| Course | DNP 751 DNP Applied Project II (DNP/751) |
|---|---|
| Week | 7 |
| Paper type | Ethics section and determination request |
| Length | about 1,202 words, 4 double-spaced pages plus title page and references |
| Format | APA 7 student paper |
| School | University of Phoenix |
| Program | DNP |
| Updated | September 2026 |
Free sample paper for DNP 751 Week 7
Is This Research? A Quality Improvement Determination Request, Risk Assessment and Privacy Plan for a Diabetes Distress Screening Pilot
[Student Name]
University of Phoenix
DNP/751: DNP Applied Project II
Week 7 Assignment: Proposal Section 7 and Determination Request
[Instructor Name]
[Date]
The health center, staff and figures are composites written for a model paper.
The Question Before the Reviewers
Before the pilot can start, two bodies, one at the university and one at the health center, must decide whether it is human subjects research, which requires institutional review board approval, or quality improvement, which follows the health center's own review process. Federal guidance from the Office for Human Research Protections holds that quality improvement activities are not automatically research, that many improvement projects fall outside the human subjects regulations, and that some do not, depending on their design and purpose (U.S. Department of Health and Human Services, Office for Human Research Protections, n.d.). This paper gives the reviewers what they need to decide.
Applying Ethical Criteria for Quality Improvement
Lynn et al. (2007), in a report from a Hastings Center working group, treated quality improvement as a normal duty of health care organizations, one to be held to its own ethical requirements rather than to rules built for experiments. Their requirements can be applied to this pilot one at a time. Social value: the pilot addresses a gap between a national standard of diabetes care and practice at the site. Scientific validity: it uses validated tools and a design suited to its question. Fair participant selection: every eligible adult with type 2 diabetes is offered the screen, in English or Spanish. Favorable ratio of benefit to risk: the screen takes a minute and opens a route to help. Respect for participants: patients may decline, and results are used for their care. Informed participation: patients are told what the questions are for. Independent review: the determination request itself.
The same report identified features that raise the need for formal oversight: randomization, delayed feedback of results to clinicians, additional burden or risk beyond usual care, and use of data for purposes other than the patients' own care. This pilot has no randomization, feeds results to the clinician at the same visit, adds a minute of questions that national standards already recommend, and uses aggregate data for improvement reporting. On each criterion the pilot sits on the improvement side of the line, though the final judgment belongs to the reviewers, who may see features the project lead has missed.
Risks and Benefits
The risks to patients are mostly minimal: a few minutes of time, possible discomfort in rating feelings about diabetes, and the chance that a result is seen by someone the patient did not expect, such as a family member looking at the tablet. The medical assistant will hand over the tablet privately and step away. The main expected benefit is recognition of distress and a follow-up response matched to its source. Staff face added work and the possibility that their screening rates are visible to peers on the weekly charts; charts will show site totals only, never individual names.
The Serious Risk: Disclosure of Self-Harm
Asking about the burden of diabetes can prompt patients to reveal hopelessness or thoughts of self-harm. The site already uses the PHQ-9, and its ninth question screens for passive or active thoughts of death and self-injury; Kroenke et al. (2001) validated the nine questions against interviews by mental health professionals in primary care and obstetric clinics and showed that scores track the severity of depression. Safety protocol: any patient scoring 3.0 or more on the emotional burden subscale will complete the PHQ-9 that day if it has not been done; any response above "not at all" on item 9 will be reported to the clinician before the patient leaves; the clinician or behavioral health consultant will assess risk the same day and complete a safety plan under the site's crisis policy; and the care manager will call within 48 hours. The project lead will review every such event within one business day to confirm that the protocol was followed.
Privacy and Data Security
Scores are clinical data and will be stored in the electronic health record like any other screen. Project reports will use study numbers assigned by the quality coordinator, who alone holds the key linking numbers to records. Files will remain on the health center's secure drive, never on personal devices or email. Results will be reported in aggregate, and any count below 11 will be suppressed so that individuals in small subgroups cannot be identified.
Voluntariness and Consent
Patients may decline the screen or the full scale at any point without any effect on their care, and declines are recorded as such. Because the pilot uses routine care and existing records, the project does not plan written research consent; if the reviewers require it, a consent script and form are ready. Staff surveys are anonymous and optional.
Protections for Patients Who Prefer Spanish
Fourteen percent of the site's patients prefer Spanish, and a screening program offered well in English but poorly in Spanish would add an unfair burden and withhold a benefit. Both instruments will be used in the Spanish versions made available by their developers, reviewed by the health center's certified interpreters for local wording. Medical assistants who are not fluent will use the interpreter line to introduce the screen, and care manager follow-up will be conducted in Spanish or through an interpreter. Screening and follow-up rates will be reported by language so that any gap is visible.
Reporting Unexpected Events
Any unexpected event linked to the pilot, such as a complaint, a privacy concern or a missed safety step, will be recorded in the health center's incident system and reported to the medical director within one business day. The project lead will summarize all events for the quality committee at the end of each improvement cycle, and the committee may pause the pilot if an event suggests harm.
