Federal Regulations define research as “a systematic investigation, including development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge1 ” (45CFR46.102(d)). As described in the Belmont Report2 “...the term 'research' designates an activity designed to test a hypothesis or answer a research question(s) [and] permit conclusions to be drawn... Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that
objective.” “Research” generally does not include operational activities such as defined practice activities in public
health, medicine, psychology, and social work (e.g., routine outbreak investigations and disease monitoring) and studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies or contracted-for services. However, some of these activities may include or constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge.
**Information within this booklet is defined under OHRP federal regulations only. For activities that involve clinical investigations covered under FDA regulations involving human subjects require IRB review.
The Belmont Report is a statement of ethical principles (including beneficence, justice, and autonomy) for human subjects research by the U.S. Department of Health, Education, and Welfare.