SoTL projects that are human subjects research typically fall under two types of regulatory laws: The Federal Regulations for the Protection of Human Research Subjects (45CFR46) and regulations that govern the educational setting like the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA).  The IRB will review the study protocol for your planned SoTL project for compliance with both laws to provide approval.

SoTL projects tend to be minimal risk with regard to participation for human subjects. However, it is the IRB’s role to review the planned protocol for your specific study and make a determination regarding compliance. If the study is considered to be more than minimal risk, or if a full board determination must be made, then the study will need to be reviewed at an IRB Full Board Meeting. These meetings are held twice monthly. It is important to understand that the review process takes time and to plan for enough time to complete IRB review when designing your study. 

Steps to create your study and submit for IRB review and approval:

1. Write Your Protocol for IRB Approval
   1. Creating and Submitting a new iProtocol
   2. iProtocol Question Guide
2. Upload Relevant Documents
   1. Data collection tools (e.g., surveys, interview protocols, etc.)
   2. Recruitment and Consent
3. You will need the Dean’s Approval after the IRB pre-reviewer has worked with you on your protocol.
   1. In iProtocol, under “Permission to Access Data Source and Participant Group”: 
   2. Select Yes in response to “Are there any rules or restrictions…”
   3. Describe the rules or restrictions following the template below:
      1. Official permission from the Associate Dean is required to conduct this study. The UVA Department Notification Form detailing the study will be provided and the response will be uploaded. 
4. Submit iProtocol - The IRB pre-reviewer will send back the protocol draft to you for the Dean’s Approval to be uploaded.
5. Obtain Dean’s Approval
   1. Complete and share the UVA Departmental Notification Form with your Associate Dean.
   2. In iProtocol, under Permissions and/or Agreements, upload the following:
      1. Departmental Notification
      2. Email correspondence: Your initial email to the dean, and their approval email if it was received. (These should be in the same document; if no approval is received, still upload your initial contact email as proof of attempted contact.)
6. Complete iProtocol Revisions
7. Submit again to return the updated protocol for IRB review and to obtain IRB approval.

1. Power and Authority. As an instructor, you are inherently in a position of power over your current students; you assign grades. Your teaching assistants are in a similar position of power. Having this position of power and authority can make it challenging to obtain voluntary informed consent. Students may feel—even if told otherwise—that they need to participate in the study to get a good grade in your course. To mitigate this concern, a researcher unaffiliated with your course, who is not in a position of power over students, should manage recruitment and consent. You should not know who participated in your study until after final grades are submitted, if at all. 

2. Normal Educational Practice. Consider what students will be asked to do—what is part of the course, regardless of your research project? And what are you asking students to do that goes beyond that? Make sure you are clear in your IRB if what you are doing for your SoTL study is part of your normal educational practice or not. 
3. Incentives. All students must have equal access to incentives. Researchers are allowed to offer incentives to participants as long as the incentives allow for voluntary participation. If the principal investigator is the course instructor or classroom teacher, you can offer students course credit for completing the work, but not for participating in the study. The credit needs to be awarded in a way that does not alert the instructor as to who is participating in the study. If the study is conducted through a participant pool and offers course credit, alternate opportunities for earning course credit need to be made available to participants.

4. Grades and Learning. Your research must not compromise students’ grades or their learning. The study should not take away from students’ educational time, and all students should be able to participate fully in the course regardless of whether they consent to participate in your research. Study participation should not influence a student’s grade.

5. Privacy. All reporting of the data should protect students’ privacy. Do not disaggregate data when you have a small number of participating students or subgroups of students (5 or fewer students in a group or subgroup). Collect anonymous data when possible, and when it is not (e.g., when you need to connect data sources, like pre/post surveys or surveys and course artifacts), ensure identities are kept confidential. 

6. Minors. Some university students are still minors (i.e., under age 18) and you will either need to state that you will exclude minors from your study or you will need to provide a parent consent/minor assent form and procedure in your protocol in addition to the consent form and procedure for students over the age of 18.

An informed consent process is the ethical foundation for any research involving human participants—SoTL is no exception. In addition, federal regulations require IRBs to ensure that participants are fully informed about a study before they agree to participate.

For minimal risk studies, including SoTL studies, the requirement for documentation of consent can be more flexible. At minimum, students must be notified about the research study. This can be done through a Study Information Sheet (also called a consent without signature). The plan for consent documentation must be provided to the IRB for review and approval. The consent templates were created by the IRB to help you create the documents you will need.

If you conduct a SoTL project with colleagues at another institution, you will need to determine whether UVA will be the lead institution or if it will be relying on another institution’s IRB. If you decide to designate another institution as the lead, this is possible and the IRB looks forward to working with you to make this project a success.  Please reach out to us at: mjm6ny@virginia.edu