{"id":29,"date":"2025-12-02T17:06:18","date_gmt":"2025-12-02T22:06:18","guid":{"rendered":"https:\/\/www.clarku.edu\/sponsored-programs-and-research\/?page_id=29"},"modified":"2025-12-04T16:31:23","modified_gmt":"2025-12-04T21:31:23","slug":"what-is-human-subjects-research","status":"publish","type":"page","link":"https:\/\/www.clarku.edu\/sponsored-programs-and-research\/irb-human-subjects\/what-is-human-subjects-research\/","title":{"rendered":"What is Human Subjects Research?"},"content":{"rendered":"\n
\n
\n

Activities that meet the federal definition of \u2018human subjects\u2019<\/strong> under 45 CFR 46.102(e) and \u2018research\u2019<\/strong> under 45 CFR 46.102(l) require IRB review and approval, or a formal determination that the project is exempt. The IRB is responsible for determining whether activities and projects meet these definitions and when or whether IRB review and approval is required. These determinations are made by the IRB Chair or by another IRB member designated by the Chair.<\/p>\n\n\n\n

All research involving human subjects that meets the criteria set forth in 45 CFR 46.102, irrespective of funding and\/or funding source, conducted at Clark University and\/or by any Clark University faculty, staff, or student (full-time\/part-time status and\/or undergraduate\/graduate level), must be reviewed by the IRB. No human subjects research may commence until the IRB has reviewed and approved the protocol and issued a written notice of approval or exemption. There is no provision in federal regulations that allows for IRB approval of non-exempt research that has already been conducted.<\/p>\n\n\n\n

The IRB applies two definitions of research depending on the type of project under consideration. If a project meets at least one<\/strong> of these definitions it is considered to be research for purposes of IRB review. The first definition is most commonly applicable to research conducted at Clark University.<\/p>\n\n\n\n

Definition 1: Research<\/h2>\n\n\n\n

Research <\/strong>is defined as a systematic investigation<\/em>, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.<\/em> Learn more here<\/a>.<\/p>\n\n\n\n

Systematic investigation<\/summary>\n

A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan. Systematic investigations ordinarily:<\/p>\n\n\n\n