If you are planning an assessment or research project in the Library, one important step is to consider whether your project needs to be vetted by the Institutional Review Board (IRB) at the University of Michigan. IRBs are committees that exist at most universities and other research-focused institutions (e.g., hospitals), and their goals are to ensure that studies with human subjects are ethical, that subjects are protected from unnecessary psychological or physical risks or harms, and that subjects are participating in a fully informed and voluntary manner. IRBs were established in the United States after research practices infused with bias and/or harm were exposed, such as the Tuskegee syphilis study and Stanley Milgram’s important but ethically-problematic research on obedience.
IRBs consist of at least five individuals that are qualified to evaluate various types of research activities (typically faculty members). Research institutions must make efforts to assemble IRBs that are demographically diverse because these groups will consider concerns specific to vulnerable populations (e.g. children, prisoners, pregnant women, people with disabilities, etc.). Further, IRBs must include at least one person who is not connected with the research institution, and who does not have a conflict of interest (such as a relative who works at the institution).
IRBs have the power to approve, reject, and actively monitor research involving humans. Here at the University of Michigan, Ann Arbor, we have two IRBs: one for the Health Sciences and Behavioral Sciences (HSBS), and one for the medical school and hospitals, Michigan Medicine (IRBMED). The focus of this blog post will be HSBS.
Many people who engage in assessment activities in the U-M Library work with human participants in one way or another (e.g., survey research, interviews, focus groups, wayfinding studies, UX research, instruction assessment). Questions often arise about when one needs to go through the U-M IRB to get approval for a data collection effort.
‘Not Regulated’ Assessment: When You Don’t Need an IRB Application at All
If your project involves data collection with human subjects and the only goal is to use the data to inform/improve internal practices, then you do not need to submit any type of IRB application (not even an application for exemption). This is a category of data collection referred to as ‘not regulated.’ The IRB only reviews activity that has a ‘research aim.’ Internally-focused assessment does not have a research aim, as defined by the IRB. *
Importantly, taking this approach -- i.e., no IRB application -- means that you have no plans to present or publish the data you collect. If you plan from the outset to present or publish your data, you must submit an IRB application. When submitting an IRB application, there are conditions under which you may be able to submit a quick application for ‘exemption’ (described below). If you are conducting internally-focused data collection without a research aim (i.e., without an IRB application) and you later decide to present or publish those existing data, you must submit an IRB application for the ‘secondary use’ of those data.
Even if you’re asking sensitive questions, you don’t need to go through the IRB if you don’t have a research goal. But if you have any questions about IRB requirements or human subjects protections, please consult with the library assessment specialist or the HSBS IRB about your library assessment projects in order to discuss research aims and to mitigate risks to assessment participants.
Creating an IRB Application with a Self-Generated Exemption
The HSBS IRB has created a self-determination option for people conducting research activity that is characterized by some of the following:
- poses no more than minimal risk
- does not involve vulnerable populations (e.g., prisoners, children, pregnant women)
- does not involve deception
- does not involve access to student education records under FERPA
Using this option, when appropriate, can allow a principal investigator (PI) to quickly move ahead with an exempted research project.
In the self-determination process, the question flow in the eResearch application system uses the truthful responses of the PI to ascertain whether the research project meets criteria for exemption. If these criteria are met, the PI can then use the eResearch system to generate an exemption determination letter. Importantly, the self-exemption option will not be available unless the PI has an active PEERRS human subjects certification.
The IRB staff members do review self-determinations to ensure that the PI has properly arrived at the exemption status for their research activity. If a PI prefers to have the IRB make a decision about whether exemption is appropriate for a research project, the PI can submit the study for IRB review using the eResearch system, instead of choosing the self-determination pathway.
If Your Study is Exempt
The HSBS IRB does not require continuing reviews of exempt studies, and amendments are not required as long as the research does not breach the boundaries of what made it exempt in the first place. In other words, you don’t need to submit an amendment for an exempt study simply for things like adding new study team members, formatting changes to surveys or documents, or transferring data collection instruments (e.g., surveys) to new software/web-based platforms.
If you have an exempt study, the IRB also does not review the study’s informed consent process. However, the IRB still encourages PIs to embed a consent process in the study, so that study participants can make informed decisions regarding participation. The University provides examples of language that can be used when obtaining informed consent.
When a study is not regulated or exempted by the IRB, the investigator still has obligations to protect human subjects. All people involved in Library assessment activities should learn about and adhere to key human subjects protections guidelines laid out in the PEERRS training.
If Your Study Is Neither Not Regulated nor Exempt
In some cases, data collection activity in the library will involve human subjects, will have a research aim, and will not qualify for exemption (e.g., it may involve more than minimal risk, it may involve a vulnerable population). In this case, a full IRB application will be needed. You can consult with the library assessment specialist if you need help with this longer type of application and IRB review process, or would like to see examples of previous IRB applications.
If you have questions after reading this, or want help with things like creating consent documents or IRB applications, please feel free to reach out to the library assessment specialist (Craig Smith: firstname.lastname@example.org). There are also many resources available online, such as a decision tree for determining exempt status,** a wide range of information, guides, tips, and templates from the HSBS IRB, and information about the eResearch system used for submitting IRB applications (you can log in at the top of this page to access your own eResearch dashboard).
* Under HHS Regulations (46.102) research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” In other words, research activity involves a goal of publishing or presenting data in order to advance knowledge in a field or discipline. If there is any element of research in an activity, that activity should undergo review for the protection of human subjects.
** PHI in this decision tree means protected health information