Division of Research

Does My Project Need HRPP/IRB Review?

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Does My Project Need HRPP/IRB Review?

Brown University has assured federal regulatory agencies that the institution will review and approve all human subject research as defined by the U.S. Department of Health and Human Services (HHS). Determining whether or not a project meets that definition is a two-step process.

First, the investigator must determine if the project meets the federal definition of “research” and, if so, then determine if the project includes human subjects.

Brown’s Human Research Protection Program (HRPP) team, which supports the Institutional Review Board (IRB), provides self-assessment resources for students and researchers to use to determine if a project requires HRPP or IRB review, including downloadable tools and checklists; a step-by-step decision chart; and a comprehensive comparison table.

Self-Determination Tools and Checklists

Guides to assist Brown researchers

Self-determination tools and checklists are guides to assist Brown researchers in complying with federal regulations and institutional policy. These guides are not applications and do not require submission to the HRPP team for review unless the project is eligible for an exception as outlined within the documents.

Division of Research Tools

National Institutes of Health (NIH) Decision Tool

The NIH Office of Extramural Research developed an interactive online survey to help you determine if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research.

NIH Decision Tool: Am I Doing Human Subjects Research?

Determination of Human Subject Research Decision Chart

Brown’s Human Research Protection Program (HRPP) team has put together a Determination of Human Subject Research decision chart to help guide researchers in determining whether they need to submit an application to the IRB. The steps on the decision chart are detailed below; this information can also be viewed and downloaded in a PDF version.

PDF Version: Determination of Human Subject Research Decision Decision Chart (PDF)

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. Ask the following questions to determine whether your project fits the definition of research and may need IRB review.

A systematic investigation is a detailed or careful examination that involves a prospectively identified approach to studying a specific topic, answering a specific question, testing a specific hypothesis 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.

Your research should:

  • include a question or hypothesis the study is trying to answer or test;
  • be an activity that is methodologically driven; 
  • include clearly defined inclusion and exclusion criteria;
  • involve a prospective plan;
  • collect data or information in an organized and consistent way;
  • involve some kind of analysis of the data or information; and
  • draw conclusions from the results of the investigation.

If the answer is NO to the bullets above, the study does not meet the regulatory definition of research and you do not need to submit an IRB application.

If the answer is YES, proceed to Question 2.

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:

  • The resulting knowledge 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 the answer is NO, the study does not meet the regulatory definition of research and you do not need to submit your study materials for HRPP/IRB review.

If the answer is YES, proceed to Step 2.

Step 2: Does Your Project Involve Human Subjects?

Federal regulations for the protection of human subjects defines a human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.”

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

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 that 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 may not make that person a human subject.

If any of the following is true, your research activity involves human subjects.

If the answer is NO, the study does not meet the regulatory definition of including human subjects and you do not need to submit your study materials for HRPP/IRB review.

If the answer is YES, proceed to Question 4.

An interaction includes communication or interpersonal contact between investigator and subjects. This may include face-to-face interviews as well as remote surveys administered via internet or phone.

An intervention includes all physical procedures (i.e., blood draw) to gather information or biospecimens and all physical, psychological or environmental manipulations that are performed for research purposes.   

If the answer is NO, proceed to Question 5. 

If the answer is YES, this project meets the regulatory definition of including human subjects. Please submit your study materials for HRPP/IRB review prior to starting any study procedures.

“Identifiable private information” and “identifiable biospecimen” mean that the identity of the subject is or may readily be ascertained by the investigator or associated with the information or biospecimen.

Examples of identifiable private information or identifiable biospecimen include the following:

  • a dataset that includes identifying information such as name, date of birth (DOB), address, phone number, etc. 
  • a combination of variables that would allow an investigator to readily identify individuals
  • a blood sample containing subject DNA

If the answer is NO, proceed to Question 6. 

If the answer is YES, this project meets the regulatory definition of including human subjects. Please submit your study materials for HRPP/IRB review prior to starting any study procedures.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. 

Examples of private information include medical records, school records, observation of behavior in a person’s own home and observation of online activities of a closed group.

If the answer is NO, the study does not meet the regulatory definition of including human subjects. You do not need to submit your study materials for HRPP/IRB review.

If the answer is YES, this project meets the regulatory definition of research with human subjects. Please submit your study materials for HRPP/IRB review prior to starting any study procedures.

Defining ‘Personally Identifiable Information’

Personally identifiable information (PII) is information that can be used to distinguish or trace an individual’s identity (such as name, Social Security number and biometric records), either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual (such as date and place of birth or mother’s maiden name).

A lot of information that is considered personally identifiable information is publicly accessible, such as on social media platforms, in directories, in information for purchase and through the U.S. Census.

Unless specifically stated on the public site that the personally identifiable information may be used for research purposes without restriction, this project meets the regulatory definition of research with human subjects. Please submit your study materials for HRPP/IRB review prior to starting any study procedures. A definition of Personally identifiable information can be found on the HRPP/IRB Glossary.

HRPP/IRB Glossary

Human Subject Research vs. Other Project Types Comparison Chart

The HRPP team provides a comprehensive comparison chart to assist students and researchers with distinguishing whether a project qualifies as human subject research or falls into a separate category of activities commonly seen at Brown, such as quality improvement or assurance, program evaluation, student project or scholarly and journalistic activities. 

HRPP or IRB approval is required only for activities that meet 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 HRPP/IRB review. If your project falls squarely into one of the other columns, then HRPP/IRB review is not required. 

Comparison Chart: Human Subject Research vs. Other Project [PDF]

Do Undergraduate Projects Need IRB Review?

Planning to publish the results of a study in a journal or disseminate results in any way has no bearing on whether a study meets the definition of “research” as defined by the federal government.

To facilitate interpretation and application of this definition in the context of undergraduate work involving human subjects, and to ensure the ethical and safe treatment of human participants, the IRB in collaboration with the HRPP team provides guidance for undergraduates and their faculty advisors in determining if they need to submit a protocol for HRPP/IRB review.

Undergraduate Work Involving Human Subjects

Still Have Questions?

If you are unsure if your project meets the definition of research, or if you require documentation that your project does not require HRPP/IRB review, please contact the HRPP team at 401-863-3050 or irb@brown.edu to discuss.

If you are a student, you are strongly encouraged to first work with your advisor or mentor to discuss whether the proposed project meets the definition of human subjects research before contacting the HRPP.