining IC differ markedly in guidance
documents and legislation
contradictory, deficiencies, differences
What is Informed Consent?
“A process by which the subject
VOLUNTARILY confirms his or her
willingness to participate in a particular
trial, after having been informed of all
aspects of the trial that are relevant to
the subject’s decision to participate.”
ICH GCP 1.28 p.5
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Definition from an ethical perspective
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Process of information sharing and decision
making based on mutual respect and
participation in the process by both the
researcher and the pt (McQuoid-Mason et al., 2011).
The fundamental qualities of dignity and
autonomy is central to the question of
informed consent in research
Act No. 108 of 1996 The Constitution of
the Republic of South Africa
Section 12(2)(c)
“not to be subjected to medical or scientific experiments without
their informed consent.”
SA Constitution, 1996 underpins right to
autonomy…
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When should IC be obtained?
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Before any research related activities
E.g………
Why?
Ethical and Legal IC Process :
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Information sharing/disclosure (IC/assent
document)
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(informed part of informed consent)
Assessment of
understanding/comprehension
(informed part of informed
consent)
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Active voluntary decision making (written consent)
(consent or refusal of consent part of informed consent)
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Subsequent efforts to confirm voluntary
participation throughout the [long term]
research study
Function of a REC?
Ensure pts are protected by safeguarding their
rights and well-being (which includes dignity and
safety) to avoid exploitation
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Which moral theories
are at stake regarding the
function/obligation of the REC?
Kantian Deontology: Respect, Dignity
Principle-based Ethics: Beneficence and nonmaleficence
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Informed Consent Requirements
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REC to approve ICF as well as any other
documents/information to be provided to participants
such as questionnaires, scales, appointment cards,
advertisements etc
New information becomes available/Amendments
e.g. change in study procedures
Participants should not be coerced or unduly
influenced to participate – How can participants be
influenced?
Written consent (?but it may be threatening to some
pts due to culture?)
Culturally acceptable practices - consider ethnic or
social origin Understand pt world-view or value
system
Consultation
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Impossible to make voluntary absolute – no person
is entirely free from influence
Requirement for voluntary informed consent is
substantial autonomy
Pts are allowed to consult
Researchers to ask about pts view and values –
never assume
Deferred consent is not allowed e.g…..?
Individual consent can not be bypassed (autonomy)
Consultation (continue)
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Community leader can give permission for
research to be conducted in community
Principle of autonomy does not recognise the
way in which communities and traditions
contribute to self formation in African context
Apply autonomy-based practice in a culturally
sensitive manner
BUT universal first-person consent is
required
Content of Informed Consent
Documents
Some guidance documents and regulations
provide guidance for verbal discussion as
well as the content of the Informed Consent
Document.
Enhancement of overall understanding of key information will
promote higher ethical standards in research
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Comprehension / Assessment of
understanding
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Substantial knowledge
No need for full understanding of all aspects
of the research (Beauchamp & Childress, 2001)
Understand as a minimum the
nature, effect, consequences,
risks involved of the act for which
consent is being sought,
withdrawal
Language of Consent
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Language barriers is common problem (different cultures)
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Non-technical, understandable (ICH GCP)
Non-maleficent action if language will enhance
understanding
Adapt according to age & education Age to
consent?
Wording should be clear - carry the correct meaning
intended
Language of choice (SA GCP) (prevents manipulation) vs home
language (“blue book”)
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Illiterate participants
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Need for first-person consent based on respect for
autonomy
Verbal consent by an illiterate prospective participant
is ethically correct and legally binding but not
prudent when disputes arise
No legislation regarding the manner in which illiterate
individuals should agree to a contract
An independent (impartial) witness is essential to
attend entire consent discussion and to verify in
writing (by signing the consent document) that the
prospective pt understood the proposed research
and gave verbal consent for participation
Illiterate participants (continue)
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Pt can sign by cross or thumb print
Should the impartial witness be literate or
illiterate? (see SA GCP 3.5 and Blue Book)
Who can act as an impartial witness ?
Consent for special cases
specific to clinical research
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Surrogate Consent
When is surrogate consent required?
 Legally incompetent
 Mentally incompetent
 Emergency care research
Who can act as a surrogate?
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Legally incompetent pts
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Age for consenting to CR participation in SA is…?
In case of prospective pt does not have legal
capacity
parent/guardian/caregiver to
exercise a decision
NHA No 61 (2003) section 8(2)(b) and SA Children’s
Act No 38 (2005) requires that the prospective pt is
informed of research to the extend s/he understands
Deontological Ethics & Principle of Autonom:y pt still
understands to a degree and right to choose
Legally incompetent pts (continue)
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Consent vs assent?
Consent - mental & legal capacity to
give permission
Assent – not full decision-making
capacity; based on less than full
understanding
Criteria to determine competency to
assent
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Comprehension (to a degree)
Exercise a choice
Communicate the choice
Assent for minors
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Assent form or verbal assent?
From age 7 (literature)
Reasoning ability from age 14
Depends on complexity of research
Dissent should be respected
Mentally incapacitated participants
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Ethically the intent is more NB than outcome
Attempt to respect pts’ autonomy is ethically
correct
May however not fulfil criteria for competency
Not able to assent but not declining
treatment
surrogate decides on
beneficence
Mental impairment can change e.g….?
Emergency care research
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Extra vulnerable
Consent refer to an individual’s choice
First-person consent (ethically & legally required)
Presumed surrogate consent – substituted
(not proxy consent)
Presumed incl pts’ choices, wishes & values
Paternalistic idea of beneficence changed over
last century
Emergency care research (continue)
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Deferred or subsequent consent is NOT
retroactive authorisation for research
initiation! (also not universalisable)
Beneficence competes here with autonomy
Deontology & Principle-based Ethics:
Intrinsic worth therefore dignity & autonomy
should be respected
SA Constitution, 1996 underpins autonomy
Surrogate in case of emergency care
(NHA section 7(1)(b))
Specific order:
 Spouse/Partner
 Parent
 Grandparent
 Adult child
 Brother or sister of the person
Highly unlikely that a court order will be issued for research to
continue without written informed consent as discussed e.g.
research to continue only if REC has approved the research
(as required by Declaration of Helsinki 2008)
Challenging but researchers should consider this in the planning of
the research protocol
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Bibliography
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BEAUCHAMP, T.L. & CHILDRESS, J.F. 2001. Principles of biomedical ethics. 5th ed.
Oxford: University Press. 454 p.
GILLON, R. 2003. Ethics needs principles – four can encompass the rest – and respect for
autonomy should be “first among equals”. Journal of biomedical ethics, 29(5):307-311, Oct.
GILLON, R. 1994. Principles of biomedical ethics. British medical journal, 309(6948):184185, 16 Jul.
HEUBEL, F. & BILLER-ANDORNO, N. 2005. The contribution of Kantian moral theory to
contemporary medical ethics: a critical analysis. Medicine, health care and philosophy, 8:515.
MOODLEY, K. 2011. Respect for patient autonomy. (In Moodley, K., ed. Medical ethics,
law and human rights. Pretoria:Van Schaik publishers. p. 41-56.)
RACHELS, J. & RACHELS, S. 2010. The elements of moral philosophy. 6th ed. New
York: McGraw-Hill p. 122-172.
VAN NIEKERK, A.A. 2011. Ethics theories and the principlist approach in bioethics. (In
Moodley, K., ed. Medical Ethics, law and human rights: a South African perspective.
Hatfield, Pretoria.: Van Schaik Publishers. p.19-39.)