Data Retention
Project files will be kept on the secure drive for three years after the final report, in line with the health center's records policy, and then deleted by the quality coordinator. The linking key will be destroyed at the end of the analysis, leaving only de-identified data.
Conflicts of Interest and Dual Role
The project lead is a nurse practitioner employed at the site. To limit influence, the quality coordinator runs all data reports, the champion times rooming and observes fidelity, the lead will not screen patients from the lead's own panel during the pilot, and no one's performance review will draw on project data. There are no financial interests.
Determination Request
Project title: Distress Check and Response: Screening and Follow-Up for Diabetes Distress in Primary Care. Lead: DNP student and site nurse practitioner. Site: east side clinic. Summary: a 12-week quality improvement pilot adding a validated two-item distress screen at diabetes visits, a 17-item scale for positive screens and nurse care manager follow-up, evaluated with weekly process data, paired distress scores and anonymous staff surveys. Data: existing record fields reported with study numbers. Risks: minimal, with a safety protocol for disclosures of self-harm. Requested determination: quality improvement, not human subjects research.
Summary
The pilot meets the ethical requirements for quality improvement and carries one serious risk, managed by a written protocol. Privacy, consent and conflicts are addressed. The final section of the proposal draft follows next week.
References
Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x
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
U.S. Department of Health and Human Services, Office for Human Research Protections. (n.d.). Quality improvement activities FAQs. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html
What the DNP 751 Week 7 instructions ask
DNP 751 Week 7 typically asks students to prepare the ethical considerations section of the proposal and the materials for institutional review, which may be an institutional review board application or a request for a quality improvement or non-research determination, depending on the university and site. Prompts usually ask students to classify the project and justify the classification, identify risks and benefits for participants, describe protections for privacy and confidentiality, address consent, and disclose conflicts of interest. Many sections require the completed form or a draft of it. The section often runs four to six pages plus forms. Faculty expect a careful, specific treatment rather than a statement that the project poses no risk, and they check that the plan matches the methods already written.
How this DNP 751 Week 7 example is built
The paper opens with the question the reviewers must answer and summarizes the federal view that quality improvement activities are not automatically research, but some are. It then applies the ethical requirements for quality improvement described in the Hastings Center report, one by one, to this pilot, showing why it falls on the improvement side of the line. A risk assessment follows, separating minimal risks, such as time and discomfort in answering, from the rare but serious risk of uncovering suicidal thoughts, which gets a written safety protocol tied to the PHQ-9. Privacy, data security, voluntariness, staff protections and a disclosure of the project lead's dual role follow. The determination request closes the paper, written in the committee's format with a one-paragraph summary.
DNP 751 Week 7 grading rubric: where the points go
Rubrics for the ethics section generally give most points to the accuracy of the classification and the quality of its justification, with reference to regulations, guidance or accepted criteria. Faculty also look for a thorough, honest risk assessment, specific protections for privacy and data, attention to voluntariness and vulnerable groups, and disclosure of conflicts of interest. Completion of the required form, or a faithful draft of it, is often scored. Alignment with the methods and data plan counts, since reviewers compare them. APA format and professional tone make up the rest. Sections that simply assert that a project is exempt, or that list risks without responses, tend to be returned for revision before DNP 752 can begin.
DNP 751 Week 7 help: mistakes to avoid
A common mistake in DNP 751 Week 7 is deciding the classification yourself and writing that the project is exempt. Only the designated review body can make that call; your job is to give it what it needs. Another is overlooking the risks your intervention creates, such as distress screening prompting disclosures that need an immediate response. Write the protocol, including who responds and how fast. Students also describe privacy in general terms; say where data are stored, who holds the key and how small counts are protected. Disclose any dual role honestly and show how you will limit its influence. Finally, check that every detail in the request matches the methods section, since reviewers notice when sample sizes or data elements differ.
Related DNP 751 sample papers
Other DNP 751 week samples
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- DNP 751 Week 2: Literature Review Synthesis
- DNP 751 Week 3: Theoretical Framework Chapter
- DNP 751 Week 4: Methodology and Project Design
- DNP 751 Week 5: Implementation Plan and Timeline
- DNP 751 Week 6: Evaluation and Analysis Plan
- DNP 751 Week 8: Complete Proposal Draft
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DNP 751 Week 7 questions, answered
What does DNP/751 Week 7 usually ask for?
Many sections ask students to prepare the ethics section of the DNP applied project proposal and the IRB application or quality improvement determination request, with risks, protections, consent and conflicts of interest.
Where can I find a free DNP 751 Week 7 sample paper?
The ethics section and determination request above make up the free Week 7 sample, complete and annotated. For a version tailored to your project and review body, request a first custom sample free.
Who decides if a DNP project is research or quality improvement?
The university's institutional review board or its designee, and often the site's own review body, make the determination; the student prepares the request and supporting documents.
Does a quality improvement project need patient consent?
Many quality improvement projects that use routine care and existing records do not require written research consent, but patients should still be able to decline new screening, and the review body decides what is required.
What should happen if a patient reports suicidal thoughts during a DNP screening project?
The project should follow a written safety protocol, usually the site's crisis policy, with same-day assessment by a qualified clinician and a documented safety plan before the patient leaves.
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