The College of St. Scholastica 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 on-line training course through the CITI Program as part of the IRB application process. Once an investigator completes the education requirement, he/she will receive a certificate that is active for three years.
• Upon expiration, a refresher course must be completed to renew the certification. All faculty and student 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.

Welcome!

All applications to The College of St. Scholastica Institutional Review Board must be submitted through the web-based system IRBNet. This is true for students, faculty, and staff at the main campus and all distance learning campuses.

The application form and other templates that researchers may need as part of their application can be found in IRBNet under the Forms and Templates tab. Please use only the application form in IRBNet as it represents the most current version.

How to Submit a New Application Using IRBNet

Submitting an application to the CSS IRB via IRBNet is a five-step process.

1. Register an account with IRBNet.
   1. Go to the IRBNet website and click the New User Registration tab.
   2. Follow the prompts to create a user name and password.
   3. During the registration process, you will receive an email from IRBNet that asks you to authenticate your registration via your e-mail account. Sometimes the authentication e-mail is not recognized by your e-mail provider, and may be routed as spam or junk. If you have registered correctly, and you don't receive the authentication e-mail in your inbox, be sure to first check your spam or junk folder before contacting the CSS IRB for assistance.
   4. If you would like to read an IRBNet document that will guide you through the account registration process, visit the IRBNet training website. NOTE: you will be prompted to enter a username ("css") and password ("training") in order to access training materials.
   5. During the process of registering an account with IRBNet, you should provide your CITI Program training certificate. Go to:
      • Add a Training & Credentials Record;
      • Select "other" for document type;
      • Add a description such as CITI certificate;
      • Enter the effective (completion) date;
      • Choose the file to upload.
   6. Important: ALL members of the research team must register an account and upload their CITI Program training certificate into IRBNet; this includes any faculty and students who are working together on a research project.
      
      If you would like to read an IRBNet document or watch a video that will guide you through the process of creating an application (steps 2 - 5 below), visit the IRBNet training website and find the R1:New Project Submission link. NOTE: you will be prompted to enter a username ("css") and password ("training") in order to access training materials.
2. Create a new application project in IRBNet.
   1. Log into IRBNet.
   2. Select Create New Project from the left side bar menu.
   3. In the Project Information box, provide the requested information (boxes with red stars indicates required information; it is ok to leave the others empty).
   4. Designer page [the Principal Investigator (PI) provides this information]
      • Step 1 - select and download the application form to your computer. Once you have completed the application form, save it as an MS Word or pdf file format (Google doc links are not accepted). Remember that you should use the application template found under forms and templates in IRBNet as this represents the most current version.
      • Step 2 - upload your completed application form and any other documents that are relevant to your project by clicking the "Attach New Document" tab. Other documents may include consent forms, children's assent forms, parental permission forms, letters of affiliation from institutions outside CSS, recruiting fliers, or copies of questionnaires, surveys, or other assessments. All documents you upload will appear in a box titled "Documents in this Package".
3. Share the application package with ALL members of the research team.
   1. This is the job of the PI. You will find the "Share the Package" tab on the left side bar.
   2. The PI will search for team members who will have access to the application package; if the name of a team-mate doesn't appear in the list, that likely means they haven't registered an account with IRBNet yet. Remember, all members of the research team must have an account with IRBNet.
   3. Once the application package has been shared, all team members will receive an email indicating the application has been shared. At this time, all members should review the uploaded documents to ensure they are correct and ready for review by the IRB.
4. Sign the application package.
   1. This must be done by ALL members of the research team.
   2. Find the "Sign This Project" tab on the left side bar.
   3. Each member electronically signs indicating they have read and agree that all application materials are complete and ready for IRB review.
5. Submit the application package.
   1. This is the job of the PI. You will find the "Sign the Package" tab on the left side bar.

How to Amend an Approved Application

If you have a currently approved application but would like to make an amendment, you will need to submit the Protocol Amendment Form before continuing your research study. To do this, log into IRBNet and click into your currently approved project. Find the Forms and Templates link and click on the Protocol Amendment Form. This is a word document that you can download to your computer and use to describe your modifications. Once done, go into IRBNet and click into your current IRBNet package and click on the "Create a New Package" link. You will be able to upload the Protocol Amendment Form to the new package. The principal investigator and all co- investigators should electronically sign this package and then the principal investigator can click submit. Your protocol amendment form will be reviewed within two weeks.

How to submit a continuing review

Log into IRBNet and click into your currently approved project. Click on the Forms and Templates link and click on the Continuing Review Form. Download this word document and provide your information. Once done, go into IRBNet and click into your current IRBNet package and click on the "Create a New Package" link. Upload the Continuing Review Form to the new package. The principal investigator and all co- investigators should electronically sign this package and then the principal investigator can click submit. Your submission will be reviewed within two weeks.

I've received a Needs Modification letter, how do I submit revised materials?

Log into IRBNet and click into your current application. Once inside your current application, click on "Create a New Package". Note that this is not a new application project, but rather a new "package" within the main application "project"; the application number will remain the same, but you should notice this new package has a "-2" after the assigned number. You will be able to upload revised documents to this package based on feedback in the Needs Modification Letter. Once you are done uploading your revised documents, the principal investigator and all co-investigators need to electronically sign this second package; you do not need to upload CITI Program training certificates to this package. The principal investigator should then submit this package.

