My name is Shawn Miller, and I am a Research-Teaching postdoctoral fellow in the group of Professor Jeffrey Moore at the University of Illinois at Urbana-Champaign. We are working on integrating student genetic information into the general and organic chemistry lecture sequence and investigating the impact on student curiosity and performance. As you might imagine, obtaining Institutional Review Board (IRB) approval for the project was critical and potentially perilous, considering our desire to use student genetic information. Although the IRB at different institutions may operate differently, we thought it would be useful to describe how we went through the process of obtaining IRB approval so those who wish to do something similar have an idea of what to expect.
What is the IRB?
The IRB (which may go by different names at your institution) is a committee that ensures that all biomedical and behavioral research involving humans at your institution is done ethically. In particular, the board’s job is to evaluate the risks and the benefits of a research project to ensure that human subjects are protected from physical and psychological harm. The IRB has the power to approve, review and reject a research proposal. No IRB approval means no research project, which means no grants, conference presentations or publications. You can view the UIUC IRB website for context here: http://oprs.research.illinois.edu/
How does the IRB review process work?
The IRB at your institution may work differently, but at UIUC there is a pre-review process. A member on the IRB staff looks over proposals, ensures that all required materials are submitted, and provides initial feedback on the application by responding with questions and concerns about the research project. These questions and concerns must be addressed prior to the application proceeding further into the approval process.
Again, this may vary depending on the institution, but at Illinois there are three outcomes once the pre-review process is complete. If the application meets certain criteria — such as investigating pedagogical methods (e.g., new homework system) in a normally meeting class — an application may be declared exempt from IRB review. The investigator does not decide that their project is exempt; the IRB does. If you intend to use student genetic information in a course, it is unlikely your project will be considered exempt. The second outcome is expedited review, where a single IRB board member considers the application. Working through the assigned pre-review staff member, the board member provides his or her own questions and concerns. Again, the investigator does not decide their project qualifies for expedited review; the IRB does. Our application was processed using expedited review. The third possible outcome is review by the entire IRB. The IRB meets on a regular schedule ( once a month at UIUC) in committee to discuss applications.
Application submission and review timeline
Planning well in advance is essential. When we were submitting our IRB application, the UIUC IRB was functioning on a deadline basis. For example, submitting before the September deadline meant that the earliest an application would be considered by the full IRB was in October. As of the fall of 2015, the UIUC IRB considers applications based on their readiness. In other words, the sooner the pre-review issues are addressed, the sooner an application is considered. It is crucial that you know the timeframe for IRB application and review because, as will be discussed in the next section, there is a significant amount of work that needs to be done in order to craft a complete IRB application.
When should you start your IRB application?
For some context, early conversations about the IRB application within our research group happened in early April of 2015. The initial application was submitted on June 4. After the pre-review and expedited review process, our application was accepted July 14, which allowed us to begin recruiting students during the fall semester of 2015. We submitted several major revisions over the next few months, the latest revisions to the application were submitted in December. We are launching our experimental course sequence this Spring semester.
The most important thing you must do when seeking IRB approval is to plan your timeline accordingly. We wanted to begin recruiting students in the fall semester, which meant we wanted IRB approval before the semester began in August. Working backwards and keeping the IRB’s scheduled meeting times in mind, the absolute latest we could submit was in July to ensure we met the August IRB meeting date. Since submitting at the very last minute is rarely a wise decision, we tried to make the June submission deadline to make the July IRB committee date. Since we started talking about the IRB in April, this left us essentially two months to pull together the application.
A successful IRB application requires the following components:
- Documentation of training for all members of the research team
- Deciding whether your project is behavioral or biomedical in nature. If it is an education project, it is probably behavioral. This determines the type of training required for the research team members: http://oprs.research.illinois.edu/?q=education/RequiredTrainingInvestigators.html
- A complete description of where the research will be conducted, information on the demographics and number of research subjects, and specific inclusion/exclusion criteria for those subjects
- A complete description of recruitment procedures
- A complete description of research protocols
- The inclusion of final drafts of all instruments (e.g., surveys, questionnaires, etc.) that will be used in the project
- A complete description of what data will be collected, how that data will be collected, how that data will be stored, how that data will be secured, and how that data will be disseminated
- A complete description of how informed consent will be obtained, including final drafts of the informed consent forms plus any required supplemental forms (e.g., waiver of documentation for informed consent when using an online informed consent form at UIUC: http://oprs.research.illinois.edu/?q=forms-and-instructions/InformedConsentWaivers.html)
- A complete analysis of risks and benefits to research subjects, with justification for how risks will be minimized and why the benefits outweigh the risks
- Inclusion of all required supplemental forms (e.g., equipment form at UIUC: http://oprs.research.illinois.edu/?q=forms-and-instructions/initial-application.html)
To get IRB approval, you must have a completely developed research project. You cannot have a half-baked idea and expect to make it through the IRB process. In our case, at the start, we had a general idea of what the project involved, but few specifics. Fortunately, we had the benefit of assistance in crafting the instruments we needed from UIUC’s Center of Innovation of Teaching and Learning (CITL) – a campus group that uses leading pedagogical approaches, research-based methodologies, innovative instructional technologies and comprehensive assessment practices to strengthen teaching efforts and improve student learning outcomes.
