Brown's IRB has assured federal regulatory agencies that the institution will review and approve all research that meets the federal definition of human subject research. Determining whether or not a project meets the federal definition of human subjects research is a two-step process. The investigator must first determine if the project meets the federal definition of research and, if so, then determine if the project includes human subjects.
In addition to the information below, the Brown HRPP has provided self-assessment resources for students and researchers to use to determine if their project requires IRB review:
- A comprehensive comparison table to assist students and researchers with distinguishing whether a project qualifies as human subject research, quality assurance/quality improvement, program evaluation, a student project or scholarly & journalistic activities.
- A decision chart to help guide researchers in making a determination of whether they're conducting human subject research and need to submit an IRB Application.
- A Human Subjects Research Determination Form to assess whether your research study meets the federal definition of human subject research.
- *NEW* The NIH Decision Tool: Am I Doing Human Subjects Research? Developed by NIH to help you determine if your research involves human subjects, may be exempt from federal regulations, or is not considered human subjects research.
Step 1: Is your Project Considered Research?
Federal regulation defines "research" as a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge.
A "systematic investigation" is a detailed or careful examination that has or involves a prospectively identified approach to studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory based on a system, method, or plan. Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research. Projects that are not systematic investigations include, for example, oral histories, journalism, and phenomenological activities. Program evaluation is seen as a gray area and requires further assessment of design and intent.
Developing or contributing to "generalizable knowledge" means that the intent or purpose of the systematic investigation is to produce knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. This usually includes one or more of the following concepts:
- knowledge that contributes to a theoretical framework of an established body of knowledge;
- the primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study;
- dissemination of the results is intended to inform the field of study (this alone does not make an activity constitute research “designed to contribute to generalizable knowledge”);
- the results are expected to be generalized to a larger population beyond the site of data collection;
- the results are intended to be replicated in other settings.
If your project is not considered research, you do not need to submit an IRB application. If your project does meet the definition of research, proceed to Step 2.
Step 2: Does it involve human subjects?
The Federal Policy for the Protection of Human Subjects (Common Rule) defines a human subject as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
Examples that do not meet the definition of Human Subjects:
- Analysis of data about people who are deceased
- Secondary analysis of anonymous data
- Interviews with “key informants” about topics other than themselves
Note that the definition of human subject focuses on what information is obtained about people or material that is acquired from people. If either of the following is true, your research activity involves human subjects:
Data about living individuals through intervention or interaction
An intervention may be physical procedures (e.g. venipuncture) or manipulations of living individuals or the living individuals’ environments.
An interaction may be communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices.
Why “about whom” is key
Consider if the project focuses on the person or if the focus is on policies, practices or procedures about which the person is knowledgeable. Projects which collect information about policies, practices or procedures – even if the person who provided that information is identified – do not constitute human subject research. Asking a person about someone else does not make that person a human subject.
Identifiable private information about living individuals
Identifiable means 1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or 2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.
Private Information is information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical record, employee or student records).
Examples of identifiable, private information include the subject’s name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.
What is NOT considered identifiable, private information: If the information cannot be linked to a living individual, or is considered public or is given with the expectation that it will be made public and that it will be linked to the individual (e.g. biography or news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set that does contain identifiers or codes linked to individuals does involve human subject research.
If you obtain/purchase/are given specimens/cells/material/data that has already been collected by someone else for some other purpose, and the specimens/cells/material/data are not linked to any identifiers that would make it reasonably possible to identify an individual, the activity is not considered research with human subjects.
If your activity does not involve human subjects as defined in the regulations, your activity does not fall under the purview of the IRB. You do not need to submit an application.
If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin (the IRB can not review projects retrospectively).
Still unsure or require documentation that your project does not need IRB review?
If you are unsure if your project meets the definition of research, or if you require documentation that your project does not require IRB review, please contact the HRPP at (401) 863-3050 or [email protected] to discuss. If you are a student, we strongly encourage you to first work with your advisor / mentor to discuss whether the proposed project meets the definition of human subjects research before contacting the HRPP.
If you have questions, please contact us at 401-863-3050 or [email protected].