1. Davies, Claire C. PT, PhD
  2. Monroe, Martha PhD, RN
  3. Beckman, Dee DNP, MBA, MSN, RN, NE-BC
  4. Brockopp, Dorothy PhD, MSN, RN, FAAN

Article Content

As research consultants (RCs) at a 434 bed Magnet(R) hospital we face a new set of challenges. In this role we assist employees to develop research questions, design studies, create data analysis plans, assist with IRB applications, and work with investigators to publish findings. Some employees conduct research within their professional role; many are in graduate programs that require completion of a project. For example, at present, approximately 174 nurses are pursuing additional degrees at this facility. This pursuit of education has led in part to nurses at our institution becoming authors or co-authors of 85 publications of study findings in peer reviewed journals over a period of 14 years.


Four challenges RCs have faced to date are related to requirements of graduate nursing programs. First, some students are asked to submit a proposal through an IRB "for the experience" however, they will not conduct the study. This approach results in use of IRB resources without a meaningful outcome. In addition to lack of a meaningful outcome, increasingly, IRBs at hospitals and other organizations charge students a considerable amount of money to approve a study. This practice is a disadvantage for students, particularly if they do not have a positive outcome related to their work.


Another challenge is related to faculty members' acceptance of projects that involve small sample sizes (N < 10). The rationale provided is that students will have the "experience" of conducting a project. While that experience can be important to the student, available resources can be an issue with this approach.


A third challenge that once more relates to use of resources as well as the value of graduate students educational experience, is the increasing requirement by graduate programs in nursing to provide proof of submission of a manuscript that describes their project prior to graduation.1 Student/ employees at this institution have presented manuscripts to RCs that clearly will not be published. Rationale for RCs decisions' include, small sample size, poor organization of written material, data analysis unclear and presentation of findings questionable. In addition to a misuse of hospital resources, editors and reviewers of journals are spending time on unpublishable documents.


Lastly, faculty advisors in some graduate nursing programs inform students that their projects fall within the category of quality improvement (QI) and therefore do not need IRB. According to federal regulations many of these projects do meet the criteria for IRB approval. This issue is related to a conflict that is increasingly apparent across the country in hospitals and graduate programs. In 2006, a Hastings Center Report2 described the problem healthcare was facing related to a lack of clarity between research and QI regarding human subject's protection. Today hospitals across the country are developing processes and criteria in an attempt to differentiate these two approaches to improving patient care.


The goal of QI has traditionally been to resolve patient care problems at a given institution and not disseminate findings across populations.3 When defined as "systematic, data-guided activities designed to bring about immediate improvements in health delivery in a particular setting,"4 protection of human subjects was not a major issue. Given increasing presentations and publications of QI findings, concerns regarding participants' rights have grown and differentiation between QI and research is frequently unclear.


Research is a process of systematic inquiry that entails collection of data; documentation of critical information; and analysis and interpretation of that data/information, in accordance with suitable methodologies set by specific professional fields and academic disciplines.5 Protection of human subjects is essential. IRB approval is required.


Within the past two years, five students (hospital employees) from three programs in two states have been guided to consider their projects QI when IRB consultants at this institution have required IRB approval for students to move forward. This requirement protects our staff by ensuring projects are conducted in an ethical manner and manuscripts resulting from projects can be published. Most conferences and journals require confirmation of IRB approval. Confusion resulting from these situations causes students a great deal of anxiety, and stress and may force them to spend an extra semester in school.


In conclusion, hospitals that support nurses returning to school need to be aware of potential problems in terms of resource use and protecting human subjects. A strategy under development at this hospital involves the identification of a process students must follow in order to complete a project at this institution as well as clear criteria that will enable them to differentiate QI from research.




1. Fulton JS. Faulty Responsibilities with Publishing Students Work. Clinical Nurse Specialist. 2018;32(1):5-6. [Context Link]


2. Jennings B, Baily MA, Bottrell M, Lynn J. Health Care Quality Improvement: Ethical and Regulatory Issue. Hastings Report. 2006;36(3). Accessed June 1, 2021. [Context Link]


3. Health Resources and Service Administration (2017), Brockopp DY, Hill KS, Bugajski AA, Lengerich AJ, eds. In: Establishing a Research-Friendly Environment: a Hospital-Based Approach. Vol. 16. 1st ed. Burlington, MA: Jones & Bartlett Learning; 2020. [Context Link]


4. Children's Hospital of Philadelphia Institutional Review Board. Quality Improvement vs Research. Accessed June 1, 2021. [Context Link]


5. Hampshire College Institutional Review Board. What is Research? Accessed June 29, 2021. [Context Link]