The purpose of the Institutional Review Board is to safeguard the rights and welfare of human subjects involved in research activities conducted at or sponsored by the University of St. Thomas. The University IRB requires completion of the Application for Initial Review and supporting documents to begin the process toward approval of a research study involving human subjects.
Step 1: Determine Whether IRB Approval is Required
According to 45 CFR 46.102, human subjects research is defined as:
"A systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge, [involving] a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual, or (ii) identifiable private information."
Investigations designed to develop or contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy, create theories, or generalize findings that may be disseminated beyond the University of St. Thomas. While such research is often distributed through scholarly publication or presentation of the data, research results do not have to be published or presented to qualify as generalizable knowledge. The intent to contribute to generalizable knowledge makes an experiment or data collection 'research' regardless of publication or presentation. If a major goal of the proposed activities is to learn something for the purpose of benefiting people other than the research subjects, and the research may be disseminated outside the University of St. Thomas, then the project is defined as 'research' and must be approved by an IRB prior to any contact with human subjects.
Step 2: Determine the Level of Review
Before you begin your application, determine the level of review for your study. The IRB recognizes three levels of review: exempt, expedited, and full. To determine the level of review for your research project, see Levels of Review, or contact the IRB office for more information.
Step 3: Create an Account on IRBNet
If you do not already have one, create an account on www.IRBNet.org. Federal regulations require the University of St. Thomas IRB to maintain records of all project documents for a minimum of three years upon completion of the study. IRBNet is our online system for documentation and record-keeping. If you do not already have an IRBNet account, you must create one to begin your application. Be sure to select "University of St. Thomas--Minnesota" as your affiliated institution. Instructions for using IRBNet can be found here. All application forms and templates (including consent and assent forms) are available in the Designer tab or Document Library in IRBNet.
Step 4: Obtain a Letter of Permission from Organizations, Agencies, or Institutions if Necessary
Contact any organizations, agencies, or institutions you would like conduct research with or recruit participants through for your research study. Investigators who plan to recruit participants or obtain existing data through any organization outside of the University of St. Thomas must provide a letter of permission from an appropriate authority within the organization. It can take several weeks, and on rare occasions several months, to receive a letter of permission. Additionally, investigators who wish to obtain existing data from any department at the University of St. Thomas must provide a letter of permission from the appropriate authority.
Step 5: Complete the Application for Initial Review
The Application for Initial Review is the primary document that must be completed by all investigators seeking IRB approval. First, download the application from the list of documents in the IRBNet Document Library. The application should be completed by the principal investigator and any co-investigators. Faculty should avoid completing applications for their student advisees unless they are a co-investigator. Give yourself plenty of time to read directions carefully and provide specific, thorough answers. You should complete the application as if you are discussing your project with someone who does not know anything about it or your field of study. Applications with missing information or lack of detail will be returned to the principal investigator for completion before the project will be reviewed by any board members. Please contact the IRB office with questions at any stage of the application process.
Step 6: Complete Supporting Documents
Once you have completed the Application for Initial Review, be sure to complete any required supporting documents, such as: consent form(s); letters of permission from organizations; all surveys, questionnaires, or research instruments; recruitment materials, such as fliers; etc. Templates for consent forms and other materials are available for download on IRBNet. There is a complete list of supporting materials that may be required for your study in section H of the Application for Initial Review. Once these are completed, upload the completed Application for Initial Review and supporting documents to your project page on IRBNet.
Step 7: Electronic Signatures
Electronically share your IRBNet project package with co-investigators and/or research advisors. Each person must have their own IRBNet account in order for the primary investigator to share their project. It is the responsibility of co-investigators and research advisors to review completed applications prior to final submission. Once co-investigators and research advisors have reviewed and approved the application, they must electronically sign the project on IRBNet. Each signee must log in to their own account, and click "Sign this Package" to electronically sign the protocol.
The primary investigator must also sign the protocol on IRBNet. By signing the project, you agree to all terms outlined in section I of the Application for Initial Review. Submitted applications with missing signatures will be returned to the investigator prior to review.
Step 8: Submit the Application on IRBNet
To submit your application on IRBNet, click "Submit this Package" on your project page. The IRB office will receive an email notification that your application has been submitted. Initial review of your application will take place within 0-8 days of receipt of your application by the IRB office. Missing information, lack of detail, or missing signatures may delay the review process. If your project requires full review, it may take up to 19 days for review by the full board if you submit your application the day after a submission deadline.
Step 9: Complete the CITI Program Education Requirement
Starting January 1, 2016, all investigators (faculty, staff, and students) conducting human subjects research sponsored by the University of St. Thomas must complete a short, online course to become "certified" in human subjects protections through the Collaborative Institutional Training Initiative (CITI) Program. See CITI Program Education Requirement for details.