Assessing Risks and Potential Benefits
Assessing risks and potential benefits is inexact, but investigators need to be able to explain to the funding agency, the IRB and the potential research participants how and why the potential benefits of research outweigh the risks of participating in a particular study.
The principle of beneficence requires that investigators consider a number of factors including:
- Protecting the privacy of research participants and the confidentiality of research data
- Establishing oversight mechanisms to protect the rights and welfare of research participants and to determine the significance of the data