Institutional Review Board (HU-IRB)

The HU-IRB operates 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). This precedent is the guiding policy that governs all Howard University research activities involving human participants.

HU-IRB assurance information can be found in the Resources column below.

The HU-IRB, in addition to conducting full and expedited reviews on a research project-by-project basis, engages in continuing reviews. These continuing reviews occur annually because the HUIRB does not approve any Howard research effort for more than a year at a time. Continuing reviews prior to HU-IRB review require submission of all appropriate documentation, including progress reports (either the Application for Continuing Review Form A-2, or the Application for Continuing Review Form C-2 are acceptable) from the project.

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

  • Report expeditiously any proposed changes in previously approved human participant research activities, as these changes cannot be initiated without HU-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 HU-IRB on the basis of projected risks to participants, but no less than once per year; and
  • 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 HU-IRB reviews and provides oversight for all research involving human participants at Howard University. It thereby is authorized to inspect any Howard University research facility and to obtain the records of and observe the consent process for any research program, suspend or terminate research, or take any other action it deems necessary to enforce compliance of a research activity with federal and University regulations.

The HU-IRB monitoring process requires more than oversight. Internally, it requires that all research records and staff be accountable to external review and monitoring by funding agencies. HU-IRB has engaged in a successful external audit, one for the Food and Drug Administration. Additionally, the ORRC has responded to queries from the U.S. Department of Health and Human Services’ (DHHS) Office on Research and Integrity (ORI) and DHHS regarding matters pertaining to the HU-IRB.

Contact the ORRC for IRB meeting schedule information.

The ORRC staff is available to assist committee members, faculty, staff, and students.


Research Regulatory Compliance
Howard University
1840 7th Street, NW
Suite 309
Washington, DC 20001
(202) 865-8597
huirb@howard.edu

Assurances
The HU-IRB also responsible for providing assurances to the federal government that Howard University is in compliance with federal regulations. The HU-IRB operates under the following:

  • Federal Wide Assurance Number (FWA)
    00000891 (expires February 13, 2017)
  • Parent Institution/Organization Number
    IORG0000085
  • Howard U IRB Number
    IRB00000123