Human Subject Research Protection Program

Howard University is committed to the highest ethical standards in the conduct of research and specifically to its obligation to ensure the rights and welfare of human research subjects. Human research protection is a shared responsibility involving the University, the Institutional Review Boards (IRBs), investigators, and research staff.

Any undertaking, regardless of funding source, in which a University faculty member, staff member, or student conducts research involving human subjects or a clinical investigation requires IRB review and approval prior to initiation. The University applies the applicable federal definitions for “research”, “human subjects”, and “clinical investigation” in determining which activities require prior IRB review and approval.

This Standard Operation Policies and Procedures are guided by the Ethical Principles of the Belmont Report, and in accordance with the Common Rule set forth by 45 CFR 46 Subpart A through D.

Goals and Objectives

• Comply with all relevant federal, state, and local regulations governing human subjects research.

• Ensure the safety and wellbeing of human research participants by minimizing risks and maximizing benefits.

• Provide ongoing education and training on human research protections to all members of the research community.

Roles and Responsibilities

• Encourage researchers to adhere to ethical principles and professional standards in all aspects of their work.

• Create an environment where researchers openly share their methods, data, and findings to facilitate reproducibility and public trust.

The ORRC under the leadership of the AVP for RRC is responsible for managing protocol review; assisting the University in responding to federal initiatives affecting the ethical conduct of research, policy development, agency liaison, education, quality improvement, federal record keeping and reporting; and handling allegations of noncompliance.