Before this question is answered, it is essential to understand how research ethics have evolved. While research has occurred throughout history, research inquiry truly began in the 18th and 19th centuries. However, fraud and abuse were common and unregulated. One marker in research ethics was the Nuremberg Code, which resulted from unethical research on human subjects during the Nazi regime in World War II. The Nuremberg Code lists rules that include voluntary consent, the benefits of research outweighing risks, participant autonomy in terminating participation at any time, and the fact that any research conducted must have scientific merit. Another important marker in research ethics history was the Tuskegee Syphilis Study that occurred between 1932 to 1972. The U.S. Public Health Service conducted a research study in which hundreds of low-income African American males who were infected with syphilis were monitored for 40 years but were not made aware of their disease. Even though there was a proven cure, penicillin, which became available in the 1950s, the study continued until 1972 with participants being denied treatment so physicians could better understand how syphilis affected the human body. The study was only stopped in 1973 after its existence was publicized. Because of the fallout from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed. This act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission identified basic ethical principles that are the foundation for conduct involving human subjects: respect for persons, beneficence, and justice (Barlow, 2020). The National Research Act of 1974 also established the Institutional Review Board (IRB).

Ultimately, the IRB is responsible for ensuring that the rights and safety of human subjects are protected and that all research is conducted ethically and in compliance with federal and institutional regulations and guidelines (Eldridge, 2017). IRB membership is diverse, with members having different backgrounds and perspectives. Members must include the perspective of both a scientist and a nonscientist and include an individual with no affiliation to the research institution (Office for Human Research Protections, 2021). Together, the group must be qualified to review the institution's research activities. For healthcare organizations, any project or study involving human subjects must be reviewed through an institutional review process and this will typically involve the IRB.

It is often easy for nurses to say, “Oh, this is just a quality improvement project,” or “This is just an evidence-based practice project, so it does not need to go through the full IRB review process.” However, this decision can only be made by the IRB and not by the researcher or project lead (Eldridge, 2017, Oermann, 2021; Bass & Maloy, 2020). The IRB provides an independent review of proposed studies and makes the decision if the study is exempt from review, appropriate for expedited review, or requires full and complete review (Eldridge, 2017). The decision of whether a study is exempt is not based on the project type, but rather, on the level of risk to the human subjects in the study (Eldridge, 2017). The level of risk can range from loss of confidentiality all the way to participant harm. One often-seen example is a project involving chart reviews. Depending on the volume and type of data collected, there may be a high risk of loss of confidentiality, and this may require the project to undergo full IRB review and approval. Furthermore, it is possible for a quality improvement project or evidence-based practice change to interact with human subjects research. Examples of this may include:

• Randomizing units to use three different interventions to see which one improves antibiotic turnaround time, but the project leads do not know which intervention is best;
• A novel educational program is implemented to improve nurse competency and after several courses demonstrate success, the lead wants to share generalizable results externally;
• Implementing a practice change that has not been studied on a particular patient population on one unit, performing chart reviews and collecting patient medical record numbers (MRNs), and comparing patient outcomes to a unit that is not implementing the practice change.

Another important factor to consider is the definition of “human subjects,” as this often carries the connotation that this refers solely to projects that involve patients. The Office for Human Research Protections, in 45 CFR §46.102 defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimen through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens,” (Office for Human Research Protections, 2019). Human subjects include not just patients, but also other nurses, patient care assistants, ancillary staff, leaders, and essentially all interprofessional team members. It is important for nurses to understand that patients and colleagues are all still considered human subjects and must be afforded the rights and protection of participating in any clinical inquiry work. This further highlights the importance of nurses taking the appropriate steps to ensure any clinical inquiry and nursing science projects are appropriately reviewed and approved.