Research with human subjects includes, but is not limited to:
- Studies of a physiological, biochemical, or pathological process.
- Studies that measure human response to a specific intervention, including the diagnosis of the preventive or therapeutic measures.
- Studies designed to determine the consequences of specific or therapeutic preventive measures in individuals and/or communities.
- Studies relating to the human behavior in a diversity of circumstances and environments.
A research proposal is not subject to review by PAHOERC when:
- It does not involve human subjects.
- The data (including health-care records and specimens) being studied already exists and is either publicly available or recorded by the investigator in such a manner that the identity of individuals cannot be established.
- Public officials are interviewed in their official capacity on issues that are in the public domain.
- Proposals in which the intervention is limited to public health surveillance or monitoring of public health programs carried out pursuant to statutory or regulatory authority.