20221211 DoH Expert Meeting-Steinberg

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BIG DATA & ARTIFICIAL INTELLIGENCE –
THE CHALLENGE OF INFORMED CONSENT
PROF. AVRAHAM STEINBERG, MD
CLASSIC INFORMED CONSENT
• Over the past 70 years, the development of several ethical principles and
codes of ethics has resulted in a greater focus on informed consent in the
biomedical context.
• Informed consent in clinical and research medicine is one of the most
important achievements of modern bioethics.
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CLASSIC INFORMED CONSENT
• The Nuremberg code—first created in 1947 – following the Nazi
Doctors’ Trial, stated that voluntary consent ought to be
sought from patients before undertaking procedures.
• The Declaration of Helsinki—first adopted in 1964, and
revised several times since, focused on informed consent, but
provided explicit recognition to the vulnerability of certain
individuals or groups, who may be incapable of giving
consent.
• The creation of IRBs to supervise ethical conduct in human
experimentations, with a great focus and emphasis on
informed consent.
CLASSIC INFORMED CONSENT –
DECLARATION OF HELSINKI – 7TH AMENDMENT 2013
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of research subjects and the
confidentiality of their personal information.
Informed Consent
25. Participation by individuals capable of giving informed consent as subjects in medical research
must be voluntary … no individual capable of giving informed consent may be enrolled in a research
study unless he or she freely agrees.
26. … each potential subject must be adequately informed of the aims, methods, … the
anticipated benefits and potential risks of the study and the discomfort it may entail, … The
potential subject must be informed of the right to refuse to participate in the study or to withdraw
consent to participate at any time without reprisal …
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CLASSIC INFORMED CONSENT –
DECLARATION OF HELSINKI – 7TH AMENDMENT 2013
28. For a potential research subject who is incapable of giving informed consent, the physician
must seek informed consent from the legally authorised representative…
32. For medical research using identifiable human material or data, such as research on material
or data contained in biobanks or similar repositories, physicians must seek informed consent for its
collection, storage and/or reuse. There may be exceptional situations where consent would be
impossible or impracticable to obtain for such research. In such situations the research may be done
only after consideration and approval of a research ethics committee.
INFORMED CONSENT – DEVIATIONS
Invasive, physical-emotional harm vs violating human respect, autonomy and privacy
• Contrary to clinical trials that include direct interventions on human beings, data are detached from
human subjects. One explanation for this asymmetry is that informed consent in the medical
context can be associated with procedures that put a person at risk of death or serious injury,
whereas allowing one’s personal information to be used, or having one’s privacy invaded in some
way, might be seen as less of a significant risk inasmuch as it does not usually result in physical
harm
• Lack of information of the nature and purpose of the use of big data, inability to explain correctly because of lack of
knowledge, i.e., a machine learning algorithm may be so complex that not even the creators
understand how it works, so there can’t be a meaningful ‘informed’ consent
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INFORMED CONSENT – DEVIATIONS
Currently, informed consent is waived – totally or partially – in various
situations
• In many experiments, especially at the early phases, there is lack of
knowledge and hence the “informed” is lacking
• Informed consent by proxy – for a potential research subject who is
incapable of giving informed consent, the physician must seek
informed consent from the legally authorized representative
• For a long time, the use of data has been considered exempt from
consent requirements under certain conditions. Hence, retrospective
research projects use file data without consent
BD & AI AND INFORMED CONSENT
• BD & AI poses great challenges to the implementation of informed consent, and they seriously erode the
role of informed consent as it pertains to the use of personal information.
• The era of BD & AI has exacerbated the ethical and legal debate about appropriate consent for
data use, in the clinical and experimental medical arena and outside it.
• On the one hand, respect for autonomy requires the provision of maximum information and
choice to those whose data are being used, and their protection against harm. On the other
hand, there are interests that override the right to informed consent; for example, data may be
accessed without consent to prevent epidemics or crimes.
• Furthermore, the complexities of big data make fully informed consent procedures impractical.
A common example is the often uninformed “consent” given by users to the terms and
conditions of apps and social media companies. Users rarely take the time to try to read and
understand what they are “ticking themselves into” when they join Internet platforms or use
services.
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BD / AI – ETHICAL ISSUES
PRO
• There are clear, compelling and practical benefits from applying AI algorithms to large
datasets – Big Data – containing our personal information.
• The use of medical data from entire patient populations is important to advance medical
knowledge, and to detect adverse reactions to medications or other side effects of medical
treatments.
• It has tremendous benefits in improving the quality of life, innovativeness, and problem-solutions.
• That justifies to override the classic informed consent notion, but not necessarily alternative and
adjusted forms of consent.
BD / AI – ETHICAL ISSUES
CON
BD & AI might violate many moral imperatives
• Human dignity – treating individuals as a means to achieve certain ends, and as objects rather than free
individual agents
• Autonomy, particularly as manifested in free informed consent
• Privacy, particularly by the ability to Re-Identification
• Transparency / Explanation, particularly due to lack of knowledge and expectation
• Abuse of AI & BD, i.e., moving large datasets to large private companies for business and profit purposes
• Significant biases, due to distorted mass data
• Discrimination, particularly of deprived and minority groups
• Uncontrolled / unexpected results
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AI / BD – POSSIBLE SOLUTIONS
• Strict legislations with greater penalties for those who fail to gain informed
consent – problematic to implament
• Adopting a stringent moral rule-based approach to permissible and
prohibited conducts – by adjusting the Declaration of Helsinki
• Looking into alternatives to express consent – not necessarily by the classic written
detailed informed consent charts but perhaps by adjusted written consent, or by some
electronic devices which may have control over the use of the data.
AI / BD – proposed solutions
The classic individual informed consent is impossible, but the idea of informed consent in
protecting fundamental moral principles may be implemented in different ways
• Obtain a priori consent from every patient to use big data in the future. This can be achieved either by a
classic but simplified, short and friendly written informed consent, or using a variety of technological
methods, provided IRB will approve that research.
• Already currently such a written model is in practice regarding left-over unused human specimens where a
person signs a permission to use such materials in the future for as yet unknown research, provided IRB will
approve that research.
• There should be a clear and easy way to withdraw from the consent.
• Ensure and protect total anonymization and de-identification, although true anonymization is difficult.
• Complement this requirement with mechanisms that ensure protection from harm or guarantee
appropriate compensation in the case of harm.
• Enact legislations and punishments against re-identification.
• IRBs should review the purpose of the use of BD & AI, and governments should require their approval.
Since BD & AI are new and complex modalities, IRBs should be supplemented with experts in these fields.
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THANK YOU