Ethical Challenges

7. The Global Norm of Ethics Committees

Government authorized ethics committees, because of their diverse membership from and outside the institution, are seen as being more free of bias and conflicts of interest than an internal institutional group, the investigators themselves or a committee composed entirely of scientists. Although under the aegis of an institution or government that is not devoid of interests, the ethics committee model has been adopted worldwide as the best choice that is available and practical.

The ethical principles that are part of the US Regulations are applied by investigators in design and conduct of research. They also are applied by the IRB and scientific review group in their assessment of the scientific importance, soundness and suitability of the research.

Ethical guidelines/codes stipulate that research involving humans should be subject to prior ethical review to ensure that:

  • Ethical guidelines are followed;
  • Research is scientifically valid;
  • Risks of harm are minimized to extent possible;
  • Potential benefits outweigh risks of harms;
  • Selection and recruitment are fair;
  • Research participants (or their representatives) provide voluntary informed consent; and
  • Research fosters health, human rights, care of participants and/or their communities.
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