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Case Studies

More than 70 cases pair ethics concepts with real world situations. From journalism, performing arts, and scientific research to sports, law, and business, these case studies explore current and historic ethical dilemmas, their motivating biases, and their consequences. Each case includes discussion questions, related videos, and a bibliography.

A Million Little Pieces

James Frey’s popular memoir stirred controversy and media attention after it was revealed to contain numerous exaggerations and fabrications.

Abramoff: Lobbying Congress

Super-lobbyist Abramoff was caught in a scheme to lobby against his own clients. Was a corrupt individual or a corrupt system – or both – to blame?

Apple Suppliers & Labor Practices

Is tech company Apple, Inc. ethically obligated to oversee the questionable working conditions of other companies further down their supply chain?

Approaching the Presidency: Roosevelt & Taft

Some presidents view their responsibilities in strictly legal terms, others according to duty. Roosevelt and Taft took two extreme approaches.

Appropriating “Hope”

Fairey’s portrait of Barack Obama raised debate over the extent to which an artist can use and modify another’s artistic work, yet still call it one’s own.

Arctic Offshore Drilling

Competing groups frame the debate over oil drilling off Alaska’s coast in varying ways depending on their environmental and economic interests.

Banning Burkas: Freedom or Discrimination?

The French law banning women from wearing burkas in public sparked debate about discrimination and freedom of religion.

Birthing Vaccine Skepticism

Wakefield published an article riddled with inaccuracies and conflicts of interest that created significant vaccine hesitancy regarding the MMR vaccine.

Blurred Lines of Copyright

Marvin Gaye’s Estate won a lawsuit against Robin Thicke and Pharrell Williams for the hit song “Blurred Lines,” which had a similar feel to one of his songs.

Bullfighting: Art or Not?

Bullfighting has been a prominent cultural and artistic event for centuries, but in recent decades it has faced increasing criticism for animal rights’ abuse.

Buying Green: Consumer Behavior

Do purchasing green products, such as organic foods and electric cars, give consumers the moral license to indulge in unethical behavior?

Cadavers in Car Safety Research

Engineers at Heidelberg University insist that the use of human cadavers in car safety research is ethical because their research can save lives.

Cardinals’ Computer Hacking

St. Louis Cardinals scouting director Chris Correa hacked into the Houston Astros’ webmail system, leading to legal repercussions and a lifetime ban from MLB.

Cheating: Atlanta’s School Scandal

Teachers and administrators at Parks Middle School adjust struggling students’ test scores in an effort to save their school from closure.

Cheating: Sign-Stealing in MLB

The Houston Astros’ sign-stealing scheme rocked the baseball world, leading to a game-changing MLB investigation and fallout.

Cheating: UNC’s Academic Fraud

UNC’s academic fraud scandal uncovered an 18-year scheme of unchecked coursework and fraudulent classes that enabled student-athletes to play sports.

Cheney v. U.S. District Court

A controversial case focuses on Justice Scalia’s personal friendship with Vice President Cheney and the possible conflict of interest it poses to the case.

Christina Fallin: “Appropriate Culturation?”

After Fallin posted a picture of herself wearing a Plain’s headdress on social media, uproar emerged over cultural appropriation and Fallin’s intentions.

Climate Change & the Paris Deal

While climate change poses many abstract problems, the actions (or inactions) of today’s populations will have tangible effects on future generations.

Cover-Up on Campus

While the Baylor University football team was winning on the field, university officials failed to take action when allegations of sexual assault by student athletes emerged.

Covering Female Athletes

Sports Illustrated stirs controversy when their cover photo of an Olympic skier seems to focus more on her physical appearance than her athletic abilities.

Covering Yourself? Journalists and the Bowl Championship

Can news outlets covering the Bowl Championship Series fairly report sports news if their own polls were used to create the news?

Cyber Harassment

After a student defames a middle school teacher on social media, the teacher confronts the student in class and posts a video of the confrontation online.

Defending Freedom of Tweets?

Running back Rashard Mendenhall receives backlash from fans after criticizing the celebration of the assassination of Osama Bin Laden in a tweet.

Dennis Kozlowski: Living Large

Dennis Kozlowski was an effective leader for Tyco in his first few years as CEO, but eventually faced criminal charges over his use of company assets.

Digital Downloads

File-sharing program Napster sparked debate over the legal and ethical dimensions of downloading unauthorized copies of copyrighted music.

Dr. V’s Magical Putter

Journalist Caleb Hannan outed Dr. V as a trans woman, sparking debate over the ethics of Hannan’s reporting, as well its role in Dr. V’s suicide.

East Germany’s Doping Machine

From 1968 to the late 1980s, East Germany (GDR) doped some 9,000 athletes to gain success in international athletic competitions despite being aware of the unfortunate side effects.

Ebola & American Intervention

Did the dispatch of U.S. military units to Liberia to aid in humanitarian relief during the Ebola epidemic help or hinder the process?

Edward Snowden: Traitor or Hero?

Was Edward Snowden’s release of confidential government documents ethically justifiable?

Ethical Pitfalls in Action

Why do good people do bad things? Behavioral ethics is the science of moral decision-making, which explores why and how people make the ethical (and unethical) decisions that they do.

Ethical Use of Home DNA Testing

The rising popularity of at-home DNA testing kits raises questions about privacy and consumer rights.

Flying the Confederate Flag

A heated debate ensues over whether or not the Confederate flag should be removed from the South Carolina State House grounds.

Freedom of Speech on Campus

In the wake of racially motivated offenses, student protests sparked debate over the roles of free speech, deliberation, and tolerance on campus.

Freedom vs. Duty in Clinical Social Work

What should social workers do when their personal values come in conflict with the clients they are meant to serve?

Full Disclosure: Manipulating Donors

When an intern witnesses a donor making a large gift to a non-profit organization under misleading circumstances, she struggles with what to do.

Gaming the System: The VA Scandal

The Veterans Administration’s incentives were meant to spur more efficient and productive healthcare, but not all administrators complied as intended.

German Police Battalion 101

During the Holocaust, ordinary Germans became willing killers even though they could have opted out from murdering their Jewish neighbors.

Head Injuries & American Football

Many studies have linked traumatic brain injuries and related conditions to American football, creating controversy around the safety of the sport.

Head Injuries & the NFL

American football is a rough and dangerous game and its impact on the players’ brain health has sparked a hotly contested debate.

Healthcare Obligations: Personal vs. Institutional

A medical doctor must make a difficult decision when informing patients of the effectiveness of flu shots while upholding institutional recommendations.

High Stakes Testing

In the wake of the No Child Left Behind Act, parents, teachers, and school administrators take different positions on how to assess student achievement.

In-FUR-mercials: Advertising & Adoption

When the Lied Animal Shelter faces a spike in animal intake, an advertising agency uses its moral imagination to increase pet adoptions.

Krogh & the Watergate Scandal

Egil Krogh was a young lawyer working for the Nixon Administration whose ethics faded from view when asked to play a part in the Watergate break-in.

Limbaugh on Drug Addiction

Radio talk show host Rush Limbaugh argued that drug abuse was a choice, not a disease. He later became addicted to painkillers.

U.S. Olympic swimmer Ryan Lochte’s “over-exaggeration” of an incident at the 2016 Rio Olympics led to very real consequences.

Meet Me at Starbucks

Two black men were arrested after an employee called the police on them, prompting Starbucks to implement “racial-bias” training across all its stores.

Myanmar Amber

Buying amber could potentially fund an ethnic civil war, but refraining allows collectors to acquire important specimens that could be used for research.

Negotiating Bankruptcy

Bankruptcy lawyer Gellene successfully represented a mining company during a major reorganization, but failed to disclose potential conflicts of interest.

Pao & Gender Bias

Ellen Pao stirred debate in the venture capital and tech industries when she filed a lawsuit against her employer on grounds of gender discrimination.

Pardoning Nixon

One month after Richard Nixon resigned from the presidency, Gerald Ford made the controversial decision to issue Nixon a full pardon.

Patient Autonomy & Informed Consent

Nursing staff and family members struggle with informed consent when taking care of a patient who has been deemed legally incompetent.

Prenatal Diagnosis & Parental Choice

Debate has emerged over the ethics of prenatal diagnosis and reproductive freedom in instances where testing has revealed genetic abnormalities.

Reporting on Robin Williams

After Robin Williams took his own life, news media covered the story in great detail, leading many to argue that such reporting violated the family’s privacy.

Responding to Child Migration

An influx of children migrants posed logistical and ethical dilemmas for U.S. authorities while intensifying ongoing debate about immigration.

Retracting Research: The Case of Chandok v. Klessig

A researcher makes the difficult decision to retract a published, peer-reviewed article after the original research results cannot be reproduced.

Sacking Social Media in College Sports

In the wake of questionable social media use by college athletes, the head coach at University of South Carolina bans his players from using Twitter.

Selling Enron

Following the deregulation of electricity markets in California, private energy company Enron profited greatly, but at a dire cost.

Snyder v. Phelps

Freedom of speech was put on trial in a case involving the Westboro Baptist Church and their protesting at the funeral of U.S. Marine Matthew Snyder.

Something Fishy at the Paralympics

Rampant cheating has plagued the Paralympics over the years, compromising the credibility and sportsmanship of Paralympian athletes.

Sports Blogs: The Wild West of Sports Journalism?

Deadspin pays an anonymous source for information related to NFL star Brett Favre, sparking debate over the ethics of “checkbook journalism.”

Stangl & the Holocaust

Franz Stangl was the most effective Nazi administrator in Poland, killing nearly one million Jews at Treblinka, but he claimed he was simply following orders.

Teaching Blackface: A Lesson on Stereotypes

A teacher was put on leave for showing a blackface video during a lesson on racial segregation, sparking discussion over how to teach about stereotypes.

The Astros’ Sign-Stealing Scandal

The Houston Astros rode a wave of success, culminating in a World Series win, but it all came crashing down when their sign-stealing scheme was revealed.

The Central Park Five

Despite the indisputable and overwhelming evidence of the innocence of the Central Park Five, some involved in the case refuse to believe it.

The CIA Leak

Legal and political fallout follows from the leak of classified information that led to the identification of CIA agent Valerie Plame.

The Collapse of Barings Bank

When faced with growing losses, investment banker Nick Leeson took big risks in an attempt to get out from under the losses. He lost.

The Costco Model

How can companies promote positive treatment of employees and benefit from leading with the best practices? Costco offers a model.

The FBI & Apple Security vs. Privacy

How can tech companies and government organizations strike a balance between maintaining national security and protecting user privacy?

The Miss Saigon Controversy

When a white actor was cast for the half-French, half-Vietnamese character in the Broadway production of Miss Saigon , debate ensued.

The Sandusky Scandal

Following the conviction of assistant coach Jerry Sandusky for sexual abuse, debate continues on how much university officials and head coach Joe Paterno knew of the crimes.

