IRB Application Procedure

Deadlines

Applications are accepted on a continual basis from Aug. 15 - May 15. The full IRB will be convened monthly as needed.

Required Documents for IRB Application

All documents are to be as an Application Package. Please refer to the IRB Net User’s Guide for more information on the submission process. The various documents required within the application are detailed below.

Research Determination Tool: The application process begins with completion of the Research Determination Tool. This tool allows researchers to determine if their proposal meets the Office of Human Participant Research’s definitions of research and human participant. No IRB Application is needed for Excluded or Exempted research (see details on the Types of Review page of this website), but the completed tool must be included when an IRB Application is needed.
Collaborative Institutional Training Initiative: Collaborative Institutional Training Initiative (CITI) Certificates are required for the Primary Investigator, all co-investigators, Faculty Advisor and/or PhD Committee Chair. The specific modules that must be completed and kept up to date are:

• Social & Behavioral Research Basic/Refresher
• Social & Behavioral Responsible Conduct of Research
• Conflict of Interest
• Information, Privacy, Security

Application form: The IRB Application is submitted by the Primary Investigator of the proposed research. A fillable document can be found here as well as on the My �山ǿ�� portal. Information that must be provided includes identification of all co-investigators (including all students) and faculty advisors, type of application, and determinants of level of risk. Please note that there is a size limit on the Application, which we are not able to change.
Full Informed Consent Template.
: To gain access to participants, Site Permission Letter(s) may be needed. Drafts of the intended wording of these letters are to be included with an IRB Application but must not be sent until IRB Approval has been received. If requesting permission to access students at AU, the letter is addressed to the Chair of the AU IRB. Letterhead is NOT to be used except by employees of AU for whom the research is part of their employment. Researchers should develop a Participant Packet, which discloses all activities involved in the research and specifies exactly what procedures will be performed and what the participants are required to do. Use of a timeline or table is a helpful way to display this information to participants. This packet should include the Informed Consent letter which states that participation is voluntary, provides provisions for privacy/confidentiality, and discloses the name and contact information of the Primary Investigator and the AU IRB.
Study Completion: Once the data collection aspect of a research project has been completed, primary researchers are responsible for notifying the IRB of this by submitting this document as a subsequent package in a project (instructions available in the IRB Net User Guide).
Study Modification: The primary researcher is responsible for notifying the AU IRB of any changes to the originally approved project, including but not limited to personnel, recruitment, and location changes using this form. All data collection research activity must be stopped until the primary investigator receives approval for any modification made to the project.
Study Continuation: Research projects are approved for one year only. If research has not been completed within that year, the primary investigator is required to request approval to continue the research process using this form prior to the expiration date.
Unanticipated Problem Form: If any unanticipated problem occurs (see IRB Policy Manual for definition details), the primary investigator is required to cease all research activity and file this report immediately using instructions for submitting a subsequent package within a project.