example of research ethics violation

Human Research Violations By UCSD Eye Doctor Showcase A National Problem

Tens of millions of people have volunteered their time and bodies to help create breakthroughs in medicine. You see the results with the pain relievers in your medicine cabinet, the vaccines that protect you from disease, the pacemakers that keep your heart beating and the innovations happening now with stem cells.

Yet the systems meant to protect those volunteers from harm are far from perfect, and research violations by Dr. Kang Zhang , an eye doctor at the University of California San Diego, show just how easily that well-intentioned framework can collapse.

Zhang is the chief of eye genetics at UCSD and has a lab named after him at the university. He receives millions of dollars in federal grants and presents at symposiums around the world.

A few years ago, he helped develop a way to remove cataracts from infants and regenerate their lenses using their own stem cells. He also built a tool that scanned over a million patient records and diagnosed illnesses with more than 90% accuracy.

But several of Zhang’s studies were riddled with violations of basic human research standards. A U.S. Food and Drug Administration warning in 2017 and a UCSD audit that followed reveal a pattern that put patients in harm’s way for years.

The 56-year-old doctor enrolled people he shouldn’t have for his medical trials, failed to document what happened to 25 units of a study drug, performed HIV tests on participants without their permission, kept poor records on his patients and didn’t complete necessary ethics training for a stem cell study.

When asked by the FDA to create a plan to prevent more violations from happening in the future, Zhang didn’t provide one.

“There ought to be some serious penalties for this sort of thing,” said Spencer Hey, a Harvard Medical School expert in biomedical research ethics.

inewsource reached out to Zhang, the director of the eye institute where he works and the director of UCSD’s human research protection program for interviews. In response, UCSD sent a statement that said the university had “implemented a comprehensive management plan to address these issues” and suspended Zhang indefinitely from serving as a primary researcher overseeing human research studies at UCSD. He may continue to apply for federal grants, publish in medical journals and train the next generation of scientists.

UCSD later told inewsource , “Zhang’s research had undergone multiple audits since 2012,” which prompted his suspension. When asked if that meant the university had known about Zhang’s violations for five years before taking action, a UCSD spokeswoman would not comment further.

After speaking with five ethics experts for this story, it appears Zhang’s violations — and what happened after they were discovered — are symptomatic of larger problems impacting the field of human subject research in the U.S. Those include patchwork oversight and poor communication between watchdog agencies, a lack of transparency and dialogue with the public, and a combination of money and prestige that sometimes safeguard an institution’s reputation more than patient welfare.

“Science is accelerating always,” said Stacey Springs , Harvard University’s research integrity officer. “But it feels that it’s accelerating in ways that are pushing on regulatory compliance like never before. So we really need to focus now, and learn from each other, and apply these best practices – because it's coming fast.”

An early warning

Zhang received his medical degree and doctorate in genetics from Harvard, then taught at Johns Hopkins University and the University of Utah before founding UCSD’s Institute for Genomic Medicine in 2009.

His accomplishments have landed him on CBS’ “60 Minutes” and in The New York Times, The Wall Street Journal and the Los Angeles Times. He’s received dozens of honors from national and international associations and universities, published or co-authored more than 100 peer-reviewed manuscripts in top journals and recruited human research subjects from around the world – including from the San Diego VA and UCSD’s Shiley Eye Institute on the La Jolla campus.

It was during Zhang’s time at the institute, in the summer of 2016, when the FDA inspected one of his ongoing human trials to ensure the “rights, safety, and welfare” of his patients were protected.

For five years, Zhang had been testing a drug to reverse the effects of a common age-related eye disease. He received approval to enroll patients whose vision had already started to decline – to see if the drug could restore their sight.

Zhang’s research team injected ranibizumab once a month into each test subject’s eyes, 12 times total for each patient. The drug can produce side effects that include eye haemorrhages, pain, inflammation and spots in a field of vision. In rare cases, it can prompt serious cataracts or blindness.

The FDA letter prompted UCSD to suspend enrollment in all of Zhang’s active research projects at the time, pending the results of an internal audit.

Amy Caruso Brown is an assistant professor of bioethics, humanities and pediatrics at New York’s Upstate Medical University. She also is a member of an institutional review board – a safety committee that approves and oversees projects like Zhang’s.

Brown spoke to inewsource after reading the UCSD audit and said, “I have not seen this number of issues in the five years that I've been on an IRB.”Twelve people had participated in the study by the time the FDA stepped in and found five of them were ineligible because they didn’t have the vision problems Zhang outlined for participants. Another patient’s eyesight wasn’t correctly evaluated before the person was injected with the drug.

“If it had been one out of a hundred, we could probably chalk that up to an error that doesn’t reflect a pattern of misconduct,” said Michael Carome , a former associate director at the U.S. Office for Human Research Protections, one of many federal agencies that protects human research subjects.

“But to enroll half the subjects not meeting enrollment criteria – that is more than just an occasional error. That suggests something systematically wrong with how they’re doing the research,” said Carome, who spent years investigating these kind of violations while at the agency.

He left the Office for Human Research Protections in 2010 during a decade of decline, when the office all but stopped using its enforcement tools in favor of “a more friendly approach toward institutions,” he said.

Carome is now a director of the health research group at Public Citizen , a consumer advocacy nonprofit based in Washington, D.C.

He told inewsource that research on otherwise healthy patients needs to be performed carefully, because they aren’t sick enough to justify taking chances.

“Both from a scientific standpoint and ethical human subjects standpoint, not complying with the enrollment criteria is a big deal,” Carome said, calling the guidelines “crucial in terms of ensuring that human subjects are protected.”

The FDA agreed. It issued Zhang a warning letter in January 2017 that called out his use of ineligible patients and his failure to perform required screenings and procedures, poor recordkeeping and lack of documentation about what happened to 25 units of the unused study drug (which Zhang said were destroyed).

Though not mentioned in the letter, the UCSD audit that followed said Zhang also enrolled patients while the study was suspended.

The FDA uses warning letters to document serious research problems and mandate corrective actions. Three times in the letter, it told Zhang his actions raised “concerns about the validity and integrity of the data collected,” and three times it told Zhang he didn’t have an adequate plan to keep his patients safe moving forward.

“We are unable to undertake an informed evaluation of your written response because you did not provide a corrective action plan that, if properly carried out, would prevent this type of violation in the future,” the FDA wrote.

The study was eventually shut down, and inewsource could find no articles published based on the research.

‘Major league science’

Zhang’s work at UCSD should be viewed in context.

He is one of more than 1,600 faculty members in the schools of medicine and pharmacy, one part of a healthcare system at a university ranked among the top research institutions in the country.

UCSD secured $1.2 billion in sponsored research support in 2018 – with $686 million going toward UC Health Sciences – and had more than 7,000 patients participating in clinical trials. Its scientists have made breakthroughs in diabetes research, understanding cancer genes, identifying early signs of autism and treating Alzheimer’s disease. It counts 16 Nobel laureates among current and former faculty.

All of that makes UCSD’s investigation of Zhang unique. The university has published 249 internal audits since July 2010, and the Zhang report is the only one inewsource could find specific to an individual researcher.

Auditors reviewed Zhang’s training records, enrollment logs, regulatory binders and files for ongoing projects that had enrolled human research patients. They found problems everywhere they looked: Zhang failed to get the proper consent from all patients; didn’t report problems to UCSD’s institutional review board; lost documents; kept inaccurate records; wrongly billed patients; and didn’t complete the training required to work with human embryonic stem cells.

In one study, Zhang’s staff tested patients’ blood for HIV and AIDS without telling them, against federal policy.

“He’s lucky there weren’t any major patient harms,” Brown said. ”But if you act like this all the time, eventually you will hurt someone.”

The auditors found Zhang’s actions may have “negatively impacted the rights, welfare, and safety of human subjects in clinical research.” One of his studies, sponsored by the California Institute for Regenerative Medicine , collected tissue from donors with blinding eye disease for a stem cell bank. California voters created the institute in 2004 to fund this type of research.

The study’s rules stated no one under 50 years old was allowed to enroll. UCSD audited files for 50 of the more than 400 patients and found seven were too young, including a minor.

Carome, the former federal director, laughed when he read that section.

“That’s not a subtle mistake,” he said.

Another finding noted the importance of “credible and valid data” when describing a study that was missing 25 of 50 patient progress reports.

