Definitions
Research is a systematic investigation, including testing and evaluation, designed to develop or contribute to generalized knowledge.
Human subject is a living individual about whom an investigator conducting research obtains either [1] data through intervention or interaction with the individual or [2] identifiable private information by review of documents or records.
Risk is the possibility of harm (physical, psychological or social) that may occur as a consequence of any activity that goes beyond the application of established and accepted methods needed to meet the patient's needs.
Benefit is a valued or desired outcome or an advantage. Payment for participation is not a benefit.
Adverse events are undesirable and unintended though not necessarily unexpected results arising during the course of a research protocol.
Compliance with the IRB Regulation and Decisions
- Research investigators shall be responsible for complying with IRB decisions, conditions and requirements. Failure to comply with application, amendment, reporting, record keeping, informed consent or any other IRB requirements may result in suspension or termination of the research approval by the IRB.
- Any audits by outside or internal groups of research compliance must be forwarded promptly to the IRB. The IRB may require an audit of research compliance if concerns about conduct are reported to it or complaints are received.
- If there are concerns about statements made on data submitted for review based on discrepancies of IRB files and investigator assertions, the IRB will request an internal review of the conduct of research by the hospital compliance officer.
