Comparison chart: Human Subject Research vs. Other Project Types

IRB approval is required only for activities that meet the federal definition of human subject research. Certain activities may have the characteristics of research and involve some level of interaction with people, but do not require IRB review. The Brown HRPP* includes activities of this type most commonly seen at Brown in the below table to assist students and researchers in determining whether your project meets the federal definition of human subject research.

If your project has one or more of the characteristics in the human subject research column, the project may require IRB review. If your project falls squarely into one of the other columns, then IRB review is not required.

HUMAN SUBJECT QUALITY PROGRAM STUDENT PROJECT SCHOLARLY & JOURNALISTIC RESEARCH IMPROVEMENT OR EVALUATION ACTIVITIES ASSESSMENT Common Rule: “Research means Intent of the project is Intent of the project is Intent of the project is This category of activities concerns certain INTENT a systematic investigation, to improve a practice to evaluate a specific to provide an activities in various fields that focus directly on including research development, or process within a program, only to educational experience the specific individuals about whom testing and evaluation, designed particular institution or provide information for about the research information are collected (e.g., oral history, to develop or contribute to ensure it conforms to and about that process or methods journalism, biography, literary criticism, legal generalizable knowledge.” expected norms. program. research, and historical scholarship).

Belmont Report: “[T]he term Literary criticism …because while a piece of ‘research’ designates an activity literary criticism might focus on information designed to test a hypothesis, about the author(s), it would typically focus on permit conclusions to be drawn, the specific author(s) in view. and thereby to develop or contribute to generalizable Legal research… because it would often focus knowledge (expressed, for on the circumstances of specific plaintiffs or example, in theories, principles, parties involved in a case. and statements of relationships). Research is usually described in a It is not the particular field that removes the formal protocol that sets forth an activity from the definition [of HSR], but rather objective and a set of procedures the particular activity's focus on specific designed to reach that objective.” individuals.

OHRP: “The question "what is research" frequently arises in relation to an investigator or institutional activity being planned to gather data to evaluate a specific program, such as a QA/QI activity. Although the determination as to whether the activity will contribute to 'generalizable knowledge' is often based on whether the data will be disseminated by means of publication or presentation, this should not be the sole factor used to make the determination. In general, OHRP gives guidance that if the data will be used to draw conclusions related to a larger entity, then the activity is considered 'research'.” Project occurs in large part as a Project occurs Project not initiated by Project occurs as part Project occurs to portray the individuals MOTIVATION result of individual professional regardless of whether the evaluator and of assigned involved. goals and requirements (e.g., individual(s) conducting occurs regardless of course/class work or a FOR PROJECT seeking tenure; obtaining grants; it may benefit whether individual(s) requirement of an completing a thesis or professionally from conducting it may educational program in dissertation). conducting the project. benefit professionally order to learn a new from conducting the technique or pass a project. course/fulfill an assignment. Designed to develop or Not designed to Not designed to Not designed to Designed to collect and use information about DESIGN contribute to the scientific develop or contribute develop or contribute develop or contribute specific individuals themselves, and not storehouse of knowledge; may to generalizable to generalizable to generalizable generalizing to other individuals. involve randomization of knowledge; generally knowledge; does not knowledge; design is individuals to different does not involve involve randomization often an example or treatments, regimens, or randomization to of individuals, but may template provided by a processes; novel research ideas different practices or involve comparison of professor or course or experimental activities that processes. variations in programs. book. are not yet known to be efficacious. May be designed to prove a relationship or correlation. MANDATE Activities not mandated by Activity mandated by Activity mandated by Activity mandated by Activities not necessarily mandated by institution or program. the institution or clinic the program, usually its regularly assigned institution or program. as part of its funder, as part of its coursework or operations. operations. educational program. EFFECT ON Findings of the study are not Findings of the study Findings of the Findings of project are N/A PROGRAM OR expected to directly or are expected to directly evaluation are not expected to directly immediately affect institutional affect institutional expected to directly affect the program; the PRACTICE or programmatic practice, practice and identify affect the conduct of project will mainly EVALUATED although they may also be used corrective action(s) the program and generate raw data, not for this purpose. Activity will be needed. identify improvements. generalizable used to develop a problem knowledge. statement, research questions, and/or theory-based hypotheses. SUBJECT Human subject means a living Information on all or Information on Can either include all, Preamble to revised Common Rule: “… the POPULATION individual about whom an most receiving a participants receiving a most, or a subset of focus is on the specific activities that collect and investigator (whether particular treatment or particular treatment or individuals; statistical use information about specific individuals professional or student) undergoing a particular undergoing a particular justification may be themselves, and not generalizing to other conducting research obtains (1) practice or process practice or process used in the context to individuals, and that such activities occur in Data through intervention or expected to be expected to be used; understand the process various fields of inquiry and methodological interaction with the individual, or included; exclusion of exclusion of of subject selection; traditions… It is not the particular field that (2) Identifiable private information from some information from some however, recruitment removes the activity from the definition, but information. May involve a individuals significantly individuals significantly often utilizes rather the particular activity's focus on specific subset of individuals; universal affects conclusions. affects conclusions. convenience sampling. individuals.” participation of an entire population (e.g., clinic, program, or department) is uncommon; generally, statistical justification for sample size is used to ensure endpoints can be met. BENEFITS Participants may or may not Participants expected No benefit to Participants may or Individual benefit may or may not be benefit directly – benefit, if any, to benefit directly from participants expected; may not benefit anticipated. to individuals is likely to be the activities. evaluation directly; benefit is incidental or delayed. concentrates on primarily for the program improvements student conducting the or whether the project for the program should fulfillment of continue. educational requirements. DISSEMINATION Intent to publish or present Intent to publish or Intent to publish or Any presentations, Intent to publish or present generally presumed OF RESULTS generally presumed at the outset present generally not present generally posters, or publishing at the outset of the project; dissemination of of project as part of professional presumed at the outset presumed at the outset (including online) is information occurs to document a specific expectations, obligations; of the project; of the project; simply to document the historical event or the experiences of dissemination of information dissemination of dissemination of educational experience individuals without intent to draw conclusions usually occurs in information often does information to program or completion of or generalize findings. research/scientific publications, not occur beyond the stakeholders and programmatic grant proposals, or other institution evaluated; participants; may be requirements. research/scientific forum; results dissemination of publicly posted (e.g., expected to develop or information may occur website) to ensure contribute to generalizable in quality improvement transparency of results; knowledge by filling a gap in publications; when when published or scientific knowledge or published or presented presented to a wider supporting, refining, or refuting to a wider audience, audience, the intent is results from other research the intent is to suggest to suggest potentially studies. Results of the project will potentially effective effective models, be disseminated outside the models, strategies, strategies, assessment institution for the purpose of assessment tools or tools or provide sharing the outcomes or provide benchmarks or benchmarks or base implications of the project, not base rates rather than rates rather than to just the process. to develop or develop or contribute contribute to to generalizable generalizable knowledge. knowledge.

*The Brown HRPP expresses its gratitude to Oregon State University for providing permission to adopt and adapt this table for the Brown University research community.