The policy governs all Research activities involving human participants and/or their data or specimens conducted by or under the auspices of Brown University (the University) and promotes compliance with applicable federal and state regulations, institutional policies, and applicable international regulations. It describes the requirements of the University and its researchers in protecting the rights and welfare of Research participants, and in following the highest ethical standards for the treatment of human participants and their data or specimens.

This policy applies to all individuals engaging in Research activities involving Human Subjects and/or their data or specimens that are conducted by or under the auspices of the University.

The University respects the rights and welfare of individuals recruited for or participating in Research activities conducted by or under the auspices of the University. Research activities at the University are guided by the ethical principles outlined in the Ethical Principles and Guidelines for the Protection of Human Subjects Research (“Belmont Report”). Activities involving Human Subjects Research, as defined in 45 CFR Part 46, are also subject to applicable federal regulations and relevant state law, including but not limited to the Department of Health and Human Services Federal Regulations for the Protection of Human Subjects (45 CFR 46), the Food and Drug Administration Policy for the Protection of Human Subjects (21 CFR 50), and the Food and Drug Administration Policy for Institutional Review Boards (21 CFR 56). Individuals conducting activities at the University that do not meet the federal definition of Human Subjects Research still must follow and maintain the highest ethical principles and standards consistent with the Belmont Report.

The Human Research Protection Program (HRPP) at Brown University uses Standard Operating Procedures, manuals, worksheets, checklists, and templates as tools to adhere to applicable regulatory requirements and ethical standards. Brown HRPP may also develop additional guidance tools or documents as needed. Together, these materials form the policies and procedures of the Brown HRPP (HRPP Policies and Procedures). All individuals who engage in Research activities involving human participants and/or their data or specimens at the University are required to review and conduct these activities in accordance with HRPP Policies and Procedures.

For the purpose of this policy, the terms below have the following definitions:

All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors and employees with student oversight duties are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure and enforce compliance with it.

Failure to comply with this and related policies and procedures is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.

Brown University is a community in which individuals are encouraged to share concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).

The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.