| Course | GB590 Ethics in Business and Society |
|---|---|
| Unit | Unit 2 |
| Paper type | Ethical framework application |
| Length | About 1,110 words, 7 pages double-spaced |
| Format | APA 7 student paper |
| School | Purdue University Global |
| Program | MBA |
| Updated | October 2026 |
Free sample paper for GB590 Unit 2
Two Hundred Ten Doses and One Plea: A Unit 2 Ethical Framework Application to an Expanded Access Request
[Student Name]
Purdue University Global
GB590: Ethics in Business and Society
Unit 2 Ethical Framework Application
[Instructor Name]
[Date]
The company, the patient and every figure are composite and illustrative; the laws, the 2014 episode and the sources cited are real.
The Facts
The company has forty employees and one product, an investigational antiviral in a Phase 2 trial for a drug-resistant viral infection that threatens transplant recipients. It has manufactured 210 doses, enough for the patients enrolled and a small reserve for those who need longer courses. Making more would take about five months.
A 34-year-old kidney transplant recipient has an infection resistant to every approved drug. She does not meet the trial's entry criteria, because her kidney function is below the study's threshold. Her physician has asked the company to supply the drug outside the trial, and her family has launched a public campaign that has reached national news. The company has a policy, posted as federal law requires, stating that it does not provide the drug outside the trial while Phase 2 is under way.
What the Law Allows
Two legal routes would permit the company to supply the drug. The FDA's expanded access program lets a physician request an investigational drug for a patient with a serious condition and no comparable alternative, with FDA review. The federal Right to Try Act of 2018 lets eligible patients obtain certain investigational drugs directly from the manufacturer without FDA authorization of the individual request. Neither requires the company to say yes. Darrow et al. (2015) note that manufacturers decline many requests, often because supply is limited or because outcomes outside a trial could complicate the drug's review. The company's choice is therefore ethical, not legal.
The Utilitarian Count
Utilitarian reasoning judges the release by its total effect on every person it touches. The count can be drawn narrowly or widely, and the answer changes.
Narrow count. If only this patient and the trial participants are counted, releasing one course, about six doses, gives the patient a chance of recovery she would not otherwise have, while the trial keeps enough doses for its enrolled patients. On this count, releasing the doses is clearly better.
Wider count. A wider count includes future patients who would benefit if the drug is approved, other patients who will make similar requests once one is granted and the company's ability to finish the trial. Each release draws on a reserve meant for enrolled patients who need longer treatment. If the patient experiences a serious adverse event, regulators may ask the company to explain it, which could delay the trial. And a granted request in the public eye invites more, which a forty-person company cannot evaluate one by one without pulling staff from the trial. Mill (1863) held that the right act maximizes overall well-being, but the wide count shows how uncertain that total becomes once future patients are included.
On the wide count, a single release is a modest net good only if the company can limit how many more it grants and keep the trial on schedule. That condition matters because it turns a question about one patient into a question about a policy, which is where the rights analysis also ends up.
The Rights Analysis
A rights analysis asks what the patient is entitled to, and from whom. Her right to seek the drug is clear: the law permits it, and nothing stops her physician from asking. A right to receive it would be a positive right, a claim against the company to provide something. It is hard to locate such a claim. The company did not cause her illness, made no promise to her and has no relationship with her. Her claim, if any, is not to the drug but to fair consideration: a process that treats her request on its merits rather than on the size of her family's campaign.
The trial participants, by contrast, do have a claim against the company. They enrolled on the understanding that the drug would be available for their full course. Their right is the one the company has actually created.
The patient has a right to be heard fairly; the trial participants have a right to the doses they were promised.
What the Company Owes the Public
One more consideration sits outside both frameworks but shapes how the company should act. The family's campaign has made the company's decision public, and many people following it will not know that Phase 2 doses are limited, that the drug's safety in patients with poor kidney function is unknown, or that a bad outcome outside the trial could delay approval for everyone. The company owes the public, and the patient's family, a clear explanation of why it decides as it does. A refusal stated only as policy will read as indifference; a decision explained in terms of the trial participants' claims and the risks to future patients can be understood even by people who disagree with it. Whatever it decides, the company should publish its reasoning and its criteria at the same time as its answer.
Where the Frameworks Part
The two analyses agree that the trial participants' supply must be protected. They part on the patient. The narrow utilitarian count says release the drug; the rights analysis says she has no claim to it, only to a fair process. The wide utilitarian count sits between them: a release is defensible only if it is limited and fair to other requesters. That convergence points to a process, not a single yes or no.
In 2014, a similar public campaign led Chimerix, a small company developing an antiviral, to reverse an initial refusal within days by opening a small study for patients like the one at the center of the campaign. The episode showed both the pressure such campaigns create and the possibility of a structured response.
Recommendation: An Open Protocol of Fifteen Doses
The company should set aside fifteen doses from its reserve, enough for about two courses, and open an expanded access protocol with criteria published in advance: a serious resistant infection, no approved alternative and a physician willing to report outcomes. Requests would be reviewed in order by an outside physician, not by staff exposed to publicity. If this patient qualifies, she would be first, because her request is first, not because her campaign is loudest. Jarow et al. (2017) describe how such protocols operate under FDA oversight. The arrangement protects the trial, gives the patient a fair chance and limits the company's exposure to future campaigns.
