Chapter 6: End-of-Life Issues

Informed Consent in Clinical Trials Case Description: A 50-year-old man with cancer is offered a Phase I trial for a new drug. The consent form lists risks but emphasizes potential benefits, downplaying the experimental nature. Ethical Question: Is this informed consent ethical?

A. Yes, as risks are disclosed.
B. No, it’s biased toward benefits.
C. Yes, if he signs willingly.
D. No, unless he’s a scientist.

Placebo Use in Trials Case Description: A researcher designs a trial for a new hypertension drug, using a placebo arm despite effective standard treatments. Participants are informed of the placebo chance. Ethical Question: Is this trial design ethical?

A. Yes, if participants consent.
B. No, it denies standard care.
C. Yes, if the condition is mild.
D. No, unless no treatments exist.

Vulnerable Population Recruitment Case Description: A study on a new antidepressant recruits homeless individuals, offering payment. The researcher ensures consent but knows they may feel coerced by the money. Ethical Question: Is this recruitment ethical?

A. Yes, if consent is obtained.
B. No, due to potential coercion.
C. Yes, if payment is minimal.
D. No, unless they’re not vulnerable.

Data Fabrication Case Description: A researcher falsifies trial data to show a drug’s efficacy, believing it will save lives once approved. A colleague discovers this. Ethical Question: What should the colleague do?

A. Report it to the ethics board.
B. Confront the researcher privately.
C. Ignore it, as it benefits patients.
D. Wait for publication to act.

Consent for Stored Samples Case Description: A patient’s tissue sample from surgery is stored for future research without specific consent, only a general hospital waiver. Years later, it’s used in a genetic study. Ethical Question: Was this use ethical?

A. Yes, if anonymized.
B. No, without specific consent.
C. Yes, if the waiver covers it.
D. No, unless he’s notified.

Conflicts of Interest in Funding Case Description: A researcher receives funding from a drug company to test its product. She doesn’t disclose this to participants, believing it won’t affect results. Ethical Question: Is this nondisclosure ethical?

A. Yes, if results are unbiased.
B. No, it violates transparency.
C. Yes, if the company approves.
D. No, unless it alters outcomes.

Pediatric Research Consent Case Description: A 12-year-old with leukemia is enrolled in a trial. Her parents consent, but she refuses, fearing side effects. The trial could benefit her. Ethical Question: Should the trial proceed?

A. Yes, with parental consent.
B. No, respecting her refusal.
C. Yes, if benefits outweigh risks.
D. No, unless she consents.

Deception in Research Case Description: A psychology study uses deception, telling participants it’s about memory when it’s about stress responses. They’re debriefed afterward. Ethical Question: Is this deception ethical?

A. Yes, if debriefed.
B. No, it undermines trust.
C. Yes, if harm is minimal.
D. No, unless unavoidable.

Unapproved Protocol Changes Case Description: A researcher alters a trial protocol mid-study to improve results, without ethics board approval, believing it’s minor. Ethical Question: Is this change ethical?

A. Yes, if it improves outcomes.
B. No, it bypasses oversight.
C. Yes, if participants agree.
D. No, unless retroactively approved.

Publication Bias Case Description: A researcher suppresses negative trial results for a new device, publishing only positive findings to secure future funding. Ethical Question: Is this publication ethical?

A. Yes, if funding is critical.
B. No, it distorts science.
C. Yes, if anonymized.
D. No, unless required by law.

Consent in Emergency Research Case Description: A trauma patient is unconscious and enrolled in an experimental resuscitation study without prior consent, under an IRB waiver for emergencies. Ethical Question: Is this enrollment ethical?

A. Yes, with IRB approval.
B. No, without consent.
C. Yes, if family is later informed.
D. No, unless he survives.

Animal Research Ethics Case Description: A study tests a new pain drug on mice, causing significant suffering, though it could lead to human benefits. Alternatives exist but are costlier. Ethical Question: Is this study ethical?

A. Yes, if benefits justify harm.
B. No, due to avoidable suffering.
C. Yes, if approved by an ethics board.
D. No, unless alternatives are used.

Recruiting Prisoners Case Description: A trial recruits prisoners, offering reduced sentences for participation. They consent, but the researcher worries about coercion. Ethical Question: Is this recruitment ethical?

