St. Kate's IRB COVID-19 update
Effective May 10, 2021, research and quality improvement projects involving face-to-face interaction with participants can be conducted in-person as long as the primary investigator submits an in-person interaction addendum and outlines how they will follow existing local COVID-19 restrictions (city/county), including the St. Kate’s COVID-19 Preparedness Plan (masking, social distancing, cleaning, etc).
St. Catherine University COVID-19 Preparedness Plan
Covid-19 In-Person Interaction Addendum
Mentor IRB — Online IRB Application Tracking System
Mentor IRB is the St. Kate's online application management system. New IRB applications are submitted via the Mentor IRB system for IRB review as well as approved applications are monitored via Mentor IRB (amendments, completions, etc). Mentor IRB is accessible using your St. Kate's username and password.
Mentor IRB directions - For Investigators
Mentor IRB directions - For Faculty Advisors
Mentor IRB - Submit your IRB Application Tutorial Video (5 minutes)
Estimated IRB Application Review Time Frame is 3-4 weeks
- Student PI's require faculty advisor approval before the review process can begin. The review time does not start until the faculty advisor has approved the IRB application within Mentor IRB.
- The review time will take longer if there are questions for the PI during the review process, requests for missing documents, and/or required revisions to the submitted documents.
- November - January is a busy period for the IRB and review times can take up to two additional weeks. This does not include the days the University is closed (such as the holiday break) when IRB members do not review applications. The same is true for other holidays and breaks during the year.
- The St. Kate's IRB does review IRB applications over the summer months.
The St. Kate's IRB is here to help ensure human subject research is conducted ethically. Feel free to contact the IRB, with questions prior to submitting your IRB application at email@example.com, or contact either an IRB chair or member directly. The following are St. Kate's policies which are related to human subject research.
Research Involving Human Subjects Policy
IRB Policy addendum for Cooperative Research
Mandatory Research Education Policy
Human subject research is overseen by the Office for Human Research Protections(ORHP) within the U.S. Department of Health & Human Services(HHS). 45 CFR 46 contains the federal regulations for the protection of human subjects in research and is typically referred to as the Common Rule (45 CFR 46 Subpart A). Federal regulations require you to obtain informed consent, show that the potential benefits of your research outweigh risks, minimize risk to participants, utilize sound research methodology, and ensure the privacy of your subjects. Additional federal regulations may apply to your research outside of the purview of the IRB, such as financial conflict of interest and responsible conduct of research.
The St. Kate's Human Subject Research Policy requires the IRB to review research projects even when they are exempt from IRB review per Federal Regulations. Depending on the nature of the research and the degree of risk, projects will typically qualify for one of the following levels of review: Exempt, Expedited or Full. In addition to these 3 levels of review, we also have a process for handling collaborative research with external institutions (single IRB or sIRB), quality improvement projects, and classroom protocols. If it is determined that an IRB review is not required, you can still submit an IRB application and request an official letter stating the IRB has determined a review is not required.
Consider the following to determine if IRB approval is required when conducting human subject research:
- Will you be conducting a systematic investigation to gather information about living individuals?
- Do you intend to collect information and then present it to a public audience or at a conference?
- Do you intend to publish findings or disseminate information based upon your work?
- Will you be conducting interviews, surveys, or focus groups?
- Will you need access to sensitive data or records?
- Is there any way to link the data you plan to collect with identifying information?
- Are you seeking grant funding for research on human subjects?
If the answer to any of these questions is "yes" then you should submit an IRB application for review.
The primary investigator (PI), co-PIs, research assistants and faculty advisor must complete the Human Subject Research education requirement. Researchers need to complete one course about Human Subject Research:
- Biomedical Investigators
- Social Behavioral Investigators
- Education Action Research
Your CITI completion report will automatically be uploaded into Mentor IRB if you use your St. Kate's email address within CITI or set your CITI username equal to your St. Kate's username. The HSR requirement must be completed at the time the IRB application is submitted.