“This isn’t minor league stuff. This is major league science,” said Hey, the Harvard bioethicist, who added, “this sort of pattern should raise questions about the validity of (Zhang’s) published work.”

Zhang did publish a correction in January, but not for a study included in the audit. It involved gene editing in animals, and Zhang’s paper said UCSD supervised and approved the research. That wasn’t true – it was overseen by a university and medical center in China.

inewsource couldn’t find any published articles based on the six studies reviewed by the FDA and UCSD. Yet during the audits and study suspensions, Zhang is listed as having continued a genetics research project at the San Diego VA, which did result in 10 published articles.

UCSD doctors often work as attending physi cians at the San Diego VA and share funding, research samples, data and lab space. The VA Hospital is less than a mile from the Shiley Eye Institute and on the same campus. Yet the VA said it was never notified of the UCSD or FDA reports until inewsource asked about them in March.

A VA spokeswoman would not answer questions about whether Zhang was still practicing at the VA, enrolling patients in trials or proposing new research at the institution. The San Diego VA has one of the largest research programs in the national VA network.

Nor were other related federal or state regulators notified. That includes the federal Office for Human Research Protections, which protects research subjects from harm; the National Institutes of Health , which funds many of Zhang’s studies; the Office of Research Integrity, which oversees research misconduct cases; or the California State Medical Board, which gave Zhang a license to practice medicine.

“Communication is fraught with complexity in compliance matters,” said Springs, Harvard’s research integrity officer. Things sometimes happen on a need-to-know basis, she said, and confidentiality plays a big part.

But, she said, “If there are active studies and participants are in danger, the confidentiality is out the window.”

Symptoms of a larger problem

Picture the framework for protecting research subjects as a house.

The foundation consists of a study, planned with sound scientific and ethical principles, and a responsible, ethical researcher. If and when things go wrong or change, they are communicated and addressed immediately. That didn’t happen in this case.

Institutional review boards, the first floor, are often composed of expert volunteers who spend countless hours poring over hundreds of pages of research protocols, guidelines and regulations while also working their regular jobs. They rely on researchers to keep them updated, alert them to problems and speak the truth, but they may also have the power and responsibility to audit ongoing studies. It’s often a proactive system, but it wasn’t in Zhang’s case.

And the institutional review board system is “vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud,” according to an undercover federal investigation from 2009.

Higher-ups at an institution – the second floor – may have reasons and methods to keep violations quiet and away from public scrutiny. The Zhang audit is a perfect example: It was published more than two years ago but didn’t reach the VA across campus, never made the news, and likely wouldn’t have shocked anyone who stumbled upon it because it never named Zhang as the researcher under scrutiny. The only place his name appears is on the report’s cover page – as one of 16 people copied on its transmittal within the UC system, including UCSD’s chief ethics and compliance officer, vice chancellors, various directors and others.

“It doesn’t look good for the university to be calling out these high-profile faculty for these kinds of violations and making a big deal out of it and applying sanctions, because that’s not the kind of attention you want to draw to your researchers,” Harvard’s Hey said.

Problems with internal probes

An opinion article published by three ethics experts last year in The Journal of the American Medical Association said when internal investigations are completed, the reports are often not standardized, not peer-reviewed, have limited oversight and contain conflicts of interest. “Even when institutions act, the information they release to the public is often limited and unhelpful,” they wrote.

Calling out lucrative researchers can also result in lost funding. Last fiscal year, federal agencies including the National Institutes of Health, National Science Foundation and U.S. Department of Defense gave UCSD $681 million in research funding. UCSD prides itself on how much grant money flows its way each year and has defended that stream aggressively: It sued the University of Southern California in 2015 for poaching one of its most lucrative researchers.

And as quickly as those funding agencies give, they can take away – or even require repayment if serious violations happened using taxpayer dollars.

At the very top of the house, the roof is made up of agencies that regulate human subject protection across the country. The big one – the Office for Human Research Protections – protects those involved in research funded or conducted by the U.S. Health and Human Services Department. It can investigate allegations of wrongdoing but often does not, choosing instead to refer investigations back to the institutions themselves. It can also revoke an entire institution’s ability to perform human research, though that hasn’t happened since 2007.

At Harvard, Springs said she often uses these agencies as a lever in talks with researchers to get them to understand and follow rules. She said the patchwork of institutional, academic and statewide regulations can be messy, so there’s a hope that the feds will act consistently, “because they really are the heavy in these conversations.”

But, she added, “Then they aren't predictable, and you're like, ‘Wow, OK. So they have these enforcement mechanisms and they're not using them. Or they're using them selectively.’”

The Office for Human Research Protections never took action in the Zhang case, which isn’t surprising for two reasons. One, they weren’t informed by the FDA or UCSD of his violations. Two, the agency has drastically cut down on enforcement over the past decade.

For example, it charged institutions with investigating misconduct allegations 94 times in 2002. In 2015, it did that three times. For the same period, the agency went from issuing 146 “determination letters” – an important tool for communicating findings of misconduct – to issuing five.

It’s not due to a lack of funding or a drop in complaints. In fact, institutional misconduct reports sent to the office jumped 400 percent from 2002 to 2014.

Carome said his former agency’s current leadership is “less interested in issuing harsh findings and embarrassing institutions.”

The problem with that, he said, is enforcement actions are “one of the more important tools the office has to change behavior.”

The Office of Research Integrity , another federal agency that oversees research misconduct investigations, has also been criticized for slowing its enforcement. It recently went nearly 10 months without issuing a single finding of research misconduct, though the agency has since stepped up its actions.

One medical ethicist quoted in an industry publication in 2017 called the lack of oversight by the Office of Research Integrity and the Office for Human Research Protections “nothing short of appalling.”

Even if oversight agencies were operating at full speed, a lack of transparency and data sharing would still be major flaws in safeguarding patients that could rip the roof apart.

Compliance data at the Office for Human Research Protections is kept in-house and offline, and getting at it requires a public records request, weeks to months of wait time and then skilled data analysis. The California Medical Board publishes doctor information online , but it’s more concerned with things like medical malpractice judgments, physician substance abuse and negligence in the course of routine health care than monitoring human research and clinical trials. Its database isn’t designed to incorporate audit findings, FDA warning letters or federal databases.

Academic investigations – at least in California – are kept far from Google’s reach, and typically require a public records request and the knowledge they exist. The same goes for institutional review board investigations, reviews and audits.

And none of these systems communicate with each other in any meaningful way.

Carome added one more problem plaguing the field: “Much noncompliance goes undetected or unnoticed.”

Zhang’s audit likely would have gone unnoticed if inewsource weren’t digging into the risks associated with human research, yet Springs said this may prove an opportunity for UCSD.

“When these cases emerge in the press, or people come to hear about them in some way, it highlights our failures – and that should happen,” she said.

But even then, Springs said, it doesn’t always “turn into constructive discussion and dialogue around how we can fix it.”

Audits like Zhang’s are often unintelligible to the community, to patients enrolled and even to academics, even though they are the people who should be providing feedback and criticism, she said.

“These are opportunities where we can actually promote transparency,” she said, “and say, ‘Hey, this is what happened. This is how we approached it,’ and model effective dialogue with communities on how we can work better on this.”

Correction: An earlier version of this story cited a 2017 industry publication that said the Office of Research Integrity had gone a year without making a research misconduct finding. Since the story published, the office has clarified that it went nine months and 21 days without a finding of research misconduct between 2016 and 2017.

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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Annual Review of Ethics Case Studies

What are research ethics cases.

For additional information, please visit Resources for Research Ethics Education

Research Ethics Cases are a tool for discussing scientific integrity. Cases are designed to confront the readers with a specific problem that does not lend itself to easy answers. By providing a focus for discussion, cases help staff involved in research to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for dealing with hard problems on their own.

