Quality Improvement, Not Research, and Still Protected: The Ethics Review Submission for a Food Insecurity Screening Project
Student Name
Doctor of Nursing Practice Program, Aspen University
DNP880: DNP Project
Instructor Name
Month Day, Year
Quality Improvement, Not Research, and Still Protected: The Ethics Review Submission for a Food Insecurity Screening Project
Every DNP project that involves patients must pass through an ethics review, and the student must decide how to present it. This submission asks the university's institutional review board to determine that the Maple Street food insecurity screening and referral project is quality improvement, not human subjects research, and describes the protections the project will apply regardless of that determination: voluntary participation, privacy, minimal data, secure storage, and a pathway to help for every patient who screens positive.
Project Summary for Reviewers
Over 16 weeks, medical assistants at two clinics of a composite federally qualified health center will ask adults with type 2 diabetes two validated questions about food insecurity during rooming. Patients who answer affirmatively will be offered a same-visit meeting with a community health worker, who can complete an electronic referral to the regional food bank and will call two weeks later to confirm whether food was received. The DNP student will extract screening, referral, follow-up, visit length, and A1c data from the electronic record to evaluate the change using run charts. No experimental treatment is introduced, no patient is randomized, and no care is withheld.
Why the Project Is Quality Improvement
A working group convened by the Hastings Center characterized improvement work as systematic, driven by data, and aimed at prompt gains in how one organization delivers care, and argued that most of it falls outside human subjects research and belongs under the ordinary supervision of clinical practice rather than board review (Lynn et al., 2007). The project fits that definition on each characteristic the group described. Its purpose is to improve care at Maple Street, not to produce generalizable knowledge. The intervention, screening and referral, reflects recommended practice rather than an unproven treatment. The changes are tested in iterative cycles and adjusted locally. The data are those the clinic would use to monitor its own performance. And the risks to patients are no greater than those of usual care.
The student intends to present results at a professional conference and in a DNP project repository. Dissemination alone does not convert quality improvement into research, but because institutions differ on this point, the student is requesting a formal determination rather than deciding the question alone. The student does not decide whether a project is research; the board does.
The Protections the Project Keeps
Even if the board determines the project is not research, the ethical requirements for work involving patients still apply. Emanuel et al. (2000) argued that consent alone does not make a study ethical and set out seven conditions; among them are that the work have value, that it be sound in method, that participants be chosen fairly, that its benefits outweigh its risks, and that the people involved be treated with respect, including protection of their privacy and freedom to withdraw. Several translate directly to this project. Its value is clear: it addresses an unmet need in a population with poor diabetes control. Its selection is fair: every adult with diabetes seen at the two clinics is offered screening, not only those judged likely to be poor. Its risk-benefit balance is favorable because the screen is brief and each positive result leads to an offer of help. And respect for patients is built in through privacy, the right to decline, and follow-up that stops if the patient asks.
Voluntary Participation and the Information Sheet
Because screening becomes part of routine care, the project will not collect signed consent, which the Hastings Center group judged unnecessary for minimal-risk improvement work integrated into usual care (Lynn et al., 2007). Patients will instead receive a one-page information sheet in English and Spanish, handed to them at check-in, that states:
The clinic is asking all patients with diabetes two questions about food, because food affects blood sugar. You can skip the questions, and skipping them will not change your care. If you tell us food has been hard to get, a community health worker can help you connect with the food bank today. Your answers go into your medical record like other health information and are protected the same way. A nursing student is studying how well this new process works, using information from records without your name.
Medical assistants will be trained to ask whether the patient is willing to answer before reading the questions, and to record a decline without comment.
