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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.

IRB 

  IRB Policies and Procedures (Effective January 21, 2019)

  Limited Review

  CITI Final Rule Material Changes to Exempt Determination Process

  Human Research Student Protection and Institutional Review Boards (IRB) Standard Operating Policies and Procedures (SOPP) (Old - Pre-2018)

​  Institutional Review Board for Human Subject Review of Protocol Fee Policy 

​  Addendum/Revision to: Human Research Subject Protection and Institutional Review Boards (IRB) 
  Standard Operating Policies and Procedures (SOPP)

Sub-sections for IRB Policies and Procedures (Effective January 21, 2019): 

1.0  Overview

2.0  Determining Activities That Qualify as Human Research or Clinical Investigations

3.0 Purview and Training

4.0 Protocol Violation

5.0 Reviewing Research Involving Vulnerable Subjects 

6.0 Handling Allegations of Noncompliance

7.0 Deviation and Exception of Previously Approved Protocol

8.0 Coordination Among the Office of Regulatory Research Compliance, IRB, and Institutional Biological Safety Committee (IBC) 

9.0 Minutes of Convened Meetings 

10.0 Prompt Institutional Review Board Reporting 

11.0 Record Keeping 

12.0 Inspections by External Regulatory Agencies 

13.0 Preparation, Scheduling, and Conduct of Convened Meetings of The Institutional Review Board (IRB) 

14.0 Review of Data and Safety Monitoring Plan(s) 

15.0 Investigator Reporting of Unanticipated Problems or Adverse Events 

16.0 Submitting A Cooperative Group Pediatric or Adult Protocol to The National Cancer Institute (NCI) 

17.0 Reviewing Protocol Violation

18.0 Conducting Expedited Initial Review 

19.0 Procedures for The Exempt Review Process

20.0 Initial Full Review by the Institutional Review Board (IRB) 

​21.0 Obtaining And Documenting Informed Consent/Assent 

22.0 Coordination of IRB Review and Oversight Conducted at Off-Site locations or Multiple Sites

23.0 Conducting Continuation Review (CR) 

24.0 Closing a Study 

25.0 Acknowledgements


IACUC
Policies and Procedures
Office of Regulatory Research Compliance
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