Which of the Following Studies Need IRB Approval?
Under the U.S. Department of Health and Human Services (HHS) regulations, any research project involving human subjects must be reviewed and approved by an institutional review board (IRB) prior to the study or any interactions/interventions with the subjects. This is to ensure the safety and well-being of the participants in the study, as well as to maintain the ethical standards of the research.
The IRB determines if the proposed research meets the criteria for approval based on considerations such as scientific merit, risks to human subjects, expected benefits, and general ethical principles. All research projects that involve human subjects must be approved by the IRB before any data collection or experimentation begins. This includes any “live” research that involves actual human individuals or their private information such as medical records.
The following types of studies typically require IRB approval:
- Medical research studies. These may include clinical trials, epidemiological studies, or other kinds of medical research projects.
- Behavioral studies. Any study that involves research into human behavior, such as psychology studies or studies on education.
- Survey studies. These include studies that use interviews, questionnaires, or other survey methods to collect data from human participants.
- Biomedical research studies. These include studies that use biological specimens or data collected from human subjects.
- Social science studies. These include studies that research social phenomena, such as sociology studies or studies on crime.
- Research involving vulnerable populations. This includes studies that involve participants who are pregnant, institutionalized, or have limited mental or physical abilities.
It is important to note that research projects involving student volunteers may also require IRB approval, depending on the specifics of the study and the age of the participants. Additionally, certain types of research may be exempt from IRB approval, such as research done using existing data/specimens that do not involve any additional data collection.
In summary, any research project involving human participants must be reviewed and approved by an IRB before the study can begin. The IRB will determine if the proposed research meets the criteria for approval based on considerations such as scientific merit, risk to participants, expected benefits, and ethical principles. In general, research studies that involve medical topics, behavioral topics, surveys, biomedical topics, social science topics, and research involving vulnerable populations typically require IRB approval.