The Varsity Blues Scandal

A college admissions prep advisor told wealthy parents that while there were front doors into universities and back doors, he had created a side door that was worth exploring.

Providing radiation therapy to cancer patients, Therac-25 had malfunctions that resulted in 6 deaths. Who is accountable when technology causes harm?

Welfare Reform

The Welfare Reform Act changed how welfare operated, intensifying debate over the government’s role in supporting the poor through direct aid.

Wells Fargo and Moral Emotions

In a settlement with regulators, Wells Fargo Bank admitted that it had created as many as two million accounts for customers without their permission.

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• 2.3 Using ethical concepts to analyze case studies

Ethical case analysis is a common exercise for identifying and reasoning about ethical challenges in complex situations. Analyzing ethical case studies with your mentors, colleagues, and peer students also provides opportunities for each participant to articulate her own ethical values and to seek ethical consensus within the group. The Rock Ethics Institute provides a 12-step approach for analyzing ethical case studies. This step-by-step framework includes:

1. State the nature of the ethical issue you’ve initially spotted 2. List the relevant facts 3. Identify stakeholders 4. Clarify the underlying values 5. Consider consequences 6. Identify relevant rights/duties 7. Reflect on which virtues apply 8. Consider relevant relationships 9. Develop a list of potential responses 10. Use moral imagination to consider each option based on the above considerations 11. Choose the best option 12. Consider what could be done in the future to prevent the problem

Application of the 12 steps to an ethics scenario is illustrated in a series of instructional videos .

For those of you who are familiar with engineering design, could you identify the parallel between this ethical reasoning framework and the engineering design process? When we rephrase the 12 steps using the language of design, we might see that both emphasize an iterative process for identifying and solving open-ended challenges (see Figure 4).

Figure 4 A Design-Based Framework for Ethics Case Analysis.

As big data technologies become widely adopted by business and governmental sectors, we find ourselves often confronted by the following question: To what extent can we trust computer algorithms to make ethical decisions for us? Another way to ask this question is: Do algorithms have ethical agency? Ethical agency is the ability to act responsibly according to one’s ethical judgment of right and wrong (MacIntyre, 1999; van der Velden, 2009). For example, adult human beings have ethical agency because they have a sense of what is ethically right. That is, we accept that adults make intentional choices to act ethically or not, and they can be held accountable for their actions. Admittedly, machines (and computers) can be programmed to do things we consider ethically right. For example, we can program an electrical system to turn off the lights when the sensors detect no people in a room. In this case, it is the programmer, not the electrical system, that decides avoiding energy waste is ethically right. The human programmer is able to fully grasp the meanings of and connections between “no people in a room,” “turning off the lights,” and “avoiding energy waste.” However, in the case of big data analysis, the human actors (e.g., authors of the algorithms) may have less grasping of the entire situation because 1) they do not interact directly with the data (the algorithms do so), and 2) they might be working on a tiny proportion of a vast network of interrelated algorithms (Ananny, 2016). Faced with enormously complex systems and incomplete information, the human actors (e.g., researchers and programmers) involved in big data analysis sometimes have to delegate the power of making ethical decisions to algorithms. Yet algorithms are not fully capable of making sense of the patterns they recognize or the impact of their recommendations. Or we can say that algorithms have at the best “partial ethical agency.” The following case study highlights the challenges of letting algorithms with partial ethical agency to make important decisions on behalf of humans.

Identifying potential terrorists with algorithms?

In early 2016, counter-terrorism officials from the federal government met with leaders of giant tech companies in the Silicon Valley to discuss strategies for identifying and preventing terrorism on social networks. Among the proposals was a suggestion for the tech companies to develop a security algorithm that will detect, measure, and flag “radicalization” from social network posts. The federal officials who proposed this algorithm also cited the example of the Facebook suicide prevention mechanisms, which allows Facebook users to report suicidal content to the company.

You could also listen to a discussion about this proposal at WNYC .

Questions for Case Analysis

• What are ethically sound responses to the federal officials’ proposal? Use the 12-step approach or the Design-Based Framework to analyze this case.
• Which of the four ethical concepts (integrity, rights, impact, and epistemic norms) introduced in the above section are applicable to this case?

The Ethics of Data Management

• Introduction

Unit 1: Planning for Data

• Unit 2: Generating Data

Unit 3: Processing Data

Unit 4: using, sharing, and preserving data.

• 1.1 Definitions of data
• 1.2 The ecosystem of data: multiple actors and stakeholders
• 2.1 The research process and relevant actors
• 2.2 Relevant ethical concepts
• 2.4 Overall strategies for ethical data management
• Summary and references

Unit 2: Generating data

• 1. Sources of Data
• 2.1 Poor data practices in the lab
• 2.2 Research culture, proper protocols, and training
• 2.3 Lab notebook
• 2.4 Collective review of data
• 3.1 Human subjects: The Common Rule and IRB
• 3.2 Additional ethical concerns for collecting data from human subjects
• 3.3 Use of animals in research: The Animal Welfare Act and IACUC
• 1. Statistics and Data Integrity
• 2.1 Data fishing and trimming
• 2.2 Image manipulation
• 3.1 Conflict of interest
• 3.2 Interests, (implicit) biases, and uncertainty
• 1.1 The communal, practical, and educational purposes of research
• 1.2 Principles of disseminating research
• 2.1 Intellectual property: copy rights, trade secrets, and patents
• 2.2 Transparency, accountability, and profitability
• 2.3 Data sharing policies from funding agencies and journals
• 2.4 Open access
• 3.1 Methods of data storage
• 3.2 Period of retention
• 3.3 Data security

Unit 5: Big Data

• 1.1 Cognitive questions
• 1.2 The question of risk
• 1.3 The question of justice
• 2. Metadata and Algorithms
• 3. Cloud Computing

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• RIT Libraries
• LEAD 200 Dimensions for Ethical Leadership

Writing a Case Study Analysis

• Introduction
• About LEAD 200
• Course Textbook
• Ethical Dialogues
• Ethical Issues and Dilemmas
• Movies & Media
• Reference Works (Encyclopedias, Handbooks, Dictionaries)
• Article Databases
• APA Citation Style
• Presentation Preparation
• Self-Assessments
• Code of Ethics: Professions
• Using ethical concepts to analyze case studies
• A Guide to Writing an Ethical Reasoning
• How to Write an Ethics Paper
• How To Write a Case Study Step-by-Step
• How to Write a Case Study

Examples of Ethical Case Studies/Analyses

• Business Ethics Assignment: Case Analysis Of Johnson & Johnson And Ethical Leadership
• Case Study Application of an Ethical Decision-Making Process for a Fragility Hip Fracture Patient
• Case Study of an Ethical Dilemma
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Ethical Action in Global Research

Case examples.

• Global Research
• Ethical Stories

In reviewing case studies and examples brought to our workshops by researchers, it is clear that:

Ethical issues in global research are extremely complex.

Solutions are rarely simple or perfect. They need to be contextually relevant if they are to work.

It may be that a ‘fully worked’ solution is not clear but that parts of the solution will give enough traction to begin a process of resolution.

Different individuals and different groups often come to different conclusions. Both may follow a principled stance but make different justifiable choices at a number of decision-making points. Some solutions might be a better fit for different research teams, depending on the skills and expertise of each member.

Ethical decision making is more than following a set of rules. It should be about being open to exploring a range of possibilities, each of which may be ethical but may have different implications and may have different pragmatic constraints. 

Ethical issues emerge across all stages of the research journey and may change over time. 

Helpful questions in finding a solution include:

                     - What might have pre-empted the issue (this is relevant to future proofing)?

                     - What were the early warning signs?

                     - How could key issues be assessed once they have arisen?

                     - What should be the immediate response?

                     - What should be the follow-up response at each subsequent stage of the research journey?

Case Analysis Template

We have developed a template to help your team analyse ethical conflicts and look for solutions. This template highlights the importance of considering all phases of the research journey. It also highlights the importance of considering Place, People, Principles and Precedent both in the analysis and in the search for solutions.

Please see the case examples below. We do not claim that these examples are applicable to different contexts. We know that ethical conflicts need to be analyzed according to their own context. What works in one place can be disastrous in another.

Case Study 1

• Read more about Case Study 1

Case Study 2 and 3 (Paper: COVID-19)

In this paper we offered two case analyses  to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19.

The paper was published as: Clara Calia , Corinne Reid , Cristóbal Guerra , Abdul-Gafar Oshodi , Charles Marley , Action Amos , Paulina Barrera & Liz Grant (2020): Ethical challenges in the COVID-19 research context: a toolkit for supporting analysis and resolution, Ethics & Behavior, DOI: 10.1080/10508422.2020.1800469 

• Read more about Case Study 2 and 3 (Paper: COVID-19)

Case Study 4: Facing an ethical breach

• Read more about Case Study 4: Facing an ethical breach

Case Study 5: Protecting vulnerable groups (in English and Spanish)

Case 5 (en Español)    Case 5

• Read more about Case Study 5: Protecting vulnerable groups (in English and Spanish)

Case Study 6: Data interpretation and consent

• Read more about Case Study 6: Data interpretation and consent

Case Study 7: Consent

• Read more about Case Study 7: Consent

Case Study 8: Research project development and engaging communities

• Read more about Case Study 8: Research project development and engaging communities

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How should political actors behave? What is good representation? When is it appropriate to make a compromise? Is releasing confidential information ever justified? How do you change deeply entrenched social norms? Should you? These are just some of the questions raised by the teaching cases in this section, which ask students to consider the implications and ramifications of real-world ethical scenarios, with sources of conflict ranging from personal to structural dilemmas.

Through a New Lens: Physicians for Human Rights’ Photovoice Research with Kenyan Survivors of Sexual Violence

Publication Date: June 12, 2024

 In 2022, Physicians for Human Rights (PHR), a US- and Kenya-based non-governmental organization, was eager to evaluate the impact of a multi-year project to improve mental health services for survivors of sexual violence in Kenya. In doing...

Fallen Idol? Aung San Suu Kyi & the Rohingya Humanitarian Crisis Epilogue

Publication Date: January 25, 2024

This epilogue accompanies, "Fallen Idol? Aung San Suu Kyi & the Rohingya Humanitarian Crisis," HKS Case Number 2139.0. Soon after Myanmar’s longtime democracy crusader and opposition leader, Aung San Suu Kyi, was...

Climate Resilience in New York City: The Battle over East River Park

Publication Date: November 28, 2023

What makes climate change different as a policy challenge? Why is it so hard to solve? And how can we balance the need for the right technical solutions with the importance of having the process be as democratic and participatory as possible?The...

Reckoning with History: Confederate Monuments in American Cities Practitioner Guide

Publication Date: November 15, 2023

This practitioner guide accompanies case 2235.0. When the Reverend Clementa Pinckney and eight worshipers were massacred during bible study at the Emanuel African Methodist Episcopal church in Charleston, South Carolina in 2015, a widely...

