Assuring research compliance  with laws, regulations and Howard University policies.  
COMMUNICATING WITH THE OFFICE OF REGULATORY RESEARCH COMPLIANCE (ORRC)

To better track and streamline the processing of research and other applications, the Office of Regulatory Research Compliance (ORRC) will begin accepting these submissions via newly designated e-mail addresses. This new process becomes effective September 11, 2017. Details are enumerated below.

IRB-medical.orrc@howard.edu -- Medical-IRB (Medical Institutional Review Board): For review of "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.

IRB-nonmedical.orrc@howard.edu  -- Non-Medical IRB (Non-Medical Institutional Review Board): For review of 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).

IACUC.orrc@howard.edu -- IACUC (Institutional Animal Care and Use Committee): For review of research involving animals.

IBC.orrc@howard.edu  -- 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.)

Exclusions.orrc@howard.edu - (Excluded Research): For review of studies and or projects that do not involve the use of human participants or human data, biohazardous materials, animals.

MTA.orrc@howard.edu -- MTA (Material Transfer Agreement): For reviews, involving the transfer of incoming or outgoing biohazardous materials and data.

Theorrc@howard.edu -- For general communications or to report compliance issues/concerns

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 IRBIACUC, or IBC:
The e-mail subject line must include:
         oProtocol # (if assigned)
         oPrincipal Investigator's last name
         oThe 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.









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
theorrc@howard.edu 
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
Home
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.

Home
Home
Office of Regulatory Research Compliance
Welcome to the Office of Regulatory Research Compliance website!
ANNOUNCEMENTS

AAALAC, Intel. Accreditation Site Visit 

The Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, Intl) will conduct its regular triennial site visit to Howard University on November 20, 2017. 

AAALAC, Intl. is a non-profit organization comprised of professional societies in the life sciences. It is not a governmental agency, has no regulatory or legal function, and does not formulate animal care or use policies or regulations. Rather, AAALAC, Intl. accreditation is a voluntary peer-review process, and certifies whether standards of excellence in animal care programs are attained and maintained. Howard University's animal care and use program and facilities have been accredited since 1967. 
To read more, click here.
___________________________________________________________________

Clinician Scientists - Harmonization of HIPAA Training Requirements 

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.  

 ___________________________________________________________________

HHS Proposes Significant Changes to the Federal Policy for the Protection 
of Human Subjects ("Common Rule")


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-subjectsseeks 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

___________________________________________________________________
Research
Exempt
Expedited
Waiver
Additional Resource

Home