An undergraduate project conducted to fulfill a course or thesis requirement may qualify for Brown’s undergraduate exception and may not require an HRPP/IRB submission when all of the following conditions are met:

• The project is conducted solely to fulfill an academic requirement.
• The project presents no more than minimal risk to participants.
• There are no concrete plans to present the results at a conference or prepare a manuscript for submission to a scientific, peer-reviewed journal.
• The project does not involve vulnerable populations, such as children, prisoners, or individuals with cognitive impairments.
• Information is collected and recorded in a manner that does not identify participants or allow them to be readily reidentified.

The Regulatory Advising Unit will review the information submitted through the Undergraduate Determination Survey and confirm whether the project qualifies for the undergraduate exception.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated from the project are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.

An undergraduate project requires additional review by the Regulatory Advising Unit when it includes one or more of the following:

• The project is designed to develop or contribute to generalizable knowledge.
• There are concrete plans to present the results at a conference or prepare a manuscript for submission to a scientific, peer-reviewed journal.
• Project procedures may present more than minimal risk.
• The project involves vulnerable populations.
• Participants will be identifiable or information will be recorded in a manner that allows participants to be reidentified.

Following its review, the Regulatory Advising Unit may issue a determination, request additional information, recommend a consultation, or refer the project for an HRPP/IRB submission.

Undergraduate students cannot serve as Principal Investigators on IRB submissions. If an HRPP/IRB submission is required, an eligible faculty member must serve as the Principal Investigator. Students should account for the time needed to prepare and review an IRB submission when planning their projects.

Faculty advisors are responsible for:

• Helping the student assess the ethical and regulatory considerations associated with the proposed project
• Reviewing the project design, recruitment materials, data-collection instruments, and participant-facing materials
• Ensuring that participants are treated ethically and that appropriate privacy and confidentiality protections are in place
• Mentoring the student regarding the ethical principles applicable to activities involving people
• Ensuring that required human subjects protection training is completed
• Serving as the Principal Investigator when an undergraduate project requires an IRB submission
• Contacting the Regulatory Advising Unit when questions arise

For undergraduate projects that do not require IRB review, the HRPP and Regulatory Advising Unit strongly recommend providing participants with the Letter of Introduction for Undergraduate Work Involving Human Subjects.

The letter should explain the purpose of the project, what participation involves, that participation is voluntary, and whom participants may contact with questions.

Only Brown University contact information should be included. Students and faculty advisors who need a Brown telephone number or project-specific Brown email address should contact the Office of Information Technology.

Undergraduate Determination Survey

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.

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.

Purpose: Improve a specific process, program, or service; may include testing internal practices or standards.
Benefits: Focused on immediate, local improvement; may not directly benefit participants beyond the service.
Risks: Does not introduce additional risk beyond potential privacy or confidentiality concerns.
Knowledge: Not generalizable beyond the specific setting.
Design: Non-experimental; part of routine operations.

Purpose: Assess how well a program achieves its intended goals.
Benefits: Identifies strengths and areas for improvement; participants typically do not directly benefit.
Risks: Limited to privacy or confidentiality concerns.
Knowledge: Not generalizable beyond the program.
Design: Non-experimental; evaluative.

Purpose: Develop or contribute to generalizable knowledge (e.g., evaluating a treatment or intervention for broader application).
Benefits: May or may not directly benefit participants.
Risks: May introduce additional risks depending on study design.
Knowledge: Intended to be generalizable beyond the study population.
Design: May include experimental or interventional activities.