Reckoning with History: Confederate Monuments in American Cities (Abridged)

This is an abridged version of case 2235.0. Abstract: When the Reverend Clementa Pinckney and eight worshipers were massacred during bible study at the Emanuel African Methodist Episcopal church in Charleston, South Carolina in 2015, a widely...

Reckoning with History: Confederate Monuments in American Cities

Publication Date: March 3, 2023

When the Reverend Clementa Pinckney and eight worshipers were massacred during bible study at the Emanuel African Methodist Episcopal church in Charleston, South Carolina in 2015, a widely circulated photograph showed Dylann Roof, the white...

Galvis City Schools Collective Bargaining Simulation

Publication Date: June 8, 2022

This is a seven-party exercise, with six negotiators and one facilitator. Representatives from a large school district and its affiliated teachers’ union must negotiate for three rounds. The Mayor serves as a facilitator and convening...

The Making of a Public Health Catastrophe: A Step-by-Step Guide to the Flint Water Crisis

Publication Date: January 12, 2022

The Flint water crisis, which began in 2014, is widely regarded as a textbook example of structural racism and injustice. This teaching case provides a close examination of the building blocks of the catastrophe, some all-too-familiar in...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA Practitioner Guide

Publication Date: October 8, 2020

This practitioner guide accompanies HKS Case 2191.0. In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA Epilogue

This epilogue accompanies HKS Case 2191.0. In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented immigrants in her...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA

In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented immigrants in her city. Oakland had been a “sanctuary...

Antanas Mockus: The Prohibition of Fireworks in Bogotá Sequel

Publication Date: October 10, 2019

In 1994, Antanas Mockus, an unlikely politician and former President of the prestigious National University of Colombia, became Bogotá’s first independent mayor, bringing with him a unique vision of harmonious citizenship. The...

Princeton Dialogues on AI and Ethics

Princeton University

Case Studies

Princeton Dialogues on AI and Ethics Case Studies

The development of artificial intelligence (AI) systems and their deployment in society gives rise to ethical dilemmas and hard questions. By situating ethical considerations in terms of real-world scenarios, case studies facilitate in-depth and multi-faceted explorations of complex philosophical questions about what is right, good and feasible. Case studies provide a useful jumping-off point for considering the various moral and practical trade-offs inherent in the study of practical ethics.

Case Study PDFs : The Princeton Dialogues on AI and Ethics has released six long-format case studies exploring issues at the intersection of AI, ethics and society. Three additional case studies are scheduled for release in spring 2019.

Methodology : The Princeton Dialogues on AI and Ethics case studies are unique in their adherence to five guiding principles: 1) empirical foundations, 2) broad accessibility, 3) interactiveness, 4) multiple viewpoints and 5) depth over brevity.

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• Code of Ethics
• Code of Ethics Case Studies

ACM Code of Ethics and Professional Conduct

Using the Code

Case studies.

The ACM Code of Ethics and Professional Practice (“the Code”) is meant to inform practice and education. It is useful as the conscience of the profession, but also for individual decision-making.

As prescribed by the Preamble of the Code, computing professionals should approach the dilemma with a holistic reading of the principles and evaluate the situation with thoughtful consideration to the circumstances. In all cases, the computing professional should defer to the public good as the paramount consideration. The analyses in the following cases highlight the intended interpretations of members of the 2018 Code task force, and should help guide computing professionals in how to apply the Code to various situations.

Case Study: Malware

Rogue Services touts its web hosting as “cheap, guaranteed uptime, no matter what.” While some of Rogue’s clients are independent web-based retailers, most are focused on malware and spam, which leverage Rogue for continuous delivery. Corrupted advertisements often link to code hosted on Rogue to exploit browser vulnerabilities to infect machines with ransomware. Rogue refuses to intervene with these services despite repeated requests.

Case Study: Medical Implants

Corazón is a medical technology startup that builds implantable heart health monitoring devices. After being approved by multiple countries’ medical device regulation agencies, Corazón quickly gained market share based on the ease of use of the app and the company’s vocal commitment to securing patients’ information. Corazón also worked with several charities to provide free or reduced access to patients living below the poverty line.

Case Study: Abusive Workplace Behavior

A new hire with the interactive technologies team, Diane became the target of team leader Max’s tirades when she committed a code update that introduced a timing glitch in a prototype shortly before a live demo. Diane approached the team’s manager, Jean, about Max’s abusive behavior. Jean agreed that the experience was unpleasant, but that was the price to pay for working in an intense, industry-leading team.

Case Study: Automated Active Response Weaponry

Q Industries is an international defense contractor specializing in autonomous vehicles. As an early pioneer in passive systems, such as bomb-defusing robots and crowd-monitoring drones, Q established itself as a vendor of choice for military and law enforcement applications. Q’s products have been deployed in a variety of settings, including conflict zones and nonviolent protests. Recently, however, Q has begun to experiment with automated active responses.

Case Study: Dark UX Patterns

The change request Stewart received was simple: replace the website’s rounded rectangle buttons with arrows, and adjust the color palette to one that mixes red and green text. But he found the prototype confusing. He suggested to his manager that this design would probably trick users into more expensive options they didn’t want. The response was that these were the changes requested by the client.

Case Study: Malicious Inputs to Content Filters

The U.S. Children’s Internet Protection Act (CIPA) mandates that public schools and libraries employ mechanisms to block inappropriate matter on the grounds that it is deemed harmful to minors. Blocker Plus is an automated Internet content filter designed to help these institutions comply with CIPA’s requirements. During a review session, the development team reviewed a number of complaints about content being blocked inappropriately.

Guiding Members with a Framework of Ethical Conduct

Learn more about ACM’s commitment to ethical standards: the ACM Code of Ethics, Software Engineering Code of Ethics and Professional Practice, and Committee on Professional Ethics (COPE), which is guiding these and other intiatives.

Ask an Ethicist

Ask an Ethicist invites ethics questions related to computing or technology. Have an interesting question, puzzle or conundrum? Submit yours via a form, and the ACM Committee on Professional Ethics (COPE) will answer a selection of them on the site.

Guidance in Addressing Real-World Ethical Challenges

The Integrity Project, created by ACM's Committee on Professional Ethics, is a series of resources designed to aid ethical decision making. It includes case studies demonstrating how the principles can be applied to specific ethical challenges, and an Ask an Ethicist advice column to help computing professionals navigate the sometimes challenging choices that can arise in the course of their work.

Supporting the Professionalism of ACM Members

The ACM Committee on Professional Ethics (COPE) is responsible for promoting ethical conduct among computing professionals by publicizing the Code of Ethics and by offering interpretations of the Code; planning and reviewing activities to educate membership in ethical decision making on issues of professional conduct; and reviewing and recommending updates to the Code of Ethics and its guidelines.

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• v.22(1); 2019 Mar

Case Study Application of an Ethical Decision-Making Process for a Fragility Hip Fracture Patient

In Canada, up to 32,000 older adults experience a fragility hip fracture. In Ontario, the Ministry of Health and Long Term Care has implemented strategies to reduce surgical wait times and improve outcomes in target areas. These best practice standards advocate for immediate surgical repair, within 48 hours of admission, in order to achieve optimal recovery outcomes. The majority of patients are good candidates for surgical repair; however, for some patients, given the risks of anesthetic and trauma of the operative procedure, surgery may not be the best choice. Patients and families face a difficult and hurried decision, often with no time to voice their concerns, or with little-to-no information on which to guide their choice. Similarly, health-care providers may experience moral distress or hesitancy to articulate other options, such as palliative care. Is every fragility fracture a candidate for surgery, no matter what the outcome? When is it right to discuss other options with the patient? This article examines a case study via an application of a framework for ethical decision-making.

INTRODUCTION

Every year, over 30,000 Canadian older adults experience a fragility hip fracture. The Ministry of Health and Long Term Care of Ontario has promoted best practice recommendations which advocate for immediate surgical repair, within 48 hours of admission, in order to achieve optimal recovery outcomes. ( 1 , 2 ) The majority of patients are good candidates for surgical repair; however, given the risks of anesthetic and trauma of the operative procedure, surgery may not be the best choice for all. The patients at higher risk of poor outcomes perioperatively deserve the opportunity to explore options and articulate their values. Unfortunately, as a short pre-operative interval predicts the best outcomes, patients and families face a difficult and hurried decision, potentially with limited time to voice their concerns, and little to no information on which to guide their decision.

From a systems perspective, quality of care and health outcomes have not always incorporated the patient-centred perspective. ( 3 ) Patient-centred care is “a moral concept and philosophy, considering it to be the right thing to do when designing and delivering respectful, humane, and ethical care”. ( 4 , 5 ) Patients and families have reported in the past that they feel left out of crucial conversations and decisions surrounding care, ( 6 ) and that relevant information is not always provided. ( 7 )

To better understand the underlying ethical complexities which arise from critical decisions in the acute care setting, this paper will examine a case study to demonstrate application of the Corey et al . ( 8 ) 8-step framework (see Appendix A ) for ethical decision-making.

Ms. Jones is 93 years old and lives in a Long Term Care residence. She was admitted to hospital with a fragility hip fracture after being found on the floor in the middle of the night. Ms. Jones has dementia and is unable to make her own decisions. She has limited mobility, previously used a walker. Her two daughters are at her bedside. They state her health has been declining over the last few weeks, with increasing confusion and she now rarely leaves her room.

On admission, the team discovered a pleural effusion, taking up much of her right lung. Her pre-operative assessment also revealed a heart murmur; the resulting echocardiogram demonstrated a heart in very poor condition, with significant valve issues. Between her cardiac and pulmonary function, the surgery poses an increased risk of perioperative complications—she may never survive the surgery, or come off of the ventilator once she is intubated.

Interprofessional teams (surgery, anesthesia, nursing) are of differing opinions. The issue at hand is very difficult. The family is informed that the risk of not having surgery will likely result in death, yet in this patient’s case, proceeding with surgery carries its own risk. The family is left with an hour to think things over. Should they pursue the palliative care route or proceed with surgery?

Step 1. Identify the Problem or Dilemma

In our case study, 93 year old Ms. Jones is admitted to hospital with a fragility hip fracture. As a first step, we must recognize that there is actually an ethical dilemma; in this case, the dilemma is whether the patient should proceed with surgery or not, given her underlying medical conditions and potential for perioperative complications. We also need to acknowledge that there is an underlying assumption from all involved (staff, Ms. Jones’ family) that surgery will occur, and that health-care providers (HCPs) may not clearly articulate the option of ‘no surgical intervention’. The stakeholders who are required to proceed through the decision-making process include the patient and family, the surgical team, anesthesia, nursing staff, social work, and potentially the palliative care team and bioethics team.