CITI - New User Tutorial Video (4 minutes)
Depending on the nature of the research and the degree of risk, projects will qualify for one of the following types of review. Additional information is available below for each type of review:
- Exempt - Research involving no more than minimal risk, and meets one of 8 exemption categories identified in 45 CFR 46.104.
- Expedited - Research involving no more than minimal risk and meets an expedited category of research identified by ORHP (1998).
- Full IRB Committee Review - Research requiring Full review places the subject at greater than minimal risk.
- Quality Improvement - These studies require IRB review to verify they are not research.
- Cooperative Research - Research that involves investigators from St. Catherine University and one or more external institution.
- Program Evaluations (includes accreditation activities) - These studies do not require IRB review as they are not intended to generate generalizable knowledge and results are typically only shared within the organization.
- Classroom Protocols - Research done as part of a class project which is only presented to an internal audience at the University and not intended to be generalizable.
Minimal risk means that 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.
Research is defined as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge".
The Office for Human Research Protections (ORHP) provides the following decision tree to help determine your required level of review.
Research studies which meet the criteria for Exempt, Expedited, or Full Review (as defined above) will be submitted via Mentor IRB. PI’s self-select their review type within Mentor IRB. If you have questions about which review type is appropriate contact the IRB at IRB@stkate.edu.
Has your research already been determined to be a Quality Improvement (QI) by an external institution? Do you think your project is not human subject research but rather a Quality Improvement project? The St. Kate’s IRB requires quality improvement PI’s to submit an IRB application so the IRB can verify the project does not meet the federal definition of human subject research. Refer to the following documents for help determine if your project is eligible for a Quality Improvement review:
QI vs Research Decision Tree UW
If you feel your project is eligible for a Quality Improvement Review select "Quality Improvement" as the review type within Mentor IRB. If your application has already been deemed as a QI project by an external institution, you can upload the application from the other institution, their determination letter and any supporting documents into Mentor IRB. You are required to answer additional questions within Mentor IRB from the QI worksheet above if your project has not been reviewed by another IRB. Each of the questions within Mentor IRB must be answered with a 'TRUE' response. If any question is responded to with a 'FALSE or NOT SURE', your project is not considered QI based on St. Catherine University's IRB criteria and you are required to select a different review type in Mentor IRB (Exemption, Expedited or Full).
When filling out the IRB application for a QI project not every section or question is applicable:
- Section 1: Research Summary: This section is important so the IRB can understand your study.
- Section 2: Subjects: The most important question to answer is Target Population, who is your project intending to study.
- Section 3: Recruitment: QI projects do not typically have a recruitment process but we want to know how you are identifying and contacting your subjects.
- Section 4: Risks and Benefits: Please identify any risks/benefits related to your QI project.
- Section 5: Confidentiality of Data: This section outlines how you will store project data and maintain anonymity/confidentiality of the information obtained from subjects.
- Section 6: Informed Consent: While collecting informed consent is recommended, QI projects do not require an informed consent process. If you are not collecting informed consent simply answer N/A.
- Section 7: CITI Training: CITI training is required for QI projects.
Has your research already been approved by a different institution’s IRB or will it need to be approved by an additional IRB? The St. Kate’s IRB wants to reduce the amount of rework when a study has to be approved by multiple IRBs so the IRB developed an IRB policy addendum specific to cooperative research.
IRB Policy addendum for Cooperative Research
When your application has been already been approved as Exempt by a different IRB, you can upload the application form from the other institution, their approval letter and any supporting documents into Mentor as an Exempt application. We will process your application in a similar process as we do all Exempt applications, with the exception that we do not require you to fill out a St. Kate IRB application.
When your application has been approved as either Expedited or Full by a different IRB, you may be able to delegate IRB oversight to a Single IRB of Record (sIRB). To start this process, upload the IRB application form from the other institution, their IRB letter of approval and any supporting documents into Mentor IRB with a review type of Delegate to external IRB. The IRB chair will review your application to determine whether the St. Kate’s IRB is willing to allow the delegation to a sIRB. To complete the delegation to another IRB, an IRB Authorization Agreement (IAA) will need to be signed by both institutions engaged in the research.
