<< Previous Section | < Previous Page | Next Page > | Next Section >> Approval and Monitoring Issues Requires an approved local IRB as well as an IRB from the sponsoring institution to approve the protocol and there are numerous misunderstandings and conflicts requiring a rational adjudication process. The IRBs and sponsors must agree on much more than in a developed country study. It is here that paternalism conflicts with national self-determination. There is conflict over whether controls should receive the developed nation standard of treatment rather than what would normally be available to them in their own country. Studies require an effective Data and Safety Monitoring Board to adjudicate problems as well as to monitor the progress of the study but that might not be so easy to arrange. Adverse medical, social, and psychological events are not predictable but must be dealt with. Studies need a Standard Operating Procedure (SOP) for dealing with the unexpected. << Previous Section | < Previous Page | Next Page > | Next Section >> 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)