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Epidemiological and Social Science Research

  1. These create new kinds of risks for social groups as well as individuals, including stigma, denial of access to health care, etc.

  2. In the epidemiological setting, ascertainment of the condition for the group may compete with privacy for the individual. The issue of societal need versus privacy commonly occurs with public health.

  3. Clinical trials are more fraught with difficulty because of local issues. These include
    • Ascertainment bias in design
    • Bias in reporting
    • Inappropriate access to data
    • Adverse event reporting
    • Appropriate monitoring
    • Monitoring of Phase 1 and 2 trials

  4. Protection of subjects. This includes:
    1. Assessing risks and benefits of treatments and of controls in the field
    2. Estimation of equipoise, individual and societal
    3. Data and safety monitoring in the field
    4. Social risks and psychological risks as they develop in the field. These may not be anticipated.
    5. Privacy and confidentiality in diverse communities with curious and meddling officials
    6. Therapeutic misconception of naïve subjects who don't understand the idea of research.

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Chapter 6
Quick Links


International Clinical Research

Underlying Conditions

Approval and Monitoring Issues

Study Population Issues

Structural Issues

Epidemiological and Social Science Research

Cases

Bibliography


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