The University of St. Thomas IRB requires completion of the appropriate application form and supporting documents to begin the process toward approval of a research study involving human subjects. The following steps are designed to guide researchers through the application process.
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.
Take Action: Contact the IRB office to discuss your project and determine whether IRB review is required.
Before you begin your application, determine the level of review for your study. The IRB recognizes these levels of review: exempt, limited, 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.
Take Action: Read through the exempt/limited and expedited categories on the IRB website. If your project does not fit into any of these categories, the project may require full review. Contact the IRB office if you do not know what level of review to expect. The IRB office will designate the appropriate review level once your project is submitted for review.
If you do not already have one, create an account on www.IRBNet.org. Federal regulations require the University of St. Thomas IRB 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.
Take Action: 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 IRBNet Document Library.
Investigators who plan to recruit participants or obtain existing data through any organization or private entity must provide a letter of permission from an appropriate authority within the organization. Receiving a letter or email of permission may take several weeks (or on rare occasions, several months). Additionally, investigators who wish to obtain private data or recruit employees or students from any department at the University of St. Thomas must provide a letter of permission from an appropriate authority. Emails in PDF form are accepted if an organization logo or signature and all heading fields are visible upon submission.
Take Action: Speak with an individual who is authorized to give you permission for recruitment or research partnership as early as possible in the IRB application process. Be sure the individual granting permission has the authority to do so and understands how you are asking individuals within the organization to be involved in the study. If you are unsure whether a letter is required or an email is acceptable, contact the IRB office.
Depending on your research, you will complete one of three applications:
- Application for Initial Review
- Application for Exempt Research
- Application to Use Existing Data
The Application for Exempt Research is used for studies which fall into an exempt category, do not collect identifying information, and are minimal risk. The Application to Use Existing Data is for studies seeking permission to use an existing data set only. All other studies will use the Application for Initial Review.
Log into your IRBNet account to download the correct application from the list of documents in the 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. Applications must be completed 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.
Take Action: Download the correct application form from the IRBNet Document Library and read through the application before completing any sections. Contact the IRB office if you are unsure which application to use or how to answer any questions or fields.
Templates for consent forms and other materials, such as confidentiality agreements, are available for download in the IRBNet Document Library. You may view a list of supporting materials that may be required for your study at the end of the application. Once these forms are completed, upload the completed appropriate application and supporting documents to your project page on IRBNet. Separate surveys, questionnaires, study instruments, and interview questions may be submitted in PDF or Word document format.
Most investigators will submit the following (as applicable to your study):
- All surveys/instruments for data collection;
- Any interview questions or schedules; and/or
- All consent documents, including consent form(s), parent/guardian consent form(s), online survey consent page, and/or assent form(s).
Depending on research plans, the following forms may also be required:
- Letters of permission from institutions, agencies, or organizations providing private information for recruitment or where the study will take place; and/or
- Research Assistant Confidentiality Agreement(s) or Transcriber Confidentiality Agreement(s).
Take Action: Go to end of your application and flag the supporting documents you will need in addition to your application. Log into IRBNet and download any templates or forms you may need; read through the forms and make changes to the templates so the materials are applicable to your study.
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/or research advisors to review completed applications prior to final submission. Once co-investigators and/or research advisors have reviewed and approved the application, they must electronically sign the project on IRBNet. Each signee must log into their own account and click "Sign this Package" to electronically sign the protocol.
The principal investigator must also sign the protocol on IRBNet. By signing the project, the principal investigator agrees to all terms outlined in section I of the appropriate application. Submitted applications with missing signatures will be returned to the investigator prior to review.
Take Action: Contact your research team and advisor to ask if they have an IRBNet account. If not, ask them to create one. Share your project with your research team by clicking "Share this Project." Email your research team and/or advisor once you have shared your project to verify that they have signed the project in 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 zero (0) to eight (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.
Take Action: Verify that all documents have been uploaded to your IRBNet project package, then click "Submit this Package."
All investigators and research team (faculty, staff, and students) who will have contact with research participants or private, identifiable data in connection with a research project sponsored by the University of St. Thomas must complete an online course to become certified in human subjects protections through the Collaborative Institutional Training Initiative (CITI) Program. This online program fulfills federal education requirements. See CITI Program Education Requirement for details.
Take Action: If you have not already done so, register as a user in CITI Program and complete the correct course. This may be completed while you are waiting for response from the IRB office, but must be completed for approval. Contact the IRB office if you have completed CITI Program or a comparable program (such as NIH) at a different institution within the last four years.