Ethical Considerations of Quality Improvement and Human Subjects Research: Is There a Slippery Slope?

The question of consent presents certain ethical and legal concerns for subjects, investigators, publishers, and end-users of research. In this context, consent in a broad sense is the process that allows a human subject to make decisions with respect to participation in an investigational study. The decision may impact a subject emotionally, physically, or both. As bariatric nursing emerges as an evidenced-based science, nurses have been increasingly active in building this body of evidence. However, distinctions between quality improvement (QI) measures and human subjects research (HSR) can be confusing. Regardless, the underlying theme seeks to recognize the universal requirement to protect subjects from harm. This article examines issues pertaining to consent and a special and vulnerable population. Further, strategies to differentiate between the two categories of investigation are described. Specific examples of QI opportunities are included.