Assuring research compliance with laws, regulations and Howard University policies.
CONTACT US
Office of Regulatory Research Compliance
Howard University
Howard University Research Building 1
1840 7th Street, NW
Suite 309
Washington, D.C. 20001
(202) 865-8597
Office of Regulatory Research Compliance
Welcome to the Office of Regulatory Research
Compliance website!
Is Your Activity Research or Qualify for Exempt, Expedited or Waiver of Documented Informed Consent
MISSION STATEMENT
Important Information
Given the recent re-organization in the Office of Regulatory Research Compliance, we advise that all correspondence to the IRB should be directed as follows:
For Medical IRB: Dr. Evaristus Nwulia (Chair of the Medical IRB)
For Non-Medical IRB: Dr. Alfonso Campbell (Chair of the Non-Medical IRB)
Please, note that the IRB Chairs are acting on behalf of the Howard University Human Subject Compliance Program. Therefore, we emphasize that all IRB and protocol -related communications to the Chairs, be channeled through the following email addresses:
Medical IRB: [email protected]
Non-Medical ORRC: [email protected]
To read more, click the pdf file.
In an effort to better streamline the Health Insurance Portability and Accountability Act (HIPAA) training procedures, the Office of Regulatory Research Compliance (ORRC) and the Institutional Compliance Office have reached the following agreement. Henceforth, Clinician Scientists and Research Staff should only complete the Clinician Scientist module of the Collaborative Institutional Training Initiatives (CITI). A certificate of successful completion of this module is considered sufficient to meet the HIPAA training requirements of the ORRC and the Institutional Compliance Office. The certification is good for 2 years.
To read more, click the pdf file.
To better track and streamline the processing of research and other applications, the Office of Regulatory Research Compliance (ORRC) will accept your communications via newly designated e-mail addresses. This new process becomes effective September 11, 2017. Details are enumerated below.
• [email protected] -- Medical-IRB (Medical Institutional Review Board): For "Human Subjects Research" involving the study of specific diseases and conditions (mental or physical), including detection, cause, treatment and rehabilitation of persons; the design of methods, drugs and devices used to diagnose, support and maintain the individual during and after treatment for specific diseases or conditions; and/or scientific investigation.
• [email protected] -- Non-Medical IRB (Non-Medical Institutional Review Board): For research that deals with human attitudes, beliefs, and behaviors and is often characterized by data collection methods such as questionnaires, interviews, focus groups, direct or participant observation, and non-invasive physical measurements (qualitative or quantitative).
• [email protected] - (Excluded Research): For review of studies and or projects that do not involve the use of human participants or human data, biohazardous materials, animals.
• [email protected] -- IACUC (Institutional Animal Care and Use Committee): For review of research involving animals.
• [email protected] -- IBC (Institutional Biosafety Committee): For review of research utilizing recombinant DNA or synthetic nucleic acid molecules, viral vectors, plasmid vectors, or other infectious agents, genetically modified plants or biohazardous materials (i.e. blood, human tissue, etc.)
• [email protected] -- MTA (Material Transfer Agreement): For reviews, involving the transfer of incoming or outgoing biohazardous materials and data.
• [email protected] -- For general communications or to report compliance issues/concerns
• [email protected] -- COI (Conflict of Interest)
When submitting materials/applications, each e-mail should include items for only one study. For example, the e-mail may contain the protocol, consent document, and investigator brochure for one study.
• Submit only complete, fully-signed documents. An e-mail acknowledgement in place of a signed application will not be accepted. If electronic signatures are not available, the signature pages may be signed and scanned as a separate PDF document and attached to your submission e-mail.
• Unless requested, please do not submit additional study related information until the protocol has been approved.
When submitting your materials to the IRB, IACUC, or IBC:
• The e-mail subject line must include:
o Protocol # (if assigned)
o Principal Investigator's last name
o The type of submission (new project, amendment, renewal, protocol
deviation, serious adverse events, etc.)
