Human subjects review Institutional Review Board (IRB)

All research involving human subjects must be reviewed by the IRB. 

Human subjects research is classified into three federally defined categories of review: Exempt; Expedited; and Full Committee Review. These designations are made by the IRB committee members based on the level of risk associated with the proposed research study as outlined by the Common Rule (45 FR 46) set forth by the U.S. Department of Health and Human Services.  

Researchers and their mentors (as applicable) are NOT permitted to deem their own research as an exception from IRB review. However, researchers may use this information, and UWL's Researcher's Guide, to better understand which level of review their research will likely need to be compliant to.

Research Eligible for Exempt Review

Exempt does not mean 'exempt from any IRB review', but rather 'exempt from further IRB review.' Researchers and their mentors are NOT permitted to deem their own research as exempt from IRB review. 

Research that falls under one or more federally defined exemptible categories will qualify for an abbreviated IRB review or, in many circumstances, use of the UWL IRB Exempt Decision Tool, and may not be subject to further IRB requirements (e.g., annual reviews).  Categories of exemptible research are defined under “Exemptible Research” in the Researcher’s Guide and in 45 CFR 46.104(d) of the Common Rule. 

Projects that often qualify include classroom research, surveys, interviews, and benign behavioral interventions UNLESS they are conducted with vulnerable populations (e.g., minors, prisoners). 

Process for Exempt Review

Researchers believing their research to be exempt must either: 

1. If eligible, submit your protocol using the IRB Exempt Decision Tool. If successful, researchers will receive a confirmation email that the protocol is exempt from further review, pending verification by an IRB administrator. 
2. Submit a complete protocol to irb@uwlax.edu  for review. Directions to do this can be found on the IRB Researcher's Guide. Reviews are conducted by the IRB Coordinator and select members of the IRB Committee throughout the academic year and intermittently during the summer. You may receive requests for revisions or additional information. Once revisions are complete, if a protocol meets all IRB requirements, you will receive an IRB approval letter confirming research can proceed and specifying any additional conditions. 

IRB Exempt Decision Tool Eligibility

UWL faculty, staff, and students can use the tool to seek an exempt designation for some research projects involving human subjects. To be eligible to use the tool, the following requirements must be met: 

1. Proposed research meets at least one of the exemptible research categories listed in the Researcher’s Guide, but exemption is NOT being claimed under research categories 4(c), 4(d), 5, 7, and/or 8. 
2. All researchers are UWL-affiliated. Exemptions provided by the tool are only valid if requested by and granted to a current UWL employee or currently enrolled UWL student. 
3. Participants are NOT from vulnerable populations (e.g., minors, prisoners, and individuals with impaired decision-making ability).
4. Monetary or variable participant incentives are NOT offered.
5. Other institutions will NOT by relying on UWL's IRB to provide review and oversight.

Additionally, students must also meet these requirements:

1. A mentor/advisor must be listed on the protocol. 
2. At least the primary mentor/advisor must also have completed the required CITI training.

IRB Exempt Decision Tool Submissions 

Before submitting your protocol through this survey, you can review the IRB Exempt Decision Tool Preview to ensure you have all of the required information. Some of this information includes, but is not limited to:

1. Names and email addresses of all individuals listed on your protocol (e.g., mentors/advisors; co-investigators; personnel)
2. All applicable IRB training completion certificate(s) collated into a single PDF document
3. Project title
4. Project abstract, including the research question, procedures/data collection plan, and general information about the project
5. Depending on the nature of the project: A consent form, debriefing form, and/or survey/interview questions as applicable

DO NOT GUESS on any of the answers in the survey. If you are unsure how to answer a question, reach out to your advisor, colleagues, or the IRB, and return to complete the survey.

After completing the survey, you will receive an email either declaring your described project as under review by an IRB administrator, or you will be directed to submit a complete protocol for IRB review.

Once you have complied all the necessary materials and have determined your project is eligible, you can submit using the IRB Exempt Decision Tool.

Research Eligible for Expedited Research

Some types of research that puts human subjects at no more than minimal risk may be eligible for expedited IRB review. In general, this includes research that presents no more than minimal risk to human subjects and falls under the following categories (refer to the Researcher’s Guide): 

1. Clinical studies of drugs when an investigational new drug application is not required or medical devices being used in accordance with cleared/approved labeling 
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture within certain populations 
3. Collection of biological specimens by noninvasive means 
4. Collection of data through noninvasive, routine clinical procedures except for x-rays or microwaves. This includes studies of moderate exercise, strength, or flexibility testing. 
5. Research involving materials that have been collected or will be collected solely for non-research purposes that don’t qualify as exempt 
6. Data collection from voice, video, digital, or image recordings that don’t qualify as exempt 
7. Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies that don’t qualify as exempt 
8. Continuing review of research previously approved by IRB in certain circumstances 

Expedited Review Process

Expedited reviews are conducted by the IRB Coordinator and select members of the IRB Committee throughout the academic year and intermittently during the summer. 

You may receive requests for revisions or additional information from ORSP staff or an IRB member. Once revisions are complete, if a protocol meets all IRB requirements, you will receive an IRB approval letter confirming research can proceed and specifying any additional conditions. 

Expedited Submission Process

Submit a complete protocol for review to irb@uwlax.edu. Follow the directions in the Researcher’s Guide. Materials to have prepared include, but are not limited to:

1. Attachment A
2. All applicable IRB training certificates
3. Narrative Statement
4. Consent and/or assent forms OR a request for waiver of consent forms (using the Attachment D)
5. Debriefing form(s); survey questions; external approvals (e.g., school approval; district approval; organization approval) as applicable

Research Requiring Full Committee Review

Research that does not qualify for exempt or expedited review must be reviewed by the full IRB committee.

Such research often includes more than minimal risk interventions, such as research asking participants to report child abuse or neglect; asking vulnerable populations potentially triggering questions or to participate in activities outside of what they may encounter in everyday or educational settings; involving prisoners; involving medical interventions; requiring FDA oversight; or for which the reviewer feels the researcher has not adequately mitigated risks to participants.

Students are not generally encouraged to act as PIs on full review protocols due to timeline restrictions and increased risks to both the researcher and participants. Therefore, such projects should NOT be part of a student’s standard course work.

Refer to the Researcher’s Guide, “Full Protocol Review Procedures” section for more information.

Process for Full Committee Review

Full reviews can only be conducted during scheduled IRB committee meetings during the academic year. Meetings are held on Fridays beginning at 8:45 a.m. about once a month. Specific dates are listed on the applicable section of the IRB website.

To be placed on a meeting agenda, non-clinical protocols must be received no later than noon on the preceding Wednesday. Any protocols that include medical interventions and/or are subject to FDA oversight must be received at least two weeks in advance of the meeting date by noon. 

Researchers will be expected to attend the IRB meeting to describe and answer questions regarding their protocol. Within approximately one week of the meeting, the researchers will receive a letter indicating the decision of the committee.  

Full Committee Review Research Submissions

Submit a complete protocol for review to irb@uwlax.edu. Follow the directions in the Researcher’s Guide. Materials to have prepared include, but are not limited to:

1. Attachment A
2. All applicable IRB training certificates
3. Narrative Statement
4. Consent and/or assent forms OR a request for waiver of consent forms (using the Attachment D)
5. Debriefing form(s); survey questions; external approvals (e.g., school approval; district approval; organization approval) as applicable

Overview

Training is provided online through the platform CITI, and IRB training is valid for five years.

All faculty, staff, and student investigators conducting human subjects, as well as primary faculty/IAS mentors of student-submitted IRB protocols, must have up-to-date IRB training in CITI. The minimum passing aggregate score for quizzes is 80%, which is automatically tracked by CITI.

Determining Which CITI Training You Need

CITI training completion certificates must be attached to the Attachment A – Application for University IRB Review for all personnel listed in the protocol. Once enrolled in CITI, select the appropriate Learner Group/CITI course based on the type of research that will be conducted. Use the table below to determine which is most applicable to you:

How to Register

If you do not have a CITI account yet, follow these directions to create your account. 

1. Go to the CITI registration webpage. Under 'Select Your Organization Affiliation,' type “Wisconsin" in the box and then select “University of Wisconsin-La Crosse.”
   1. Check the boxes to agree with the terms of service and affirm you are affiliated with UWL. Click “Create a CITI Program Account.” 
2. Enter your first name, last name, and email address.
   1. Your name should be entered here as you would like it to appear on your completion reports.
   2. Using your UWL-issued email address is preferred for account recovery. Click “Continue to Step 3.” 
3. Choose a username, password, security question, and security answer. Click “Continue to Step 4.” 
4. Enter demographic information. Click “Continue to Step 5.” 
5. Click “No” when asked if you want to request Continuing Education Unit (CEU) credits. Answer the following two questions, and click “Continue to Step 6.” 
6. Complete the personal information requested.
   1. For “Department,” students can use their major.
   2. For the “Role in Research,” choose a role that is most appropriate for your involvement in the research. Click on “Continue to Step 7.” 
7. Scroll to Question 7: Human Subjects Research.
   1. Select the applicable learner group [link to “Required Training Course” dropdown above] based on the type of research you will conduct. If you are not sure which category applies, contact your faculty advisor or irb@uwlax.edu.
8. Scroll to the bottom of the page. Click “submit.” 

How To Enroll

If you already have a CITI account, but need to enroll an IRB course, follow these directions: 

1. Log-in to CITI.
2. Select “Add a Course.” 
3. Scroll to Question 7: Human Subjects Research. Select the applicable learner group [link to “Required Training Course” dropdown above] based on the type of research you will conduct. 
4. Scroll to the bottom of the page. Click “submit.” 

How to Affiliate Your CITI Account

If you already have a CITI account, but it is not affiliated with the UW-La Crosse, follow these instructions to re-affiliate your account: 

1. Log-in to CITI.
2. Select: "Add Affiliation." You do not need to remove any current affiliations to do so.
3. Enter "University of Wisconsin-La Crosse" with no spaces around the hyphen/dash symbol.
   1. Review and agree to the Terms of Service & Privacy Policy.
   2. Affirm that you are affiliating with the University of Wisconsin-La Crosse. Select "Continue."

Note: This is important because even though other universities and organizations use this platform, the content of the courses/trainings vary across institutions.

How to Access Your CITI Training

You can access your CITI training by following these directions: 

1. Log-in to CITI. 
2. Click “View Courses.” 
3. From your list of courses, select the IRB course you have enrolled in.
   1. The first time selecting a course, check the box and click "submit" to complete the Assurance Statement. The system will allow you to start taking course modules after completing it.
   2. You will only need to complete the Assurance Statement the first time you access a course. 
4. Once you are within the course, complete the required modules and associated quizzes.  
   1. Read the course’s main page for “Instructions,” as there may be some elective modules you need to complete. Supplemental modules are optional unless assigned by a professor, supervisor, supervising investigator, or required by the IRB due to the nature of your project.
5. When you complete all required modules successfully, CITI will generate a Completion Certificate, which is required as part of your IRB Application.  

Completion Requirements

The minimum passing aggregate score for quizzes is 80%. See the course’s main page to track your progress. Quizzes may be repeated to improve scores. Scores obtained after a completion report has been issued will not be reflected on the completion report. 

Accessing Your Completion Certificate

To access your CITI Completion Certificate, follow these directions: 

1. Log-in to CITI. 
2. Click “My Records” at the top of the page.  
3. Scroll to the completed IRB course and click “View-Print-Share" under the “Completion Record” heading. 
4. Click “View/Print” to download the Completion Certificate. 
5. Save the certificate as a PDF or Word document to be attached to your protocol submission.
6. If supplemental modules have been required, you should also download, save, and attach a copy of the Completion Report from the same page, in addition to your Completion Certificate. 

When does my IRB CITI Completion Certificate expire? 

Your IRB training expires five years following the initial completion date. This is also listed on your Completion Certificate in the upper right corner.

Who do I contact for help with CITI?

For help resetting your password, contact irb@uwlax.edu. 

For help with technical issues with the CITI website, contact CITI directly at support@citiprogram.org or (888)529-5929. 

IRB Meetings

The IRB Committee is scheduled to meet in-person at 8:45 a.m. Please see the meeting information column of the webpage to review dates and location (see top right). However, the schedule is subject to change at the discretion of IRB Committee.

IRB Review Timelines

During the academic year, September to early May:

• Full protocols submitted by the deadlines are expected to be reviewed at the next IRB meeting. Please see the meetings schedule.
• Expedited and exempt protocols are reviewed on an ongoing basis. Review decisions are generally made within three to four weeks of protocol submission.

During the summer, mid-May to August:

• Full protocol review is subject to committee availability. It is not recommended.
• Expedited and exempt protocol review is completed monthly. Review decisions may take up to six weeks following protocol submission.

Note: Protocols that require clinical review are due to irb@uwlax.edu at least two weeks in advance of an upcoming meeting.

The Operating Guidelines and Organizational Policies document outlines the purpose, authority, membership, and policies of the Institutional Review Board on behalf of the University of Wisconsin-La Crosse. The document can be accessed here: 

Operating Guidelines and Organizational Policies

If you would like to report what you believe to be an instance of noncompliance for research involving human subjects, or have concerns that your own research may be in noncompliance, please email irb@uwlax.edu or fill out the reporting form.

Submit concerns about IRB noncompliance anonymously via the IRB Noncompliance Reporting Form.

See the IRB Noncompliance Policy for additional information. 

See the following policy document for information on how noncompliance in human subjects research is mitigated on our campus:

IRB Noncompliance Policy

Human Health Services (HHS) requires that all non-exempt human subjects research conducted by UWL faculty, staff, and/or students report if their study results in any Unanticipated Problems (UPs). 

Policy Information

See the IRB Adverse Events & Unanticipated Problems policy to review these standards and reporting requirements:  

Adverse Events & Unanticipated Problems Policy

Reporting Unanticipated Problems

Unanticipated Problems should be reported to irb@uwlax.edu with an Attachment C form.