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Structural Issues
  1. Obtaining and sustaining privacy and confidentiality may be a serious problem. Physical privacy for exams and questioning may be hard to find. Secure storage of data may be problematic. In certain cultures, the study personnel may be subject to intimidation to give up private information. Privacy extends to recruiting as well as to execution.

  2. Investigators must ensure that scarce health personnel and facilities are not usurped by a study to the detriment of local health care.

  3. Processing and transport of biological specimens may be problematic, especially if transported out of the country.

  4. It is highly desirable to utilize local personnel to help plan and manage the study and often this means a number of meetings and training sessions

  5. Often there is a requirement for a long-term continuation of care or technical support to the community but the degree and duration remain negotiable and if adverse events occur, the extent of required support might be extremely contentious. Community demands may not be affordable.

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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



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