Research Ethics Cases for Use by the NIH Community

• Theme 23 – Authorship, Collaborations, and Mentoring (2023)
• Theme 22 – Use of Human Biospecimens and Informed Consent (2022)
• Theme 21 – Science Under Pressure (2021)
• Theme 20 – Data, Project and Lab Management, and Communication (2020)
• Theme 19 – Civility, Harassment and Inappropriate Conduct (2019)
• Theme 18 – Implicit and Explicit Biases in the Research Setting (2018)
• Theme 17 – Socially Responsible Science (2017)
• Theme 16 – Research Reproducibility (2016)
• Theme 15 – Authorship and Collaborative Science (2015)
• Theme 14 – Differentiating Between Honest Discourse and Research Misconduct and Introduction to Enhancing Reproducibility (2014)
• Theme 13 – Data Management, Whistleblowers, and Nepotism (2013)
• Theme 12 – Mentoring (2012)
• Theme 11 – Authorship (2011)
• Theme 10 – Science and Social Responsibility, continued (2010)
• Theme 9 – Science and Social Responsibility - Dual Use Research (2009)
• Theme 8 – Borrowing - Is It Plagiarism? (2008)
• Theme 7 – Data Management and Scientific Misconduct (2007)
• Theme 6 – Ethical Ambiguities (2006)
• Theme 5 – Data Management (2005)
• Theme 4 – Collaborative Science (2004)
• Theme 3 – Mentoring (2003)
• Theme 2 – Authorship (2002)
• Theme 1 – Scientific Misconduct (2001)

For Facilitators Leading Case Discussion

For the sake of time and clarity of purpose, it is essential that one individual have responsibility for leading the group discussion. As a minimum, this responsibility should include:

• Reading the case aloud.
• Defining, and re-defining as needed, the questions to be answered.
• Encouraging discussion that is “on topic”.
• Discouraging discussion that is “off topic”.
• Keeping the pace of discussion appropriate to the time available.
• Eliciting contributions from all members of the discussion group.
• Summarizing both majority and minority opinions at the end of the discussion.

How Should Cases be Analyzed?

Many of the skills necessary to analyze case studies can become tools for responding to real world problems. Cases, like the real world, contain uncertainties and ambiguities. Readers are encouraged to identify key issues, make assumptions as needed, and articulate options for resolution. In addition to the specific questions accompanying each case, readers should consider the following questions:

• Who are the affected parties (individuals, institutions, a field, society) in this situation?
• What interest(s) (material, financial, ethical, other) does each party have in the situation? Which interests are in conflict?
• Were the actions taken by each of the affected parties acceptable (ethical, legal, moral, or common sense)? If not, are there circumstances under which those actions would have been acceptable? Who should impose what sanction(s)?
• What other courses of action are open to each of the affected parties? What is the likely outcome of each course of action?
• For each party involved, what course of action would you take, and why?
• What actions could have been taken to avoid the conflict?

Is There a Right Answer?

Acceptable solutions.

Most problems will have several acceptable solutions or answers, but it will not always be the case that a perfect solution can be found. At times, even the best solution will still have some unsatisfactory consequences.

Unacceptable Solutions

While more than one acceptable solution may be possible, not all solutions are acceptable. For example, obvious violations of specific rules and regulations or of generally accepted standards of conduct would typically be unacceptable. However, it is also plausible that blind adherence to accepted rules or standards would sometimes be an unacceptable course of action.

Ethical Decision-Making

It should be noted that ethical decision-making is a process rather than a specific correct answer. In this sense, unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct.

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Japanese hospital uncovers flood of research ethics violations

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A brain and heart hospital and research centre in Japan has found 158 cases of studies being done in violation of ethics standards since 2013.

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Research: We Should Speak Up About Ethical Violations More Often

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Those who are vocal about little infractions are six times more likely to be vocal about the big ones.

Whistle-blowing reveals not just acute misdeeds, but chronic and longstanding patterns of misconduct. For example, Edward Snowden’s bombshell release of more than 200,000 documents revealed questionable government surveillance programs that existed for years. Miami Dolphins player Jonathan Martin withdrew from play, alleging more than a year of emotional abuse from teammate Richie Incognito. These high-profile cases are just a few examples of what happens in organizations large and small every day.

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O’Toole, Kathleen. "The Stanford Prison Experiment: Still powerful after all these years." Stanford University News Service 8 (1997): 1797.

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Violation of ethical principles in clinical research. Influences and possible solutions for Latin America

• Borys Alberto Cornejo Moreno 1 &
• Gress Marissell Gómez Arteaga 2  

BMC Medical Ethics volume  13 , Article number:  35 ( 2012 ) Cite this article

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Even though we are now well into the 21st century and notwithstanding all the abuse to individuals involved in clinical studies that has been documented throughout History, fundamental ethical principles continue to be violated in one way or another.

Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials: paternalism, improper use of informed consent, lack of strict ethical supervision, pressure exerted by health institutions to increase the production of scientific material, and the absence of legislation regarding ethics in terms of health care and research. Are researchers ready to respect fundamental ethical principles in light of the ample window of information provided by individual genomes, while defending the rights of the subjects participating in clinical studies as a major priority?

As one of the possible solutions to this problem, education regarding fundamental ethical principles is suggested for participants in research studies as an initial method of cognitive training in ethics, together with the promotion of ethical behavior in order to encourage the adoption of reasonable policies in the field of values, attitudes and behavior.

Peer Review reports

Ethical principles such as autonomy, beneficence, nonmaleficence and justice [ 1 ] are useful for both researchers and participants in a clinical trial as an overarching frame of reference. They are also helpful for making decisions concerning each individual case, as a means of avoiding abusive situations in experimental processes that involve human beings. Nevertheless, close supervision of both researchers and research subjects is necessary to achieve compliance with ethical principles.

Unfortunately, some of the populations that are most exposed to abuse are vulnerable groups (i.e. confined or chronically ill individuals, elderly patients, pregnant women, single mothers, economically disadvantaged populations), whose main weakness is a latent need to be treated, receive medical care or be assisted in some other way. These people are an easy target for abuses related to their own rights, as their situation forces them to look for help without having many options and generally being less informed about their rights. Some questions arise when considering this situation in a generation that should be familiar with the ethical principles of scientific investigation: Are we ready to act ethically in the genomics era, when a significant number of illnesses and their prognoses are directly related to genome analysis? Would it be a better option to make the principles known in order to empower vulnerable populations, helping them to be aware of their rights and educating them on the ways in which they could suffer abuse? Would this prevent manipulation and promote a change of attitude in terms of values, such as respect and tolerance, in our generation?

Factors that promote noncompliance with ethical principles

Lack of strict ethical surveillance.

There is currently no evidence of strict ethical surveillance in many countries of Latin America that participate in clinical investigation, thus making the abuse of ethical principles very likely, as well as factual. The lack of strict ethical supervision encourages the researcher not to inform the participants of their rights. This enables the researcher to have more freedom for the development of the trial. Although it might be assumed that all the necessary information concerning individual rights will be provided by him, in fact this rarely occurs.

Paternalism

An additional factor is paternalism, a situation that allows the treating physician or investigator to perform actions without consulting the patient, and in some cases even with a certain level of concealment that allows them, according to their own judgment, to act in the most convenient manner [ 2 ]. In this setting, the patients see the physician/researcher as their savior, voluntarily giving up their ability to make decisions and subtly losing their autonomy throughout the process. A frequent mindset in participant subjects that are simultaneously being treated in clinical trials is to think of the physician as the person responsible for deciding the treatment, since they have the necessary training and a better capability for making illness-related decisions. This blind trust in the physician/researcher allows him to act almost without limits, minimizing what patients might understand about their illness or what their genetic information might represent. The only thing needed from the patients from this moment on will be their signatures on a document that they rarely understand but acknowledge as a requirement for being treated [ 3 ], the informed consent form.

Informed consent (IC)

The IC form was created to protect the rights of research subjects. However, it currently appears to be used more as way for investigators to protect themselves from any legal situation in which they could be indicted for suspicion of abuse. It has been done as a routine procedure without regard to its real meaning. There are currently very few studies analyzing the effectiveness of the IC form 3 in Latin America or verifying whether the advantages and disadvantages of a trial are fully explained to the patient –i.e. whether or not there are benefits or if these benefits will be direct or long-term-. These kinds of circumstances are frequently covered or not explicitly explained in the IC form, due to the repercussions they might have on recruitment. In an effort to avoid unnecessary difficulties in the research process, only positive expectations are presented, such as: "this study will help discover the cure for your illness", without a clarifying statement to explaining that the probability of success could be extremely low.

The Informed Consent form was created to help the patients understand all the information related to every aspect of the study they would participate in and −particularly important in our times− full disclosure by the investigator of every aspect concerning the experiment, including risks, benefits and interests; as well as complete comprehension of the information by the patient. Where the research involves studies in genetics, it is essential to add the assurance of confidentiality for the obtained information, since this provides substantial and valuable data for both treatment and prognosis [ 4 ].

