The Authors' Reply
Dr Wise raises a practical issue associated with a rigorous quality improvement (QI) program and describes their organizational or system criteria to help guide staff in determining if a protocol should be submitted for Institutional Review Board (IRB) review and approval. Integrated or networked healthcare organizations often have centralized QI initiatives. Sharing results and lessons learned within system hospitals would be an appropriate use of QI data with the intent to improve care in system facilities. If the intent is to generalize knowledge beyond the clinical, organizational, or system setting, then it is research.
The additional hospital-specific criteria described help to differentiate between QI and research and are consistent with our thinking. Our organization provides a Web-available algorithm for staff to complete to determine if their project is QI or research (https://e-irb.jhmi.edu/eIRB). The only criteria that would need some clarification is subject recruitment. In QI, we do not consider patients or nurses to be subjects, but they are still invited to answer surveys or questions about their experience with our care. There is no formal written or oral consent, but we may inform them about why we are collecting the data and how it will be used. It would be expected that their responses would be handled in a way that processes can be improved, and they would not be exposed to additional risks. By subject recruitment in research, there is usually a detailed plan for how subjects will be screened and recruited, who will approach them to invite them to participate, and details on the consent process.
We also understand Dr Wise's concerns regarding increasing the burden on staff and the IRB when the intent of the project or publication is to generalize results. In addition, many community hospital do not receive federal funding for research, and may or may not have an assurance with the Office of Human Research Protection. Our institution has decided to apply the federal regulations to all projects that fall within the regulatory definition of "human subject research," and reviews all those projects under the same standards. The law in our state, Maryland, also requires that all studies conducted here, whether or not they receive public funding, comply with the federal human subjects regulations. Other institutions in states which do not have these requirements, and which may not be as focused on federally funded or commercially sponsored research, may not adapt the same standards. However, when the intent of the protocol or project is research, the burden on the staff or IRB in reviewing additional protocols is not ethically compelling when weighed against the subjects' rights to respect, beneficence, and justice. Conducting research using human subjects is not a "right" of the healthcare practitioner.
Robin P. Newhouse, PhD, RN, CNA, CNOR
Joan C. Pettit, JD, MA, CIP
Stephanie Poe, MScN, RN
Laura Rocco, MS, RN