Step 2. Identify the Potential Issues Involved

There are several assumptions made when a patient presents to the hospital with a fragility hip fracture: a) the fracture will be repaired; b) the patient will recover; and c) the patient will eventually go home or to rehabilitation. With a critically ill, frail, and/or previously compromised patient, this standard trajectory should be questioned. Barry and Edgman-Levitan ( 9 ) promote an ideology of patient-centredness, with the argument that an intervention should only be considered standard if there is ‘virtual unanimity amongst patients about the overall desirability… of the outcomes’.

The first potential issue is the ‘standard’ intervention of surgical repair—the assumption to proceed with the surgery, as directed by best practice recommendations. Is this standard intervention appropriate in all patients with a fragility hip fracture? A second potential issue arises with the patient and their family—the presumption that the acute medical issue will be resolved and the patient will eventually return home. Given her underlying health, this concept is in jeopardy. To add to the complexity, Ms. Jones is likely not able to articulate her wishes and values, as she has dementia. Finally, there is the potential issue of moral distress experienced by health-care providers (HCPs) who feel uncomfortable with the expectant surgical trajectory of this patient, and may feel they are not empowered to advocate for the wishes of the patient.

As health-care professionals, we are guided by moral principles in our decision-making process, namely, autonomy, non-malfeasance, beneficence, justice, fidelity, and veracity. ( 10 ) A focused examination and application of the principles to the case study will help to support potential resolutions for the identified issues.

The spirit of ‘patient-centred care’ endorses that patients should be involved at their level of choice to make an autonomous decision. ( 11 ) However, it is important to recognize that no decision is made in isolation. ( 12 ) The decision at hand is not a simple or straightforward one; literature demonstrates that patients and families have a difficult time with making decisions at time of a critical illness, identifying fear, worthlessness, and a lack of autonomy within the hospital system. ( 7 ) Differing levels of patient and family participation requires an individualized approach to convey meaningful, accurate, and timely information. ( 8 ) Older adult patients tend to take a ‘non-participative’ stance in their care. They often have limited participation in the process for decision-making for a variety of reasons, thereby increasing the risk of their inability to understand or find value within the end decision. ( 6 , 7 , 13 )

Non-malfeasance

Hospitalization can cause the patient to experience “needless mental and physical suffering” ( 14 ) in any number of ways (i.e., pain, waiting for surgery, uncertainty of outcomes, patient/family relationship stress). Evidence indicates that the number of different HCPs involved causes immense anxiety to the family, especially when they do not hear the same message from all members of the team. ( 13 , 15 ) HCPs must ensure that they are not withholding information, or are untruthful as to the options in order to expedite a decision. A study by Ekdahl, Andersson, and Friedrichsen ( 13 ) found that physicians perceive they are ‘too short’ of time for patients to participate in the decision making process, that decisions were ‘too complex’ and ‘time consuming’ to fit into the schedule. Ekdahl et al. ( 13 ) also found that physicians feel frustration with the ‘health-care production machine’, especially in those older adult patients with multiple co-morbidities.

Beneficence

Beneficence promotes wellbeing; or is an action that is carried out to benefit another. ( 8 ) The hospitalization ‘process’ promotes assessment of a patient, treatment of the illness, followed by a physical approach to recovery (allowing recovery to be measured against specific milestones), and discharge in a timely manner. ( 15 , 16 ) This ‘process’ may promote beneficence in an overarching global perspective of the system; however, on an individual level, it often falls short. On an individual level, key actions that have been found to be beneficial and meaningful are open communication and sharing of information. ( 6 , 7 , 14 , 17 )

“Practitioners have a responsibility to provide appropriate services to all clients”. ( 8 ) Older adult patients may not receive information about options available, especially if the HCPs feel that it would take too much time to thoroughly explain, or if HCPs assume that patients are too ill to participate in the decision-making process, ( 13 ) or if the assumption is made that all patients want to proceed with surgery. Focusing on each older adult’s individual health goals is time-consuming—in this case, the patient has dementia, and a family meeting would be required. The concept of patient-centred care revolves around patient and HCP partnerships, yet older adult patients face unique problems with hospitalization—a slower communication process, a decreased level of functioning, and a degree of family involvement. ( 14 ) Can we provide this type of relationship and communication effort equally for every patient? Or only for those patients who may be at higher risk of negative outcomes?

Fidelity and Veracity

Fidelity involves fulfilling ones’ professional roles, creating a trusting relationship, and veracity ensures that we are truthful and honest to the patients. How do we ensure that as a HCP we are providing an unbiased opinion? Do we take the same amount of time to present patients with the option of conservative, non-surgical treatment, including palliative care, as we take to advocate for surgery? The HCP team assumes that patients will commit to surgery; however, a patient often displays a suboptimal understanding of the risks and benefits of surgery. ( 18 ) Similarly, there is the very real risk of bias towards an argument of palliative care in those frail patients or those with dementia. HCPs must return to the voice of the patient through their family, to understand that patients’ identity, their meaning of life, and desired goals which emphasize the patients’ dignity. ( 12 )

It is important to acknowledge assumptions that the patient and family may have made upon admission to hospital—that surgery will occur and the patient will recover. Have we presented the patient and their family with as much information as they need to make a decision in a clear format (without medical jargon)? In addition to understanding risks of surgery, it is paramount that the family understands the non-surgical option may result in death or decreased function (if any functional ability returns). It is in an acute situation such as this that families require truthful and open communication with physicians, nurses, and other members of the health-care team. ( 11 )

Self Care (HCPs)

Can we consistently provide care that prioritizes a patient’s values? HCPs are not always able to preserve all of the values and interests at stake. ( 19 ) We know that the most common cause of moral distress in nursing is prolonged, aggressive treatment which we do not believe will be likely to have a positive outcome. ( 20 ) As a HCP, we must look to root causes operating within the larger system, to prevent and/or respond to feelings of moral distress. ( 19 )

From a systems perspective, does the hospital provide an avenue for exploration of patient values within a timely fashion? Is there a framework in place to enhance the HCP’s understanding of moral distress and provide strategies for coping with situations such as these (i.e., an opportunity for a team debriefing with the entire team, or opportunities for learning how to deal with situations that may cause moral distress)?

Step 3. Review the Relevant Ethics Codes

The philosophy of patient-centred care within the hospital encourages active listening, respect, and an attempt to understand individuals. The Canadian Medical Association (CMA) supports “practicing the profession of medicine in a manner that treats the patient with dignity and as a person worthy of respect”. ( 21 ) The College of Nurses of Ontario (CNO) supports the view that nurses “must use the client’s views as a starting point”. ( 22 ) Across all HCPs is the similarity of the need to listen, understand, support, and advocate for a respect of patients’ values with the expected course of treatment.

The importance of collaboration with the patient and respecting a patient’s values are highlighted within similar statements: ”…it is the patient who ultimately must make informed choices about the care he or she will receive”. ( 21 )

Step 4. Know the Applicable Laws and Regulations

In Ontario, legislation and common law require that the wishes of patients or substitute decision-makers be respected. ( 22 ) However, in many systems, health care is not truly patient-centred; rather, patients are required to adapt to the system. ( 11 ) A number of initiatives have been undertaken in the last few years in an attempt to improve the focus of patient-centredness, with the principle assertion that patients should be involved at the level of their choice. ( 11 )

Step 5. Obtain Consultation

It is important to realize that we bring our own biases to the decision-making process, making it difficult to view the current patient/family’s situation objectively. As an individual HCP, our previous experiences will have an impact on the messaging that we provide. From a systems perspective, we are likely to pose a ‘knowledge’ bias towards meeting treatment based outcomes—for example, surgery within 48 hours, immediate post-operative mobility, and the expected length of stay for this type of patient.

Inter-disciplinary consultations with patients and their families ensure review of unbiased information about the risks and benefits of proceeding with surgery, allowing for a fully informed decision. In addition to discussing the operative plan with the surgical team, there is an opportunity to provide Ms. Jones’ family with other options that may be available to her. Consultation with extended family members, clergy, social workers, or an ethics team may help the family to reflect on the patient values; what this illness means to them as a family unit, and how best to proceed. A discussion with palliative care may help the family to better understand what symptom management consists of for their mother. Social work may also be able help explore community services available to the family in this situation—for example, is the patient able to return to home with the future of wheelchair dependence? Are there any other options which may be available to this patient and her family that were not originally considered? How do we, as HCPs, ensure that the family is afforded the opportunity to obtain all the necessary information from differing disciplines to make an informed choice?

Step 6. Consider Possible and Probable Courses of Action

In order to fully understand the options, it is helpful to outline all the possible and probable courses of action that are open to Ms. Jones and her family.

• Surgical team offers a ‘purposeful pause’ to discover Ms. Jones’ core values; to discuss the consequences of a) delaying surgery, b) proceeding with surgery, and c) the non-surgical intervention. From an ethical and legal perspective, this may meet the concept of patient-centred care, but does not likely provide the patient and her family with all the information they need to make an informed choice. They may have more questions that the surgical team may not be able to answer, or they may request more time to consider. Additionally, the patient and her family would still be expected to adapt to the system in place in order to make a decision within the proposed wait time frame (admission to surgery less than 48 hours).
• Advocate for a family meeting with the primary nurse, social work, palliative care team, clergy, internal medicine, in addition to the surgical (surgeon, anesthesia) team, to fully explore both options, and to explore what the ‘non-surgical’ option would mean. From a legal and ethical perspective this embodies the concept of patient-centred care, with as many members of the health-care team at the table to help Ms. Jones’ family fully explore their options.
• Apply the current standard of care recommendations to Ms. Jones’ situation, without consideration of the patient’s needs, values, or preferences. From an ethical and legal perspective, this approach does not represent patient-centred care.

Step 7. Enumerate the Consequences of Various Decisions

With the first option, the surgical team takes a ‘purposeful pause’ to discover the patient’s core values and discusses pros and cons of a surgical intervention. Often, this may be most ‘efficient’ way to deal with the situation at hand. It may also be the preference of the patient; some patients have reported that they value this limited level of involvement—“I get a description of what is going to happen”. ( 13 ) As a consequence, there will be a number of patients who will want to have a greater sense of involvement other than a simple description of planned events. The first option does recognize the principle of autonomy, but does not follow the principle of justice; practitioners have the responsibility to provide information about other options which may be available. The principles of beneficence and non-maleficence are not completely met, as the team approaches the solution primarily to benefit the system (i.e., efficiency). The principles of fidelity and veracity are also partially met, as the surgical team provides an honest perspective, although it may be biased towards proceeding with surgery.

