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 whole discipline of biomedical ethics rises from the ashes of the Holocaust”Arthur Caplan

“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

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

A BC

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

‘Fully Informed’ Consent

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

Failure of Informed Consent

Deception

CoercionLack Of

Information

Lack Of Capacity to Understand

Lack Of Understanding

Informed Consent

Failure of Informed Consent

Lack Of Information

Lack Of Understanding

Copyright © American Society of Clinical Oncology

Beardsley, E. et al. J Clin Oncol; 25:e13-14e 2007

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)

Informed Consent

Failure of Informed Consent

Lack Of Information

Lack Of Understanding

Too MuchInformation!

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

Informed Consent

Lack of Deception

Lack of Coercion-Voluntary and

Right to Withdraw

Adequate Information

Protection For Those Lacking Capacity

Access to Further Information

Risk and Consent

• Understanding of risk is generally poor

• Bias in – understanding of risk– estimating clinical benefit

↑ Risk

↓ Participation

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

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

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

IndividualRandomisation

ClusterRandomisation

Simple PIS

Confirm Verbally

Posters+ PIS on Request

± Verbal Confirmation

DocumentEntry/Refusal/Withdrawal

DocumentConsent/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 leavefrom his sentence at the State prison……..”

‘Final Thoughts’

“I am right there in the room and no one even acknowledges me”