Human Research

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 participants. The ORRC developed a Human Research Protection Program (HRPP) that is responsible for:

• Managing the review and approval of research study protocols involving human participants;
• 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;
• Handling allegations of noncompliance.

The HRPP is a shared responsibility involving the University, the Institutional Review Boards (IRBs), investigators, and research staff. The Program is guided by the Ethical Principles of the Belmont Report and the Office for Human Research Protections in accordance with regulations, including the Common Rule, set forth by 45 CFR 46 Subpart A through D, 21 CFR 50, and 21 CFR 56.

Institutional Review Board (IRB)

Howard University has two IRBs (a Medical IRB and a Non-Medical IRB) which review and provide oversight for all research involving human participants at Howard University. Any undertaking, regardless of funding source, in which a HU faculty member, staff member, or student conducts research involving human participants or a clinical investigation requires IRB 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.

Both IRBs are authorized to:

• Review and make the decision to approve or deny research studies at Howard University.
• Inspect any Howard University research facility.
• Obtain and review the records of any study participant.
• Observe the consent process for any research study.
• Suspend or terminate research.
• Take any action it deems necessary to ensure compliance with federal and University policies and regulations.

To achieve the overarching goal of ensuring Howard University’s compliance with all federal and regulatory requirements relating to its research enterprise, the Howard University IRBs require PIs to:

• Ensure the safety and wellbeing of human research participants by minimizing risks and maximizing benefits.
• Report expeditiously any proposed changes in previously approved human participant research activities as these changes cannot be initiated without Howard University IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
• Report immediately any injuries or other unanticipated problems involving risks to participants and others, including research staff.
• Report progress of approved research, as often as and in the manner prescribed by the Howard University IRB on the basis of projected risks to participants, but no less than once per year.
• Identify and chronicle any modification(s) or clarification(s) in detail to the IRB, which becomes an addendum to the original application.

IRB Membership

In accordance with federal law, Howard University IRBs are qualified through the experience and expertise of its members to oversee institutional research involving human participants. In compliance with federal requirements from 21 CFR 56.107, each Howard University IRB is comprised of the following:

• At least 5 faculty members from across the various disciplines at the University with experience in research involving human participants.
• Each Committee has at least one member who is not affiliated with the University to provide representation for general community interests in the ethical treatment of humans.
• A member to act as a Prisoner Advocate in cases where a study includes prisoners as research participants.

Medical IRB Chairperson
Evaristus Nwulia, M.D., MHS - Professor of Psychiatry and Behavioral Sciences

Non-Medical IRB Chairperson
Alfonso Campbell, Ph.D. - Professor of Psychology