Ethics and Evidence-Based Research DQ
Three headed sections, and the first sets up the other two. Research safeguards were designed for a different activity, and saying exactly which features do not transfer is the argument the essay runs on.
Editorial process
Last reviewed · August 22, 2026
Why research safeguards do not transfer to improvement work
Part one is a question about fit rather than about ethics being optional, and the answer comes from what the two activities are. Clinical research generates generalisable knowledge from a population recruited for that purpose, so individual informed consent, review board approval and the right to decline all make sense. Quality improvement changes a local process that everyone in that setting is already subject to, often iteratively, and frequently there is no way for an individual patient to opt out of a changed handover procedure or a new checklist. Requiring individual consent would make many improvement projects impossible and would also be incoherent, since the previous process was never consented to either. Say plainly that this is an argument about which safeguards fit, not about whether oversight is needed, because the boundary is genuinely blurred once improvement work is written up for publication, which is precisely where the oversight question resurfaces.
For part two, choose three controversies that differ and map each onto the four principles. Whether improvement projects need review board oversight engages respect for autonomy and justice; randomising patients between two care processes within an improvement project engages beneficence and non-maleficence because someone receives the less good arm; publishing improvement work without consent engages autonomy again but in a different form; and the distribution of burden, where a change is piloted on one unit or one population, engages justice. Part three is the sharpest section, because the claim that patients have an ethical responsibility to improve health care sits awkwardly with autonomy and with justice. A duty to participate cannot easily be voluntary, and asking people who are unwell to contribute effort falls hardest on those least able to bear it. Resolve it the way the literature does, by distinguishing a duty of easy rescue from an enforceable obligation and keeping participation genuinely optional.
Likely learning objectives
- Explain why research safeguards may not fit improvement work.
- Distinguish an argument about fit from an argument about exemption.
- Map improvement controversies onto the four core principles.
- Analyse a claimed patient duty against autonomy and justice.
Assignment instructions
Read the full question
Review every instruction before using the planning guidance that follows.
Write a 1250-1500 word essay addressing each of the following points/questions. Be sure to completely answer all the questions for each bullet point. There should be three main sections, one for each bullet below. Separate each section in your paper with a clear heading that allows your professor to know which bullet you are addressing in that section of your paper. Support your ideas with at least two (2) sources using citations in your essay. Make sure to cite using the APA writing style for the essay. The cover page and reference page in correct APA do not count towards the minimum word amount. Review the rubric criteria for this assignment. Part 1: Describe why ethical safeguards designed for clinical research may not be feasible or appropriate for evidence-based practice or evidence-based practice implementation projects. Part 2: Review the sectioned headed, Two Ethical Exemplars in Chapter 22 of the textbook (Melnyk and Fineout-Overholt, 2015, pages 518-519). Discuss three main ethical controversies related to implementing Evidence-Based Quality Improvement (EBQI) Initiatives. Describe how these controversies relate to the four core ethical principles. Part 3: Identify which ethical principles may be in conflict with the concept of “patients having an ethical responsibility in improving healthcare.” Discuss how these conflicts may be resolved. Assignment Expectations: Length: 1250 – 1500 words Structure: Include a title page and reference page in APA format. These do not count towards the minimum word count for this assignment. Your essay must include an introduction and a conclusion. References: Use appropriate APA style in-text citations and references for all resources utilized to answer the questions. A minimum of two (2) scholarly sources are required for this assignment.
Course-wide instructions that accompany this question
You must proofread your paper. But do not strictly rely on your computer’s spell-checker and grammar-checker; failure to do so indicates a lack of effort on your part and you can expect your grade to suffer accordingly. Papers with numerous misspelled words and grammatical mistakes will be penalized. Read over your paper – in silence and then aloud – before handing it in and make corrections as necessary. Often it is advantageous to have a friend proofread your paper for obvious errors. Handwritten corrections are preferable to uncorrected mistakes. Use a standard 10 to 12 point (10 to 12 characters per inch) typeface. Smaller or compressed type and papers with small margins or single-spacing are hard to read. It is better to let your essay run over the recommended number of pages than to try to compress it into fewer pages. Likewise, large type, large margins, large indentations, triple-spacing, increased leading (space between lines), increased kerning (space between letters), and any other such attempts at “padding” to increase the length of a paper are unacceptable, wasteful of trees, and will not fool your professor. The paper must be neatly formatted, double-spaced with a one-inch margin on the top, bottom, and sides of each page. When submitting hard copy, be sure to use white paper and print out using dark ink. If it is hard to read your essay, it will also be hard to follow your argument
Turn the brief into deliverables
- 01The differences between research and improvement that drive the safeguard question.
