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Vulnerable Populations

Vulnerable Populations. Objectives. Criteria for permissible research Levels of risk justified Capacity assessment Surrogate decision-making and consent. IRB SOP 005 . Research Involving Vulnerable Populations. Subject vulnerability.

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Vulnerable Populations

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  1. Vulnerable Populations

  2. Objectives • Criteria for permissible research • Levels of risk justified • Capacity assessment • Surrogate decision-making and consent

  3. IRB SOP 005 • Research Involving Vulnerable Populations

  4. Subject vulnerability “when some or all of the subjects are likely to be vulnerable to coercion or undue influence,…additional safeguards must be included in the study to protect the rights and welfare of these subjects.” 45 CFR 46.111(b)

  5. Diminished autonomy • Mental capacity—ability to understand and process information • Voluntariness—freedom from the control or influence of others

  6. Examples of vulnerable subjects • Children, prisoners, pregnant women • Handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons • Students, employees, members of the armed forces • Patients with incurable diseases, persons in nursing homes, patients in emergency situations

  7. What are they vulnerable to? • Physical control • Coercion • Undue influence • Manipulation

  8. When can research be done? • They comprise the only appropriate study population • The research question focuses on an issue unique to subjects in this population

  9. Degree of risk • Minimal risk • “Minor over minimal” • Acceptable risk-knowledge ratio • “Maximal potential risk”

  10. Capacity to consent • Presumed competent to consent unless there is evidence of serious mental disability • Provide a plan for determining the incapacity

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