A. Yes, with informed consent.
B. No, due to coercive incentives.
C. Yes, if risks are low.
D. No, unless incentives are removed.

Post-Trial Access to Drugs Case Description: A trial for a new HIV drug ends successfully, but participants in a poor country can’t afford it afterward, despite benefiting during the study. Ethical Question: Is it ethical to deny post-trial access?

A. Yes, it’s not the researcher’s duty.
B. No, it exploits participants.
C. Yes, if funding is unavailable.
D. No, unless alternatives exist.

Consent for Genetic Research Case Description: A patient consents to a cancer study but isn’t told her DNA will be sequenced and shared with other researchers. Ethical Question: Is this consent adequate?

A. Yes, if anonymized.
B. No, it omits key details.
C. Yes, if she signed a form.
D. No, unless she’s a researcher.

Researcher’s Personal Gain Case Description: A scientist patents a drug developed in a publicly funded trial, planning to profit personally without disclosing this to participants. Ethical Question: Is this ethical?

A. Yes, if the drug helps patients.
B. No, it lacks transparency.
C. Yes, if disclosed later.
D. No, unless profits are shared.

Unequal Risk Distribution Case Description: A trial tests a risky procedure on low-income patients but plans to market it to wealthier ones who can afford it. Ethical Question: Is this design ethical?

A. Yes, if consented.
B. No, it exploits the poor.
C. Yes, if risks are low.
D. No, unless benefits are equal.

Withdrawal from a Trial Case Description: A 40-year-old woman in a diabetes trial wants to withdraw due to side effects, but the researcher pressures her to stay, citing study importance. Ethical Question: Is this pressure ethical?

A. Yes, for scientific value.
B. No, it violates autonomy.
C. Yes, if she’s compensated.
D. No, unless she’s critical to results.

Misleading Recruitment Ads Case Description: A trial ad promises “cutting-edge treatment” for arthritis, implying guaranteed benefits, though it’s experimental with risks. Ethical Question: Is this ad ethical?

A. Yes, if it attracts participants.
B. No, it’s misleading.
C. Yes, if risks are in the consent form.
D. No, unless benefits are proven.

Research on Fetuses Case Description: A study uses aborted fetal tissue to develop a vaccine, with maternal consent but no public disclosure, fearing backlash. Ethical Question: Is this study ethical?

A. Yes, with maternal consent.
B. No, without transparency.
C. Yes, if anonymized.
D. No, unless publicly approved.

Consent in Illiterate Populations Case Description: A trial in a rural area enrolls illiterate participants using verbal consent, but they don’t fully grasp the risks due to language barriers. Ethical Question: Is this consent valid?

A. Yes, if verbally explained.
B. No, without full understanding.
C. Yes, if a witness signs.
D. No, unless translators are used.

Data Sharing Ethics Case Description: A researcher shares trial data with a competitor without participant consent, believing it advances science. Ethical Question: Is this sharing ethical?

A. Yes, for scientific progress.
B. No, without consent.
C. Yes, if anonymized.
D. No, unless participants benefit.

Research on Indigenous Groups Case Description: A study collects DNA from an indigenous tribe for a genetic disorder, with consent but without consulting tribal leaders, risking cultural harm. Ethical Question: Is this approach ethical?

A. Yes, with individual consent.
B. No, without community approval.
C. Yes, if anonymized.
D. No, unless risks are zero.

Early Trial Termination Case Description: A trial for a new heart drug shows early promise, and the sponsor wants to stop it to market sooner, though long-term risks are unclear. Ethical Question: Is early termination ethical?

A. Yes, if benefits are evident.
B. No, it risks safety data.
C. Yes, if participants agree.
D. No, unless fully analyzed.

Consent for Observational Studies Case Description: A researcher observes patient-doctor interactions in a clinic for a study without informing patients, claiming it’s low risk. Ethical Question: Is this ethical?

A. Yes, if no harm occurs.
B. No, without consent.
C. Yes, if anonymized.
D. No, unless approved by IR

Paying Participants Case Description: A trial offers $1,000 to healthy volunteers for a risky drug test. Some join only for the money, not understanding risks. Ethical Question: Is this payment ethical?