The second option, offering the patient and her family a meeting with all stakeholders, strongly aligns with the fidelity and veracity principles. The information offered is truthful and complete, and is in Ms. Jones’ best interest, as it attempts to discover her values that will affect the family’s final decision. Principles of beneficence and autonomy would be met with patient empowerment through information sharing, and secondly, by allowing the patient and family to arrive at their own decision with that information. As a consequence, taking the time to arrange for a family meeting with all stakeholders may not be possible for all patients, and the principles of justice and non-maleficence are brought to the forefront for future patients. A potential consequence could be harm to the patient, as the time it takes to arrange a meeting could push the time to surgery beyond the recommended 48 hours post-admission, placing the patient at greater risk of negative post-operative outcomes.

The third option is one of passive action, with a lack of communication and recognition of patient-centred care values. Ms. Jones would be placed on the operating room list, and the surgical repair will occur. Consent must legally be obtained for the surgery; however, the family may not think of key questions to ask that may be relevant in this situation. The onus remains on the HCP to provide a full explanation of all options to the family. The only benefit would be to the system, as the procedure will be carried out in a timely manner. Ms. Jones may benefit from the surgery; we cannot assume that surgery is a negative option. As a consequence of this option, HCPs do not explore patient values, and this option is against almost all of the ethical principles. Additionally, this option is likely to cause the highest moral distress amongst staff, as they are unable to meet the unique needs of Ms. Jones and her family.

Step 8. Choose what Appears to be the Best Course of Action

Virtue ethics asks us if we are doing the best action for our patients, and compels us to be conscious of our behaviours. ( 8 ) We need to take the necessary time to discover the patient’s values within the unique situation they are now experiencing. Simply stated, we need to remember that they are a person, with feelings, emotions, past experiences, future hopes/plans, and usually an element of fear and anxiety. The goal is to work with Ms. Jones and her family to decide together on the current care plan and the best plan for action (or inaction), a plan that truly aligns with the patient’s values.

From an ethical perspective, the best course of action is to hold a family meeting with all stakeholders to discover Ms. Jones’ values about a meaningful life and a meaningful death, and come to a consensus as to what the right decision is for this patient. ( 12 ) The team must ensure that the patient and the family have all the necessary tools in which to make this decision. Have we provided them with all the information required? Do they understand the information? Do they understand the consequences of their decision? From a systems perspective, we need to continue to strive towards engaging patients and family members more fully and consistently in care and decision-making processes. ( 6 ) Dissemination of lessons learned from assisting patients and families through difficult decision-making may be helpful to other health-care teams experiencing similar moral conflicts.

As a next step, the HCP team may consider development of an educational reference for future patients to assist with similar decisions, including promotion of an advanced care plan to help communicate goals and concerns to HCPs. ( 12 , 18 ) Additionally, decision aids, such as videos and brochures, can help deliver information to patients and their families. ( 9 ) The use of readily available technology, such as iPads and cellphones, means that families are better able to access these materials at any time of day. A recent Cochrane Review demonstrated that, in comparison to usual care, decision aids can increase knowledge, resulting in a higher proportion of patients choosing the option which most aligns with their values. ( 23 ) Providing patients with information that outlines potential options with risks and benefits clearly explained can also meet many of the ethical principles that are to be considered with ethical decision-making.

The in-depth review of the case study has helped us to examine the underlying issues that come into play when helping this patient and her family to make a critical decision. Although each patient is an individual, literature tells us that many perceive the concept of patient-centredness to represent an ‘involvement in their care’. The level of involvement may vary from person to person, but all patients want the care they receive to reflect their values and preferences, and to make them feel that they have been treated as a whole person. ( 24 )

Clinicians also like to believe that they deliver patient-centred care, yet the characterization of the concept will vary with the health-care provider, their relationship with the patient, and the circumstances surrounding the admission to hospital. Recognizing that there is potential for an ethical dilemma when patients present with a critical illness is important to ensure that we continue to act upon the key concept of understanding a patients’ values and proceeding to align provision of care with those values.

ACKNOWLEDGEMENTS

The author wishes to acknowledge Dr. Tracy Trothen (Queen’s University) for her time and expertise as a ‘practical ethicist’.

Appendix AFramework for Ethical Decision-Making (Corey et al ., 2014)

• Identify the problem or dilemma
• Identify the potential issues involved
• Review the relevant ethics codes
• Know the applicable laws and regulations
• Obtain consultation
• Consider possible and probable courses of action
• Enumerate the consequences of various decisions
• Choose what appears to be the best course of action

CONFLICT OF INTEREST DISCLOSURES

The author declares that no conflicts of interest exist.

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This material is based upon work supported by the National Science Foundation under Award No. 2055332. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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A, Distribution of reports of SSNHL by week of vaccination and time to onset after vaccination. The rate of SSNHL reports per 100 000 vaccine doses (blue line) is overlaid. B, Mean age of people reporting SSNHL to VAERS according to the time period reported who met the definition of probable SSNHL (n = 555). Note that the weekly time periods are identical in A and B. VAERS indicates Vaccine Adverse Events Reporting System.

A, Includes 555 cases reported to the VAERS database that met the definition of probable SSNHL during the period examined. B, Includes 21 patients in multi-institutional case series. The x-axis extends to only 15 days after vaccination because no new cases were observed after day 15. VAERS indicates Vaccine Adverse Events Reporting System.

eTable 1. Representative Examples of VAERS Incident Reports Meeting Criteria for Probable SSNHL Compared With Those Unlikely to Represent True SSNHL

eTable 2. Rate of SSNHL Reports in VAERS by Vaccine Manufacturer

eFigure 1. Scattergrams of Pretreatment and Posttreatment Hearing Results

eFigure 2. Audiogram Revealing Unilateral Sensorineural Hearing Loss Occurring 14 Days After Each of 2 COVID-19 Vaccine Doses in 1 Patient

eFigure 3. Number of People in the US With at Least 1 COVID-19 Vaccine Dose According to Age Group at 3 Points During the Initial COVID-19 Vaccination Rollout

• Studies Examine Risk of Hearing Loss After COVID-19 Vaccination JAMA News From the JAMA Network May 3, 2022 Anita Slomski
• Association Between COVID-19 Vaccine and Sudden Sensorineural Hearing Loss JAMA Otolaryngology–Head & Neck Surgery Original Investigation April 1, 2022 This cohort study of patients in Israel assesses whether the BNT162b2 messenger RNA COVID-19 vaccine is associated with sudden sensorineural hearing loss. Yoav Yanir, MD; Ilana Doweck, MD; Rana Shibli, MD, MPH; Ronza Najjar-Debbiny, MD; Walid Saliba, MD, MPH
• Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited—An Ongoing Conversation—Reply JAMA Otolaryngology–Head & Neck Surgery Comment & Response August 1, 2022 Eric J. Formeister, MD, MS; Daniel Q. Sun, MD
• Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited—Reply JAMA Otolaryngology–Head & Neck Surgery Comment & Response August 1, 2022 Yoav Yanir, MD, MPH; Ilana Doweck, MD; Walid Saliba, MD, MPH
• Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited JAMA Otolaryngology–Head & Neck Surgery Comment & Response August 1, 2022 Selena E. Briggs, MD, PhD, MBA; Michael J. Brenner, MD; Sujana S. Chandrasekhar, MD
• Error in Data JAMA Otolaryngology–Head & Neck Surgery Correction November 1, 2022
• Hearing Loss After COVID-19 Vaccination Does Not Outweigh Vaccine Benefit JAMA Otolaryngology–Head & Neck Surgery Invited Commentary April 1, 2022 Angela K. Ulrich, PhD, MPH; Maria E. Sundaram, PhD, MSPH; Michael T. Osterholm, PhD, MPH

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Formeister EJ , Wu MJ , Chari DA, et al. Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination. JAMA Otolaryngol Head Neck Surg. 2022;148(4):307–315. doi:10.1001/jamaoto.2021.4414

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Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination

• 1 Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
• 2 Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts
• 3 Department of Otolaryngology–Head and Neck Surgery, University of Massachusetts School of Medicine, Worcester, Massachusetts
• 4 Anne Arundel Ear, Nose, and Throat Surgery, Annapolis, Maryland
• Invited Commentary Hearing Loss After COVID-19 Vaccination Does Not Outweigh Vaccine Benefit Angela K. Ulrich, PhD, MPH; Maria E. Sundaram, PhD, MSPH; Michael T. Osterholm, PhD, MPH JAMA Otolaryngology–Head & Neck Surgery
• News From the JAMA Network Studies Examine Risk of Hearing Loss After COVID-19 Vaccination Anita Slomski JAMA
• Original Investigation Association Between COVID-19 Vaccine and Sudden Sensorineural Hearing Loss Yoav Yanir, MD; Ilana Doweck, MD; Rana Shibli, MD, MPH; Ronza Najjar-Debbiny, MD; Walid Saliba, MD, MPH JAMA Otolaryngology–Head & Neck Surgery
• Comment & Response Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited—An Ongoing Conversation—Reply Eric J. Formeister, MD, MS; Daniel Q. Sun, MD JAMA Otolaryngology–Head & Neck Surgery
• Comment & Response Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited—Reply Yoav Yanir, MD, MPH; Ilana Doweck, MD; Walid Saliba, MD, MPH JAMA Otolaryngology–Head & Neck Surgery
• Comment & Response Sudden Sensorineural Hearing Loss and COVID-19 Vaccination Revisited Selena E. Briggs, MD, PhD, MBA; Michael J. Brenner, MD; Sujana S. Chandrasekhar, MD JAMA Otolaryngology–Head & Neck Surgery
• Correction Error in Data JAMA Otolaryngology–Head & Neck Surgery

Question   Is COVID-19 vaccination associated with sudden sensorineural hearing loss (SSNHL)?

Findings   In this cross-sectional study and case series involving 555 cases of SSNHL among adults reported to the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System, no increase in the rate of hearing loss after COVID-19 vaccination was found compared with the incidence in the general population. Assessment of 21 adult patients who presented to tertiary care centers with SSNHL after COVID-19 vaccination did not reveal any apparent associations with respect to clinical or demographic factors.

Meaning   These results suggest that there is no association between vaccination and the development of SSNHL among adults who received a COVID-19 vaccine.

Importance   Emerging reports of sudden sensorineural hearing loss (SSNHL) after COVID-19 vaccination within the otolaryngological community and the public have raised concern about a possible association between COVID-19 vaccination and the development of SSNHL.

Objective   To examine the potential association between COVID-19 vaccination and SSNHL.

Design, Setting, and Participants   This cross-sectional study and case series involved an up-to-date population-based analysis of 555 incident reports of probable SSNHL in the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System (VAERS) over the first 7 months of the US vaccination campaign (December 14, 2020, through July 16, 2021). In addition, data from a multi-institutional retrospective case series of 21 patients who developed SSNHL after COVID-19 vaccination were analyzed. The study included all adults experiencing SSNHL within 3 weeks of COVID-19 vaccination who submitted reports to VAERS and consecutive adult patients presenting to 2 tertiary care centers and 1 community practice in the US who were diagnosed with SSNHL within 3 weeks of COVID-19 vaccination.

