Division of Research

Human Subjects Research at Brown

The Human Research Protection Program (HRPP) is a team of staff responsible for reviewing all research involving human subjects conducted at Brown University and helping to ensure researchers understand and comply with federal and state laws, and Brown policies.

Part of Research Integrity, the HRPP team promotes high-quality, ethical research by ensuring the protection of the rights and welfare of individuals who participate in research programs conducted by faculty, staff, students and researchers at Brown.

Inquiries for HRPP staff can be submitted to irb@brown.edu, or researchers can view individual staff information by visiting Research Integrity.

HRPP and the IRB

Human Research Protection Program (HRPP) staff support Brown’s Institutional Review Board (IRB), the committee that is required by federal regulations to protect human subjects participating in research at Brown. HRPP staff members pre-review all studies involving human subjects to determine whether they require full IRB review and work with the submitting researcher to help them navigate that review, and appropriately manage the research that follows.

The HRPP team reviews research projects under one of three categories based on the project’s potential risk to human subjects and the federal guidelines that define the categories of review:

  • Exempt Review
  • Expedited IRB (Non-Committee) Review or
  • Convened IRB (Committee) Review

HRPP staff members determine that review category in consultation with the IRB, as needed.

Visit the IRB page to learn more about the IRB board and view IRB meeting dates and deadlines.

The Institutional Review Board (IRB) at Brown is an independent committee of scientists, nonscientists and members unaffiliated with Brown and appointed by the Vice President for Research. The IRB was established to protect the rights and welfare of human subjects recruited to participate in biomedical or social/behavioral research conducted by Brown researchers.
Research Integrity is a group of teams — including Animal Research Compliance, Export Controls, the Human Research Protection Program, Quality Assurance and Quality Improvement, Conflict of Interest and Regulatory Compliance — that partner with the research community to facilitate ethical research guided by governing policies and regulations.
The review and regulatory boards within Brown University’s Division of Research provide ethical oversight, guidance and support to Brown researchers; ensure compliance with regulations and standards; monitor quality assurance of research processes and policies; and enable feedback and effective communications between investigators and research administrators within the University.

Planning Research with Human Subjects? Where To Start

Planning research involving human subjects requires substantial preparation before submitting your study protocol and other materials for HRPP/IRB review.

Once submitted, a study goes through stages of pre-review, review and post-review. Investigators then must continue to maintain compliance with all federal and University regulations and eventually close the study. Details about each of these stages of the process, including important forms and resources, can be found on the pages linked below, and on other pages throughout the Division of Research website.

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.
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Brown’s Human Research Protection Program (HRPP) team and Institutional Review Board (IRB) review a study according to federal regulations and by following the three basic principles laid out in the Belmont Report — Respect for Persons, Beneficence and Justice — and their corresponding applications — Informed Consent, Assessment of Risks and Benefits and Selection of Subjects.
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The Human Research Protection Program (HRPP) team and Institutional Review Board (IRB) have established guidance and policies to facilitate human subjects research activities conducted under the auspices of the University.
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Understanding Brown’s policies, procedures and timelines will help you prepare your submission for review by the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) and ensure your research activities can begin as soon as possible.
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Brown uses the electronic submission system Huron to receive human subjects research protocols for Human Research Protection Program (HRPP) and Institutional Review Board (IRB) review. Study workflow in Huron includes pre-submission, pre-review and review stages, as well as opportunities to make modifications and request clarifications.
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During the conduct and oversight of human subjects research, noncompliance, unexpected adverse events and unanticipated problems involving risks to participants or others may occur. All members of the Brown community have an obligation to promptly report events related to the conduct, management or oversight of Brown human subjects research to Brown’s Human Research Protection Program (HRPP) for review.
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In compliance with Brown Institutional Review Board (IRB) policy, all research personnel who are engaged in human subjects research at the University are required to have appropriate education and training to protect participants in research.
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