A. Yes, if they consent.
B. No, it may coerce participation.
C. Yes, if risks are low.
D. No, unless payment is minimal.

Research on Dying Patients Case Description: A study tests a new pain drug on terminal cancer patients, with consent, but some are too ill to fully comprehend the study. Ethical Question: Is this ethical?

A. Yes, with proxy consent.
B. No, without full capacity.
C. Yes, if benefits outweigh risks.
D. No, unless they’re alert.

Authorship Dispute Case Description: A junior researcher contributes significantly to a study but is excluded from authorship by the lead, who claims credit. Ethical Question: Is this exclusion ethical?

A. Yes, if the lead decides.
B. No, it denies fair credit.
C. Yes, if she’s acknowledged.
D. No, unless she agrees.

Risk Disclosure Omission Case Description: A trial consent form omits a rare but serious side effect to avoid scaring participants, though it’s known to the researcher. Ethical Question: Is this omission ethical?

A. Yes, if rare.
B. No, it undermines consent.
C. Yes, if benefits are high.
D. No, unless disclosed later.

Research in War Zones Case Description: A study tests a trauma drug in a conflict zone, with consent, but participants are desperate and may not weigh risks fully. Ethical Question: Is this ethical?

A. Yes, if consented.
B. No, due to desperation.
C. Yes, if risks are low.
D. No, unless conditions improve.

Reusing Data Without Consent Case Description: A researcher reanalyzes old trial data for a new study without re-consenting participants, assuming original consent covers it. Ethical Question: Is this reuse ethical?

A. Yes, if anonymized.
B. No, without new consent.
C. Yes, if original consent is broad.
D. No, unless participants benefit.

Industry Pressure on Results Case Description: A drug company pressures a researcher to highlight positive trial outcomes and downplay side effects in a publication. Ethical Question: Should the researcher comply?

A. Yes, to maintain funding.
B. No, it compromises integrity.
C. Yes, if side effects are minor.
D. No, unless fully disclosed.

Research on Pregnant Women Case Description: A trial tests a drug’s safety in pregnant women with consent, but fetal risks are uncertain and not fully explained. Ethical Question: Is this ethical?

A. Yes, with maternal consent.
B. No, without fetal risk clarity.
C. Yes, if benefits are high.
D. No, unless risks are known.

Placebo in Pediatric Trials Case Description: A trial for a new asthma drug uses a placebo in children, despite effective treatments, with parental consent. Ethical Question: Is this ethical?

A. Yes, if consented.
B. No, it denies standard care.
C. Yes, if asthma is mild.
D. No, unless no alternatives.

Confidentiality in Research Case Description: A study publishes participant data with initials and ages, making some identifiable in a small community. Ethical Question: Is this publication ethical?

A. Yes, if consented.
B. No, it breaches confidentiality.
C. Yes, if risks are low.
D. No, unless fully anonymized.

Research Without IRB Approval Case Description: A doctor conducts a small study on a new procedure without IRB approval, believing it’s low risk and beneficial. Ethical Question: Is this ethical?

A. Yes, if low risk.
B. No, without oversight.
C. Yes, if patients consent.
D. No, unless retroactively approved.

Consent in Mental Illness Case Description: A trial recruits patients with schizophrenia, obtaining consent during stable periods, but some relapse during the study. Ethical Question: Is this consent valid throughout?

A. Yes, if initially competent.
B. No, capacity may lapse.
C. Yes, with proxy consent.
D. No, unless reassessed.

Exploitation in Global Trials Case Description: A trial tests a drug in a low-income country with lax regulations, offering minimal benefits to participants but profits for the sponsor. Ethical Question: Is this ethical?

A. Yes, if consented.
B. No, it exploits participants.
C. Yes, if benefits are shared.
D. No, unless regulations match.

Peer Review Misconduct Case Description: A reviewer steals ideas from a submitted research paper during peer review, using them in his own work. Ethical Question: Is this ethical?

A. Yes, if unpublished.
B. No, it’s plagiarism.
C. Yes, if credited later.
D. No, unless approved.

Research on Rare Diseases Case Description: A study on a rare disease enrolls all available patients, risking over-representation of a small group, with consent but high risks. Ethical Question: Is this ethical?

A. Yes, for scientific need.
B. No, it overburden risks.
C. Yes, if risks are low.
D. No, unless alternatives exist.