Monthly Archives: March 2006

Ethics of Clinical Trial

What makes clinical trial ethical? [Notes from Clinical Research Training Program of NIH]

• Collaborative partnership: To be ethical, clinical research must involve the community in which it occurs.
• Social Value: To be valuable, clinical research must lead to improvements in health or advancement in generalizable knowledge.
• Scientific Validity:
• Fair Subject selection:
• Favourable Risk/Benefit ration:
• Independent Review: Independent review helps to minimize the influence of potential conflicts of interest that you will encounter as a Principal Investigator and it also assures society that your study will not benefit from the abuse of your subjects.
• Informed consent:

1. Purpose and duration of participation
2. Risks
3. Benefits
4. Alternatives
5. Voluntariness and right to withdraw without penalty
6. Confidentiality of records
7. Compensation for injuries
8. Person to contact for answers to questions

• Respect for human subjects: