The College of St. Scholastica Institutional Review Board (IRB)

• All principal investigators and co-investigators must participate in a training tutorial — the CITI Program Education Course — on the ethical principles of research. 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.

Application Process beginning March 5, 2019

Beginning of March 5, 2019, the CSS IRB will begin using the web-based system, IRBNet, to submit and track all applications. IRBNet will be the only way to submit an application to the CSS IRB. This is true for students, faculty, and staff at the main campus and all distance learning campuses. All submissions must be submitted via IRBNet.

Have these two things done prior to registering an account with IRBNet.

• Go to the Types of IRB Review page to determine the level of review needed. If you have any doubts about the level of review that is appropriate for your study, please contact the IRB Chairperson at irb@css.edu.
• Once you have determined the type review that is appropriate for your project, complete the online CITI Program training tutorial.

If you are a first time user of IRBNet, please see this link to training documents, including on how to register a new account with IRBNet; you will be prompted to enter a username and password in order to access training materials. Use the following username (css) and password (training). When you create an IRBNet account, you will submit your CITI completion certificate at this time.

Once you login to IRBNet, you can select Create New Project and use the Forms and Templates to create your submission. Watch the short video on submitting a new project in IRBNet or view this PDF with detailed instructions.  Remember to use the username (css) and password (training) to access these training materials.

All investigators involved in the research study must register with IRBNet. An investigator is anyone who has participated in the planning of the research study and will have access to the collected data. This includes the principal investigator, co-investigators, faculty mentors, and collaborators who may not be employed by CSS.

Note: during the registration process, you will need to authenticate your registration via your e-mail account. Sometimes the authentication e-mail is not recognized by your 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.

Steps to remember as you complete your application in IRBNet:

• The principal investigator (or their designee) enters everything in the IRBNet system.

• The project must be SHARED with the entire research team. This is the method that the IRB staff uses to verify that all members of the team have read all documents and have completed the required research ethics training.

• The project will not be approved unless all members of the team have completed their required research ethics training and uploaded certificates. Training can be checked by the investigator on IRBNet prior to submission to the IRB (once the project is submitted this feature is not available).

• When you get all the documents uploaded, the principal investigator should complete a final review to ensure the project is ready for IRB review. If everything is in place, all members of the team must electronically SIGN the application package in IRBNet; this includes the principal investigator, co-investigator, faculty mentor, and any other collaborators who are on the team.

• Click here to view a video or a PDF on how to successfully update project documents and submit a subsequent (ex. Modifications Required) package to a committee and other advanced topics. Remember to use the username (css) and password (training) to access these training materials.

• Click here to view instructions on submitting a revision.

Diane Vertin, Ed.D.
Interim Vice President of Academic Affairs
(218) 723-6035
dvertin@css.edu

Steven Cope, Sc.D.
Professor, Department of Occupational Therapy
IRB Chairperson
(218) 723-5915
irb@css.edu

Iwalani Else, Ph.D.
Director, Institutional Research & Assessment
IRB Administrator
(218) 723-6583
ielse@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 Office
School of Nursing
(218) 723-6624

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

Robert Larson, Ph.D.
Assistant Professor, Communication, Theater, and Art
School of Arts and Letters
(218) 723-6719

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

Nicole Nowak-Saenz, Ph.D.
Assistant Professor Psychology and Sociology, Psychology Department
School of Sciences
(218) 625-4988

Brooke Palkie, EDD, RHIA
Associate Professor, HIIM
School of Health Sciences
(218) 733-2245

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

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

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

Community Representative:
Jacqulin Sebastian, MA, JD

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.

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.

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. If that IRB member believes that the project is not exempt, the project will be reviewed at a higher level.

A study is exempt if the research...

1. is part of classroom instruction and involves only the students in the class under the supervision of the instructor. This research is not exempt when it involves participants outside of the class, and it should be reviewed at least at the department level.

2. is institutional research and is commonly conducted in the course of business (e.g., annual placement study, market study, comparison of college entrance scores and GPA, etc.).

3. is conducted in established or commonly accepted educational settings, involving normal educational practices.

4. involves the use of educational tests (cognitive, diagnostic, aptitude, or achievement).

5. involves observation of public behavior.

6. involves the collection of data about or from elected or appointed officials OR from candidates for public office.

7. involves the collection of publicly available existing data, documents, records, pathological specimens, or diagnosis specimens.

8. examines public benefit or service programs or agencies (Federal or State); procedures for obtaining benefits or services under these 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.