Research conducted in a school or classroom does not automatically qualify for exempt IRB review. While certain educational research may qualify under Exempt Category 1, the research must meet specific criteria. The fact that a study involves students, teachers, schools, or educational activities is not enough on its own. Understanding what Category 1 covers can
Surveys, interviews, questionnaires, and observational research are common methods for collecting information in social and behavioral research. Because these activities may appear straightforward or involve minimal risk, researchers sometimes assume that they automatically qualify for exempt research. However, that is not always the case. Certain research involving educational tests, survey procedures, interview procedures, and the
Exempt Category 2: Surveys, Interviews, and Educational Tests Read Post »
Secondary research is common across many areas of human subjects research. Researchers may use existing medical records, survey responses, databases, educational records, registries, or other previously collected information to answer new research questions. Because the information already exists, researchers sometimes assume that secondary research does not require IRB review. However, that is not always the
Exempt Category 4: Understanding Secondary Research Read Post »
Surveys and questionnaires are common tools in human subjects research. They can be used to collect information about attitudes, behaviors, experiences, opinions, health, demographics, and many other topics. Surveys may seem relatively simple compared with other research procedures, but the IRB still needs to see their full contents. The questions participants are asked—and how those
When researchers think about IRB review, they often think about the research protocol and informed consent form. But what happens before a potential participant ever reaches the consent process? How someone learns about a study, what they are told about it, and how they are invited to participate are also important parts of human subjects
Why the IRB Needs to See Your Recruitment Materials Read Post »
Receiving comments or revision requests from an Institutional Review Board (IRB) is a normal part of the research review process. For researchers, however, an IRB revision request can sometimes feel overwhelming—especially when several changes are requested or when the reasoning behind a comment is not immediately clear. Understanding how to respond effectively to reviewer comments
One of the most important parts of any research study isn’t the protocol, data collection plan, or statistical analysis—it’s the information participants receive. Whether you’re creating an informed consent form, recruitment flyer, survey instructions, or follow-up communications, your study materials should be written with the participant in mind. Clear, participant-friendly study materials help individuals make
Research depends on trust. Participants trust researchers to conduct studies ethically, institutions trust investigators to follow regulations, and the public trusts that scientific findings are based on objective evidence. One important way to maintain that trust is by identifying and managing conflicts of interest (COIs). A conflict of interest does not automatically mean that a
Everyone deserves time away from work, including Principal Investigators (PIs). However, research studies don’t always pause when a PI goes on vacation. Participant questions, reportable events, regulatory deadlines, and study activities can continue even when the lead investigator is out of the office. Proper planning before taking time off can help ensure that research activities
Research involving the Department of Defense (DoD), veterans, active-duty military personnel, or members of the armed forces comes with unique ethical and regulatory considerations. Whether a study involves clinical research, behavioral surveys, retrospective chart reviews, or device testing, investigators must ensure their research complies with federal regulations and additional DoD-specific requirements designed to protect military
Department of Defense Research and IRB Review: What Researchers Should Know Read Post »
