Balancing Risks

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Balancing Risks Benefits

• By
• Mohamed G. Shams
• Surgical Oncologist
• National Cancer Institute, Cairo University
• Certified trainer, University of Maryland, School
  of Medicine, Baltimore

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• Medical progress is based on research.
• This research ultimately rests in part on
  experimentation involving human subjects
• This involves subjects exposure to risks and
  burdens (potential harm).

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• There should be a BALANCE between the research
  aim to scientific progression and development of
  generalizable knowledge and the ethical
  obligation to protect the welfare and rights of
  human research subjects.

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• CIOMS (Council for International Organizations of
  Medical Science )
• For all biomedical research involving human
  subjects, the investigator must ensure that
  potential benefits and risks are reasonably
  balanced and risks are minimized.

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• WMA declaration of Helsinki
• In medical research on human subject,
  considerations related to the well-being of human
  subject should take precedence over interests of
  science and society.

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• The Belmont report
• The three basic ethical principles
• Respect for persons.
• Beneficence/ Non-maleficence.
• Justice.
• The three applications
• Informed consent.
• Assessment of Risk and Benefits
• Selection of subjects

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• What level of harm (risk) should a subject be
  allowed to withstand in the name of research?

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• Risk
• is a function of both the probability and
  magnitude of the harm.
• For example
• 2 probability of causing death maybe
  considered very risky,
• while 60 probability of causing dizziness
  or headache may be not very risky.

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Types of risks?

• Physical
• Psychological (anxiety, shame)
• Social (stigmatization, confidentiality
  breaching)
• Economic (directly or indirectly)
• Legal
• Risks to groups of persons

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Levels of risk?

• Minimal risk
• More than minimal risk
• High risk

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Minimal risk

• The probability and magnitude of harm or
  discomfort anticipated in the research are not
  greater in and of themselves than those
  ordinarily encountered in daily life or during
  performance of routine physical or psychological
  examinations or tests. CFR 45 part46.102(i)

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Minimal risk

• Examples
• 1. Surveys?
• 2. Observational studies?
• 3. Venepuncture?

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Benefits

• Benefits conceptually are a function of
  opportunity rather than probability.
• Ex A study with a small probability of a great
  benefit ( cure from a fatal illness) is
  considered more beneficial than another one with
  a high probability of a minimal benefit.

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Benefits

• Are either
• Benefits to research subjects.
• Benefits to society.
• N.B. Payment or incentives should NOT be assessed
  as potential direct benefit to the subject.
  (Offering big sum of money to a high risk study?)

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Benefits to research subjects

• Direct Treatment, increased knowledge assisting
  in diagnosis.
• Indirect ( Collateral) extra supervision, access
  to medical care, unplanned or unanticipated
  benefits.

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Risk Benefit assessment

• Two main rules (CIOMS)
• 1. Reasonable balance between risks and benefits.
  
• 2. Risks are minimized ( Using sound research
  design scientific validity, inclusion and
  exclusion criteria, sample size, qualified
  personnel, safety monitoring,,).

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Risk Benefit assessment

• Risks of interventions of direct diagnostic,
  therapeutic or preventive benefit for the
  individual subject is justified in relation to
  expected benefits to the individual subject.
• Risks of interventions of no direct diagnostic,
  therapeutic or preventive benefit for the
  individual is justified in relation to the
  expected benefits to society (generalizable
  knowledge).

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In vulnerable populations

• Ex. In Children, mentally ill, terminally ill,
  prisoners or economically deprived populations,
• Only a minor increase over minimal risk or
  minimal risk studies are justifiable in
  non-therapeutic procedures (with no direct
  potential benefit to subjects).
• In therapeutic procedures, risks should be
  reasonably balanced to benefits.

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• Thank You