use of an independent person to monitor the consent process.use of informational or educational techniques.use of standardized assessment of cognition and/or decisional capacity.use of an independent party (independent of the study investigator with appropriate expertise) to assess the capacity of the potential subject.Such safeguards may include any of the following: In evaluating a protocol involving the enrollment of persons with decisional impairment, the IRB may consider requiring additional safeguards, as appropriate, for a given protocol. Presents a minor increase over minimal risk to involved subjects and which does not have the potential for direct individual benefit provided that the knowledge sought has direct relevance for understanding or eventually alleviating the subjects' disorder or condition.Presents an increase over minimal risk to involved subjects, but which offers the potential for direct individual benefit to the subject.Presents no greater than minimal risk to the involved subjects.The research offers therapeutic or other benefits to the individual participant when standard approaches are ineffective, unproven, or unsatisfactory.Īnd that the research meets one of the following criteria:.The research pertains to conditions, phenomena, or circumstances that commonly or uniquely affect the research participants and may contribute in important ways to the current or future welfare of the study population or.The research bears a direct relationship to the decisionally impaired subject’s condition or circumstance.The IRB will approve the research only if it finds that:
Internal Review RequirementsĪlthough not specifically addressed in the regulations as a vulnerable population, the University of Pittsburgh IRB requires additional safeguards for research involving persons with decisional impairment. Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. The impairment may be temporary, permanent or may fluctuate. This decisional impairment may result from a psychiatric, organic, developmental or other disorder that affects cognitive or emotional functions, or may result from the effect of drugs or alcohol. Decisionally impaired persons are those who have a diminished capacity to understand the risks and benefits for participation in research and to autonomously provide informed consent.
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