The Required Information on an Ethical Clearance Application for Ethical Assessment
|Risk/Anticipated Benefit Analysis
|Selection of Subject
|Research Plan for Collection, Storage, and Analysis of Data
|Additional Items IRBs Must Review
Ethical Review Guide Questions
Furthermore, the following questions can be used by the reviewer in considering the decision of ethical approval application and may also help the researcher in writing the protocol:
Risks and Benefits
Privacy and Confidentiality
Conflict of Interest
The guiding questions above are adapted from “The IRB Member Module – ‘What Every New IRB Member Needs to Know” module in IRB Member course of CITI Program.
Download this guide: Requirements of Information for Ethical Review Guidelines.