Non-Regulated Research

Non-Regulated ResearchNon-Regulated Researchactivity that does not meet the regulatory definition of research. projects do not require IRB approval. However, we strongly encourage you to submit a brief description using our short form so that we can make an official determination. You may find this useful if you plan on submitting your research to a journal or professional meeting.

Activities are not regulated research if they do not involve a systematic approach involving a predetermined method for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory.

The purpose of the project does not include hypothesis testing, theory development or replication of another research study. In addition, the project should not be be described as research in grants, public presentations, academic dossier or other representations. Finally, a federal ( DHHSDHHSDepartment of Health and Human Services is responsible for Improving the health and well-being of America. The National Institutes of Health (NIH), Center for Disease Control (CDC), Health Resources and Services Administration (HRSA) and the Substance Abuse and Mental Health Services Administration are examples of DHHS agencies. ) grant cannot have been awarded to conduct this project as human subjects researchHuman Subjects Researchresearch involving living individuals whenever the investigator obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens or interacts/intervenes for research purposes. .

Examples include:

Scholarly and journalistic activities
Public Health Surveillence
Criminal Justice Activities
Federally Authorized Operations
Routine Quality ImprovementQuality Improvementsystematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects QI is generally not considered research Ð however, QI activities can be research if they are also intended to contribute to generalizable knowledge.
Medical Quality AssuranceQuality Assuranceactivities particular to an institution's QA program, such as those activities protected from disclosure by the Department of Veterans Affairs as part of its confidential medical quality-assurance program or other equivalent programs. (e.g., see VHA Directives or equivalent university or institutional policy)
Program EvaluationProgram Evaluationassessments of the success of established programs in achieving objectives when the assessments are for the use of program managers, for example, a survey to determine if program beneficiaries are aware of the availability of program services or benefits. Not generally considered a research activity as long as the evaluation is designed to assess or improve the program or service rather than to generate knowledge about a disease or condition.
Customer Satisfaction SurveyCustomer Satisfaction Surveyrefers to surveys of program users to obtain feedback for use by program managers.
Case Reports
Community Outreach