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.
• IRBemail@example.com -- 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. • IRBfirstname.lastname@example.org -- 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.email@example.com -- IACUC (Institutional Animal Care and Use Committee): For review of research involving animals. • IBC.firstname.lastname@example.org -- 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.email@example.com - (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.firstname.lastname@example.org -- 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 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.