The concealment of information or the omission of any part of this document also constitutes a form of abuse, even though it may well be an everyday practice in some Latin American countries. When there is no interest in verifying the level of understanding of the patients concerning the study in which they participate, autonomy and justice are voluntarily left out of the equation and the principle of “nonmaleficence " is at risk. Autonomy is also threatened when, not being aware of all the aspects of a particular situation, patients are asked to make decisions that make them responsible for the direct consequences of an action. When only a partial truth is revealed, other people make the actual decisions and autonomy becomes a mere simulation. Justice is placed at risk because the subjects do not receive what they are entitled to when participating in a study, which is to know the reality concerning their situation, the process and the information currently available in the field regarding their entity. The principle of nonmaleficence is also endangered when there is a risk of damaging the subjects while deciding on their behalf, since we do not know if our decision and the decision of the participant are equal.

Lack of healthcare legislation to promote the protection of vulnerable subjects

The General Healthcare Law of Mexico, as updated on June 7, 2012 does explicitly mention the risk of incurring these circumstances. The lack of attention to the aforementioned factors in different countries contributes to an inadequate prevention of abuse [ 5 ].

Other related factors

There is pressure exerted by healthcare institutions on investigators in terms of the productivity of scientific material. Since a large portion of the research funds in both developed and developing countries come from government budgets and from non-governmental organizations, productivity goals are always considered. This is one of the reasons why scientists are pressured to produce; and to do so, they are tempted to abridge the information given to subjects, leaving out what they consider irrelevant for the knowledge of patients, thus accelerating the process of recruitment and production. In cases where transparency complicates the research process, the truth could not be prioritized, which in turn limits value-driven actions.

Are these kinds of acts justifiable?

Notwithstanding the fact that everyone is accountable for their actions, responsibility mostly lies with decision makers who know the consequences of previously noticed actions. Regardless of the motivation, this is not justifiable to the point of leaving ethical principles aside and adopting purely utilitarian stances where "the means are justified by the end," without regard to beneficence, justice and autonomy of the subjects. This is analogous to what happened in the past when experiments were performed on human beings without any consent or benefits and by infringing on their rights.

Article 4 of the Political Constitution of Mexico, in the first item referring to personal rights, states that: "every person has the right to health care protection" [ 6 ] in addition to stating the right to social security and physical and mental healthcare, as second-generation human rights [ 7 ]. When omissions of information happen, healthcare is not protected, nor is social security provided.

Possible solutions

Ethics committees, established for the supervision of international treaties such as the Declaration of Helsinki [ 8 ], could be overhauled in terms of surveillance measures to allow a stricter monitoring of patients participating in clinical trials. For instance, accessibility to ethics committees could be useful for subjects in trials, who would be interviewed and asked to answer questionnaires adapted to their academic training; aiming to explore their level of understanding about the study they are involved in and to assess their actual perception. Despite the fact that in recent years the level of comprehension of participants in clinical trials has been a controversial subject, it is necessary to acknowledge that anyone who voluntarily participates in a research study and signs an IC form deserves, and has a right to an explanation according to their own cognitive capabilities. Likewise, it is essential to design and build a strategic plan for the promotion of values, attitudes and ethical principles as a short or medium-term plan of action to educate the general population, particularly vulnerable groups. This promotion of values could be the cornerstone of a comprehensive and effective educational plan running alongside an established program, to avoid losing resources, that is, unnecessary expenses in a budget focused on an educational campaign to prevent abuse. If the necessary education is not provided, the risk of standing outside of an ethical context is high; a context where moral values are reduced to the memorization of concepts that are not practiced or to a merely ethical positivism where our random emotions lead our actions. An actual knowledge has to be pursued for the implementation of principles with intelligence, specificity and consideration.

There is no current evidence to support the contention that fundamental ethical principles are applied in many countries that carry out clinical investigations, particularly in Latin America and regarding aspects related to safeguarding the rights of individuals and the privacy of confidential information such as data proceeding from the human genome. So long as concrete measures are not taken, vulnerable groups will continue to be the most affected populations. Abuse-related factors are predictable and can be prevented by working hard and collectively committing to the solution. In the advent of the genomics era, it is urgent to start closely monitoring compliance with fundamental ethical principles for research to prevent having massive leaks of information along with mistreatment, harm and violation of fundamental ethical principles, particularly in vulnerable groups.

Abbreviations

Informed Consent.

Beauchamp TL, Childress JF: Principles of Biomedical Ethics. 2008, USA: Oxford University Press, 5th

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Acknowledgements

We thank the Healthcare Services Management of the Mexican Institute of Social Security at Hidalgo Delegation for the support in the preparation and publication of this manuscript.

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Borys Alberto Cornejo Moreno

Planning and Institutional Liaison Coordinator, Healthcare Services Management, The Mexican Institute of Social Security, Hidalgo Delegation, Boulevard Luis Donaldo Colosio n° 516, Canutillo, Pachuca de Soto, Hidalgo, CP, 42070, Mexico

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Cornejo Moreno, B.A., Gómez Arteaga, G.M. Violation of ethical principles in clinical research. Influences and possible solutions for Latin America. BMC Med Ethics 13 , 35 (2012). https://doi.org/10.1186/1472-6939-13-35

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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

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On Being a Scientist: Responsible Conduct in Research, Second Edition (1995)

Chapter: responding to violations of ethical standards.

investigated and adjudicated through different channels. Regulations adopted by the National Science Foundation and the Public Health Service define misconduct to include "other serious deviations from accepted research practices," in addition to falsification, fabrication, and plagiarism, leaving open the possibility that other actions could be considered misconduct in science. The problem with such language is that it could allow a scientist to be accused of misconduct for using novel or unorthodox research methods, even though such methods are sometimes needed to proceed in science. Federal officials respond by saying that this language is needed to prosecute ethical breaches that do not strictly fall into the categories of falsification, fabrication, or plagiarism and that no scientist has been accused of misconduct on the basis of using unorthodox research methods. This area of science policy is still evolving.

Another category of behaviors—including sexual or other forms of harassment, misuse of funds, gross negligence in a person's professional activities, tampering with the experiments of others or with instrumentation, and violations of government research regulations—are not necessarily associated with scientific conduct. Institutions need to discourage and respond to such behaviors. But these behaviors are subject to generally applicable legal and social penalties and should be dealt with using the same procedures that would be applied to anyone.

RESPONDING TO VIOLATIONS OF ETHICAL STANDARDS

One of the most difficult situations that a researcher can encounter is to see or suspect that a colleague has violated the ethical standards of the research community. It is easy to find excuses to do nothing, but someone who has witnessed misconduct has an unmistakable obligation to act. At the most immediate level, misconduct can seriously obstruct or damage one's own research or the research of colleagues. More broadly, even a single case of misconduct can malign scientists and their institutions, result in the imposition of counterproductive regulations, and shake public confidence in the integrity of science.

To be sure, raising a concern about unethical conduct is rarely an easy thing to do. In some cases, anonymity is possible-but not always. Reprisals by the accused person and by skeptical colleagues have occurred in the past and have had serious consequences. Any allegation of misconduct is a very important charge that needs to be

taken seriously. If mishandled, an allegation can gravely damage the person charged, the one who makes the charge, the institutions involved, and science in general.

Someone who is confronting a problem involving research ethics usually has more options than are immediately apparent. In most cases the best thing to do is to discuss the situation with a trusted friend or advisor. In universities, faculty advisors, department chairs, and other senior faculty can be invaluable sources of advice in deciding whether to go forward with a complaint.

An important consideration is deciding when to put a complaint in writing. Once in writing, universities are obligated to deal with a complaint in a more formal manner than if it is made verbally. Putting a complaint in writing can have serious consequences for the career of a scientist and should be undertaken only after thorough consideration.

The National Science Foundation and Public Health Service require all research institutions that receive public funds to have procedures in place to deal with allegations of unethical practice. These procedures take into account fairness for the accused, protection for the accuser, coordination with funding agencies, and requirements for confidentiality and disclosure.

In addition, many universities and other research institutions have designated an ombudsman, ethics officer, or other official who is available to discuss situations involving research ethics. Such discussions are carried out in strictest confidence whenever possible. Some institutions provide for multiple entry points, so that complainants can go to a person with whom they feel comfortable.

Government agencies, including the National Science Foundation and Public Health Service, enforce laws and regulations that deal with misconduct in science. At the Public Health Service in Washington, D.C., complaints can be referred to the appropriate office through the Office of Research Integrity. At the National Science Foundation in Arlington, Virginia, complaints can be directed to the Office of the Inspector General. Within universities, research grant officials can provide guidance on whether federal rules may be involved in filing a complaint.

Many institutions have prepared written materials that offer guidance in situations involving professional ethics. Volume II of Responsible Science: Ensuring the Integrity of the Research Process (National Academy Press, Washington, D.C., 1993) reprints a number of these documents. Sigma Xi, a national society of research scientists headquartered in Research Triangle Park, North Carolina, the American Association for the Advancement of Science in Washington, D.C., and other scientific and engineering professional organizations also are prepared to advise scientists who encounter cases of possible misconduct.

The research system exerts many pressures on beginning and experienced researchers alike. Principal investigators need to raise funds and attract students. Faculty members must balance the time spent on research with the time spent teaching undergraduates. Industrial sponsorship of research introduces the possibility of conflicts of interest.

All parts of the research system have a responsibility to recognize and respond to these pressures. Institutions must review their own policies, foster awareness of research ethics, and ensure that researchers are aware of the policies that are in place. And researchers should constantly be aware of the extent to which ethically based decisions will influence their success as scientists.

THE SCIENTIST IN SOCIETY

This booklet has concentrated on the responsibilities of scientists for the advancement of science, but scientists have additional responsibilities to society. Even scientists conducting the most fundamental research need to be aware that their work can ultimately have a great impact on society. Construction of the atomic bomb and the development of recombinant DNA—events that grew out of basic research on the nucleus of the atom and investigations of certain bacterial enzymes, respectively—are two examples of how seemingly arcane areas of science can have tremendous societal consequences.

The occurrence and consequences of discoveries in basic research are virtually impossible to foresee. Nevertheless, the scientific community must recognize the potential for such discoveries and be prepared to address the questions that they raise. If scientists do find that their discoveries have implications for some important aspect of public affairs, they have a responsibility to call attention to the public issues involved. They might set up a suitable public forum involving experts with different perspectives on the issue at hand. They could then seek to develop a

Since the first edition of On Being a Scientist was published in 1989, more than 200,000 copies have been distributed to graduate and undergraduate science students. Now this well-received booklet has been updated to incorporate the important developments in science ethics of the past 6 years and includes updated examples and material from the landmark volume Responsible Science (National Academy Press, 1992).

The revision reflects feedback from readers of the original version. In response to graduate students' requests, it offers several case studies in science ethics that pose provocative and realistic scenarios of ethical dilemmas and issues.

On Being a Scientist presents penetrating discussions of the social and historical context of science, the allocation of credit for discovery, the scientist's role in society, the issues revolving around publication, and many other aspects of scientific work. The booklet explores the inevitable conflicts that arise when the black and white areas of science meet the gray areas of human values and biases.

Written in a conversational style, this booklet will be of great interest to students entering scientific research, their instructors and mentors, and anyone interested in the role of scientific discovery in society.

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Potential ethical violations

Learn how you and your psychologist can work together to avoid problems.

Know your rights and your psychologist’s responsibilities in several common ethical dilemmas:

Multiple relationships

Your psychologist shouldn't also be your friend, client or sex partner. That’s because psychologists are supposed to avoid relationships that could impair their professional performance or harm their clients.

Of course, it’s usually impossible for psychologists to avoid all contact with clients outside their offices. Relationships that don’t hinder psychologists’ performance or harm their patients are ethically OK.

One type of relationship that’s never acceptable is a sexual relationship with a current client. And even though sexual relationships that occur at least two years after therapy ends may be technically acceptable, they can still be harmful. 

Confidentiality

Employers, spouses, school administrators, insurance companies and others often ask psychologists to provide information about their clients. APA’s Ethics Code says that psychologists may only share the minimum information necessary.

Your psychologist should be clear about whether and why he or she is disclosing information. Sometimes, for instance, a law requires psychologists to disclose something, such as possible abuse.

Your psychologist should let you know the limits of confidentiality and explain how confidential records are stored.

Informed consent

Your psychologist should give you the information you need to give informed consent right from the start. Topics to discuss include:

Limits of confidentiality

Nature and extent of your psychologist’s record-keeping

Expertise , experience and training

What services your psychologist can’t or won’t provide

Estimated length of therapy

Alternative approaches to treatment or service

Fees and billing practices

Your right to terminate your treatment and any resulting financial obligations.

Sometimes a therapist in training may provide your treatment. The therapist should let you know he or she is a trainee and give you the supervising psychologist's name.

Keep in mind that bills may be under the supervisor’s name, not the trainee’s. You don’t want to report a billing problem when none exists!

When psychologists work with organizations or groups, there may be confusion about who the actual client is.

In court, for instance, it may not be clear whether a psychologist is serving as an expert witness or an advocate for one side. Confusion is also possible when psychologists provide services to one person at the request of another, such as parents requesting therapy for children or police departments requesting evaluations of officers.

Psychologists should be clear from the start about who the client is and what their own role is.

They should also discuss limits to confidentiality, what services they’ll provide to whom and how they or others could use the information obtained.

Psychologists should only practice in areas where they are competent.

If you’re in a custody battle, for instance, a psychologist who’s unfamiliar with working with courts could harm your case no matter how well-intentioned he or she is.

If you ask your psychologist to write a letter to the judge about your child’s relationship with you and your spouse, the psychologist could get in trouble by failing to note something like the fact that she never met the child’s father.

Your psychologist has an ethical obligation to bill patients and insurers accurately. Your psychologist should explain financial policies at the beginning of treatment.

Sloppy bookkeeping lands some psychologists in hot water. Others get in trouble because they try to manipulate the system to get clients more benefits than they’re entitled to.

Don’t ask your psychologist to bill for a service that’s covered rather than what was actually provided. And don’t ask your psychologist to exaggerate your diagnosis to justify more visits or to give you a less damaging diagnosis for fear of what your employer or others will think.

And, expect your psychologist to bill you rather than your insurance company if you miss an appointment.

End of therapy

You should know the difference between treatment termination and abandonment.

Psychologists can ethically discontinue treatment when clients aren’t benefiting from therapy, may be harmed by treatment, no longer need therapy or threaten the therapist, themselves or others.

Your psychologist should explain why the current treatment is no longer appropriate, suggest alternative service providers, address feelings of rejection and resolve any practical issues.

In contrast, abandonment occurs when a psychologist inappropriately ends treatment.

Adapted from “ 10 ways practitioners can avoid frequent ethical pitfalls ” APA Monitor on Psychology

Ethics at APA

Ethics Code

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National Institute of Environmental Health Sciences

Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

Promoting Ethical Conduct in Science

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Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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NeurIPS Code of Ethics

The Code of Ethics aims to guide the NeurIPS community towards higher standards of ethical conduct as it pertains to elements of research ethics and the broader societal and environmental impact of research submitted to NeurIPS. It outlines conference expectations about the ethical practices that must be adopted by the submitting authors, members of the program and organizing committees. The Code of Ethics complements the NeurIPS Code of Conduct , which focuses on professional conduct and research integrity issues, including plagiarism, fraud and reproducibility concerns. The points described below also inform the NeurIPS Submission Checklist, which outlines more concrete communication requirements. 

Potential Harms Caused by the Research Process 

Research involving human subjects or participants:

• Fair Wages: all human research subjects or participants must receive appropriate compensation. If you make use of crowdsourcing or contract work for a particular task as part of your research project,  you must respect the minimum hourly rate in the region where the work is carried out.
• Research involving human participants: if the research presented involves direct interactions between the researchers and human participants or between a technical system and human participants, authors are required to follow existing protocols in their institutions (e.g. human subject research accreditation, IRB) and go through the relevant process. In cases when no formal process exists, they can undergo an equivalent informal process (e.g. via their peers or an internal ethics review).

Data-related concerns:

The points listed below apply to all datasets used for submissions, both for publicly available data and internal datasets.

