IRB-Policies

IRB Policies

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

IRB Charge - Protocol Review Policies

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.

Institutional Review Board (IRB)

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

Office of Regulatory Research Compliance

IRB Policies and Procedures (Effective January 21, 2019)

Limited Review

CITI Final Rule Material Changes to Exempt Determination Process

Office of Regulatory Research Compliance (ORRC) Institutional Review Board (IRB) - SUPPLEMENT-1 (Revised on 3/22/2020)

Research Misconduct Policy