Unethical clinical research

Unethical is every research that is not ethical.

But what is ethical? A paper already 22 years back proposed 7 requirements that make a coherent framework.

  1. value— enhancements of health or knowledge must be derived from the research;
  2. scientific validity—the research must be methodologically rigorous;
  3. fair subject selection—scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects;
  4. favorable risk-benefit ratio—within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks;
  5. independent review— unaffiliated individuals must review the research and approve, amend, or terminate it;
  6. informed consent—individuals should be informed about the research and provide their voluntary consent; and
  7. respect for enrolled subjects—subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.

Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical.