​*New submission process and application*​
New PDF Application for Human Subjects Research​ in ​​​​Forms & Documents​

​Submit all forms for IRB review here​

​Reach out to irb@uwsp.edu with question, please ​do not submit documents via email.​​


​IRB Frequently Asked Questions

For additional questions, contact irb@uwsp.edu


​IRB Approval Timeline

What is the IRB process timeline? How long can I expect to wait for approval?

In short, approximately 2-6 weeks, depending on the type of review, the number of revisions requested, and how long you take to revise and resubmit the application.

Please see the IRB Process for more details on review and approval information. 

What is the timeframe for approvals during the academic year?

The researcher should allow at least two weeks for review of their exempt or expedited IRB applications. Generally, the process is: 

1. receive an IRB application by email, 
2. assigned a reviewer, 
3. reviewer’s comments are sent to the research by the IRB chair outlining the necessary changes to their application (it is rare that no changes are necessary)
4. IRB chair or IRB Program Associate reviews changes against the reviewer comments and either asks for additional changes or provides email approval pending a formal letter of approval
5. Formal letter of approval is sent by IRB office within about two weeks of email approval 

The researcher should submit a full board application the week prior to the full board meetings. These meetings are outlined on the IRB website.

For more details see: IRB Process

What happens with IRB in the summer?

The IRB committee does not meet during the summer; thus, no full board review of protocols occurs. The first IRB committee meeting occurs in the first couple weeks of September and the last one occurs in the first or second week of May. Full board protocols must be submitted to the IRB office one week prior to the scheduled IRB committee meeting.

IRB Chair is very part time. IRB Program Associate is full time, but only 25% of that time is spent on IRB. Operations are slower in the summer.

​Application-Related Questions

Who will serve as PI in our investigations?

Students are not permitted to be Principal Investigators. Your professor is required to be the Principal Investigator to ensure sound research design, proper completion of the application, and project follow-through.

On the IRB application, you should check the box indicating you are a student. 

Do faculty PI's on student projects need to complete CITI training too?

Yes. The PI is repsonsible for the project, even it is mostly run by a student. A faculty advisor is responsible for ensuring sound research design, proper completion of the application, and project follow-through. 

Anyone listed on the project is required to take CITI training. 

Who is included in "all research personnel" from the IRB protocol application?

Personnel is anyone working on the project in any of the 6 capacities listed (PI included). 

The roles for research personnel are: 1) research design, 2) recruitment, 3) informed consent, 4) data collection, 5) data analysis, 6) Other (indicate role)

How do you determine "minimal risk"? How is it gauged?

IRB determines minimal risk. 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 of the general population or during the performance of routine physical or psychological examinations or tests.

What protections need to be put into place to maintain privacy for research participants?

Information collected for research purposes must remain confidential at all times. You need to protect your research data whether it's electronic or paper. If you are doing a mail survey, for example, you need to keep the returned forms, even if they do not have identifiable information on them in a locked file cabinet or office. If you are doing an electronic survey through Qualtrics, you need to keep the data on a password protected computer.

Data must be retained for 7 years, then destroyed.

If planning to record interview sessions, do you need to include in your request to IRB information about storing recordings, process of transcribing (i.e., using an external transcription service)?

Yes, you need to specify how the interviews will occur, how recorded, transcribed, analyzed, how the information will be stored (the recordings, the transcriptions) and how you will keep your participants’ information (names and other revealing information) confidential and private. 

If using an external transcription service, how will you maintain confidentiality? Confidentiality must be ensured when working with outside entities. Many of them retain access to your information. Always read the fine print and check with IT services for information on UWSP-approved technology. 

How is electronic research made secure (interviews, transcription, etc.)? If research includes audio tape of interviews/video and transcribed through the usual means, who do we reach out to for assistance with keeping these secure?

You will need to describe in your IRB application how the interviews are recorded, transcribed, etc., where the recordings and transcriptions are stored and inaccessible to all but PIs and researcher. Usually, researchers use a computer that is password protected

How specific or broad should my application be?

Be as specific as possible on each question in the application.

The broader your application is, the longer the review process will be.

If I adjust the research design, does I need to apply for approval again?

The PI needs to fill out a modification form, not a whole new protocol. Any changes to the originally approved protocol require a modification. Modification forms are found on the Forms & Documents Page

If the reviewers request additional information and the PI does not meet the 30-day response time, do you have to restart the whole process?

Yes, you would need to reapply. It helps if when you re-apply that you meet the previous requests and provide context of the previous review. It may help the review go faster.

Do we provide concern or complaint forms to participants ahead of time or as needed during the research?

Your informed consent form should include contact information for the researcher in case of questions and for the IRB chair in case of complaints. Consent forms and concern/complaint forms are on the website.

When is a study considered to be complete?

When you are done collecting data, and the data is DE-IDENTIFIED, you can consider the research complete. For students (undergraduate, graduate, and doctoral), this step is one of the last things you will do prior to graduating. There is a completion form on the IRB forms and documents webpage.