• The body of your e-mail must include a list of the documents being submitted, and each document's name should reflect its content.
• We recommend that version dates are included in each document naming nomenclature.
• Incomplete applications (i.e. missing required supporting document) would be returned.
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 by the Office of the Federal Register. The NPRM, which can be accessed at the following URL: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects, seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The new comment period deadline is January 6, 2015. These departments and agencies are committed to affording the public a meaningful opportunity to comment on the NPRM and welcome comments. Read more
Introducing The Institutional Review Board (IRB) Leadership
Clinician Scientists - Harmonization of HIPAA Training Requirements
HHS Proposes Significant Changes to the Federal Policy for the Protection of Human Subjects ("Common Rule")
Communicating With The Office Of Regulatory Research Compliance (ORRC)
Please Read
National Institute of Health (3/17/20)
National Science Foundation (3/17/20)
Office of Justice Programs, DOJ (Guidance sent to Grantees, Subject to Change)
National Security Agency (Guidance sent to Contractors, Subject to Change)
Department of Energy (3/13/20)
National Aeronautics and Space Administration (3/10/20)
USDA - National Institute of Food and Agriculture
United States Army Medical Research Acquisition Activity
Food and Drug Administration
Department of Health and Human Services (3/14/20)
Department of Air Force (Sent to Contractors, Subject to Change)
Announcements: The Office of Regulatory Research Compliance (ORRC) will Transition to iMedRIS Electronic Compliance Platform
An efficient electronic compliance platform is foundational to the 21st century research infrastructure and a compliant regulatory system. The current paper-based approach to research compliance constitutes a significant administrative burden, increases regulatory risks, and hinders research growth. Notably, an ECP infrastructural support will reduce application processing inefficiencies, enable accurate compliance with the applicable Federal Regulations and the Howard University Policies and Procedures. It will streamline administrative record-keeping and, therefore, enhance productivity.
Following the University commitment, the first phase of the iMedRIS customized ECP that began in early 2020 is now complete. This initial phase includes the Institutional Review Board (IRB) and Financial Conflict of Interest in Research (FCOIR) modules.
Therefore, effective May 17, 2021, Faculty, Staff, and Students should submit their IRB applications through the iMedRIS ECP. To prepare our community for this transition, training on using the iMedRIS ECP will begin Wednesday, April 28, 2021. While a learning curve is inherent in any new system, your participation in the training activity will facilitate a smoother transition. It is required that you accept the forthcoming "training invite" before the training date to participate.
- Investigators/Study Team should submit their protocols only through the "iMedRIS Production" Environment.
- The "iMedRIS Development" Environment is only for practice - Protocols submitted through the development environment cannot be processed.
ORRC Organizational Chart
iMedRIS Electronic Compliance Platform
iMedRIS Training Meetings on Mondays at 12 noon
Topic: iMedRIS training on Mondays at 12 noon
Time: 12:00 PM Eastern Time (US and Canada)
Join Zoom Meeting
https://howard.zoom.us/j/86345250512?pwd=ZFAwOStjTTMra3ZXVkdvUytWUjJrdz09
Meeting ID: 863 4525 0512
Passcode: 33330765
One tap mobile
+13017158592,,86345250512# US (Washington DC)
+13126266799,,86345250512# US (Chicago)
How to Request Access to iMedRIS?
iMedRIS Training Videos
1. How to Access iMedRIS?
2. How to use the iMEDRIS Study Tutorial?
To access the "iMedRIS Request Form" using your handheld devices, scan the QR Code below:
ORRC Service Feedback Form
Important Announcements
Graduate Students and Student Investigators
Office of Regulatory
Research Compliance
Howard University
Manhattan Bldg.
1328 Florida Ave. NW
Washington, D.C. 20009
Phone: (202)-865-8597
ORRC is located on the
second floor of the Manhattan
Building.
