The purpose of the Institutional Review Board (IRB) at The College of St. Scholastica (CSS) is to provide initial and continuing review of all research activity involving human participants. The IRB's main aim is to ensure that the safety, rights, and dignity of research participants is protected. The CSS IRB is registered with the Office of Human Research Protections and follows the guidelines for reviewing all research provided in the Code of Federal Regulations for the Protection of Human Subjects, (CFR 45 Part 46).
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.
Submitting an application to the CSS IRB via IRBNet is a five-step process.
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.
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.
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
Iwalani Else, Ph.D.
Associate Registrar/IRB Coordinator
Associate Professor, Sociology
Ryan Sandefer, Ph.D.
Vice President of Academic Affairs
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
Lynn Kalnbach, Ph.D.
Assistant Professor, Department of Management
Stender School of Business and Technology
Dave LaBore, MPH, PA-C
Assistant Professor, Physician Assistant Studies
School of Health Science
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
Matthew Ridenour, Ed.D.
School of Education
Judi Roux, Ed.D.
Visiting Assistant Professor
School of Education
Jill Sauld, Ph.D., PNP, RN
Assistant Professor Post-Baccalaureate Nursing
School of Nursing
Amber Schlater, Ph.D.
Associate Professor, Biology
School of Sciences
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:
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...
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:
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.
CSS will not adopt the option for broad consent provided in Category 7 and 8.
Nicole Nowak-Saenz, Ph.D.
The IRB reviews exempt and expedited protocols on a rolling basis, typically within 7-10 days. Projects that rise to the level of full board review are discussed at our monthly meetings. If you think your project may require full board review (e.g., vulnerable populations, sensitive material, deception, greater than minimal physical and/or psychological risk), submit at least one week prior to our next scheduled meeting.
If you have any questions regarding the meeting schedule, please contact Dr. Nicole Nowak-Saenz.