• Privacy: Datasets should minimize the exposure of any personally identifiable information, unless informed consent from those individuals is provided to do so. 
• Consent: Any paper that chooses to create a dataset with real data of real people should ask for the explicit consent of participants, or explain why they were unable to do so.
• Deprecated datasets: Authors should take care to confirm with dataset creators that a dataset is still available for use. Datasets taken down by the original author (ie. deemed obsolete, or otherwise discontinued), should no longer be used, unless it is for the purposes of audit or critical assessment. For some indication of known depreciated datasets, please refer to the NeurIPS list of deprecated datasets.
• Copyright and Fair Use: While the norms of fair use and copyright in machine learning research are still evolving, authors must respect the terms of datasets that have defined licenses (e.g. CC 4.0, MIT, etc). 
• Representative evaluation practice:  When collecting new datasets or making decisions about which datasets to use, authors should assess and communicate the degree to which their datasets are representative of their intended population. Claims of diverse or universal representation should be substantiated by concrete evidence or examples. 

Societal Impact and Potential Harmful Consequences

Authors should transparently communicate the known or anticipated consequences of research: for instance via the paper checklist or a separate section in a submission.

The following specific areas are of particular concern:

• Safety: Contributors should consider whether there are foreseeable situations in which their technology can be used to harm, injure or kill people through its direct application, side effects, or potential misuse. We do not accept research whose primary goal is to increase the lethality of weapons systems.
• Security: Researchers should consider whether there is a risk that applications could open security vulnerabilities or cause serious accidents when deployed in real world environments. If this is the case, they should take concrete steps to recommend or implement ways to protect against such security risks.
• Discrimination: Researchers should consider whether the technology they developed can be used to discriminate, exclude, or otherwise negatively impact people, including impacts on the provision of services such as healthcare, education or access to credit.  
• Surveillance: Researchers should consult on local laws or legislation before collecting or analyzing any bulk surveillance data. Surveillance should not be used to predict protected categories, or be used in any way to endanger individual well-being. 
• Deception & Harassment: Researchers should communicate about whether their approach could be used to facilitate deceptive interactions that would cause harm such as theft, fraud, or harassment, and whether it could be used to impersonate public figures and influence political processes, or as a tool to promote hate speech or abuse.
• Environment: Researchers should consider whether their research is going to negatively impact the environment by, e.g., promoting fossil fuel extraction, increasing societal consumption or producing substantial amounts of greenhouse gasses.
• Human Rights: We prohibit circulation of any research work that builds upon or facilitates illegal activity, and we strongly discourage any work that could be used to deny people rights to privacy, speech, health, liberty, security, legal personhood, or freedom of conscience or religion.
• Bias and fairness:  Contributors should consider any suspected biases or limitations to the scope of performance of models or the contents of datasets and inspect these to ascertain whether they encode, contain or exacerbate bias against people of a certain gender, race, sexuality, or other protected characteristics.

Impact Mitigation Measures 

We propose some reflection and actions taken to mitigate potential harmful consequences from the research project. 

• Data and model documentation: Researchers should communicate the details of the dataset or the model as part of their submissions via structured templates.
• Data and model licenses: If releasing data or models, authors should also provide licenses for them. These should include the intended use and limitations of these artifacts, in order to prevent misuse or inappropriate use.
• Secure and privacy-preserving data storage & distribution : Authors should leverage privacy protocols, encryption and anonymization to reduce the risk of data leakage or theft. Stronger measures should be employed for more sensitive data (e.g., biometric or medical data). 
• Responsible release and publication strategy: Models that have a high risk for misuse or dual-use should be released with necessary safeguards to allow for controlled use of the model, e.g. by requiring that users adhere to a code of conduct to access the model. Authors of papers exposing a security vulnerability in a system should follow the responsible disclosure procedures of the system owners.
• Allowing access to research artifacts: When releasing research artifacts, it is important to make accessible the information required to understand these artifacts (e.g. the code, execution environment versions, weights, and hyperparameters of systems) to enable external scrutiny and auditing.
• Disclose essential elements for reproducibility: Any work submitted to NeurIPS should be accompanied by the information sufficient for the reproduction of results described. This can include the code, data, model weights, and/or a description of the computational resources needed to train the proposed model or validate the results.
• Ensure legal compliance: Ensure adequate awareness of regional legal requirements. This can be done, for instance, by consulting with law school clinics specializing in intellectual property and technology issues. Additional information is required from authors where legal compliance could not be met due to human rights violations (e.g. freedom of expression, the right to work and education, bodily autonomy, etc.). 

Violations to the Code of Ethics should be reported to [email protected] . NeurIPS reserves the right to reject the presentation of scientific works that violate the Code of Ethics. Notice that conference contributors are also obliged to adhere to additional ethical codes or review requirements arising from other stakeholders such as funders and research institutions.

Further reading

UNDERSTANDING LICENSES

• Towards Standardization of Data Licenses: The Montreal Data License
• Behavioral Use Licensing for Responsible AI  
• Choose an open source license  

MODEL AND DATA DOCUMENTATION TEMPLATES

• Model Cards for Model Reporting
• Datasheets for Datasets
• Using AI Factsheets for AI Governance
• ML Lifecycle Documentation Practices

SOCIETAL IMPACT

• Safety: Key Concepts in AI Safety: An Overview
• Security: SoK: Security and Privacy in Machine Learning
• Discrimination:  Bias in algorithms – Artificial intelligence and discrimination ; What about fairness, bias and discrimination?
• Surveillance: The Human Right to Privacy in the Digital Age
• Deception & Harassment: Generative Language Models and Automated Influence Operations: Emerging Threats and Potential Mitigations  
• Environment: Quantifying the Carbon Emissions of Machine Learning  
• Human Rights: Technology and Rights | Human Rights Watch  
• Bias and fairness:  Fairness and machine learning  
• Dual use problem:  Dual use of artificial-intelligence-powered drug discovery 
• Data Enrichment: Responsible Sourcing for Data Enrichment
• Synthetic Media: PAI’s Responsible Practices for Synthetic Media

RELATED ENDEAVORS

• ACM Code of Ethics  
• ACL Ethics FAQ
• ICLR Code of Ethics
• Responsible Conduct of Research Training  

RELATED RESEARCH COMMUNITIES

• IEEE SaTML 2023
• Aies Conference
• FORC 2022  

Tape Maker Illegally Disciplined Union Workers, Labor Board Says

By Robert Iafolla

An adhesive tape manufacturer violated federal labor law by suspending and disciplining union workers for their conduct during a heated meeting about a safety issue, the National Labor Relations Board ruled.

Neither Intertape Polymer Corp. workers’ conduct was so egregious that they lost the protection of the National Labor Relations Act, the NLRB held in its Monday ruling .

The decision turned on the NLRB’s application of a legal test that the current board reinstated in its 2023 ruling in Lion Elastomers LLC , a case that’s emerged as a political football in recent weeks.

For example, a business advocacy ...

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• ACM Technical Awards 2023

ACM Recognizes Innovators Who Solve Real World Problems

Award recipients’ work has impacted internet privacy, operating system software, graph processing, and ai.

New York, NY, June 18, 2024 – ACM, the Association for Computing Machinery, today announced the recipients of four prestigious technical awards. These four awards in diverse categories celebrate the hard work and creativity which underpin many of today’s most important technologies.

Prateek Mittal , Princeton University, is the recipient of the 2023 ACM Grace Murray Hopper Award for foundational contributions to safeguarding Internet privacy and security using a cross-layer approach.

The unifying theme in Mittal’s research is to leverage foundational techniques from network science, comprising graph-theoretical mechanics, data mining, and inferential modeling for tackling privacy and security challenges. For example, his research orchestrates and exploits graph-theoretic properties of the Internet topology for protecting privacy and detecting attacks. Moreover, Mittal applies these techniques in a manner that allows for complex interactions across traditional layers and boundaries of our networked systems, i.e., a cross-layer approach.

By conducting Internet-scale experiments with over 50,000 routers, Mittal’s research showed that an adversary can exploit the insecurity of internet routing to intercept traffic from trusted certificate authorities, and then allow an adversary to obtain a cryptographic key that is vouch safe by trusted authorities. To mitigate these attacks, Mittal helped develop the ingenuous idea of trusted certificate authorities validating website domain ownership from multiple vantage points on the Internet. This technology has already led to the secure issuance of over 2.5 billion digital certificates used by 350 million websites. Taken together, his contributions are impacting the privacy and integrity of global commerce, financial services, online healthcare, and everyday communications.

