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:
- Purpose and duration of participation
- Voluntariness and right to withdraw without penalty
- Confidentiality of records
- Compensation for injuries
- Person to contact for answers to questions
- Respect for human subjects: