Transcript Nalin Thakker - Association for Research Ethics

Streamlining Consent
Nalin Thakker
Consent
• How did we get here?
• What are the limitations of the the current state?
• What is the way forward?
How did we get here?
Ethical Necessity For Consent
•
•
Stems from
–
respect for autonomy of individuals
–
right to protection when autonomy is diminished
Protects in an unequal power relationship
–
Assurance that participant has not been:
•
coerced or put in a constraining situation: voluntary participation and right to withdraw
•
deceived: appropriate disclosure
Historical Perspective
“The voluntary consent of the human subject is
absolutely essential. This means that the person
involved should have legal capacity to give consent;
should be so situated as to be able to exercise free
power of choice, without the intervention of any element
of force, fraud, deceit, duress, overreaching, or other
ulterior form of constraint or coercion; and should have
sufficient knowledge and comprehension of the
elements of the subject matter involved as to enable him
to make an understanding and enlightened decision.”
Nuremburg Code 1947
“The whole discipline of biomedical ethics rises from the ashes of the Holocaust”
Arthur Caplan
Historical Perspective
Tuskegee Syphilis Experiments 1932- 1972
Historical Perspective
Guatemala 1946-1948 STD Experiments
Declaration of Helsinki 1964
• Basis of informed consent in medical research
• Voluntary participation
• Adequate information of nature of study
• Need to ensure it is understood
• Right to withdrawal
Ethical Necessity For Consent
• Data
– Privacy & confidentiality
• Tissues
– Ownership rights
– Bodily integrity
Legal Necessity for Consent
•
Overall
– ?Human Rights legislation
•
Physical intervention
– common law
•
Data
– Data Protection Act1998
•
Tissues & DNA
– Human Tissue Act 2004
•
Mental Capacity
– Mental Capacity Act 2005
•
Clinical Trials
– EU Clinical Trials Directive 2006
Clinical vs. Research Consent
• Clinical
–
–
–
–
For care & treatment of the patient
Anticipated direct personal benefit
Acceptance of risks
Fiduciary relationship
• Research
–
–
–
–
Focus on generating new knowledge or understanding
May have no anticipated personal benefit
Risks and potential benefits may not be well defined
No legal/fiduciary obligation for provision of care
Clinical vs. Research Consent
• Clinician looking after the patient is also the researcher
– Dependent relationship
– Competing interests
– Feedback of findings
• Research intervention is also a treatment
– Perceived therapeutic benefit
What are the limitations of the current state?
Limitations of Informed Consent
• Cannot get informed consent in all cases
• Not the only ethical consideration
• Not always valid
• Risk related
• Process can be cumbersome – can inhibit
research/participation
Limitations of Informed Consent
C
A
Consent
B
‘Fully Informed’ Consent
• Unrealistic and limited in most cases
• Consent can be given for a course of action only as described and
understood in a specific way
• Description cannot be exhaustive and/or understanding may be limited
• Thus consent is almost always for an incompletely described or
understood action
Limitations of Informed Consent
How ‘Informed’ is ‘Informed Consent’?
Understanding and Satisfaction (%)
Clinical Trial
Adequate
Moderate
Inadequate
Amount
80
13
7
Aim
54
23
23
Randomisation
50
0
50
Volunteerism
47
47
7
Withdrawal
44
44
2
Risks
50
25
25
Benefits
57
29
14
Therapeutic
Misconception
7
33
60
Alternatives
29
43
29
Falagas et al., The American Journal of Surgery (2009) 198, 420–435
Informed Consent
Lack Of
Understanding
Deception
Failure of
Informed Consent
Lack Of
Information
Coercion
Lack Of Capacity
to Understand
Informed Consent
Lack Of
Understanding
Failure of
Informed Consent
Lack Of
Information
Fig 1. Page numbers of consent forms during a 5-year period
QuIC-A scores also were significantly higher for trials
in which the PICF page count was seven or less (P = .010)
Beardsley, E. et al. J Clin Oncol; 25:e13-14e 2007
Copyright © American Society of Clinical Oncology
Informed Consent
Too Much
Information!
Lack Of
Understanding
Failure of
Informed Consent
Lack Of
Information
Amount Of Information Accessed By Research Participants
Question
Level Accessed (%)
1
1-2
1-3
What is our research about?
80
18
12
Why are we doing this research?
76
12
6
Why have you been invited to take part?
75
10
5
What would we like you to do?
82
11
7
Who will see the information collected?
76
10
3
What will happen to the information collected?
70
9
6
Antoniou et al., J Med Ethics 2011;37:557-562
Amount Of Information Accessed By Research Participants
Accessing any information
77%
Not accessing any information
23%
Antoniou et al., J Med Ethics 2011;37:557-562
Informed Consent
Access to
Further Information
Lack of Deception
Informed Consent
Lack of Coercion
-Voluntary and
Right to Withdraw
Adequate
Information
Protection For Those Lacking
Capacity
Risk and Consent
• Understanding of risk is generally poor
• Bias in
– understanding of risk
– estimating clinical benefit
Risk and Consent
• Understanding of risk is generally poor
• Bias in
– understanding of risk
– estimating clinical benefit
• Higher chance that participants in high-risk studies
have failed to understand the risk
• High risk studies more likely to be more complex more difficult to understand
Risk and Consent
• Less chance that participants in low risk
studies fail to understand the risk
• Low risk studies – less likely to be complex easier to understand
• Can consider streamlining consent on basis
of risk but without attenuating the consent
What is the way forward?
The Case for A Rethink on Consent
• Informed consent is often not very informed
• Researchers do many things without consent
• Real harm from restrictive requirements
• Need to consider society as well as an individual
• We have developed a culture of legal/regulatory compliance rather than ethical or
professional standards
• Regulatory and governance framework much better now than in the past.
‘Can we not relax some requirements for consent?’
Approaches To Streamlining Consent
• Reduced information with access to further information
• Generic consent
• Simpler consent
• Opt out/deemed consent
• No consent
Reduced Information With Access To Further Information
• Patient retain control what they see
– No deception or withholding of information
– No illegitimate control
• Coupled with the right to not to participate and right to
withdraw
– No coercion
Approaches To Streamlining Consent
• Reduced information with access to further information
• Generic consent
• Simpler consent
• Opt out/deemed consent
• No consent
Generic Consent and Biobanking - Concerns
• Storage of tissue (and personal information) for future unspecified use.
• Donors cannot make real judgements about how their samples are
used.
• Any ethics review cannot possibly know about potential future benefits.
• Concern about misuse of personal information.
Declaration of Helsinki 1964
• Basis of all informed consent in medical research
• Voluntary participation
• Adequate information of nature of study
• Need to ensure it is understood
• Right to withdrawal
Consent and Biobanking - Response
• Cannot realistically seek permission for each and every project on prospective basis
• Need to weigh up potential benefit against any harm
• Consent is not about ownership
• Research shows:
– Research details are poorly understood generally by donors
– Consent is given on the basis of trust in the researchers, processes and institutions and
altruism
– Very few donors refuse to give consent for unspecified future use
‘Generic’ Consent
Consent to permit use of the tissue
• with knowledge of any planned future research use
• with knowledge that one cannot be fully informed about all
• possible future uses of the tissues
• possible outcomes (including commercial exploitation)
• with appropriate checks and balances
• research ethics review
• sponsor governance oversight
• compliance with an HTA licence
Generic Consent Can Be More Informed than ‘Informed Consent’!
Approaches To Streamlining Consent
• Reduced information with access to further information
• Generic consent
• Simpler consent
• Opt out/deemed consent
• No consent
Research That Does Not Need Informed Consent
Types of Research Suitable for Simpler/Deemed Consent or
No Consent
• Comparative effectiveness research (CER)
• Quality improvement research (QIR)
Fadden et. al., Informed Consent, Comparative Effectiveness,
and Learning Health Care N Engl J Med 370;8 2014
QIR and CER
• Research with no direct impact on patient
Can proceed without consent but information to the wider patient
community
• Research that has minor but still meaningful effects
Can proceed on opt out basis
• Research that can have substantial effects
Full consent process
Fadden et. al., Informed Consent, Comparative Effectiveness,
and Learning Health Care N Engl J Med 370;8 2014
Research With No Direct Impact on Patient
• Effectiveness of sending medication reminders by text or e-mail to patient who have
previously given permission to be contacted by either mechanism
• Usefulness of repeating a routine laboratory test once or twice during a patient
hospitalization when both are standard practice.
Can proceed without consent but information to the wider patient
community
Fadden et. al., Informed Consent, Comparative Effectiveness,
and Learning Health Care N Engl J Med 370;8 2014
Research that has minor but still meaningful effects
• A pragmatic, randomized clinical trial that compares two widely used hypertension
medications with no indications that would favour one over the other for most patients
– Physician can override randomisation, retains control over dosages, additional therapies etc
– Similar toxicity profile
‘Can proceed on opt out basis’
Fadden et. al., Informed Consent, Comparative Effectiveness,
and Learning Health Care N Engl J Med 370;8 2014
HRA Consultation - Conditions for Simpler Consent Process
• Normal process is disproportionate to risk
• Comparative effectiveness research with equal uncertainty about the
merit of each intervention
• Medicines/interventions/test in routine/licenced use
• No greater risk than standard care
• No compromise about the rights of the participant
• No patient preference
• HCP can override the study protocol
Possible Scenarios
Pragmatic Comparative Effectiveness Study in GP Practice
of Two Licenced & Routinely Used Drugs
Individual
Randomisation
Cluster
Randomisation
Simple PIS
Posters
+ PIS on Request
Confirm Verbally
± Verbal Confirmation
Document
Consent/Refusal/Withdrawal
Document
Entry/Refusal/Withdrawal
Streamlining Informed Consent
• How did we get here?
– Ethical, legal and regulatory requirements
• What are the limitations of the current state?
–
–
–
–
Questionable validity of consent
Too much information & lack of understanding
Patients accessing limited information in making decisions
Risk of misunderstanding higher with higher risk projects
• What is the way forward?
–
–
–
–
–
Reduced information with access to further information
Generic consent
Simpler consent
Deemed consent
No consent,
“It’s not question of right or wrong gentlemen!
It is a question of can we get away with it”
“……and taking the opposing view on leave
from his sentence at the State prison……..”
‘Final Thoughts’
“I am right there in the room and no one even
acknowledges me”