The ACM Grace Murray Hopper Award   is given to the outstanding young computer professional of the year, selected on the basis of a single recent major technical or service contribution. This award is accompanied by a prize of $35,000. The candidate must have been 35 years of age or less at the time the qualifying contribution was made. Financial support for this award is provided by Microsoft.

Andrew S. Tanenbaum , Vrije Universiteit, receives the  ACM Software System Award  for MINIX, which influenced the teaching of Operating Systems principles to multiple generations of students and contributed to the design of widely used operating systems, including Linux.

Tanenbaum created MINIX 1.0 in 1987 to accompany his textbook, “Operating Systems: Design and Implementation.” MINIX was a small microkernel-based UNIX operating system for the IBM PC, which was popular at the time. It was roughly 12,000 lines of code, and in addition to the microkernel, included a memory manager, file system and core UNIX utility programs. It became free open-source software in 2000.

Beyond enabling the success of Tanenbaum’s textbook, the impact of MINIX has been phenomenal. It was an inspiration for LINUX, which has grown into the most successful open-source operating system powering cloud servers, mobile phones and IoT devices. MINIX was also the basis for the MeikOS operating system for Meikotransputer-based computers and runs inside popular microchips. A later version of MINIX, MINIX 3.0 is intended for resource-limited and embedded computers and for applications requiring high reliability. Beyond the direct impact of MINIX, Tanenbaum’s advocacy for microkernel design has impacted generations of operating system designers.

The ACM Software System Award   is presented to an institution or individual(s) recognized for developing a software system that has had a lasting influence, reflected in contributions to concepts, in commercial acceptance, or both. The Software System Award carries a prize of $35,000. Financial support for the Software System Award is provided by IBM.

Guy E. Blelloch,  Carnegie Mellon University; Laxman Dhulipala , University of Maryland; and Julian Shun , Massachusetts Institute of Technology, receive the ACM Paris Kanellakis Theory and Practice Award for contributions to algorithm engineering, including the Ligra, GBBS, and Aspen frameworks which revolutionized large-scale graph processing on shared-memory machines.

Beginning in 2013, Blelloch, Dhulipala and Shun began to explore how to analyze huge graphs (billions of vertices and hundreds of billions of edges) on relatively inexpensive shared-memory multiprocessors. They built several frameworks (Ligra, Ligra +, Julienne, GBBS, and Aspen) that make it much easier for programmers to efficiently solve a wide variety of graph problems. They have obtained many truly outstanding results in which their provably efficient algorithms running on an inexpensive multi-core shared-memory machine are faster than any prior algorithms, even those running on much bigger and more expensive machines. Examples of such results include clustering, clique counting, and various forms of connectivity. These ideas and implementations are being used in industry to handle real-world problems and have also had tremendous impact on research in the field.

One important upshot of this work was the paradigm-changing demonstration that shared-memory computers are an ideal platform for analyzing large graphs. At the time Ligra was first developed, the predominant approach used to analyze large graphs was distributed systems such as Pregel (developed by Google). This was overturned when, for many important large real-world graph problems, the Ligra approach turned out to be much more efficient in terms of energy, cost, and end-to-end running time.

Their work on graph processing also allows algorithms with provable performance guarantees in the PRAM model to live up to their theoretical performance in practice. Recently, the nominees addressed the emerging setting of processing streaming graphs, which models graphs that change in real time and developed Aspen, a novel graph streaming system that uses new purely functional data structures to enable low-latency updates and snapshots on massive graph datasets.

The ACM Paris Kanellakis Theory and Practice Award   honors specific theoretical accomplishments that have had a significant and demonstrable effect on the practice of computing. This award is accompanied by a prize of $10,000 and is endowed by contributions from the Kanellakis family, with additional financial support provided by ACM’s Special Interest Groups on Algorithms and Computation Theory (SIGACT), Design Automation (SIGDA), Management of Data (SIGMOD), and Programming Languages (SIGPLAN), the ACM SIG Projects Fund, and individual contributions.  

David Blei , Columbia University, receives the ACM - AAAI Allen Newell Award .

Blei is recognized for significant contributions to machine learning, information retrieval, and statistics. His signature accomplishment is in the machine learning area of “topic modeling", which he pioneered in the foundational paper “Latent Dirichlet Allocation” (LDA). The applications of topic modelling can be found throughout the social, physical, and biological sciences, in areas such as medicine, finance, political science, commerce, and the digital humanities.

Blei has also been a leader in variational inference (VI), another research area that connects computer science to statistics. VI is an optimization-based methodology for approximate probabilistic inference. Blei’s major contribution to VI has been to develop a novel framework—stochastic variational inference (SVI)—that yielded a quantum leap in the size of problems that can be solved with VI. SVI is in wide use in the AI industry and across the sciences.

Additionally, in his work on discrete choice modelling, Blei has developed a methodology for answering counterfactual queries about changes in prices, which helps to identify complimentary and substitutable pairs of products. This work has built a bridge between computer science and econometrics and has been cited for its impactful use of machine learning modeling.

The ACM - AAAI Allen Newell Award is presented to an individual selected for career contributions that have breadth within computer science, or that bridge computer science and other disciplines. The Newell award is accompanied by a prize of $10,000, provided by ACM and the Association for the Advancement of Artificial Intelligence (AAAI), and by individual contributions.

ACM, the Association for Computing Machinery , is the world's largest educational and scientific computing society, uniting educators, researchers, and professionals to inspire dialogue, share resources, and address the field's challenges. ACM strengthens the computing profession's collective voice through strong leadership, promotion of the highest standards, and recognition of technical excellence. ACM supports the professional growth of its members by providing opportunities for life-long learning, career development, and professional networking.

Contact: Jim Ormond 212-626-0505 [email protected]

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• v.86(5); 2024 May
• PMC11060189

Ethics in scientific research: a lens into its importance, history, and future

Associated data.

Not applicable.

Introduction

Ethics are a guiding principle that shapes the conduct of researchers. It influences both the process of discovery and the implications and applications of scientific findings 1 . Ethical considerations in research include, but are not limited to, the management of data, the responsible use of resources, respect for human rights, the treatment of human and animal subjects, social responsibility, honesty, integrity, and the dissemination of research findings 1 . At its core, ethics in scientific research aims to ensure that the pursuit of knowledge does not come at the expense of societal or individual well-being. It fosters an environment where scientific inquiry can thrive responsibly 1 .

The need to understand and uphold ethics in scientific research is pertinent in today’s scientific community. First, the rapid advancement of technology and science raises ethical questions in fields like biotechnology, biomedical science, genetics, and artificial intelligence. These advancements raise questions about privacy, consent, and the potential long-term impacts on society and its environment 2 . Furthermore, the rise in public perception and scrutiny of scientific practices, fueled by a more informed and connected populace, demands greater transparency and ethical accountability from researchers and institutions.

This commentary seeks to bring to light the need and benefits associated with ethical adherence. The central theme of this paper highlights how upholding ethics in scientific research is a cornerstone for progress. It buttresses the fact that ethics in scientific research is vital for maintaining the trust of the public, ensuring the safety of participants, and legitimizing scientific findings.

Historical perspective

Ethics in research is significantly shaped by past experiences where a lack of ethical consideration led to negative consequences. One of the most striking examples of ethical misconduct is the Tuskegee Syphilis Study 3 conducted between 1932 and 1972 by the U.S. Public Health Service. In this study, African American men in Alabama were used as subjects to study the natural progression of untreated syphilis. They were not informed of their condition and were denied effective treatment, even after penicillin became available as a cure in the 1940s 3 .

From an ethical lens today, this is a gross violation of informed consent and an exploitation of a vulnerable population. The public outcry following the revelation of the study’s details led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research 4 . This commission eventually produced the Belmont Report in 1979 4 , setting forth principles such as respect for persons, beneficence, and justice, which now underpin ethical research practices 4 .

Another example that significantly impacted ethical regulations was the thalidomide tragedy of the late 1950s and early 1960s 5 . Thalidomide was marketed as a safe sedative for pregnant women to combat morning sickness in Europe. Thalidomide resulted in the birth of approximately ten thousand children with severe deformities due to its teratogenic effects 5 , which were not sufficiently researched prior to the drug’s release. This incident underscored the critical need for comprehensive clinical testing and highlighted the ethical imperative of understanding and communicating potential risks, particularly for vulnerable groups such as pregnant women. In response, drug testing regulations became more rigorous, and the importance of informed consent, especially in clinical trials, was emphasized.

