For a study involving human subjects to be approved by COUHES, it must satisfy the following criteria.
- The study uses procedures that are consistent with sound research design.
- Proposed research activities minimize the potential risk to the human subjects.
- Risks to subjects are reasonable, in relation to anticipated benefits to subjects (if any), and to the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought and appropriately documented.
The research plan makes adequate provision (when appropriate) for:
- monitoring data to ensure the safety of subjects
- protecting the privacy of subjects
- maintaining the confidentiality of data
- When subjects are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, mentally disabled persons) additional safeguards are included.