Evaluation of Risks and Benefits Henry Silverman MD

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

Outline • What research guidelines say about evaluating risks against benefits • Risks – Types of risks – Minimization of risks • Benefits • Risk: Benefit analysis in research – vulnerable subjects

Requirement of Ethics Guidelines • In All Guidelines with different wordings. • Risks only to: – research subjects • Benefits to: – subjects and future patients and society

Risks: two components • Magnitude and duration of harm – Death – Slight discomfort • Probability of harm

Types of Risks • Physical • Psychological – Survey research – Genetic testing

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

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

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

Benefits to Research Subjects • Direct Benefit – arising from the intervention being studied – information that can influence care, e. g. , diagnostic

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

Benefits to Research Subjects • Inspirational • Aspirational – benefit to society (arises from the results of the study)

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

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

Risk Judgments in “vulnerable populations” • Persons incapable of giving informed consent – Patients with psychiatric illnesses – Patients with dementia – Patients with acute critical illnesses • Children

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

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. "

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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