Human subjects of research are individuals about whom a professional or student investigator conducting research obtains data through intervention or interaction, or collects identifiable private information.
- Interventions in human subjects include physical procedures by which data are gathered, and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interactions with human subjects include communications or interpersonal contacts conducted for research purposes.
- Private information includes that collected under circumstances wherein the subject can reasonably expect that no observation or recording is taking place, and information the subject can reasonably expect will not be made public in a manner exposing the identity of the subject.
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.
The systematic application of scientific and statistical procedures for measuring program conceptualization, design, implementation, and utility; making comparisons based on these measurements; and the use of the resulting information to optimize program outcomes.
The ongoing, systematic collection, analysis, and interpretation of outcome-specific data, closely integrated with the timely dissemination of these data to those responsible for preventing and controlling disease or injury. Surveillance projects that most easily fit into this category are longitudinal data collection systems.
Unanticipated problems involving risk to subjects or others.
The IRB considers certain groups of human subjects particularly vulnerable in a research setting: minors under age 18, prisoners/parolees, pregnant women, fetus/fetal tissue, elderly subjects, subject's major language not English, mentally emotionally/developmentally disabled, university students/employees, mentally and economically or educationally disadvantaged persons. In reviewing research projects, the IRB will scrutinize projects involving these vulnerable groups to ascertain that their use is adequately justified, and additional safeguards are implemented to minimize risks unique to each group.