S1-1_Urban Wiesing

Ethical Considerations: Assessing
Risks, Benefits and Burdens
during Health Emergencies
Urban Wiesing
WMA‘s Regional Expert Meeting in the Pacific
on the WMA Declaration of Helsinki
Tokyo, Nov. 30-Dez. 1 2023
Institut für Ethik und
Geschichte der Medizin
Assessing risks, burdens and benefits during
health emergencies
Distinction:
• Emergency in an individual case
• Emergency in the health care system
Institut für Ethik und
Geschichte der Medizin
Emergency in an individual case
• Risks and benefits for the patient are more
difficult to assess because of time constraints
• Informed consent not always possible
• Proxy consent not always possible
Institut für Ethik und
Geschichte der Medizin
Emergency in the health care system
• High pressure to get new knowledge/therapies
• Benefits for society: urgently needed but
probability of success more difficult to assess
• Risks and benefits for the participant more difficult
to assess because of time constraints
• Therefore, Informed Consent more difficult
Institut für Ethik und
Geschichte der Medizin
Emergency in an individual case and
Emergency in health care system
Commonality:
• Time restriction, less accurate assessment of
benefits and risks
• Informed Consent impossible or more vague
Institut für Ethik und
Geschichte der Medizin
Assessing risks, burdens and benefits during
health emergencies
• What is meant by “assess”?
• Structure of medical assessment:
– The possible information that can be
considered is always too much.
– The relevant information is usually too little.
– To keep searching for relevant information
does not make sense, because at some point
one must assess and decide in medicine.
– In particular in emergencies
Institut für Ethik und
Geschichte der Medizin
Assessing risks, burdens and benefits during
health emergencies
• In most cases, assessments in medicine are ‘to a
degree’ uncertain.
• These structures also apply to emergency
situations, only the time for assessment is more
limited.
Institut für Ethik und
Geschichte der Medizin
Assessing risks, burdens and benefits during
health emergencies
• Lack of relevant information
• Time to assess
• This characteristic can be reduced by expertise,
experience, (and AI?) to a certain extent, but not
eliminated.
Institut für Ethik und
Geschichte der Medizin
Assessing risks, burdens and benefits during
health emergencies
• Emergency represents the structures of life in a
pointed way:
• ars longa, vita brevis
• There is always more to learn and to consider
(“ars longa”) than the situation allows (“brevis”,
short)
• In life, and dramatically in emergencies
Institut für Ethik und
Geschichte der Medizin
1st Hippocratic Aphorism
Ὁ βίος βραχύς,
ἡ δὲ τέχνη μακρή,
ὁ δὲ καιρὸς ὀξύς,
ἡ δὲ πεῖρα
σφαλερή,
ἡ δὲ κρίσις χαλεπή
life is short,
the art long,
opportunity fleeting,
experiment
treacherous,
judgment difficult
The DoH and emergencies
• How should the DoH react to these structural conditions?
• DoH cannot change the structures of assessments.
• Moral conditions of research in emergencies must be
stated.
Institut für Ethik und
Geschichte der Medizin
Emergency in the DoH?
• The risk-benefit ratio is more uncertain
– higher risk of wrong assessment
– higher risk of patients coming to harm
– higher risk of insufficient informed consent
• Because the medical assessment is more uncertain in
emergencies, adequate moral conditions must be defined.
Institut für Ethik und
Geschichte der Medizin
Emergency in the DoH?
• Emergency is not mentioned in the DoH
• DoH refers in § 30 to the situation that informed
consent cannot be given by the patient, no
“representative is available and […] the research
cannot be delayed”.
• This is part of the typical situation of individual
emergency medical research.
Institut für Ethik und
Geschichte der Medizin
Emergency in the DoH?
• The DoH: “the study may proceed without informed
consent
– provided that the specific reasons for involving subjects
with a condition that renders them unable to give
informed consent have been stated in the research
protocol and the study has been approved by a
research ethics committee.
– Consent to remain in the research must be obtained as
soon as possible from the subject or a legally
authorised representative.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. 2021: DoH (and CIOMS-
Guidelines) should be “revised to include more
specific provisions on emergency medical
research”.