References
Darrow, J. J., Sarpatwari, A., Avorn, J., & Kesselheim, A. S. (2015). Practical, legal, and ethical issues in expanded access to investigational drugs. New England Journal of Medicine, 372(3), 279-286. https://doi.org/10.1056/NEJMhle1409465
Jarow, J. P., Lurie, P., Ikenberry, S. C., & Lemery, S. (2017). Overview of FDA's expanded access program for investigational drugs. Therapeutic Innovation & Regulatory Science, 51(2), 177-179. https://doi.org/10.1177/2168479017694850
Mill, J. S. (1863). Utilitarianism. Parker, Son, and Bourn.
What the GB590 Unit 2 assignment asks for
The second GB590 assignment asks you to apply two ethical frameworks, usually utilitarianism and a rights-based approach, to a single business case. State the facts first, including any legal rules that bound the decision, so the reader can see what is permitted and what is required. Then apply each framework in its own section so neither borrows the other's conclusion. For the utilitarian analysis, identify everyone affected and consider both immediate and wider consequences. For the rights analysis, identify which rights are at stake, who holds them and against whom. Compare where the two analyses agree and where they part. Recommend a course of action that answers both. Sections usually expect five or six pages, cited in APA 7.
Inside the GB590 Unit 2 example
The facts section sets out forty employees, 210 doses, a five-month manufacturing lead time and a 34-year-old patient below the trial's kidney-function threshold. A legal paragraph uses Darrow and colleagues on why manufacturers often decline. The utilitarian section runs a narrow count, which favors release, and a wide count that adds future patients and trial delays, citing Mill. The rights section separates a right to seek the drug from a right to receive it, and the highlighted sentence contrasts the patient's claim to fair hearing with the trial participants' claim to their doses. A section on public explanation follows. The 2014 Chimerix episode and Jarow and colleagues support the closing fifteen-dose expanded access protocol.
Where the points sit in the GB590 Unit 2 rubric
In the GB590 framework application, instructors award most points for keeping the two analyses separate and then comparing them honestly. A facts section that includes the legal setting shows the writer knows the decision is ethical, not merely legal. A utilitarian analysis that identifies all affected parties, and shows how the answer shifts with a wider count, demonstrates depth. A rights analysis that names the right, its holder and the party it binds earns credit over loose talk of rights. A clear statement of where the frameworks agree and part shows synthesis. A recommendation that satisfies both frameworks' shared conditions demonstrates practical judgment. Precise use of sources and APA 7 formatting take the remaining points.
GB590 Unit 2 help: mistakes that cost points
The most frequent problem in this GB590 paper is blending the frameworks, sliding from counting harms to asserting rights inside a paragraph, so the conclusion rests on whichever came last. Another is a utilitarian count limited to the people in the headline, which misses future patients, other requesters and third parties. Rights analyses often name a right without asking who owes it, which makes every claim seem binding. Some papers treat legal permission as moral obligation, or the reverse. Recommendations frequently answer only one framework. Separate the analyses, count widely, name who holds and who owes each right, compare the results openly and design a recommendation both can accept. A free custom framework paper on your own case is available through this page.
Get a GB590 Unit 2 example written to your instructions
Your first request is free. For Unit 2, the business case, the two frameworks your instructions name and the rubric are enough to produce a paper where each framework keeps its own section, the two are compared where they diverge, and a recommendation grows out of that comparison, within 24-48h. The biotech and patient are composites, and nothing here is medical guidance. The paper above is an original model document written by our desk, not a submitted student paper and not an official Purdue University Global document.
More GB590 papers and MBA samples
- GB590 Unit 1: Ethical Dilemma Post
- GB590 Unit 3: Stakeholder Map
- GB590 Unit 4: Governance Failure Case
- GB590 Unit 5: Workplace Ethics Analysis
- GB590 Unit 6: Consumer Protection Case
- GB590 Unit 7: Sustainability Trade-off Paper
- GB590 Unit 8: Global Labor Standards Analysis
- GB590 Unit 9: Ethics Program Recommendation
- GB590 Unit 10: Stakeholder Case Analysis
- GB580 Unit 2: External Environment Scan
- GB570 Unit 2: Value Chain Map
- GB560 Unit 2: Process Requirements Memo
- GB550 Unit 2: Time Value of Money Problems
GB590 Unit 2 questions, answered
Why run the frameworks in separate sections?
So neither can quietly borrow the other's conclusion. Blended papers often slide from tallying harms to asserting entitlements inside one paragraph, and the verdict ends up resting on whichever came last. The GB590 example seals each section, lets each reach its own answer on the single dose, and compares only afterward, which keeps the final choice traceable.
Does the paper name a real company?
Only as a reference point. The main case is a composite, and one sentence recalls the 2014 Chimerix episode, in which a refusal to release an unapproved antiviral was reversed within days through a small open-label study after a public campaign. Your section may assign a different real case, and the sample would state its facts as reported.
What does the law say a company must do with expanded access requests?
Very little beyond transparency. Federal law since 2016 requires sponsors of investigational drugs for serious conditions to publish their policy on evaluating expanded access requests, and neither that pathway nor the Right to Try Act compels supply. The example states this in a short legal note, so the ethical analysis carries the decision rather than a misread statute.
Where can I find a free GB590 Unit 2 sample paper?
A complete GB590 Unit 2 ethical framework application is on this page, applying a utilitarian count and a rights analysis separately to an expanded access request and recommending a fifteen-dose open protocol.
What is the difference between expanded access and Right to Try?
Expanded access requests go through the FDA, which reviews each one. The Right to Try Act lets eligible patients obtain certain investigational drugs directly from the manufacturer. In both cases the manufacturer may decline.