Documents and Resources
RGD: Research Design
Download File
RGD - Research Design K2922.pdf263.66 KB
Summary
It is the obligation of the IRB to consider the study design and overall quality of a study in order to effectively evaluate the risk-benefit ratio. If the IRB cannot determine that the risk-benefit ratio of a study is acceptable, it cannot approve the protocol under applicable ethical codes and regulations.
Type of Document
- Guidance