The Harvard University Area (HUA) IRB aims to promote a culture of compliance and to establish across the University the highest expectations for performance and oversight of research involving human subjects. The IRB is committed to the education of the Harvard research community and outreach to collaborating institutions.
The mission of the IRB is to assure that all participants are protected from any unnecessary risk when enrolled in a research study, that they can make an informed decision to participate, and when possible, that participant and/or society at large benefits from the knowledge gained from the research study. The goal of the IRB is to assist investigators in developing appropriate research protocols in accordance with federal and University policies, and within accepted ethical guidelines.
All Human Subjects Research conducted by Harvard University investigators, regardless of source of funding or location of the research, is guided by the ethical principles of respect for persons, beneficence, and justice, as set forth in the April 18, 1979 report of The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research, also known as “The Belmont Report.”
IRB Statement of Commitment
The mission and purpose of an IRB is to safeguard the rights and welfare of human participants in research, to both include and protect those whose conditions are the focus of study. IRBs are responsible for the evaluation and approval of all human participant research and should ensure that any exclusion from participation is justified and based on scientific, ethical, or safety concerns. As an IRB, we recognize our responsibility to address ethical and regulatory concerns regarding diversity, equity, and inclusion in research and to support researchers and institutional efforts that are foundational to achieving these goals. We are committed to evaluating all IRB applications, including eligibility criteria, recruitment materials, consent documents and processes, and other study documents for inclusive and equitable opportunities for potential participants. As the entity that holds investigators and research personnel accountable, we, as IRB professionals and members, are also accountable: IRB representation and membership will strive to sustain a composition that is reflective of the population we serve and protect. As part of the research community, we recognize that each member of the human research protection program, the IRB, institutional offices that support human subjects research, researchers and their study teams, research participants, and the community we serve all play an integral role in advancing research that is representative of our communities; we endeavor to reduce disparities and promote social justice. We are committed to this work.
Who We Are
The Harvard University Area includes the Faculty of Arts and Sciences, Harvard Graduate School of Education, Harvard Kennedy School, Harvard Divinity School, Harvard Business School, Harvard Law School, Harvard Graduate School of Design, the Harvard School of Engineering and Applied Sciences, Harvard University Health Services, and the Radcliffe Institute for Advanced Study. The IRB of record for the Harvard University Area is referred to as the Committee on the Use of Human Subjects (CUHS).
The IRB Office
The HUA IRB administrative office is responsible for managing the day-to-day operations and support of the IRB. The HUA IRB office staff perform a variety of functions in addition to supporting the IRB such as providing IRB determinations, reviewing studies on behalf of the IRB, assisting researchers with IRB related questions, and providing training and outreach.