Exposures   Receipt of a COVID-19 vaccine produced by any of the 3 vaccine manufacturers (Pfizer-BioNTech, Moderna, or Janssen/Johnson & Johnson) used in the US.

Main Outcomes and Measures   Incidence of reports of SSNHL after COVID-19 vaccination recorded in VAERS and clinical characteristics of adult patients presenting with SSNHL after COVID-19 vaccination.

Results   A total of 555 incident reports in VAERS (mean patient age, 54 years [range, 15-93 years]; 305 women [55.0%]; data on race and ethnicity not available in VAERS) met the definition of probable SSNHL (mean time to onset, 6 days [range, 0-21 days]) over the period investigated, representing an annualized incidence estimate of 0.6 to 28.0 cases of SSNHL per 100 000 people per year. The rate of incident reports of SSNHL was similar across all 3 vaccine manufacturers (0.16 cases per 100 000 doses for both Pfizer-BioNTech and Moderna vaccines, and 0.22 cases per 100 000 doses for Janssen/Johnson & Johnson vaccine). The case series included 21 patients (mean age, 61 years [range, 23-92 years]; 13 women [61.9%]) with SSNHL, with a mean time to onset of 6 days (range, 0-15 days). Patients were heterogeneous with respect to clinical and demographic characteristics. Preexisting autoimmune disease was present in 6 patients (28.6%). Of the 14 patients with posttreatment audiometric data, 8 (57.1%) experienced improvement after receiving treatment. One patient experienced SSNHL 14 days after receiving each dose of the Pfizer-BioNTech vaccine.

Conclusions and Relevance   In this cross-sectional study, findings from an updated analysis of VAERS data and a case series of patients who experienced SSNHL after COVID-19 vaccination did not suggest an association between COVID-19 vaccination and an increased incidence of hearing loss compared with the expected incidence in the general population.

Anecdotal reports of sudden sensorineural hearing loss (SSNHL) occurring after COVID-19 vaccination have emerged in otolaryngologic professional societies and have important public health implications. Tinnitus, dizziness, and vertigo have also been reported within 2 weeks of vaccination in a recent single-institution case series. 1 Otolaryngologists encounter increasing challenges to promoting public health conduct recommended during the pandemic when they are counseling and evaluating patients who have developed SSNHL and reported a temporal association with COVID-19 vaccination.

Other large-scale vaccination campaigns, such as those for the measles-mumps-rubella and influenza vaccines, have previously been investigated after anecdotal reports of SSNHL emerged among vaccinated individuals. In each campaign, epidemiologic studies 2 , 3 did not show an association between vaccination and SSNHL. Although data from similar epidemiologic studies are not yet available for COVID-19 vaccination, a preliminary analysis 4 of incident reports from the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) during the early phase of public COVID-19 vaccination did not identify an association between vaccination and SSNHL. However, as vaccination campaigns have expanded across the US and currently include vaccines from 3 manufacturers (Pfizer-BioNTech [BNT162b2], Moderna [mRNA-1273], and Janssen/Johnson & Johnson [Ad26.COV2.S]), questions remain regarding whether an association exists between COVID-19 vaccination and SSNHL. In addition, VAERS does not provide detailed patient-level clinical data that may be valuable in evaluating specific patient cofactors.

The purposes of the present study were to (1) extend the preliminary incidence estimate of SSNHL after COVID-19 vaccination 4 to the present phase of vaccination across 3 manufacturers and (2) examine whether emerging patterns in VAERS incident reports suggest an association between COVID-19 vaccination and SSNHL. In addition, we sought to augment this public database evaluation with an in-depth analysis of clinical characteristics among a multi-institutional series of patients who presented with confirmed SSNHL after COVID-19 vaccination.

This study was approved by the institutional review boards of Johns Hopkins University School of Medicine and the Massachusetts Eye and Ear Infirmary/Harvard Medical School. Because the VAERS records review obtained data from a publicly available deidentified database, this portion of the study was deemed exempt from review; similarly, the case series was deemed exempt because the patients’ files did not contain identifiable data.

The study was performed in 2 phases. In the first phase, VAERS was queried for reports of SSNHL after COVID-19 vaccination between December 14, 2020, and July 16, 2021. Cases deemed to represent probable SSNHL were compiled for analysis using previously dfescribed methods. 4 In brief, the search terms sudden hearing loss , deafness , deafness neurosensory , deafness unilateral , deafness bilateral , and hypoacusis were selected as adverse events (AEs) for data extraction. Because multiple symptoms could be selected for each incident report, deduplication was performed to ensure there was only 1 unique VAERS identification number per report. Narratives and laboratory data from all reports were reviewed to assess the likelihood of a report representing probable SSNHL. Inclusion criteria for probable SSNHL consisted of a temporal association with COVID-19 vaccination (defined as onset within 21 days after vaccination) and a high credibility of reporting. A report was deemed credible if it could demonstrate at least 1 of the following: (1) reference to an audiographic test result confirming hearing loss, (2) evaluation by an otolaryngologist, audiologist, or other physician resulting in a diagnosis of sudden hearing loss, or (3) evaluation by an otolaryngologist resulting in treatment with systemic steroid or intratympanic steroid medications, performance of magnetic resonance imaging, or any combination thereof. Incident reports were excluded if they did not reference evaluation by a physician or audiologist leading to a diagnosis of hearing loss, did not contain details within the report or laboratory results section to indicate that a diagnosis of sudden hearing loss was provided (eg, no mention of audiologic testing, no receipt of systemic or intratympanic steroid medications, or no magnetic resonance imaging scan), or indicated that hearing loss onset occurred more than 21 days after vaccination. In addition, reports that described the discovery of an alternative origin for hearing loss (eg, vestibular schwannoma or stroke) were excluded. Examples of narratives and their classifications are shown in eTable 1 in the Supplement .

The number of vaccine doses administered in the US during the study period was obtained from the CDC. 5 An incidence estimate of probable SSNHL on a per-person basis during the study period was obtained and annualized. To account for intrinsic uncertainties, such as the number of unique individuals receiving a vaccine relative to the number of doses administered, the true case numbers of SSNHL based on VAERS incident reports, and potential underreporting bias in VAERS, we conducted a sensitivity analysis that adjusted these assumptions to achieve a range estimate of the incidence of SSNHL. The maximum incidence estimate was produced based on the assumptions that (1) all reports submitted to VAERS represented true cases of SSNHL (eTable 1 in the Supplement ); (2) the number of reports submitted to VAERS was likely subject to a 50% underreporting bias based on previous studies of VAERS sensitivity for rare AEs, such as Guillain-Barré syndrome and anaphylaxis 6 ; and (3) each vaccinated individual received 2 doses, resulting in the smallest possible population size given the number of vaccine doses administered (ie, the highest possible incidence).

Because VAERS reports are unverified and lack detailed clinical data, 6 an in-depth record review of a multi-institutional consecutive series of all adult patients with audiometrically confirmed SSNHL after COVID-19 vaccination was performed in the second phase of the study. The study sites comprised 2 large academic neurotologic centers and 1 community otolaryngological practice. Cases were included if audiometrically confirmed SSNHL occurred within 3 weeks of vaccination and was contemporaneous with VAERS reports of SSNHL (ie, occurring between January 1 and June 30, 2021). Patients with a history of Ménière disease were excluded.

Reports of SSNHL were exported from VAERS into Excel software, version 16.57 (Microsoft Corporation). Simple descriptive statistics (means, ranges, and percentages) were calculated using this software for both the VAERS reports and the case series.

Between December 14, 2020, and July 16, 2021, 185 424 899 COVID-19 vaccine doses were administered in the US across the 3 manufacturers. 5 After deduplication, 2170 VAERS reports of hearing loss based on search criteria and occurring within 21 days of vaccination were extracted and compiled. In total, 555 of the 2170 reports met our definition of probable SSNHL. A total of 305 incidents (55.0%) occurred among women, and 250 incidents (45.0%) occurred among men, with a mean age of 54 years (range, 15-93 years) ( Table 1 ). Data on race and ethnicity were not available in VAERS. Overall, 305 incidents (55.0%) involved the Pfizer-BioNTech vaccine, 222 (40.0%) involved the Moderna vaccine, and 28 (5.0%) involved the Janssen/Johnson & Johnson vaccine.

A sensitivity analysis was then performed to estimate the incidence range on an annualized basis, revealing 0.6 to 28.0 cases of SSNHL per 100 000 people per year ( Table 2 ). In comparison, the annual incidence of idiopathic SSNHL was estimated to be 11 to 77 cases per 100 000 people per year, depending on age. 7 Because speculation has occurred regarding the novel lipid nanoparticle delivery vehicle and the messenger RNA (mRNA) technologies that underlie the Moderna and Pfizer-BioNTech vaccines, we next investigated whether vaccines produced by these 2 manufacturers accounted for a disproportionate number of reports of SSNHL. A total of 186.88 million doses of the Pfizer-BioNTech vaccine were administered, 136.48 million doses of the Moderna vaccine were administered, and 12.97 million doses of the Janssen/Johnson & Johnson vaccine were administered over the period examined. The VAERS reporting rate of probable SSNHL was similar across manufacturers, with 0.16 cases per 100 000 doses administered for both the Pfizer-BioNTech and Moderna vaccines, and 0.22 cases per 100 000 doses administered for the Janssen/Johnson & Johnson vaccine (eTable 2 in the Supplement ).

To further investigate whether reports of SSNHL were associated with COVID-19 vaccination, we examined the total number of reports of the condition submitted to VAERS over each weekly period from the beginning of the public vaccination campaign ( Figure 1 A). The number of submitted reports peaked in the last week of March 2021, which corresponded to the largest number of vaccine doses (16 177 521) administered during a 1-week period since the vaccination campaign began. 5 However, over each weekly period, the relative number of SSNHL reports decreased when accounting for the number of doses administered nationally, from 1.10 reports per 100 000 doses at the beginning of the campaign in December 2020 to 0.01 reports per 100 000 doses by June 2021.

Because the risk of idiopathic SSNHL is highly dependent on age, 7 we specifically examined the mean ages of patients who submitted reports of probable SSNHL, which remained relatively stable over the study period (eg, mean age, 45.9 years [range, 34.0-79.0 years] in December 2020 and 41.6 years [range, 19.0-54.0 years] in June 2021) ( Figure 1 B). We also estimated the age of the overall vaccinated population using publicly available data from the CDC 8 (eFigure 3 in the Supplement ). In the early phases of the vaccination campaign, no preponderance of older individuals (who may have been at higher risk of idiopathic SSNHL) receiving vaccine doses was apparent. In addition, in the later phases of the campaign, no preponderance of younger individuals (who may have been at lower risk of idiopathic SSNHL) was seen.

