Institutional Review Board (IRB)

All principal investigators and co-investigators must participate in a training tutorial — the CITI Program Research Ethics and Compliance Training Course. The College of St. Scholastica requires students, faculty, and staff to meet this educational requirement by completing an online training course through the CITI Program as part of the IRB application process. Once an investigator completes the education requirement, they will receive a certificate that is active for three years.

Upon expiration, a refresher course must be completed to renew the certification. All investigators are required to renew their research ethics training every three years; note that this is a change from the previous policy of annual renewal.

Instructions for Taking the CITI Program Educational Course

1. Create an account by going to citiprogram.org
2. Click “Register” to begin setting up your CITI Program account. Do not click “Log in through my institution.”
3. Search for and select The College of St. Scholastica as your institution; click the box agreeing to terms of service and the box confirming you are affiliated with St. Scholastica.
4. Follow the prompts for name and email address
5. Follow the prompts to create a username and password, security question and answer
6. Provide the requested demographic information
7. For the Continuing Education Credit questions, you can answer “no”
8. Provide the additional information requested by CITI Program
9. CITI Program will send an activation link to your email address. Click the link to complete the registration process.
10. Upon logging in, you will be directed to your CITI Program home page. To find the correct course, click “Add a Course.”
11. Choose the appropriate course. There are two options, basic and refresher. Student and faculty researchers who have taken a research ethics training tutorial within the previous three years may select the refresher course. Students and faculty who are taking a research ethics course for the first time should take the basic course. Select either “Human Subjects Training: Biomedical Research” or “Human Subjects Training: Social Behavioral-Educational Research” as your Learner Group. Select the course that aligns with your research (e.g., select the biomedical course if your research involves a healthcare facility or patients). The course content is listed below.
    1. Social Behavioral-Educational Researchers
       • Content includes:
         • History and Ethical Principles – SBE (ID: 490)
         • Defining Research with Human Subjects – SBE (ID: 491)
         • The Federal Regulations – SBE (ID: 502)
         • Assessing Risk – SBE (ID: 503)
         • Informed Consent – SBE (ID: 504)
         • Privacy and Confidentiality – SBE (ID: 505)
         • Research with Prisoners – SBE (ID: 506)
         • Research with Children – SBE (ID: 507)
         • Research in Public Elementary and
         • Secondary Schools – SBE (ID: 508)
         • International Research – SBE (ID: 509)
         • Internet-Based Research – SBE (ID: 510)
         • Unanticipated Problems and Reporting
         • Requirements in Social and Behavioral Research (ID: 14928)
    2. Biomedical Researchers
       • Content includes:
         • History and Ethics of Human Subjects Research (ID: 498)
         • Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2)
         • Informed Consent (ID: 3)
         • Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4)
         • Records-Based Research (ID: 5)
         • Genetic Research in Human Populations (ID: 6)
         • Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680)
         • Research Involving Prisoners (ID: 8)
         • Research Involving Children (ID: 9)
         • Research Involving Pregnant Women, Fetuses, and Neonates (ID: 10)
         • FDA-Regulated Research (ID: 12)
         • Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 14777)
         • Research and HIPAA Privacy Protections (ID: 14)
         • Conflicts of Interest in Human Subjects Research (ID: 17464)
12. After completing all the modules in your course, download and save a copy of your certificate of completion as you will need to include this with your other materials when applying to the IRB.

If you have questions, email the IRB at irb@css.edu.