If you would like to read an IRBNet document or watch a video that will guide you through the process of revising or modifying an application, visit the IRBNet training website and find the R2:Post-submission Advanced Topics. NOTE: you will be prompted to enter a username ("css") and password ("training") in order to access training materials. 

Nicole Nowak-Saenz, Ph.D.
Associate Professor, Department of Psychology and Sociology
IRB Chairperson
(218) 625-4988
nnowaksaenz@css.edu

Iwalani Else, Ph.D.
Associate Registrar/IRB Coordinator
Associate Professor, Sociology
(218) 723-6583
ielse@css.edu

Ryan Sandefer, Ph.D.
Vice President of Academic Affairs
(218) 625-4931 
rsandefe@css.edu

Members of the College of St. Scholastica IRB committee represent all Schools within the College. They are elected by their School colleagues for a three-year term. The IRB Chairperson and community member(s) are appointed by the Vice President of Academic Affairs. Requests for information should be addressed to the IRB Chair (see below), although all members are available for consultation.

Pamela Bjorklund, Ph.D.
Professor, Department of Graduate Nursing
School of Nursing
(218) 723-6624

Lynn Kalnbach, Ph.D.
Assistant Professor, Department of Management
Stender School of Business and Technology
(218) 723-5901

Dave LaBore, MPH, PA-C
Assistant Professor, Physician Assistant Studies
School of Health Science
(218) 723-4929

Mary Ann Marchal, Ph.D.
Associate Professor, Department of Social Work
School of Health Sciences

Director, Native Studies Center
Faculty, School of Arts and Letters
(218) 723-5948

Matthew Ridenour, Ed.D.
Assistant Professor
School of Education
(218) 723-7092

Judi Roux, Ed.D.
Visiting Assistant Professor
School of Education
(218) 723-6448

Jill Sauld, Ph.D., PNP, RN
Assistant Professor Post-Baccalaureate Nursing
School of Nursing
(218) 273-7041

Amber Schlater, Ph.D.
Associate Professor, Biology
School of Sciences
(218) 625-4867

Community Representative:
Jacqulin Sebastian, MA, JD

The Office for Human Research Protections has decision charts to help investigators if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A.

The Checklist for Classroom Projects provides guidance to CSS instructors in assessing whether classroom projects may be excluded from IRB review and approval by the CSS Institutional Review Board (IRB). All items in the checklist must be satisfied for classroom projects to proceed outside of IRB review.

The type of review is based mainly on the level of risk for human participants. The Federal Regulations have defined the term minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (CFR 45 Part 46.102).

There are three types of review. In general:

• Research activity with risk to subjects that is greater than minimal risk receive full-board review
• Studies with minimal risk receive expedited review
• Some research activity qualifies for exempt review; this means that the risk is low, but the researcher must still submit an application to ensure that the activity qualifies for one of the approved exemptions under the Federal Regulations

Rules for full board review

With FULL BOARD REVIEW, the research proposal will be sent to two reviewers initially to ensure completeness and to determine the need for additional information. The committee meets once a month and will review the proposal at that time. Applicants with projects that require full board IRB review should plan for one month or more between submission of the application and receipt of an approval letter.

A study requires full board review if the research...

1. uses deception of participants.
2. is evaluating the effectiveness and/or safety of a medical device.
3. involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture (less than 50 ml or 3 ml per kg in an 8 week period and collection no more than 2 times per week).
4. involves potential for physical harm to your participants.
5. involves potential for psychological harm to your participants.
6. involves any invasive tests.
7. involves vulnerable/protected/overstudied populations.
8. involves invasion of privacy.
9. involves payment of the participants.

Rules for expedited review

Research projects receiving EXPEDITED REVIEW can be reviewed outside the regularly scheduled monthly IRB meetings by two IRB members. The two reviewers will be selected based on expertise. If reviewers believe that the project does not meet the criteria for expedited review, the project will require a full IRB review. Applicants with projects that receive expedited or exempt review should expect a minimum of two weeks between submission of the application and receipt of an approval letter.

The following projects are eligible for expedited review:

1. Clinical studies of drugs or medical devices;
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture;
3. Prospective collection of biological specimens for research purposes by noninvasive means;
4. Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves;
5. Research involving materials (data, documents, records, specimens) that have been or will be collected solely for non-research purposes;
6. Collection of data from voice, video, digital, or image recordings made for research purposes;
7. Research on individual or group characteristics or behavior or research employing survey, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methods;
8. Continuing review of already approved projects

Rules for exempt review

With EXEMPT REVIEW, the research application must be reviewed by one member of the IRB and the Chairperson in order to determine if it qualifies for one of the exemptions under the Federal Regulations §46.104. If that IRB member believes that the project is not exempt, the project will be reviewed at a higher level. See the SOP for Exempt Determination Review Process and Checklist for guidance.

Below is an abbreviated summary of exempt studies. For a full description of each, see 45 CFR 46, §46.104, exempt research, in Subpart A-Basic HHS Policy for Protection of Human Research Subjects.

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording). Selected criteria must be met.
3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. Selected criteria must be met.
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens. Selected criteria must be met.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies.

CSS will not adopt the option for broad consent provided in Category 7 and 8.