Undergraduate Regulatory Determination Process

Most undergraduate research projects involving human participants or their data are scholarly activities aimed to satisfy academic requirements; those projects do not fall under the purview of the IRB. The goal of the RAU for oversight of undergraduate research is to determine if the activity is a scholarly activity, if the research activities present only minimal risk procedures, and if the project has the potential to contribute to generalizable knowledge. 

Undergraduate research projects must be submitted to the HRPP/IRB by the faculty advisor when the project:

• Involves procedures classified as more than minimal risk.
• The project is funded by a federal agency, which implies the project is systematic human research and the results are generalizable according to federal regulations.

For clarification on systematic, minimal risk and generalizability, please see the HRPP definitions. If you have additional questions, please email the RAU.

All other undergraduate projects involving human participants must fill out the Undergraduate Research Regulatory Determination survey and follow the instructions provided at the end of the survey for the green light to start the project, obtain clearance from the RAU, or obtain a referral to the IRB.

After completion of the survey, please save the outcome message as a PDF and send it by email to regulatoryadvising@brown.edu.

Undergraduate Research - Regulatory Determination

Please note that upon completion of the survey, the study may require IRB review. Timeline for review should be considered when planning the study's initiation. All undergraduate projects in this category must first notify the RAU before submitting to the IRB. 

Undergraduate students are not eligible to serve as PIs on IRB protocol submissions, and a faculty advisor with experience conducting human subjects research must be listed as the study's PI. Please plan accordingly.

Training

The RAU can conduct regular training sessions for faculty members supervising student research, focusing on responsible mentorship and ethical considerations. The unit also trains students about the ethical responsibilities of conducting research with human subjects and the IRB process. 

Graduate Regulatory Determination Process

Graduate students are not automatically eligible to serve as PI on a human subjects research study. Those individuals may be eligible to serve as PI in human research projects with prior written approval and only with a named Brown faculty mentor or advisor following the Principal Investigator Eligibility for Externally Sponsored Awards policy.

PI Eligibility Requirement Chart

For graduate research projects, the RAU can guide the principal investigator to make the determinations about the need for IRB review and support the process to obtain IRB approval. In addition, the unit will provide regulatory clearance for projects defined as program evaluation, quality improvement, or capstone projects. 

Support is also offered if help is needed filling out the self-determination form.

Responsibilities of Faculty Advisors

Faculty advisors have the primary responsibility for ensuring that human subjects are treated ethically and human subjects research is conducted following the principles of the Belmont report. 

Faculty advisors must mentor their student researchers regarding ethical principles for the protection of human subjects, which includes completion of the CITI training course (required for all undergraduates submitting to the IRB if applicable).

Faculty advisors are responsible for reviewing and making the final determination regarding materials to be submitted to the RAU or the IRB when applicable, including any survey instruments or interview questions.

Faculty advisors should contact the RAU with any questions regarding undergraduate projects involving human subjects.

The RAU can provide assistance at different times during a protocol lifecycle, including:

• When developing a project idea: the RAU will provide input on feasibility from the project's ethical and compliance perspective.
• Before the initial submission of protocols to the IRB: the RAU will work with the principal investigator (PI) to incorporate all the regulatory requirements into the protocol to be submitted.
• When revising a protocol: after receiving a "modifications required" communication from the IRB, researchers can work with the RAU to address these IRB requests and work on modifications and renewals of studies to ensure timely and accurate submission to the board.

The RAU can make the determination when there are uncertainties about whether a proposed project is considered “Non-Human Subjects Research,” or when a written determination is required. 

Tips: In addition to the information provided by the HRPP/IRB, the following items are relevant when determining non-human subjects research. Those terms should not be used interchangeably, since their definition is established in the Federal regulations, and their application has specific regulatory implications: 

• De-identified data refers to data available to the research team without any of the 18 identifiers listed by HIPAA. (See the HRPP Glossary for additional information.
• Exempt research is a category of research determined by the IRB. An “exempt study” does not mean exempt from an IRB review, it means the study will be exempt from the federal regulations once the IRB has conducted a review and has categorized the study as such. 
• Non-human subjects research is defined as projects that are not systematic or generalizable, and the information obtained is not about the individuals providing the information. 

• Capstone or scholarly projects are research activities that are not systematic or generalizable to be classified as human subject research. A systematic investigation uses a predetermined method (e.g., eligibility criteria, surveys, blood draws, etc.) to gain information by collecting and analyzing data. Interviewing or surveying individuals without a specific data collection and analysis methodology is not necessarily a systematic investigation. 

• Generalizable knowledge are conclusions that can be applied to a larger population beyond the specific site of data collection or the participants who provided the information. For the results of a study to be generalizable, the research needs to respond to a systematic methodology and analysis plan (i.e., quantitative, qualitative, or mixed methods research). 

The RAU assists researchers in setting up regulatory requirements, documenting research good practices, and self-assessing compliance during the study life as needed. The RAU supports researchers in aligning their research activities with external and internal ethical, legal, and professional regulations and standards.

The RAU can provide support on the following:

• Regulatory submissions: Federal agencies, FDA, Sponsors, and IRB
• Management of study-specific regulatory documentation

The RAU provides guidance and standards to PIs conducting industry-sponsored or investigator-initiated clinical trials for investigational drugs, devices, and software. The RAU works with the PI who is responsible for the study's compliance, managing the regulatory requirements, documentation, and interaction with sponsors and regulatory agencies. 

Clincaltrials.gov registration and maintenance

The unit provides support for posting, updating, and guiding PRS responses for faculty held ClinicalTrials.gov records.