IRB General Questions
What is the timeframe for the IRB approval process?
Approximately 2-6 weeks. This depends on the type of review (exempt or full board), the number of revisions requested, and return time from PI if revising and resubmitting the application.
Please see IRB Process for more details on review and approval information.
The researcher should allow at least two weeks for initial review of their exempt or expedited IRB applications. Generally, the process is:
1. Chair receives an IRB application through Microsoft Forms IRB Document Submission.
2. Chair either reviews or assigned a reviewer.
3. Reviewer’s comments are sent to the researcher by the IRB chair outlining the necessary changes to their application (it is rare that no changes are necessary).
4. IRB Chair or assigned member 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 Committee page.
Where can a PI or researcher search for funding?
Obtaining research funds is up to the PI or other researchers. Faculty and staff can consider an internal UPDC Research and Creative Activities grant, use funding searches for external opportunities, and/or contact ORSP@uwsp.edu for assistance.
Students can contact Undergraduate Research, Scholarly, and Creative Activity (formally known as OSCAR) within University College and work with your faculty advisor.
Should PIs compensate participants?
It depends on the research and how participants are recruited. 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. For example, research about use of public transit systems in low-income individuals may be incentivized with a bus voucher or drawing for a gas card.
More information can be found here: UW Policy – Participant Payments for Research
When working with difference cultures, are there additional considerations to include in the IRB application?
The PI should include information in the application on the form of compensation and/or explain difference of data collection due to cultural beliefs. This cultural information is important as some cultures do not share similar ideologies related to data collection.
For example:
- Traditionally when asking for something of a Native, the researcher presents tobacco, as this is the culturally accepted way to ask for something.
- 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.
What happens with IRB in the summer?
The IRB committee does not meet during the summer. As such, 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.
Application Questions
When should an IRB application be submitted?
This depends on a number of factors. Is it a class project? (If so, see SOP 2-Class Assignments) What does the researcher plan to do with the data/results? The goals and/or project must be designed before many of the IRB application questions can be answered.
If there is uncertainly with how certain research fits within IRB, click here to better understand Research and the IRB Relationship. Contact irb@uwsp.edu with further questions.
Who serves as PI in our research?
Students are not permitted to be Principal Investigators. The student’s 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, please indicate which personnel are students.
Do faculty PIs on student projects also need to complete CITI training?
Yes, anyone listed on the project is required to take CITI training. The PI is responsible 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.
What IRB category is my research?
Research may fall under one of eight exempt categories or one of nine expedited categories. Generally, full board research protocols have participants considered vulnerable in some way, such as minors.
The IRB office will determine the category of your research. The most important distinction is whether it is full board or not.
Review categories will be listed in your approval letter.
Who is included in “all research personnel” from the IRB protocol application?
Research personnel include PI, co-PI, and anyone working on the project in any of these 6 capacities:
- Research design
- Recruitment
- Informed consent
- Data collection
- Data analysis
- If other, indicate role in application
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 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. Researchers and students need to protect the research data whether it’s electronic or paper.
For example, if a mail survey is part of data collection, the returned forms must be kept in a locked file cabinet or office (even if they do not have identifiable information.) If research involves an electronic survey through Qualtrics, data must be kept on a password protected computer.
Data must be retained for 7 years, then destroyed.
If planning to record interview sessions, do PIs need to include information about storing recordings and process of transcribing? (ex. using an external transcription service)
Yes, the PI must specify how the interviews will occur, how recorded, transcribed, analyzed, how the information will be stored (the recordings, the transcriptions) and how personnel will keep participants’ information (names and other revealing information) confidential and private.
If using an external transcription service, how will researchers and personnel maintain confidentiality? Confidentiality must be ensured when working with outside entities. Many of them retain access to information. Always read the fine print and check with UWSP IT services for information on campus-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 may be.
If the research design is adjusted, does the PI need to apply for approval again?
With any changes from the originally approved protocol, including research design, the PI must fill out a modification form, not a whole new protocol. Modification forms and other forms can also be found on the Forms & Documents Page.
If the reviewers request additional information and the PI does not meet the 30-day response time, does the process need to be restarted?
Yes, the PI would need to reapply is the 30-day response time has passed. To help with review time, it helps if when the PI re-applies they reflect the previous requests and provide context of the previous review.
Does the research team need to provide concern or complaint forms to participants ahead of time or as needed during the research?
The approved 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 personnel have completed collecting data, and the data is de-identified, the PI can consider the research complete. For students (undergraduate, graduate, and doctoral), this is one of the final steps prior to graduating. There is a completion form on IRB Forms & Documents.
How does the PI/research team go about getting letters of authorization from organizations the project is working with?
This is outside IRB’s purview, the organizations must be approached by the PI or one of the research team members. Permission can be provided before submission, during submission, or after approval. If it is post-approval, the approval 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.
FERPA & IRB
If a research project is working with minors, are there additional guidelines with FERPA?
If the data collected is related to education, FERPA must be observed. FERPA training (available through CITI) is required prior to collecting data. (Read more about CITI and compliance training on IRB Training.)
If research is conducted within a school setting, it will depend on the school and the researcher needs site consent.
Almost all research with minors (FERPA-related or not) will trigger a full board review. Ensure 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 (ex. names). If race and age are important to the research design, an explanation is required on what demographic information needs to be retained in order to carry out 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. (Review a Sample Minor Assent for more information. Reach out to irb@uwsp.edu with questions.)
The information shared on FERPA was not as plentiful as the HIPPAA requirements. What should the research team be aware of when working within the constructs of FERPA?
If researchers are working with students directly, the IRB application will have a full board review. IRB will review 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 (see more below).
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. As such, they 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 IRB Forms & Documents.
Research Compliance
What happens if there is a non-compliance event?
When a non-compliance event is reported to IRB or ORSP, an investigation occurs and a report to the Federal Government is possible. The project PI is the responsible party for an approved protocol and must ensure non-compliance does not occur.
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!
- Always follow the IRB approved protocol. If it changes, fill out a modification form. For example, if conducting a survey and modifying questions, the PI 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 is collected after the protocol expiration date, this is an instance of non-compliance. The PI should not collect data after the year deadline.
The original approved application is closed after one year, but the PI can reapply. Alternatively, PIs can complete a continuing review form if they wish to continue the project beyond a year.