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Study Population Issues
  1. There are many vulnerable populations who might be study subjects especially with high illiteracy, limited exposure to the concepts of western medicine and to the idea of research. Major cultural differences must be understood sufficiently to avoid harm

  2. There is often a requirement that the community or communities of the individual participants be involved in the research process during development as well as during execution.

  3. Investigators must avoid coercion through bribery, but food supplies, health care, etc. may be the equivalent of bribes in certain cultures.

  4. The consent process must be informational, understood, and voluntary and that's often difficult. Testing for comprehension is very helpful. Also the consent process must be repeatedly reiterated during the course of the study. It's worthwhile for the entire community to understand the research.

  5. There may be joint consent (with spouse) but the subject needs to receive health information privately and decide whether or how to present it to the other party.
  6. Development of health information about individuals must be dealt with exceedingly carefully as it can easily lead to stigmatization of individuals or of groups.

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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


Chapter 6 Download (PDF)