• Langlois, A., Armstrong, S., & Siriwardena, A. N. (2021). Do National and International Ethics
Documents Accord With the Consent Substitute Model for Emergency Research? Acad Emerg Med,
28(5), 569-577
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs,
• 2) the risk–benefit ratio is favorable,
• 3) there are no known conflicts with patients’ values or
interests,
• 4) cumulative net risk is minimal, and
• 5) consent is given as soon as possible.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable,
• 3) there are no known conflicts with patients’ values or
interests,
• 4) cumulative net risk is minimal, and
• 5) consent is given as soon as possible.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests,
• 4) cumulative net risk is minimal, and
• 5) consent is given as soon as possible.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests, [is not in the DoH]
• 4) cumulative net risk is minimal, and
• 5) consent is given as soon as possible.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests, [is not in the DoH]
• 4) cumulative net risk is minimal, [the DoH demands
minimal risk/minimal burden] and
• 5) consent is given as soon as possible.”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests, [is not in the DoH]
• 4) cumulative net risk is minimal, [the DoH demands
minimal risk/minimal burden] and
• 5) consent is given as soon as possible [is in the DoH].”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests, [is not in the DoH]
• 4) cumulative net risk is minimal, [the DoH demands
minimal risk/minimal burden] and
• 5) consent is given as soon as possible [is in the DoH].”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
• Langlois et al. propose five conditions :
• “1) the research addresses the patients’ urgent medical
needs, [‘urgent’ is not in the DoH]
• 2) the risk–benefit ratio is favorable [is in the DoH],
• 3) there are no known conflicts with patients’ values or
interests, [is not in the DoH]
• 4) cumulative net risk is minimal, [the DoH demands
minimal risk/minimal burden] and
• 5) consent is given as soon as possible [is in the DoH].”
Institut für Ethik und
Geschichte der Medizin
Individual Emergency in the DoH?
Question:
• Shall the DoH add wording like
• “urgent medical needs” and/or
• “no known conflicts with patients’ values or interests”?
Institut für Ethik und
Geschichte der Medizin
Health Care Emergency in the DoH?
• High pressure to get new knowledge/prevention/therapies
• Benefits for society: urgently needed but probability of success more
difficult to assess
• Risks and benefits for the participant more difficult to assess because
of time constraints
• Therefore, Informed Consent more difficult
• So far: DoH demands balancing of individual benefit, individual risk,
benefit of groups affected
Institut für Ethik und
Geschichte der Medizin
Health Care Emergency in the DoH?
• “16 Medical research involving human subjects may only
be conducted if the importance of the objective outweighs
the risks and burdens to the research subjects.”
• “importance of the objective” in emergencies?
Institut für Ethik und
Geschichte der Medizin
Health Care Emergency in the DoH?
• “17. All medical research involving human subjects
must be preceded by careful assessment of predictable
risks and burdens to the individuals and groups involved
in the research in comparison with foreseeable benefits to
them and to other individuals or groups affected by the
condition under investigation.”
• “benefits to them and to other individuals or groups
affected”: in emergencies or pandemics?
Institut für Ethik und
Geschichte der Medizin
Health Care Emergency in the DoH?
• So far: Balancing risks/benefits is demanded!
• Are new ethical principles needed?
• Or only specifications of existing principles?
• The relevant ethical principles are mentioned in the DoH
• No new ethical principles are needed
• Specification?
• General problem: Character of the DoH!
Institut für Ethik und
Geschichte der Medizin
Health Care Emergency in the DoH?
• In Corona Pandemic:
• The most difficult question: early market approval
• “pandemic exceptionalism”
• Market approval so far not addressed in the DoH.
• Shall the DoH add a paragraph on market approval?
• No!
• DoH addresses researchers, not market approval
authorities!
Institut für Ethik und
Geschichte der Medizin
New paragraph(s) on Emergency in the DoH?
• Research in emergencies: not mentioned in the DoH!
• Neither in an individual case nor in health care system
• The relevant ethical principles are mentioned in the DoH.
• No new ethical principles are needed.
• The explicit condition “no known conflicts with patients’
values or interests” could be added.
• The potential for individual and group benefit as a
legitimising factor should not be removed.
• Risk-benefit balancing should remain in the DoH
• (Early) market approval should not be addressed
Institut für Ethik und
Geschichte der Medizin
Ethical Considerations: Assessing
Risks, Benefits and Burdens
during Health Emergencies
Urban Wiesing
WMA‘s Regional Expert Meeting in the Pacific
on the WMA Declaration of Helsinki
Tokyo, Nov. 30-Dez. 1 2023
Institut für Ethik und
Geschichte der Medizin