IRB Authorization Agreement (IAA) with an External IRB of Record
The St Kate IRB can also act as the IRB of Record for Expedited an Full review studies. If you have research which engages multiple institutions and you wish to have the St. Kate’s IRB act as the IRB of Record, a Reliance Agreement can be signed by both institutions engaged in research. Prior to signing a Reliance Agreement, your application will need to follow the standard St. Kate IRB approval process.
IRB Authorization Agreement (IAA) with St Kate's IRB as the IRB of Record
Program Evaluations are not submitted to the IRB for review. Program evaluation projects are not intended to generate generalizable knowledge and results are only shared with the organization. Any work related to program accreditation is classified as program evaluation and does not require IRB review.
PI’s can voluntarily submit an IRB application for a program evaluation project via Mentor IRB by selecting IRB Review Not Required. The IRB chair will review the documents and provide an official letter from the IRB stating the project is a program evaluation and IRB review is not required.
Masters of Public Health (MPH) practicums tend to fall into this category. The MPH practicum coordinator is responsible to help students determine when IRB review is required for MPH practicum projects and can contact the IRB chair or coordinator to help determine when IRB review is needed.
The Classroom Protocol has been established for streamlining the process when students are engaged in class projects that involve human participants. Classroom protocols must conform to the following criteria:
- All projects should be Exempt as defined by Federal guidelines
- Subjects will not provide and researchers will not keep any identifiers that will link the results back to the participants.
- Projects will not involve any personal, sensitive, or incriminating topics or questions.
- Projects will not manipulate behavior of the subjects beyond the range of usual classroom activity or college life.
- Projects will not involve physically invasive contact with subjects.
- Projects will only be presented to an internal audience at the University.
CITI human subject research training requirement for classroom protocols:
- Faculty submitting the classroom protocol must satisfy the human subject research (HSR) mandatory education requirement and upload a CITI completion certificate into Mentor IRB.
- Students are not required to complete the HSR mandatory education, however the IRB recommends the following CITI course for students doing classroom research: Introduction to Humans Subject Research for Students in the Classroom.
Instructors must submit a completed classroom protocol application to firstname.lastname@example.org as early as possible during the semester. Any student project that is not consistent with the criteria defined above must complete an individual IRB application and submit it to the IRB for standard review via Mentor IRB.
All IRB submissions must include a completed IRB application document unless already reviewed by an external IRB. You may excerpt material from your thesis or grant proposal, but your application should be relatively concise. Applications that lack clarity due to excessive errors or incomplete information may be returned to the investigator, which will delay the review. Spell- and grammar-check all documents before uploading them to Mentor IRB and remove all track changes and comments.
As stated above in the Covid-19 update, if you are conducting in-person research you will need to include a Covid-19 In-Person Interaction Addendum as part of your IRB application submission.
The IRB offers multiple templates as guides to writing your consent form(s). We recommend using these templates when full informed consent is required. You may still write your own consent form, but be sure to cover all the elements outlined in the template. The federal regulations outline the elements of informed consent in 45 CFR 46.116: General Requirements for Informed Consent.
The Standard Consent Template should be used for most research projects:
IRB Consent Template Instructions
Optional Consent Form Introduction Letter – Template
Some research projects collect data via a survey that utilizes low risk, harmless questions, and anonymous data. Low risk surveys can use a simplified consent statement prior to starting a survey.
Masters of Education and Montessori students completing an Action Research Project often use either the Active Consent Form or the Parental Permission Form template. These documents are only recommended for action research projects in traditional educational settings.
Active Consent Form template (Education Action Research Project)
Parental Permission Form template (Education Action Research Project)
Under special circumstances the IRB may permit a Waiver or Modification of Informed Consent. The criteria for modification or waiver should be reviewed by the investigator, 45 CFR 46.116(f). The IRB may also waive the requirement for documentation of informed consent, that is, getting a signed consent form from each participant, 45 CFR 46.117(c) Documentation of Informed Consent.
All official St. Catherine University IRB forms and templates are located in Mentor IRB. The forms are available as Microsoft Word documents. The following documents are required to submit a new IRB applications:
- IRB Application Document
- At least one of the following: Consent form, Assent Form, or equivalent unless you are requesting an informed consent waiver.
