TOPICS: Submission of Documents for Board Review | Applications and Instructions

SUBMISSION OF DOCUMENTS FOR BOARD REVIEW:

The schedule of IRB meeting dates and deadline dates for receipt of documents for IRB review is attached. The ORIGINAL AND THREE (3) copies of appropriately signed documents must be submitted for IRB review. Investigators or other individuals from the Division of Academic Affairs should submit their documents to the Office of the Institutional Review Board. Investigators or other individuals from the Division of Health Affairs should submit their documents to the Office of the Associate Dean for Research of the College of Medicine, Suite 533, Seeley G. Mudd Building. That office will forward the documents to the Office of the IRB.

APPLICATIONS AND INSTRUCTIONS:

• Application for IRB Review - Funded, Drugs and/or Devices and/or Greater than Minimal Risk Research - Form A-1
  Downloadable Versions: Microsoft Word or Adobe PDF


• Application for Continuing Review - Funded, Drugs and/or Devices and/or Greater than Minimal Risk Research - Form A-2
  Downloadable Versions: Microsoft Word or Adobe PDF


• Application for Chart Review Request - Form B-1
  Downloadable Versions: Microsoft Word or Adobe PDF


• Application for IRB Review - Minimal Risk and/or Student Research - Form C-1
  Downloadable Versions: Microsoft Word or Adobe PDF


• Application for Continuing Review - Minimal Risk and/or Student Research - Form C-2
  Downloadable Versions: Microsoft Word or Adobe PDF


• Application for IRB Review - Request for Exemption - Form D-1
  Downloadable Versions: Microsoft Word or Adobe PDF


• Instructions for preparing Consent Documents
  Downloadable Versions: Microsoft Word or Adobe PDF


• Instructions for applications to Federal Agencies
  The actual application signed by the authorized university official(s) that is submitted to the agency must be forwarded to the HUIRB for its review. In addition to this application, a human participants section which addresses all points, a consent document for each participant population, support documents as appropriate. A Principal Investigators Assurance Form must be signed and included in all applications.


• Instructions for applications to Non-Federal Agencies
  These are proposals submitted to private grantors such as foundations, volunteer health agencies (e.g., the American Heart Association), and other non-federal grantors that support scholarly activities that involve human participations. The actual application, signed by the authorized university official(s), that is submitted to the grantor must be forwarded to the HUIRB for review. In addition to this application, a human participants section which addresses all points, a consent document for each participant population, support documents as appropriate. A Principal Investigators Assurance Form must be signed and included in all applications.


• Instructions for Applications to Clinical Research Protocols Sponsored by the Pharmaceutical Industry
  The actual protocol developed by the industry sponsor and signed by the authorized university official(s); two (2) copies of he sponsor’s Investigator’s Brochure; a copy of a clinical research agreement (if required) by the Howard University General Counsel Office. In addition to this information, a human participants section which addresses all points, a consent document for each participant population, support documents as appropriate. A Principal Investigators Assurance Form must be signed and included in all applications.


• Instructions for Applications to Agencies which do not have a standard application format, including Howard University
  All protocols must be typed in a font size no smaller than 12 points. If the project involves drugs and/or devices or if the project involves greater than minimal risks, Application for IRB Review A-1 may be used. If the project involves minimal risks, Application for IRB Review C-1 may be used. Applications and Instruction are located at: www.huirb.howard.edu. A Principal Investigators Assurance Form must be signed and included in all applications.


• Instructions for Applications for Theses and DissertationsProposals
  The actual document, approved by the candidate’s committee is to be submitted for HUIRB review on behalf of the candidate by the candidate’s faculty advisor (FA). All protocols must be typed in a font size no smaller than 12 points. Protocols may only be submitted by a HU faculty member/advisor (FA) who will serve as the Principal Investigator (PI). The PI bears direct accountability and responsibility for the proper conduct of the project or activity described in the proposal and approved by the HUIRB. A copy of the Dissertation/Thesis Committee’s Approval Sheet must accompany all submissions. Application for IRB Review C-1 may be used. Applications and Instructions are located at: www.huirb.howard.edu. A Principal Investigators Assurance Form must be included which has been signed by the FA and the Student Investigator.