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.
Last Updated on Wednesday, 12 October 2011 05:59