We then evaluated the possible temporal association between COVID-19 vaccination and the onset of idiopathic SSNHL as documented in VAERS incident reports ( Figure 2 A). The mean time to onset of SSNHL was 6 days (range, 0-21 days), with the highest incidence occurring at 0 days (70 reports), 1 day (104 reports), and 2 days (72 reports) after vaccination and a smaller second peak occurring at 7 days (38 reports) after vaccination.

To better understand the clinical profiles of patients who reported SSNHL after COVID-19 vaccination, we examined the detailed clinical characteristics of patients with confirmed hearing loss occurring after COVID-19 vaccination in a multi-institutional case series. A total of 21 patients were identified across study sites, with a mean age of 61 years (range, 23-92 years; 13 women [61.9%]). Demographic, clinical, and audiometric characteristics of patients are shown in Table 3 . Six patients (28.6%) had a history of autoimmune disease, including eczema, episcleritis, Hashimoto thyroiditis, multiple sclerosis, and rheumatoid arthritis. The mean time to onset of SSNHL was 6 days (range, 0-15 days) after vaccination, with the highest number of cases (6) occurring at 7 days after vaccination ( Figure 2 B). Overall, 18 of 21 patients (85.7%) received treatment; of those, 9 patients (50.0%) received intratympanic steroids, 5 (27.8%) received oral corticosteroids, and 4 (22.2%) received both. No adjuvant therapies were prescribed. Complete posttreatment audiometric data were available for 14 patients, 8 of whom (57.1%) experienced audiometric improvement ( Table 3 ; eFigure 1 in the Supplement ).

One patient without any history of Ménière disease or autoimmune inner ear disease experienced new-onset low-frequency (250-500 Hz) SSNHL at 14 days after the first vaccine dose; the condition improved with oral and intratympanic steroid treatment but worsened again at 14 days after the second vaccine dose (15-dB threshold increase in hearing loss at 500 Hz) (eFigure 2 in the Supplement ).

This comprehensive cross-sectional study of CDC VAERS reports of SSNHL after COVID-19 vaccination during the first 7 months of the national vaccination campaign included 185 million doses across all 3 manufacturers. Although VAERS reports contain raw data that are unverified, they present a national snapshot of potential AEs occurring after vaccination. Our analysis found that, based on VAERS reports, the estimated incidence of SSNHL after COVID-19 vaccination did not exceed the reported incidence of idiopathic SSNHL in the general population. 7 Furthermore, despite the novel delivery vehicle and immunologic mechanism of the mRNA-based vaccines manufactured by Pfizer-BioNTech and Moderna, we did not find an increased reporting rate of SSNHL associated with lipid nanoparticle mRNA vaccines compared with the adenoviral platform used in the Janssen/Johnson & Johnson vaccine.

We also hypothesized that if an association existed between COVID-19 vaccination and SSNHL, we would find an association between the number of reports of SSNHL submitted to VAERS and the number of vaccine doses administered. However, we found the rate of reports per 100 000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week ( Figure 1 A).

We also tested the hypothesis that the increased rate of reports of SSNHL in the initial vaccination phase could be associated with older individuals being vaccinated first 9 ; our analysis of the mean ages of people reporting SSNHL after vaccination to VAERS ( Figure 1 B) and the CDC COVID-19 tracking data on the number of individuals vaccinated in each age group over time (eFigure 3 in the Supplement ) did not support this hypothesis. Given that health care professionals were also included in the first phase of vaccination, one might assume that this group would be more attuned to AEs and more likely to report SSNHL; however, the relative number of health care professionals who initially experienced SSNHL was impossible to ascertain based on VAERS data. Taken together, these data suggest that an association between COVID-19 vaccination and SSNHL during the first 7 months of vaccination was unlikely at the population level.

Because VAERS incident reports lack clinical detail, conclusions regarding specific risk factors associated with SSNHL after COVID-19 vaccination cannot be reached. Narrative information within VAERS is self-reported and highly variable, ranging from no information on medical history to detailed information on both medical history and medication use. Thus, we assessed the clinical characteristics of patients with confirmed SSNHL at 3 large otolaryngological practices. The demographic and clinical characteristics of patients examined in our multi-institutional case series ( Table 3 ) did not clearly identify any specific cofactors among those experiencing SSNHL after vaccination, and patient characteristics appeared similar to the highly heterogeneous profiles observed among those with idiopathic SSNHL and those included in case series conducted at other institutions. 1 A previous study suggested that autoimmune disease may increase the risk of idiopathic SSNHL, 10 and we observed that autoimmune disease was present in 28.6% of the 21 patients in the case series reporting SSNHL after COVID-19 vaccination. Autoimmune disease as a risk factor for SSNHL with or without vaccination remains speculative, and further research is needed.

Both the mRNA payload and the lipid nanoparticle delivery vehicle have been suggested to be potential mechanisms of autoimmunogenicity. 11 Notably, the patient in the case series who reported having normal hearing before vaccination (no prevaccination audiometric data were available) and no history of autoimmune disease ( Table 3 ) was found to have low-frequency unilateral SSNHL at 14 days after the first vaccine dose. The patient received treatment with a course of oral steroid medication and experienced partial recovery of hearing; however, the patient subsequently reported new hearing deficit at 14 days after the second vaccine dose and was found to have a 15-dB threshold increase in hearing loss at 500 Hz (eFigure 2 in the Supplement ). Although not meeting the American Academy of Otolaryngology–Head and Neck Surgery criteria for SSNHL, 12 the observed audiometric changes were nonetheless concerning. Sudden sensorineural hearing loss after each COVID-19 vaccine dose was also reported among 3 patients in a recent case series, although 2 of those 3 patients had autoimmune inner ear disease, Ménière disease, or both. 1 Thus, our findings suggested that although no association between COVID-19 vaccination and SSNHL was found at the population level, an association among some individuals cannot be excluded without further research.

We also considered the timing of SSNHL after COVID-19 vaccination because this timing may have offered insight into the mechanistic basis of any potential biological association. For instance, Wichova et al 1 hypothesized that otologic symptoms, such as dizziness or SSNHL occurring 10 to 14 days after vaccination, could coincide with the production of immunoglobulin G at 10 to 14 days after vaccine administration. In both the national VAERS reports and our multi-institutional case series, we found that the mean time to onset of SSNHL was 6 days, with the highest incidence at 0 to 2 days and 7 days after vaccination ( Figure 2 A and B). These temporal patterns were consistent with the timing of onset for other COVID-19 vaccine–associated AEs, such as myocarditis (2-4 days) 13 - 15 and vaccine-induced immune thrombotic thrombocytopenia (7-10 days). 16 In a large epidemiologic study, Baxter et al 3 reported that the mean time to onset of reported SSNHL after influenza vaccination was also 2 days.

Observed peaks in reports of SSNHL at 1 and 7 days after vaccination in both VAERS and our case series could be partly accounted for by recall bias, which has been well documented in studies of passive vaccine AE reporting. 17 , 18 For example, an analysis of AEs associated with the hepatitis B vaccine, in which patient self-reports were cross-referenced with specific vaccination records, found substantial recall bias that produced an inaccurate association between vaccination and the development of multiple sclerosis. 19 The VAERS data may have been especially sensitive to recall bias because a substantial number of reports were submitted in a delayed manner, sometimes weeks to months after the onset of SSNHL. In particular, it is possible that patients, or health care professionals reporting on their behalf, may have estimated “about 1 day” or “about 1 week” when asked about the timing to onset of hearing loss because these are intuitive intervals for estimation. Bias in the perception of vaccine-associated AEs has substantial implications for an individual’s decision to receive a vaccine, as Betsch et al 20 reported in a study of a simulated online social network. Participants in that study were more likely to overestimate true vaccine-associated AE rates if presented with narratives from others that suggested a higher risk of experiencing a vaccine-associated AE, and they were subsequently less likely to receive a vaccine. 20 Notably, narrative information included in reports of AEs was more meaningful in influencing participants’ decisions to receive a vaccine than were statistical summaries. 20

Similar to recommendations provided by other reports of AE clusters, including cerebral venous sinus thrombosis 21 and myocarditis, 13 - 15 after COVID-19 vaccination, long-term epidemiologic and vaccine safety studies supported by mechanistic research are needed to more definitively address any potential association between COVID-19 vaccination and SSNHL. Reports of recovery of SARS-CoV-2 RNA in the middle ear of individuals who died of COVID-19 22 and recent findings of the ability of SARS-CoV-2 to directly infect human vestibular hair and Schwann cells 23 provide plausible biological mechanisms for COVID-19–associated hearing loss and may open avenues of investigation into immune mechanisms in the inner ear.

This study has several limitations. One limitation of the case series is its lack of a comparison group (eg, a group of patients who did not receive a COVID-19 vaccine but experienced SSNHL within the same period examined). Nonetheless, the detailed patient data in this series may serve as a supplement to the national patterns identified through analysis of SSNHL reports in the VAERS database.

Although an important tool for systematic vaccine safety studies, 24 the VAERS incident reports used in the present study are not yet verified by the CDC and therefore need to be interpreted with caution. We specifically focused on SSNHL, which is a well-defined clinical condition with a known population-level incidence, in contrast to other otolaryngological conditions, such as tinnitus or Ménière disease. To account for inherent uncertainties associated with raw report data, we developed a standardized case definition for probable SSNHL to identify the most credible incident reports. Few data exist to guide selection of the risk interval for SSNHL after vaccination. The 3-week interval used in the present study was designed to be longer than the primary interval used in previous studies 3 to balance considerations of temporal association with the risk of overexclusion.

It was also not possible to apply American Academy of Otolaryngology–Head and Neck Surgery criteria for SSNHL (loss of 30 dB over 3 consecutive frequencies) 12 to VAERS reports given the lack of numerical audiometric testing results contained within those reports. Using a sensitivity analysis, the maximum incidence estimate was produced based on the assumptions that (1) all submitted reports represented true SSNHL, which was unlikely (eTable 1 in the Supplement ), and (2) reports were subject to an additional 50% underreporting bias based on previous studies of VAERS sensitivity to detect rare AEs, such as Guillain-Barré syndrome and anaphylaxis. 6 Therefore, our calculated maximum incidence is likely an overestimate of the true incidence of SSNHL, especially given that our 3-week time to onset interval was substantially longer than the interval of 0 to 72 hours endorsed by the American Academy of Otolaryngology–Head and Neck Surgery. 12 In the absence of incident report verification and large-scale vaccine safety studies using verified reports, the estimation strategies used in this study nonetheless provide a snapshot and a potential tool that can be used by otolaryngologists challenged by this difficult clinical issue and its important public health implications.

