Definitions – Human Subjects Research
Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Examples of systematic investigations include:
- surveys and questionnaires
- focus groups
- photovoice studies
- analyses of existing data or biological specimens
- epidemiological studies
- evaluations of social or educational programs
- cognitive and perceptual experiments
- evaluation of business process effectiveness
- medical chart review studies
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (like a class assignment).
Research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.
Examples of activities that typically are not generalizable include:
- oral histories that are designed solely to create a record of specific historical events
- service or course evaluations used only for the purpose of improving the service by the collector without presentation of application to outside entities.
- classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
- quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the GS community.
A human subject is as a living individual or a biospecimen about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
- Intervention includes both physical procedures by which data are gathered (e.g., blood draw) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record or opinion poll).
Investigators conducting human subjects research must satisfy DHHS (OHRP) regulations [45 CFR Part 46] known as the Common Rule and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable. Find a comparison of FDA and DHHS regulations at https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm
Last updated: 12/17/2018