The Stanford Prison Experiment of 1971, led by psychologist Philip Zimbardo is another prime example of ethical oversight leading to harmful consequences 6 . The experiment, which aimed to study the psychological effects of perceived power, resulted in emotional trauma for participants. Underestimating potential psychological harm with no adequate systems to safeguard human participants from harm was a breach of ethics in psychological studies 6 . This case highlighted the necessity for ethical guidelines that prioritize the mental and emotional welfare of participants, especially in psychological research. It led to stricter review processes and the establishment of guidelines to prevent psychological harm in research studies. It influenced the American Psychological Association and other bodies to refine their ethical guidelines, ensuring the protection of participants’ mental and emotional well-being.

Impact on current ethical standards

These historical, ethical oversights have been instrumental in shaping the current landscape of ethical standards in scientific research. The Tuskegee Syphilis Study led to the Belmont Report in 1979, which laid out key ethical principles such as respect for persons, beneficence, and justice. It also prompted the establishment of Institutional Review Boards (IRBs) to oversee research involving human subjects. The thalidomide tragedy catalyzed stricter drug testing regulations and informed consent requirements for clinical trials. The Stanford Prison Experiment influenced the American Psychological Association to refine its ethical guidelines, placing greater emphasis on the welfare and rights of participants.

These historical episodes of ethical oversights have been pivotal in forging the comprehensive ethical frameworks that govern scientific research today. They serve as stark reminders of the potential consequences of ethical neglect and the perpetual need to prioritize the welfare and rights of participants in any research endeavor.

One may ponder on the reason behind the Tuskegee Syphilis Study, where African American men with syphilis were deliberately left untreated. What led scientists to prioritize research outcomes over human well-being? At the time, racial prejudices, lack of understanding of ethical principles in human research, and regulatory oversight made such studies pass. Similarly, the administration of thalidomide to pregnant women initially intended as an antiemetic to alleviate morning sickness, resulted in unforeseen and catastrophic birth defects. This tragedy highlights a critical lapse in the pre-marketing evaluation of drugs’ safety.

Furthermore, the Stanford prison experiment, designed to study the psychological effects of perceived power, spiraled into an ethical nightmare as participants suffered emotional trauma. This begs the question on how these researchers initially justified their methods. From today’s lens of ethics, the studies conducted were a complete breach of misconduct, and I wonder if there were any standards that guided primitive research in science.

Current ethical standards and guidelines in research

Informed consent.

This mandates that participants are fully informed about the nature of the research, including its objectives, procedures, potential risks, and benefits 7 , 8 . They must be given the opportunity to ask questions and must voluntarily agree to participate without coercion 7 , 8 . This ensures respect for individual autonomy and decision-making.

Confidentiality and privacy

Confidentiality is pivotal in research involving human subjects. Participants’ personal information must be protected from unauthorized access or disclosure 7 , 8 . Researchers are obliged to take measures to preserve the anonymity and privacy of participants, which fosters trust and encourages participation in research 7 , 8 .

Non-maleficence and beneficence

These principles revolve around the obligation to avoid harm (non-maleficence) and to maximize possible benefits while minimizing potential harm (beneficence) 7 , 8 . Researchers must ensure that their studies do not pose undue risks to participants and that any potential risks are outweighed by the benefits.

Justice in research ethics refers to the fair selection and treatment of research participants 8 . It ensures that the benefits and burdens of research are distributed equitably among different groups in society, preventing the exploitation of vulnerable populations 8 .

The role of Institutional Review Boards (IRB)

Institutional Review Boards play critical roles in upholding ethical standards in research. An IRB is a committee established by an institution conducting research to review, approve, and monitor research involving human subjects 7 , 8 . Their primary role is to ensure that the rights and welfare of participants are protected.

Review and approval

Before a study commences, the IRB reviews the research proposal to ensure it adheres to ethical guidelines. This includes evaluating the risks and benefits, the process of obtaining informed consent, and measures for maintaining confidentiality 7 , 8 .

Monitoring and compliance

IRB also monitors ongoing research projects to ensure compliance with ethical standards. They may require periodic reports and can conduct audits to ensure ongoing adherence to ethical principles 7 , 8 .

Handling ethical violations

In cases where ethical standards are breached, IRB has the authority to impose sanctions, which can range from requiring modifications to the study to completely halting the research project 7 , 8 .

Other agencies and boards enforcing standards

Beyond IRB, there are other regulatory bodies and agencies at national and international levels that enforce ethical standards in research. These include:

The Office for Human Research Protections (OHRP) in the United States, which oversees compliance with the Federal Policy for the Protection of Human Subjects.

The World Health Organization (WHO) , which provides international ethical guidelines for biomedical research.

The International Committee of Medical Journal Editors (ICMJE) , which sets ethical standards for the publication of biomedical research.

These organizations, along with IRB, form a comprehensive network that ensures the ethical conduct of scientific research. They safeguard the integrity of research using the reflections and lesson learnt from the past.

Benefits of ethical research

Credible and reliable outcomes, why is credibility so crucial in research, and how do ethical practices contribute to it.

Ethical practices such as rigorous peer review, transparent methodology, and adherence to established protocols ensure that research findings are reliable and valid 9 . When studies are conducted ethically, they are less likely to be marred by biases, fabrications, or errors that could compromise credibility. For instance, ethical standards demand accurate data reporting and full disclosure of any potential conflicts of interest 9 , which directly contribute to the integrity and trustworthiness of research findings.

How do ethical practices lead to socially beneficial outcomes?

Ethical research practices often align with broader societal values and needs, leading to outcomes that are not only scientifically significant but also socially beneficial. By respecting principles like justice and beneficence, researchers ensure that their work with human subjects contributes positively to society 7 , 8 . For example, ethical guidelines in medical research emphasize the need to balance scientific advancement with patient welfare, ensuring that new treatments are both effective and safe. This balance is crucial in addressing pressing societal health concerns while safeguarding individual rights and well-being.

Trust between the public and the scientific community

The relationship between the public and the scientific community is heavily reliant on trust, which is fostered through consistent ethical conduct in research. When the public perceives that researchers are committed to ethical standards, it reinforces their confidence in the scientific process and its outcomes. Ethical research practices demonstrate a respect for societal norms and values, reinforcing the perception that science serves the public good.

Case studies

Case study 1: the development and approval of covid-19 vaccines.

The development and approval of COVID-19 vaccines within a short time is a testament to how adherence to ethical research practices can achieve credible and beneficial outcomes. Strict adherence to ethical guidelines, even in the face of a global emergency, ensured that the vaccines were developed swiftly. However, safety standards were compromised to some extent as no animal trials were done before humans. The vaccine development was not transparent to the public, and this fuelled the anti-vaccination crowd in some regions. Ethical compliance, including rigorous testing and transparent reporting, should expedite scientific innovation while maintaining public trust.

Case study 2: The CRISPR babies

What ethical concerns were raised by the creation of the crispr babies, and what were the consequences.

The creation of the first genetically edited babies using CRISPR technology in China raised significant ethical concerns 10 . The lack of transparency, inadequate consent process, and potential risks to the children can be likened to ethical misconduct in genetic engineering research. This case resulted in widespread condemnation from the scientific community and the public, as well as international regulatory frameworks and guidelines for genetic editing research 10 .

Recommendation and conclusion

Continuous education and training.

The scientific community should prioritize ongoing education and training in ethics for researchers at all levels, ensuring awareness and understanding of ethical standards and their importance.

Enhanced dialogue and collaboration

Encourage multidisciplinary collaborations and dialogues between scientists, ethicists, policymakers, and the public to address emerging ethical challenges and develop adaptive guidelines.

Fostering a culture of ethical responsibility

Institutions and researchers should cultivate an environment where ethical considerations are integral to the research process, encouraging transparency, accountability, and social responsibility.

Global standards and cooperation

Work toward establishing and harmonizing international ethical standards and regulatory frameworks, particularly in areas like genetic engineering and AI, where the implications of research are global.

Ethics approval

Ethics approval was not required for this editorial.

Informed consent was not required for this editorial

Sources of funding

No funding was received for this research.

Author contribution

G.D.M. wrote this paper.

Conflicts of interest disclosure

The authors declare no conflicts of interest.

Research registration unique identifying number (UIN)

Goshen David Miteu.

Data availability statement

Provenance and peer review.

Not commissioned, externally peer-reviewed.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Published online 21 March 2024