1. Follow instructions for CITI training. Choose “Human Subjects Training: Biomedical Research” or “Human Subjects Training: Social Behavioral-Educational Research” as your Learner Group. Most investigators at St. Scholastica will complete the Human Subjects Training: Social-Behavioral-Educational Research course. This training certificate is valid for three years.
2. Register for an IRBNet account.
3. Upload your CITI certificate/s through your USER PROFILE in IRBNet under Training and Credentials; this way, your credentials follow you across projects and all versions of each project. This is also how we track required training for compliance purposes.
4. To create a new project, log in to your IRBNet account. From the left-hand menu, click Create NEW PROJECT. Complete the four pieces of required information.
   On independent student projects, students are typically designated as PI (principal investigator) and the faculty advisor as an advisor. It is OK to designate multiple advisors and co-PIs.
5. From the left-hand menu, click SHARE the new project with your research colleagues, students, or faculty advisor — give them full access. The College is listed as “The College of Saint Scholastica, Duluth, MN” on IRBNet. Do not share your project with the IRB Chair or other IRB members through this mechanism; the IRB receives the application automatically after you submit it.
6. From the left-hand menu, Forms and Templates, you will find the IRB Application and Consent templates. Download and complete. Save as Word or PDF files.
7. Once everything looks good to all people on the project (e.g.,the advisor has read and approved student materials), upload documents in Word or PDF format into your project in IRBNet; all research personnel including students, advisors etc. SIGN; then the PI SUBMITs. Sign and submit options can be found in the left-hand menu.
8. Once you submit materials, you can expect to hear back from the IRB, likely through an IRBNet message or letter, within 7-10 business days. To view your decision letter (e.g., modifications required, approval, not research):
   1. Log in to your project in IRBNet
   2. Click Review Details to access the PDF letter
9. If your project requires modifications, follow the instructions in the letter to prepare and submit your revisions. In short, you will upload your revisions by:
   1. Log in to your project in IRBNet
   2. Create a new PACKAGE (not project)
   3. Upload revised documents to the package
   4. Make sure the package is shared with all researchers on the project
   5. All researchers sign the package
   6. Submit the package. Once you submit materials, you can expect to hear back from the IRB, likely through an IRBNet message or letter, within 7-10 business days.
10. All expedited and full-board projects, and some exempt or quality improvement projects, expire after 1 year from the approval date. The most likely scenario is that you finish your project within one year after approval; in this case, submit a Protocol Closure Form by:
    1. Log in to your project in IRBNet
    2. Create a new PACKAGE (not project)
    3. Download the Protocol Closure Form from Forms and Templates
    4. Complete the form
    5. Upload the form to the package
    6. Make sure the package is shared with all researchers on the project
    7. All researchers sign the package
    8. Submit the package. You will receive email confirmation from IRBNet that the project has been officially closed. Not all projects require submission of a protocol closure form; for example, most quality improvement and exempt projects. The decision letter sent by the IRB will inform researchers whether or not their project requires continuing review.

    If you are still in the data collection phase of your project after one year, submit a Continuing Review Form by:

    1. Log in to your project in IRBNet
    2. Create a new PACKAGE (not project)
    3. Download Continuing Review Form from Forms and Templates
    4. Complete the form
    5. Upload the form to the package
    6. Make sure the package is shared with all researchers on the project
    7. All researchers sign the package
    8. Submit the package. You will receive an approval letter or request for additional information from the IRB. Once you submit materials, you can expect to hear back from the IRB, likely through an IRBNet message or letter, within 7-10 business days. Not all projects require submission of a continuing review form; for example, most quality improvement and exempt projects. The decision letter sent by the IRB will inform researchers whether or not their project requires continuing review.

    It is possible that you will need to submit an amendment (e.g., you need to add researchers to the project, you need to add a new research procedure); to do so:

    1. Log in to your project in IRBNet
    2. Create a new PACKAGE (not project)
    3. Download Protocol Amendment Form from Forms and Templates
    4. Complete the form and highlight the information that is new/different from the original materials
    5. Upload the protocol amendment form and any other amended forms (e.g., consent) to your new package
    6. Make sure the new package is shared with all researchers on the project
    7. All researchers sign the package
    8. Submit the package. You will receive an approval letter or request for additional information from the IRB within 7-10 business days.

Representatives from St. Scholastica and the Twin Ports area work collaboratively as administrators and members of the Institutional Review Board (IRB).

View Administration and Members

The IRB reviews applications during the full calendar year. Most applications are minimal risk (do not require a full-board review) and can be submitted at any time. Reviews that are more than minimal risk require a full-board review and should be submitted at least two weeks prior to a scheduled IRB Committee meeting. If you have any questions about IRB applications, minimal risk or upcoming meetings, email irb@css.edu.

Upcoming Meetings

• Sept. 19, 2024
• Oct. 24, 2024
• Nov. 21, 2024
• Jan. 23, 2025
• Feb. 20, 2025
• Mar. 20, 2025
• Apr. 24, 2025
• May 22, 2025

The policies of St. Scholastica with respect to research, development and related activities involving human participants are based on the following principles:

• Participation of a human subject in any experiment must be voluntary and the information provided to gain subject consent must be adequate and appropriate. Potential participants must be informed that they are not obligated to participate and that appropriate alternatives to participation may be available.
• The risks to the subject must be acceptable when measured against any possible benefit and by the importance of the knowledge to be gained as a result of participation
• Research and training activities involving human subjects must be supervised by qualified persons
• All research programs which involve human subjects must be reviewed by, and receive the approval of, the St. Scholastica IRB prior to initiation of the protocol.

These and other principles described in this document are based on the current U.S. Code of Federal Regulations, Title 45 Part 46, and 21 CFR part 50 and 56, and the following core historical reports:

• Nuremberg Code (1949)
• Declaration of Helsinki (1964)
• Belmont Report (1976)

Of the 40 SOPs, the following four are among the most frequently referenced.

• #06 CSS IRB SOP Defining Research V. Quality Improvement
• #09 CSS IRB SOP Student Class Assignments
• #10 CSS IRB SOP Exempt Determination Review and Checklist
• #11 CSS IRB SOP Expedited Review Process and Checklist

The interpretation and implementation of these policies and procedures is the responsibility of the St. Scholastica IRB.

View Policies, Procedures and Manual