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Faculty research is a time-consuming endeavor — even in the planning stages. Researchers have to invest hundreds of hours in finding good ideas, vetting them for originality, researching funding programs, writing proposals and hiring research assistants. And for any study that involves human subjects, researchers have one more to-do: Submitting their project to be reviewed by someone from one of two main Institutional Review Boards at U-M — or possibly the entire board if the work involves tricky ethical issues. Elizabeth Molina, the U-M research compliance specialist with the IRB Health Sciences and Behavioral Sciences who handles all initial IRB review applications coming from faculty, postdocs and student researchers at ���ϸ�����-Dearborn, says IRB reviews involve carefully evaluating all aspects of a proposed research project. The goal is to make sure the methodology complies with federal and state regulations, ethical principles and U-M specific policies designed to protect the rights and welfare of human participants involved in research conducted by faculty, staff and students on U-M’s three campuses. An IRB will then give the researcher a green light or a rejection, or request changes to their project to bring it into compliance. Notably, an IRB always has a diverse mix of people, including non-scientists and community members, so that complicated issues can be evaluated from a variety of perspectives. Sometimes, if a study is reviewed by the full board, researchers and study teams are invited to the review sessions so they can work through tricky issues as a group.

In practice, Molina says her work with the IRB involves navigating a lot of nuances with consent and privacy issues. Sometimes, a review might be super quick. “The first thing we actually look for is if the work involves something that the IRB needs to review,” Molina says. “For example, if a faculty member wants to survey students in their class solely to inform their own teaching practice and not to generalize or disseminate the findings beyond their classroom, then IRB approval is not required,” Molina says. But if the faculty member envisions they might use the results down the road in a research project, then Molina would work with them to make sure they’re, say, obtaining consent in a way that complies with regulations. Depending on what a research survey is about, a review could get more or less involved. A survey asking people about what method they use to heat their homes would require a lower level of review. But if a researcher is asking people about a more sensitive subject, like their personal participation in illegal activity, then the methodology for collecting responses and how the researchers manage and present the data would have to be more carefully thought out. The goal is to ensure that nothing compromises a participant’s anonymity or inadvertently creates adverse consequences for the person.

Nuance is baked into Molina’s work. After all, it’s the nature of research to investigate novel territory, and tricky test cases are essentially how the boundaries of ethical systems get defined and refined. Moreover, while some IRB rules, like those regarding children in medical studies, are more specific, Molina says many regulations are intentionally broad and open to interpretation so they can be inclusive of a wide variety of cases. For straightforward projects, Molina can conduct a regulatory and administrative review of the application herself and communicate with the researcher or study team if she needs any additional information. If the research is “exempt,” meaning it’s research that presents minimal risk to participants and falls under specific exemption categories defined by regulations, then she can issue the approval once any issues are resolved. If a study does not meet any of the exemption categories, she refers it to another reviewer, typically an expert in the subject matter, who assesses the risk and can issue an approval. However, if the study presents more than minimal risk or there is a complicated ethical question, Molina will bring it to the IRB staff for discussion to confirm that it should go to the full board for review. The full board typically discusses three to five studies a month. Only the full board can issue a disapproval, which Molina says is rare.

There are all kinds of tricky situations, especially regarding consent. For example, Molina says if researchers want to observe people without their knowledge, or not tell a participant everything up front, the IRB would review the proposal carefully. In some cases, the IRB can approve a waiver or alteration of informed consent, but only if the study poses no more than minimal risk, doesn’t affect participants’ rights or welfare, and couldn’t be done otherwise. When possible, participants are debriefed afterward and given the option to withdraw their data once they know the full details of the study. However, Molina says there are rare cases where debriefing might actually cause more harm than good. “For example, if someone was included in a study for an embarrassing reason, or finds out they were part of a study without knowing, it could cause distress, lead to mistrust in the research process or the researchers, and discourage future participation,” she says. Moreover, if the research involves children or teenagers, the study team has to obtain consent from both the parents and the kid (referred to in the later case as “assent”). “But there may be circumstances where it would be risky to obtain parental consent,” Molina says. “Let’s say you wanted to talk with teenagers about their sexual orientation. Asking the parents if the child could participate in the research might be risky for that teenager. In situations like that, the researcher could request a waiver of parental permission, because the benefits of doing so could outweigh the risks.”

The gray areas and subtleties are essentially limitless. If a study involves observing people in a public space, that might not require consent, because people don’t have the same expectations of privacy. But if the setting were a semi-public space, like a workplace, that’s going to require a higher level of IRB review. “Or let’s say you’re recruiting participants in a public space, but you’re recruiting for an HPV study. Are participants going to feel comfortable coming to you, and are you taking steps to protect their privacy?” Molina says. Because there are so many nuances, Molina encourages researchers to reach out to talk through any questions they have before submitting their projects to the IRB for an official review. She also conducts monthly IRB “On-the-Road” sessions, where researchers can connect with her on Zoom to talk through issues, or even ask questions about the admittedly not-the-most-user-friendly eResearch software researchers use to submit their projects for review. “People often don’t know what they need to provide us, or what a particular question is asking, or the level of detail we need to provide an evaluation of risk,” she says. “Or, for approved standard studies, they might not know that if they change something on their flyer or their consent form, even something that seems small, like changing your phone number or adding a QR code, that requires an amendment. So a conversation clarifies that. That’s one reason I do the On-the-Road sessions. That way, people can meet me and see that I’m not intimidating. I’m not the police. You can tell me about your challenges and we can try to figure them out together.”

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Want to learn more about what the IRB does and its review process? Check out the . Have questions for Molina about an upcoming project? Faculty and students can reach out directly at [email protected] or attend an upcoming IRB On-the-Road session.