Definitions of Research Compliance Terms

Data and Safety Monitoring Board (DSMB) – A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.

Debriefing – Giving subjects previously undisclosed information about the research project following completion of their participation in research.

Deception Study – A research study that incorporates in the design a technique for intentionally misleading a human subject during the course of the study to obtain certain results. The subject is debriefed after the study ends or after their participation ends.

Declaration of Helsinki – A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.

Drug – Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.