Advice for Assembling the Application
- If there is more than one person on the research team, the IRB application is a team effort. While one person will probably be responsible for actually writing the application, he or she will require information from everyone on the team to ensure the application is both complete and accurately reflects what the research team intends to do.
- Know who the team members are. On a superficial level, this is important because every person whose name is on the application must complete required training. On a deeper level, it is important because, like any research project, everyone needs to pull their weight.
- Set clear expectations for team members. In our research team, we can divide the research team roughly into instructors, data analysis, data collection, tool development and support (myself and a graduate student, who know a little bit about everything and try to keep things running smoothly). This is useful for the IRB application because the person putting together the application knows exactly who to contact when seeking information about how student grades will be collected or how specific online tools will work.
- Have all research team members meet regularly in person if possible. Some things can be handled through individual or group emails, but it is often easier to really nail down misconceptions and questions about a research project in person. For example, early in the application process we spent a few meetings clearing up what, exactly, our hypothesis was and the best way to test that hypothesis. This also makes it easier to ensure everyone knows what their responsibilities are and is meeting them. If possible, appoint a project manager who keeps track of what everyone is doing.
Brief description of our project
Specific IRB Concerns for our project
One of the primary concerns of the IRB for any research project is ensuring that informed consent is given for the research project. Information how the UIUC IRB describes informed consent can be found here: http://oprs.research.illinois.edu/?q=informed-consent/ElementsOfInformedConsent.html. “Informed consent” has several aspects.
One of these aspects is “voluntariness”. Students must have the option to participate or not participate in the proposed study or exercise and be explicitly informed of that option. For our project, we have an informed consent form for student personal and academic information, so we can gauge the effect of the new course sequence and an informed consent form for the genotyping exercise. Students can choose to participate in both, neither or only one of the two.
Another aspect that had to be addressed was the potential for coercion of students. Students may want to not participate, but feel that they must out of fear of retribution from the people running the study, particularly if the people running the study are teaching the course. To address this, no instructors or teaching assistants can know who is or is not participating in the study. In our case, the data analysis and support members know because they need to in order to fulfill their responsibilities, but since they have no power over student grades there is no risk of coercion.
Confidentiality of student genetic information was another aspect of informed consent. Students are instructed to download their genetic information only to their secure computers. No member of the research team will ever have access to student genetic information. All exercises in the course that utilize genetic information that students submit for the course will use publicly available genetic information. We briefly considered having students store their genetic information on secure university servers to make certain exercises easier, but decided not to because it created a potential location for a data breach, which made the university IT and legal departments a little wary. We are developing online tools that can take that genetic data and analyze it, but no genetic data will leave the students’ computers, and all work is done locally on the students’ computers.
Confidentiality of student academic information was another concern. Student academic information should be disseminated only in aggregate and without markers that could be used to identify students.
The final portion of the informed consent was disclosure of risks. One unique problem due to our use of student genetic information was the risk of students potentially learning things about themselves that would cause distress (parentage, carrier status*, etc.) This had to be addressed not only in the risk/benefits section of the IRB application, but also in the informed consent form. Students must be fully informed of the potential risks of being genotyped. Instead of starting from scratch, we used 23andMe’s description of risks as a template and added things on to it.
No matter how thorough your initial submission, it is likely there will be revisions to make to your application based on feedback from your pre-reviewer (if you have one) and the IRB. I cannot stress enough the importance of building a good relationship with the IRB. The IRB is not the enemy. It is their job to ensure you are performing your research ethically and, in the case of an education project, with the students’ best interests at heart. Take their advice seriously, because they have no obligation to approve your project. In our case, I kept regular contact with our pre-reviewer, who was immensely valuable in providing advice and clarifications on how to best meet the IRB’s needs. The scrutiny was also valuable to us as researchers, because it helped to ensure we knew exactly how we are going to conduct our experiment and validate our data.
Once the application is accepted, you are free to begin work. Of course, as you proceed further you may find that you wish to change certain aspects of your project. For example, you may wish to change a survey question or alter the protocol in some way. These changes must be approved by the IRB. In our case, some changes, such as fixing typos, did not require a formal process. However, major changes, such as changes to informed consent forms, did require the submission of a research amendment form and subsequent IRB approval. The UIUC IRB’s research amendment form can be found here: http://oprs.research.illinois.edu/?q=forms-and-instructions/research-amendments.html. There is nothing wrong with making changes to your project, but remember that you cannot make changes without getting IRB approval, and all changes must be approved before being implemented.
Obtaining IRB approval can be a long process, but it does not need to be a hard one, so long as you have rigorously thought out and critiqued your research proposal. In my experience, interactions with the IRB were very pleasant and helpful. Most of the trouble with the application had to do with receiving necessary information from research team members, so I strongly recommend regular meetings to keep everyone on track.
Research-Teaching Postdoctoral Fellow
University of Illinois Urbana-Champaign
For more information regarding this research project, please contact Jeffrey Moore, firstname.lastname@example.org