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study design and risk

Is research generally harmful?. Levine: phase I safety trials about as safe as working as a secretary; 1/7 as dangerous as window cleaningReview of clinical trials with over 29k prisoners: no deaths or permanent disabilitiesBut, this focuses on physical harms, and safety is largely due to vigilence.

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study design and risk

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    1. Study Design and Risk/Benefit Analysis Ethics in Mental Health Research

    19. Risks Identified in Belmont Report Psychological: Boredom, anxiety, embarrassment, or psychotic relapse Physical: Sexual dysfunction, high blood pressure, or death Legal: Fines or imprisonment Social: Stigmatization, harm to reputation, or divorce Economic: Lost time at work, loss of employment, legal fees or medical bills for harms incurred in research

    20. Kinds of Vulnerability-NBAC Cognitive or communicative vulnerability Trait: Insufficiently able to comprehend information, deliberate, make or express decisions Risk:informed consent will not be properly obtained; Participant less able to protect interests Institutional vulnerability Trait: Subjected to formal authority of others –e.g., prisoners and students Risk: Participation will not be truly voluntary; participant may be exploited

    21. Deferential vulnerability Trait: Informally subordinate to another—e.g., due to gender or roles Risk: Participation will not be truly voluntary; participant may be exploited Medical vulnerability Trait: Has serious health condition for which there is no satisfactory standard treatment Risk: Trouble weighing risks and benefits; participant may be exploited due to therapeutic misconception

    22. Economic vulnerability Trait: Lacks access to adequate income, housing, or health care Risk: Potential benefits from participation may be unduly influential and threaten voluntariness Social vulnerability Trait: Others may disvalue participant and his or her interests, welfare and contributions to society Risk: Discrimination may lead to unfair treatment and stigmatization

    23. Example of Heightened Protections: Children Not greater than minimal risk Assent of children and permission of parents Greater than minimal risk with prospect of direct benefit to individual subjects Same as above plus … Risk is justified by anticipated benefits to subject Risk-benefit ratio at least as favorable as that of alternative approaches

    24. Greater than minimal risk with no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about subject’s disorder or condition Same as above plus … Risk may be only a minor increase over minimal risk Research procedures must present experiences that are commensurate with those inherent in subject’s actual or expected medical…or psychological… situations Expected knowledge should be of vital importance in understanding or ameliorating the disorder

    25. Research not otherwise approvable that presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children Secretary of Health and Human Services, after consulting with expert panel and opportunity for public comment, determines that study will be conducted in accordance with sound ethical principles Assent of children and permission of parents

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