This cross-sectional study and case series used an up-to-date analysis of VAERS case reports during the first 7 months of the US COVID-19 vaccination campaign across 3 vaccine manufacturers along with retrospective data from a series of patients with confirmed SSNHL, finding no population-level association between COVID-19 vaccination and SSNHL. Assessment of verified cases of SSNHL revealed heterogeneity in patient demographic characteristics, risk factors, and audiologic patterns. Further prospective investigation is needed to identify any potential associations between COVID-19 vaccination and SSNHL in some individuals. It is important that clinicians report all suspected COVID-19 vaccine–associated AEs rigorously and accurately to VAERS to allow verification and future performance of systematic vaccine safety studies.

Accepted for Publication: January 3, 2022.

Published Online: February 24, 2022. doi:10.1001/jamaoto.2021.4414

Corresponding Author: Eric J. Formeister, MD, MS, Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, 601 N Caroline St, 6th Floor, Baltimore, MD 21287 ( [email protected] ).

Author Contributions: Drs Formeister and Sun had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Galaiya, Kozin, and Sun contributed equally.

Concept and design: Formeister, Wu, Chari, Rauch, Remenschneider, Quesnel, Stewart, Galaiya, Kozin, Sun.

Acquisition, analysis, or interpretation of data: Formeister, Wu, Chari, Meek, Rauch, Remenschneider, Quesnel, de Venecia, Lee, Chien, Stewart, Kozin, Sun.

Drafting of the manuscript: Formeister, Wu, Chari, Stewart, Kozin, Sun.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Formeister, Wu, Sun.

Obtained funding: Sun.

Administrative, technical, or material support: Wu, Chari, Meek, Remenschneider, de Venecia, Galaiya, Sun.

Supervision: Chari, Remenschneider, Quesnel, Chien, Stewart, Galaiya, Kozin, Sun.

Conflict of Interest Disclosures: Dr Lee reported receiving personal fees from 3NT Medical and income and personal fees from Frequency Therapeutics outside the submitted work. Dr Quesnel reported receiving grants from Frequency Therapeutics and Grace Medical and personal fees from Frequency Therapeutics, and owning a patent for a protective drape to mitigate aerosol spread during otologic surgery (licensed to Grace Medical) outside the submitted work. No other disclosures were reported.

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A counterfactual analysis quantifying the COVID-19 vaccination impact in Sweden

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Background Vaccination was the single most effective measure in mitigating the impact of the COVID-19 pandemic. Our study aims to quantify the impact of vaccination programmes during this initial year of vaccination by estimating the number of case fatalities avoided, having Sweden as a case study.

Methods Using Swedish data on age-specific reported incidence, vaccination uptake, and contact structures, along with age-specific estimates on the vaccine efficacies and under-reporting from the literature, we fit a Bayesian SEIR epidemic model with time-varying community contact rate β ( t ) for COVID-19 incidence. By adding age-specific infection fatality rates, we obtain an estimate of about 5,540 (95% PI: 5,390-5,690) for the number of case fatalities from the fitted model. This estimate aligns closely with the reported 5,430 case fatalities during the same period. We then use the estimated contact rate β ( t ) in a counterfactual analysis where the population is unvaccinated, leading to more infections and fatalities.

Findings The counterfactual analysis result in a severe epidemic outbreak during the early autumn of 2021, resulting in about 52,600 (49,900-55,500) number of case fatalities. Consequently, the number of lives saved by the vaccination program is estimated to be about 47,100 (44,500-49,800), out of which 6,460 are directly saved and 40,600 are indirectly saved, mainly by drastically reducing the severe outbreak in the early autumn of 2021, which would have occurred without vaccination and unchanged community contact rate.

Interpretation Our mathematical model is used to analyze the impact of COVID-19 vaccination on lives saved in Sweden during 2021, but the same methodology can be applied to other countries. The counterfactual analysis offers insights into an alternative trajectory of the pandemic without vaccination. By incorporating estimated vaccination-related parameters, age-specific infection fatality ratio and under-reporting, our model estimates the number of case fatalities avoided. The results not only show the direct impact of vaccination on reducing deaths for infected individuals but also shed light on the indirect effects of reduced transmission dynamics.

Funding NordForsk (project number 105572).

Evidence before this study Vaccination against COVID-19 has been proven to reduce infection rates, hospitalizations, and mortality. Observational studies and clinical trials have demonstrated the efficacy COVID-19 vaccines, and mathematical modeling studies have been conducted to predict the potential outcomes of vaccination programmes under different scenarios. These models have provided insights into the benefits of achieving high vaccination coverage and the consequences of delays or interruptions in vaccine distribution. There remains a gap in analyses that quantify the impact of the vaccination programme in Sweden by comparing actual outcomes with a scenario without vaccination. This study aims to fill this gap by employing a robust counterfactual analysis method to provide a clearer picture of the COVID-19 vaccination impact in Sweden. This approach offers a understanding of the impact of vaccination by isolating the effects of the vaccination from other interventions. For our literature review, we have searched PubMed for “vaccination counterfactual analysis”, “SEIR model vaccination impact”, “quantifying effect of COVID-19 vaccination” and “COVID-19 IFR”. The Swedish Public Health Agency has provided country-specific data for Sweden.

Added value of this study The Bayesian SEIR model presented in this paper provides a flexible and data-driven framework to assess the effectiveness of vaccination strategies. Using age- and country-specific data and parameters on reported cases, under-reporting and infection fatality rate (IFR), we can quantify the effect of vaccination in Sweden 2021. This study compares the case fatalities in a factual analysis with a counterfactual analysis, which has the same contact rates but with a unvaccinated population. The comparison allows an estimate of the number of lives saved from the vaccination. The methodology can be used to evaluate the effect of vaccination in other countries, but also for other counterfactual scenarios such as different vaccination schemes.

Implications of all the available evidence Our findings highlight the critical role of vaccination in mitigating COVID-19-related mortality. Through the counterfactual analysis provided by the SEIR epidemic model, we gain insights into the effects of vaccination programmes. Beyond reducing deaths directly attributable to COVID-19 infection vaccination also exerts a broader societal impact by curbing transmission rates and easing strain on healthcare systems. Moreover, by quantifying the number of lives saved through vaccination efforts, we offer policymakers and public health officials invaluable data for optimizing future vaccination strategies and reinforcing the importance of widespread vaccine uptake. The insights gained from this study not only show the effectiveness of vaccination in saving lives but also provide a robust framework of a data-driven approach to guide evidence-based decision-making and shaping vaccination policies.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

NordForsk (project number 105572).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Data used for our analysis were publicly avaliable prior to the initialisation of this study. COVID-19 case data and vaccination is avaliable from the Swedish public health agency (PHA): https://www.folkhalsomyndigheten.se/sm ittskydd-beredskap/utbrott/aktuella-utbrott/covid-19/statistik-och-analyser/ Report on Infection fatality rate from the PHA: https://www.folkhalsomyndigheten.se/contentassets/da0321b738ee4f0686d758e069e18caa/skattning-letalitet-covid-19-stockholms-lan.pdf/. Demographics for Sweden is avalable from Statistics Sweden: https://www.scb.se/hitta-statistik/sverige-i-siffror/manniskorna-i-sverige/befolkningspyramid-for-sverige/

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

↵ * Felix Günther changed affiliation after his work on this project and now works at the Department of Infectious Disease Epidemiology, Robert Koch Institute, Germany.

Data Availability

All data used for our analysis are available online at https://github.com/fannybergstrom/vaccination_sweden/

https://www.folkhalsomyndigheten.se/smittskydd-beredskap/utbrott/aktuella-utbrott/covid-19/statistik-och-analyser/

https://www.folkhalsomyndigheten.se/contentassets/da0321b738ee4f0686d758e069e18caa/skattning-letalitet-covid-19-stockholms-lan.pdf/

https://www.scb.se/hitta-statistik/sverige-i-siffror/manniskorna-i-sverige/befolkningspyramid-for-sverige/

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Hydrogeochemical Study and Geospatial Analysis of Water Quality Using GIS based Water Index and Multivariate Statistics in Kombolcha City, Ethiopia

• Published: 26 August 2024
• Volume 235 , article number  637 , ( 2024 )

Cite this article

• Anteneh Yayeh Adamu   ORCID: orcid.org/0000-0002-5500-2180 1 ,
• Asmare Belay Nigussie 1 &
• Asnake Enawgaw Amognehegn 1  

The study was carried out to evaluate hydro geochemistry and the risk of groundwater and surface water pollution in the Kombolcha area. To achieve this, hydrogeochemical analysis, water heavy metal, geospatial data analysis, correlation matrix, principal component analysis, Heavy metal Pollution Index (HPI), and Water Quality Index (WQI) methodologies were employed. A total of 36 samples (both water and effluent samples) had been collected and assessed for major physicochemical variables and heavy metals. Hydrogeochemical methods showed groundwater mineralization due to (1) silicate weathering, (2) cation exchange processes, and (3) anthropogenic sources (i.e., contaminated discharge of sulphate, carbonate, and trace metal effluents). The study result revealed that major ions dominating the area are Ca 2+  > Na +  > Mg 2+  > K + , HCO3 −  > SO 2−  > Cl −  > NO3 − , and Fe > Mn > Pb > Cr > Cd for cations, anions and trace metals respectively with all heavy netals had mean concentrations above the WHO recommended limits. Calculated Pollution indices revealed 50.7% of the sample belongs to a low level of pollution, while 35% and 14.3% belong to a medium and high level of pollution respectively which consequently translating the area into high groundwater pollution zones. The correlation matrix revealed that no significant correlation exists between the water quality variables (Cl and NO3 − with Fe, Pb, Cr, Mn, and Cd). PCA was applied on the data set to identify the spatial sources of pollution in groundwater and in the first principal component analysis, Mn, Fe, Cr, Pb, and Cd (in descending order) were found in amounts greater than 0.5, confirming that these metals were from anthropogenic sources. The combined assessments based on WQI and HPI, the study showed that water samples in the proximity of industrial sites are polluted by factories effluent and uncontrolled waste disposal due to urbanization.

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The data used in this study are primary and available after the author’s laboratory analysis.

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Acknowledgements

We thank Wollo University, Kombolcha Institute of Technology (KIoT) for supporting and facilitating in this study and Dr. Sileshi from Department of Geology, School of Earth Sciences, Bahir Dar University for his revising work.

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Anteneh Yayeh Adamu, Asmare Belay Nigussie & Asnake Enawgaw Amognehegn

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The study conception, design, material preparation, data collection, laboratory analysis and original draft of the manuscript were performed by A.Y.A. A.B.N and A.E.A involved in writing, reviewing and editing the manuscript. All authors read and approved the final manuscript.

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Appendix 1: Source-rock deduction summary from (Piper, 1944)

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Adamu, A.Y., Nigussie, A.B. & Amognehegn, A.E. Hydrogeochemical Study and Geospatial Analysis of Water Quality Using GIS based Water Index and Multivariate Statistics in Kombolcha City, Ethiopia. Water Air Soil Pollut 235 , 637 (2024). https://doi.org/10.1007/s11270-024-07438-1

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