humanresearchmain

Office of Regulatory Research Compliance

Howard University

HU Research Bldg 1

1840 7th Street, NW

Suite 309

Washington, D.C. 20001

Phone: (202) 865-8597

Fax: (202) 232-5286

ORRC is located directly across from the Howard University Shaw Metro on 7th Seventh St.(Georgia Ave) on the third floor of the Howard University Research Building-1.

The ORRC manages all human participant research studies at Howard University and provides support to two Institutional Review Boards (IRB): The Medical IRB and the Non-medical IRB. The ORRC maintains the University’s IRB’s policies, guidelines, and procedures involving research with human participants. ORRC staff is available to provide guidance and education on research involving human participants to the Howard research community and the community at large.

ORRC staff is available to assist with any questions, concerns, and needs regarding human research studies. Please contact us at (202) 865-8597 or [email protected].

Howard University IRBs (Medical and Non-Medical IRB Committees) review and provide oversight for all research involving human participants at Howard University and operate in compliance with the regulations of the U.S. Department of Health and Human Services Office of Human Research Protections for the protection of human research participants, including 45 CFR 46, 21 CFR 50, and 21 CFR 56, which govern human participant research as amended to include the Common Rule (FR 56, No. 117,28002).

The IRBs are thereby authorized to inspect any Howard University research facility and to obtain records of and observe the consent process for any research study, suspend or terminate research, or take any action it deems necessary to ensure compliance with federal and University policies and regulations.

All research records and staff are accountable to external review and monitoring by funding agencies.

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 IRB requires PIs to:

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 a detailed letter to the chair of the HU-IRB, which becomes an addendum to the original application

The Medical IRB Committee is generally charged with reviewing research applications that originate in the Health Sciences division along with research protocols that involve medical procedures, devices, and drugs.

The Non-Medical Committee typically reviews those research applications that orginate from the Academic Affairs division along with research protocols that are generally socio-behavioral in scope.

Each Committee is comprised of faculty members from across the various disciplines at the University. Each Committee also have at least two members who are not affiliated with Howard University.