When submitting your IRB application, also include all supporting document unless. These documents do not have templates. These may include, but are not limited to
- External Organization Support letter (on letterhead or through organization email)
- Email template, Phone/Verbal script
- Evaluation tools, surveys, quizzes, etc
Submitted IRB applications for student investigators must be approved by your Faculty Advisor within Mentor IRB before the IRB will start your IRB Review.
IRB approval will come as an email from IRB@stkate.edu. Until you have received written notice that your research has been approved, you must not begin to collect data, recruit participants, or interact with human subjects. For exempt and expedited reviews, the process takes about three to four weeks from application submission to review and initial IRB response. During periods of high volume of applications (November–January), reviews may require an additional one to two weeks. Full Reviews require your IRB application to be discussed at a full IRB Committee meeting and will be scheduled based on the order in which they are received. The IRB can only accommodate 2 reviews at an IRB meeting. Notification regarding the status of a full review application will be sent within one week following the IRB Committee meeting.
All communication from the IRB will be sent to your St. Kate's email.
You may be asked by the IRB to make revisions to your application in Mentor IRB. You can do this by uploading additional documents or replacing existing documents within Mentor IRB. When revising documents, highlight the areas that have been changed. Student PIs should work with their faculty advisors on these revisions as needed, but advisors are not required to formally approve revisions within Mentor IRB.
Once the investigator receives their IRB approval letter they can begin to collect data or interact with human subjects. The investigator must not begin to collect data or interact with human subjects until they have received their IRB approval letter. The investigator is responsible to communicate with the IRB during their research project, including submitting Amendments, Renewals, Adverse Events notification, and Completion notification. Directions for each of the processes are located within Mentor IRB.
Any changes to approved protocols/applications need to be reviewed by the IRB prior to implementation as they may impact the risk/benefit ratio of the protocol/application. The PI must complete the Amendment Request Form. If the proposed changes require revisions to documents, such as the consent form, you will need to upload the revised document(s) with all changes highlighted. Submit the amendment request form and any revised document(s) using the amendment tab with Mentor IRB.
Mentor IRB Directions – Amendments
Exempt protocols/applications are not required to file continuing reviews on an annual basis but all protocols/applications approved by expedited or full board review procedures are required to submit a continuing review report to renew their IRB approval for another year. Mentor will automatically notify you of an impending report due date. Renewals are processed through Mentor IRB (see directions below). Once submitted you will hear from an IRB Chair within 7-10 days about your renewal request.
In the event that a human subject is harmed as a result of participation in your research project, it is necessary that you immediately inform the IRB by sending an email IRB@stkate.edu or contact the SPREE office at 651-690-8811. Additionally, upload the Adverse Events form (found below) to your protocol/application page. Indicate if you think that the event warrants any changes to your protocol or consent form. If changes are required, submit an amendment as well. You may want to talk with the IRB chair before submitting your amendment.
Mentor IRB Directions - Adverse Events
Once the project is complete, with no further recruitment or data collection (on going data analysis is allowed), researchers must notify the IRB that their research is complete. Expedited and Full reviewed studies will use the Renewal/Completions tab. The process for exempt research is to upload an Exemption Completion form on the Administrative Review Tab. Reference the appropriate directions below for step by step instructions.
Mentor IRB Directions - Expedited and Full Review Completion/Closing Research
Mentor IRB Directions - Completing/Closing Exempt Research
St. Kate's provides two survey tools for use by faculty, staff, and student investigators: Qualtrics and REDCap. Additional information about each survey tool can be found in Service Now.
Also, the IRB recommends you use a platform that uses a captcha to prove your participants are actual people and are not bots. Google Forms does not have this as an option and could impact your data collection. This is especially important when recruiting on social media.
Learn more about human subject research with these helpful sites.
Department of Health and Human Services, Office for Human Research Protections (OHRP)
OHRP "The Research Clinic" Training Video
Public Responsibility in Medicine and Research (PRIM&R)