Research Quality Management

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Evaluation of Risks and Benefits Henry
Silverman, MD, MA Mohamed Elhassan Abdalla
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Outline

• What research guidelines say about evaluating
  risks against benefits
• Risks
• Types of risks
• Minimization of risks
• Benefits
• RiskBenefit analysis in research
• vulnerable subjects

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Requirement of Ethics Guidelines

• In All Guidelines with different wordings.
• Risks only to
• research subjects
• Benefits to
• subjects and future patients and society

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Risks two components

• Magnitude and duration of harm
• Death
• Slight discomfort
• Probability of harm

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• Types of Risks

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Types of Risks

• Physical
• Psychological
• Survey research
• Genetic testing

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Types of Risks

• Social
• breach of confidentiality
• Stigma
• Discrimination (insurance, employment)
• Economic
• Travel to clinic

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Risk Reduction

• Risks are minimized by using procedures
  consistent with sound research design
• use of qualified personnel
• substitution with less invasive procedures
• safety monitoring
• exclude high risk subjects
• confidentiality protections
• alternation in study design
• appropriate compensation for economic risks

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Benefits

• Benefits to research subjects
• Benefits to society
• Specific new, effective intervention
• Knowledge which some time in the future may lead
  to effective interventions

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Benefits to Research Subjects

• Direct Benefit
• arising from the intervention being studied
• information that can influence care, e.g.,
  diagnostic

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Benefits to Research Subjects

• Collateral Benefit
• Also called indirect benefit
• Arising from being a subject, even if one does
  not receive the experimental intervention
• extra supervision from being in the research
  study (?)
• access to medical care not available for economic
  reasons
• unplanned or unanticipated benefits

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Benefits to Research Subjects

• Inspirational
• Aspirational
• benefit to society (arises from the results of
  the study)

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Benefits to Subjects

• Payments or incentives benefits???
• Should not be considered as benefits
• Inappropriately skew judgments concerning risks
  and potential benefits
• Any level of research risk could be offset by
  such gains if they were significant enough

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Benefits to Research Subjects

• No benefits from the research
• Phase I trials testing maximum tolerated dose
• Non-therapeutic research procedures
• Mechanism of disease

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Risk Judgments in vulnerable populations

• Persons incapable of giving informed consent
• Patients with psychiatric illnesses
• Patients with dementia
• Patients with acute critical illnesses
• Children

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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
  routine performance of physical or psychological
  examination or tests

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Clinical Equipoise

• The start of the trial, there must be a state of
  clinical equipoise regarding the merits of the
  regimens to be tested, and the trial must be
  designed in such a way as to make it reasonable
  to expect that, if it is successfully conducted,
  clinical equipoise will be disturbed."

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Clinical Equipoise

• Clinical equipoise means a genuine uncertainty on
  the part of the expert medical community about
  the comparative therapeutic merits of each arm of
  a clinical trial.
• The tenet of clinical equipoise provides a clear
  moral foundation to the requirement that the
  health care of subjects not be disadvantaged by
  research participants.

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THANKS