Many times, projects are completed prior to their expiration date. This allows the PI to complete their project with IRB and reduce administrative burden on our part

How do we go about getting letters of authorization from organizations we are working with?

How you go about contacting and getting permission is outside IRB’s purview. You must approach them with your project. Permission can be provided before submission, during submission, or after approval. If it is post-approval, your letter will state the project cannot begin without approval from the site. Site permission documents (emails, letters, etc.) must be submitted to the IRB for filing as soon as received.

​IRB Review Categories

What IRB category is my research?

This question is not straightforward to answer. Generally, full board research protocols have participants considered vulnerable in some way, such as minors.

Your research may fall under one of eight (8) exempt categories or one of nine (9) expedited categories.

The IRB office will determine the category of your research. The most important distinction is whether it is full board or not.

Review categories are listed in your approval letter.

​FERPA & IRB

If I am working with minors, are there additional guidelines with FERPA?

If the data you are collecting is related to education, FERPA must be observed. FERPA training (available through CITI) is required prior to collecting data.

If you are conducting research within a school setting, it will depend on the school. The researcher needs site consent.

Almost all research with minors (FERPA-related or not) will trigger a full board review. We will want to make sure the students' names and all related information are kept confidential and private. After the data is collected, personal information should be separated from collected data (name for example). If race and age are important to the research design, you need to explain what demographic information you need to retain in order to carry out your analysis.

Consent is always required for research, and in the case of minors, this includes their parents. Parents must give consent, and students must also assent in order to participate. In other words, two consents must occur prior to participation. 


The information shared on FERPA was not as plentiful as the HIPPAA requirements. What specifically do we need to be aware of when working within the constructs of FERPA?

If you are working with students directly, your IRB application will have a full board review. We will look to see level of risk, confidentiality and privacy issues pertaining to students.

In order to work with protected educational information and/or demographics, there must be a legitimate educational interest to use it. 

I am at a University and I want to use past student assignments in my research. Is this possible? Does FERPA play a role?

Data must be un-identifiable to be used without consent. There can be no trace connecting to a student in any way.

Using student assignments as data is allowed if there is a legitimate educational need, but informed consent must be obtained from the students.

Using past student assignments when no informed consent was obtained is not allowed. 

Why can’t I use past student assignments? Isn’t this an existing data set?

Student information and work, including assignments are covered by FERPA, and thus, cannot be used unless the researcher obtained permission from the students to use their work/assignments as research. FERPA is a federal requirement; non-compliance of FERPA results in loss of funding for the University.

For more information on what is or isn't protect by FERPA, view the FERPA Training Document on the IRB Forms & Documents webpage.

Compensating Participants

Should PI's compensate participants?

It depends on the research and how you are recruiting participants. The researcher should include compensation in the IRB application if it is part of the research plan.

Incentives should not create undue influence to sway the participant to make the decision to participate. The incentive should fit with the research. Ex: research about use of public transit systems in low-income individuals may be incentivized with a bus voucher or drawing for a gas card. 

Traditionally when asking for something of a Native, the researcher presents tobacco (this is the culturally accepted way to ask for something), how should this come into play here?

The PI should include this information in the application and include as a form of compensation.

Cultural information is important as some cultures do not share similar ideologies related to data collection. Ex: Hmong families do not sign papers because of their beliefs, which affects the IRB consent process. This is where a lack of documentation of consent may be justified.

​Research Compliance

What happens if there is a non-compliance event?

There would be an investigation, a report to the Federal Government is likely. The PI needs to make sure that non-compliance does not occur as they are the responsible party.

Following the approved protocol is the best way of mitigating unexpected events or concerns. 

What strategies are there for avoiding non-compliance?

Do not conduct human subjects research without IRB approval!

Stick with your IRB approved protocol. If it changes, fill out a modification form. Example: if doing a survey and modifying questions, researcher needs to fill out a modification form for approval of changed questions. If adding a school site, fill out a modification form with letter of support for approval by IRB.

Forward any unanticipated events or issues to IRB right away. 

Ensure ethical considerations for participants, whether they agree to participate or not.

Remove any real or perceived conflicts of interest.

For an expedited or full board IRB application, which are valid for one year, what happens if I cannot complete the data collection?

If data are collected after the protocol expiration date, this is an instance of non-compliance. The PI should not collect data after the year deadline.

Your original application would be closed after one year and you could reapply.

PI’s are expected to complete a continuing review form (found online) if they wish to continue the project beyond a year. IRB will notify you of impending expiration dates.

Other Questions

Where can we get funding?

Funding is up to you. If you are a student, contact OSCAR and work with your faculty advisor. Faculty and staff can contact ORSP for help with funding searches.

When should I submit an IRB application?

This question is vague. It depends on a number of factors. Is it a class project? (If so, see SOP 2-Class Assignments) What do you intend to do with the data/results? The goals and/or project must be designed before many of the application questions can be answered. 

If you are unsure how your research fits within IRB, click here to better understand Research and the IRB Relationship. 

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