- 02An explicit statement that the argument concerns fit, not exemption.
- 03Three ethical controversies in implementing quality improvement.
- 04Each controversy mapped to one or more of the four principles.
- 05The principles in conflict with a claimed patient responsibility.
- 06A resolution, with three headed sections and two sources.
The mismatch, three controversies, then the patient duty question
Two different activities
Distinguish research and improvement by purpose, population and generalisability.
What the assessor is likely looking for
A difference that explains why a safeguard does not transfer.
Why consent does not fit
Show that individuals cannot opt out of a changed local process.
What the assessor is likely looking for
The observation that the previous process was not consented to either.
Three controversies
Give oversight, randomisation within improvement, and publication without consent.
What the assessor is likely looking for
Three controversies that engage different principles.
Mapping to the four principles
Attach autonomy, beneficence, non-maleficence and justice to specific controversies.
What the assessor is likely looking for
A principle matched to a controversy rather than listed.
The patient's claimed duty
Test the claim against autonomy and justice and propose a resolution.
What the assessor is likely looking for
The burden falling hardest on the unwell, named as a justice problem.
Where the research and improvement boundary is documented
Recommended databases
- NCBI Bookshelf
- PubMed Central
- Office for Human Research Protections
- University Library
Search sequence
- 1.Read a source that draws the research and improvement boundary explicitly.
- 2.Find the four principles in their original formulation before mapping anything.
- 3.Look for the debate about review board oversight of improvement projects.
- 4.Search for writing on patient obligations in health care improvement.
Reference shortlist
These are authoritative starting points, not a ready-made bibliography. A qualified reviewer must confirm that each source fits the assignment and supports the claim beside which it is cited.
Medical Ethics
StatPearls, NCBI Bookshelf · 2026
Medical ethics, for the four principles the essay maps onto.
Informed Consent
StatPearls, NCBI Bookshelf · 2023
Informed consent, for what the research safeguard actually requires.
Human Subjects Research Design
StatPearls, NCBI Bookshelf · 2023
Human subjects research design, for the oversight framework and its scope.
Patient Safety and Quality
Agency for Healthcare Research and Quality, NCBI Bookshelf · 2008
Patient safety and quality, for improvement as a local process activity.
Implementation strategies for large scale quality improvement initiatives in primary care settings: a qualitative assessment
BMC Primary Care · 2023
An implementation study, as a worked example sitting on the boundary.
Before you submit this essay
Common mistakes
- Arguing that improvement projects do not need ethical oversight.
- Giving three controversies that all reduce to consent.
- Naming the four principles without mapping them to specific controversies.
- Accepting a patient duty to improve health care without examining it.
- Ignoring that a duty falling on unwell people is a justice problem.
Submission checklist
- Have you framed part one as fit rather than exemption?
- Do your three controversies differ from each other?
- Is each mapped to a named principle?
- Have you identified which principles the patient duty conflicts with?
- Are there three clear headings as the brief requires?
Use this guide to plan and review your own work. Follow your institution's rules and read Brinevia's academic-integrity policy.
Written by
Maren Caldwell
MSN, RN, CNE
Medical-surgical nursing, pharmacology and NCLEX preparation
Maren is a registered nurse with over 15 years of clinical and educational experience in medical-surgical nursing. She writes on NCLEX preparation, patient care fundamentals, pharmacology and evidence-based practice.

Reviewed by
Dr. Tessa Redmond
DNP, RN, CNE
Evidence-based practice and clinical education
Tessa is a doctorally-prepared nurse educator. She reviews Brinevia content for clinical accuracy and alignment with current evidence-based guidelines.