A project requires IRB submission if it involves human subjects and constitutes research.

Required Components for IRB Submission

To determine if IRB submission is needed, one should look for these two essential components:

1. Human Subjects: This is defined as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains, uses, studies, or analyzes identifiable private information. Examples include surveys, interviews, or the use of existing medical records with identifying information.
2. Research: This is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This means the intent is to share the findings beyond the immediate context of the project, such as through publication, presentation at a conference, or inclusion in a thesis or dissertation.

If a project involves both of these components, it requires IRB review. Projects that are for internal quality improvement or that do not involve the collection of identifiable information may be exempt, but this determination is made by the IRB, not the researcher.

Example of a Study Requiring IRB Approval

In the article titled “The Lived Experience of Nurses Caring for Patients with a Substance Use Disorder,” a qualitative study by C. B. H. M. van Boekel et al. published in Substance Abuse Treatment, Prevention, and Policy, the research needed IRB approval because it met both criteria:

• Human Subjects: The study conducted in-depth, semi-structured interviews with 18 nurses, which involved direct interaction and the collection of private, identifiable information about their experiences and feelings.
• Research: The project was a systematic investigation designed to develop generalizable knowledge about the lived experiences of a specific population of healthcare workers. The goal was to publish the findings to help other nurses and healthcare professionals better understand and address the challenges of caring for this patient group.

IRB approval was needed to ensure the protection of the human subjects involved. The IRB would review the study’s protocol to ensure the nurses’ privacy was protected, their participation was voluntary, and the potential benefits of the research outweighed any risks. For this specific study, the IRB would have been concerned with how the researchers would handle potentially sensitive information shared during the interviews and how they would ensure the confidentiality of the participants.