Risks and How They Are Minimized
The main risks are emotional and social rather than physical. Some patients may feel embarrassed or judged when asked about food. The questions will be asked privately in the exam room, not at the front desk, and in a neutral tone practiced during training. A second risk is disclosure: a record of food insecurity could be seen by people the patient did not intend. The screen result will be stored in the social history section with the same protections as other health information, and the food bank referral will share only the name, contact information, and household size the patient approves. A third risk is harm from screening without a response, which the project prevents by pairing every positive screen with an offer of same-day help. Patients who are undocumented or worried about public benefits will be told that the food bank does not ask about immigration status and that its help is not a public benefit, a message confirmed with the food bank before launch.
Data Management
The student will extract data monthly through a report built by the center's informatics analyst. The extract will contain a study number, clinic, visit date, screening result, referral and follow-up status, visit length, and most recent A1c, with no name, date of birth, address, or record number. The key linking study numbers to record numbers will remain with the analyst on the center's secure server and will not be shared with the student. The de-identified file will be stored on the university's encrypted storage, accessed only by the student and the faculty advisor, and destroyed three years after the project ends, following the university's retention policy. Results will be reported only in aggregate, and any cell with fewer than 10 patients will be suppressed to prevent identification in small subgroups.
Site Approval and Conflicts of Interest
The submission includes the health center's letter of support signed by the medical director, confirming that the project aligns with the center's priorities and that the student may access data under the center's data use policy. The student is not employed by the health center and has no financial relationship with the food bank or any vendor. The site mentor is employed by the center, and her supervisory role in the clinic will be separated from the evaluation by having the student, not the mentor, extract and analyze data.
Reporting the Ethics Review
Whatever the board decides, the final project paper will state the determination, the date it was issued, and the protections used. The SQUIRE 2.0 reporting guidelines for improvement work ask authors to describe the ethical aspects of implementing and studying the intervention, including formal ethics review and any potential conflicts of interest (Ogrinc et al., 2016). Planning that description now keeps the ethical account consistent from submission to dissemination and signals to readers and journal editors that the question was taken seriously before any patient was asked about food.
Conclusion
This submission asks the board to determine that the food insecurity screening and referral project is quality improvement, based on its purpose, design, and risk, and describes protections the project will keep regardless: a plain-language information sheet with the right to decline, private screening, limited sharing, de-identified data with separated identifiers, suppression of small cells, and a guaranteed offer of help for every patient who screens positive.
References
Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701-2711. https://doi.org/10.1001/jama.283.20.2701
Lynn, J., Baily, M. A., Bottrell, M., Jennings, B., Levine, R. J., Davidoff, F., Casarett, D., Corrigan, J., Fox, E., Wynia, M. K., Agich, G. J., O'Kane, M., Speroff, T., Schyve, P., Batalden, P., Tunis, S., Berlinger, N., Cronenwett, L., Fitzmaurice, J. M., ... James, B. (2007). The ethics of using quality improvement methods in health care. Annals of Internal Medicine, 146(9), 666-673. https://doi.org/10.7326/0003-4819-146-9-200705010-00155
Ogrinc, G., Davies, L., Goodman, D., Batalden, P., Davidoff, F., & Stevens, D. (2016). SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality & Safety, 25(12), 986-992. https://doi.org/10.1136/bmjqs-2015-004411
How this DNP 880 Module 4 example is structured
DNP880 includes IRB-facing documents for the DNP project. Aspen does not publish module deliverables, so check your classroom and your university's review board forms for the exact requirements. This example summarizes the project for reviewers, argues its category from a published framework, lists the protections it keeps, supplies the information sheet and details risks and data management.
DNP880 Module 4 questions, answered
What does DNP880 Module 4 usually ask for?
This part of the DNP project course typically asks for the documents your review board needs: a project summary, the case for a quality improvement or research determination, consent or information materials, risks and protections and a data management plan. Aspen does not publish module deliverables, so your classroom's instructions govern.
Does a DNP quality improvement project need IRB review?
Many QI projects are not human subjects research, but the student should not decide that alone. Submit the project for a formal determination by the university's review board, which decides the category.
Does publishing a QI project make it research?
Plans to publish do not by themselves make a project research, but institutions treat this differently, which is another reason to request a formal determination early.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Aspen University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.