»IRB Approval Process, Forms and Instructions
+-IRB Protocol Submission Process
Research projects that include the participation of human subjects are required to submit to the IRB for approval. This process is summarized in the Submission Procedure Flowchart (PDF).
The first step in submitting an IRB protocol application is to determine whether your research falls under one of three OHRP Categories: Exempt, Expedited, or Full Committee Review. Definitions of each category can be found below. If you are unsure of which category your research falls into, contact the IRB for clarification before completing any of the application forms. The Committee may elect to move your research into another category following review of the protocol.
Once you have completed the appropriate application form and obtained the required signatures, submit the application via email to email@example.com with any supplemental materials* for review (and revision if necessary).
*Supplemental materials include but are not limited to: Consent/Assent forms, Surveys/Questionnaires, Interview questions, recruitment advertisements, HIPAA authorization or waivers of authorization, Certification of Human Subjects Protection training, etc.
Please do not submit scanned or copied applications. All applications must be submitted in their original form to the firstname.lastname@example.org mailbox. Signature pages only may be submitted separately as may be required to obtain all signatures.
Do not submit multiple applications in a single email. Please send individual applications separately.
Once received electronically by the IRB, the review time will vary based on the type of application submitted (see below). For Full Committee Review, a schedule of meetings for this fiscal year is provided.
Submission Deadline Schedule
IRB Meeting Date
August 15, 2013
September 9, 2013
September 15, 2013
October 14, 2013
October 15, 2013
November 11, 2013
November 15, 2013
December 9, 2013
December 15, 2013
January 13, 2014 (TBD)
|January 15, 2014||
February 10, 2014
|February 15, 2014||
March 10, 2014
|March 15, 2014||April 14, 2014|
|April 15, 2014||May 12, 2014|
|May 15, 2014||June 9, 2014|
|June 15, 2014||July 14, 2014 (TBD)|
Within 3-4 weeks of submission, process should be completed.
Within 2-3 weeks of submission, process should be completed.
*SIGNED COVER SHEETS SHOULD BE SCANNED IN BLACK & WHITE AT 300dpi
+-IRB Protocol Review Process
Protocols that are categorized as exempt are reviewed by the IRB Administrator and the IRB Faculty Chair. Expedited protocols are reviewed by the IRB Administrator, IRB Faculty Chair and one or two members of the Boards as needed, depending on the study details.
Protocols that are categorized for Full Review will be assigned two members of the IRB Committee as "primary reviewers". One or both of them will contact you prior to the monthly Full Committee Review meeting to request any additional information, supplemental materials, or to discuss initial concerns. The full IRB Committee will then review the protocol, render a decision, and will notify the Principal Investigator. The protocol will either be Approved, Approved with Modifications, Tabled for Discussion to an ad-hoc or full committee, or Not Approved.
- If the protocol is Approved: the principal investigator will receive a letter of approval and the necessary documents to proceed with the research.
- If the protocol is Approved with Modifications: the primary reviewers will send the requested modifications back to the Principal Investigator for revision. Once the revisions have been made and satisfy the committee, the investigator will receive a letter of approval and the necessary documents to proceed with the research.
- If the protocol is Tabled for Discussion pending additional information or revisions: the IRB will return the protocol and outline the major concerns for the investigator. The protocol will be placed on the agenda of the next Full Committee Meeting as long as revisions are received in a timely manner. The IRB may also decide to convene an ad-hoc committee to review and approved the requested revisions if time is of the essence.
- If the protocol is Not Approved: the IRB will notify the investigator, the Human Subjects Protection Officer (Y. Uzzell) and the Institutional Official (D. Struppa) on its decision. It is the IRB's policy to work with the investigator to make the necessary revisions needed to approve the protocol.
+-IRB Application Forms
- Application for Exempt Research (for Windows/Microsoft Office 2010 users)
- Application for Exempt Research (for Mac users or older versions of Windows/Microsoft Office)
- Signature Page for Exempt Research (REQUIRED with application - for both Windows/Mac users))
- Definitions of Exempt Research Categories
For Expedited or Full Research, please use the Application and required Signature page below. You can also review what qualifies as Expedited Research in the Definitions of Expedited Research Categories below.
- Application for Expedited or Full Research (for Windows/Microsoft Office 2010 users)
- Application for Expedited or Full Research (for Mac users or older versions of Windows/Microsoft Office)
- Signature Page for Expedited or Full Research (REQUIRED with application)
- Definitions of Expedited Research Categories
In the IRB protocol application, please make sure the title of the study is consistent across all of the application documents including informed consent forms, advertisements, IRB protocols, etc.
+-Request for Project Modification Form
+-Project Continuation or Closure Form
To apply for a continuation of your protocol, the following application must be completed and received by the IRB Administrator a minimum of 45 days prior to the expiration date of your current approved protocol.
All continuing review applications are issued a new IRB number for the protocol and the previous IRB file is retired. As many protocols undergo revisions and changes over the course of the approval period it is important that the IRB receive a comprehensive summary of the protocol going forward inclusive of any and all changes and revisions approved during the previous approval period. Even if the research has not changed, a written summary protocol (full description of the research, tests, procedures, recruitment process, etc.) must be included with each continuing application. The application only provides a snapshot of the previous years’ efforts and provides an annual report of the research activity required under federal regulations. To supplement this report, a summary protocol of the research is required for all continuing reviews.
+-Notice of Complication or Adverse Event Form
+-Informed Consent Forms and Instructions
All approved consent forms will be issued with a footer that shows the IRB protocol number, approval and expiration date and IRB assurance information. This footer will be applied to each page of the consent document when approval is issued. When approval is received the original of this electronically stamped document showing the above information must be copied for use in the recruitment and informed consent of potential human subjects.
The IRB will occasionally make recommendations or edits to consent forms received for review to assure wording is consistent with the protocol and for compliance purposes.
In order for the IRB to process and approve your consent form in a timely manner we ask that you attach a version of the consent form in a Word compatible format separate from the application. Consent forms imbedded within the protocol application or received as a pdf will be returned.
- Informed Consent for Social/Behavioral Template Form
- Informed Consent for Social/Behavioral Research Guidelines and Instructions
- Informed Consent for Anonymous Web-Based Research Template Form
- Informed Consent for Biomedical Research Template Form
- Informed Consent for Biomedical Research Guidelines and Instructions
- Research Participant's Bill of Rights Social/Behavioral - English
- Research Participant's Bill of Rights Social/Behavioral - Spanish
- Research Participant's Bill of Rights Biomedical - English
- Research Participant's Bill of Rights Biomedical - Spanish
- Policy for Solicitation of Research Participants via Electronic Communication
- Social Media policy in progress and pending