Dangerous Ethics Oversight in Purdue Child Nutritional Study: Fordham University’s Dr. Celia Fisher Weighs In

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This past July. an $8.8 million dollar, camp-like nutrition study funded by the National Institutes of Health (NIH) was shut down, resulting in a vast internal investigation at Purdue University, one of the nation’s top research institutions, and raising several issues about research ethics and the role of institutional review boards (IRBs), according to Undark. What went wrong? A video of an adolescent girl showering in a dormitory was posted on social media.

The study, Camp DASH (Dietary Approaches to Stop Hypertension)  was designed to evaluate effects of a low sodium diet on 11- to 15-year-old boys and girls with elevated blood pressure. Purdue University were set to host the children in campus housing for seven weeks in the summer.

The University President Mitch Daniels shut down the study two weeks early after the incident was reported to the police and the county prosecutor began looking into additional allegations of crimes among adolescents in the study. Daniels An investigation led by Purdue University’s Vice President for Ethics and Compliance, Alysa Christmas Rollock was launched soon after. Rollock’s investigation, which Purdue University released November 28, shows over “thirty incidents of threats, violence, or sexual abuse among the study participants, many involving calls to campus police. (Two participants were arrested in the first few days of the study.)” Additionally, Rollock reported several “instances of non-compliance on the part of the study’s principal investigator, or PI, Connie Weaver, that may have contributed to unsafe conditions for the minor participants” as well as “various conflicts of interest inherent in the study’s design.”

Dr. Celia Fisher, Professor of Psychology and Ethics at Fordham University and Director of the University’s Center for Ethics Education explained to Undark that “even if the NIH approved the trial design for the Camp DASH study, they would have relied on the university’s IRB to work out the details for the protection of study participants.”

Fisher, who has been working in the field of research ethics involving vulnerable populations for several decades, and who chaired the creation of the current American Psychological Association Ethics Code, said that she would have expected Purdue University’s IRB approval to be contingent on the “gold standard in counselors.” She continued, after discovering the counselors were primarily undergraduate students, “To have a sleepover camp for young teenagers supervised by 18 to 21-year-olds who do not have an adult supervisor there monitoring…I can’t even.”

Because no federal regulations require that members of IRBs be “scientists or know anything about scientific ethics,” Fisher explained, “not all IRBs are created equal…and vary significantly from institution to institution.” IRBs are typically pulled from university faculty and not paid for their work on the board. She added that because there is a “diverse range of expertise” among IRB members that is not well-suited to every study, “They [IRB members] may try very hard to apply ethical standards, but if they have no understanding of the type of research that’s being conducted, then they may not be able to identify all the risks and benefits of the participation.”

The problem, Fisher concluded, with most university IRB members is that the “lack of expertise and the lack of funding that they get” despite being genuinely interested in the protection of human subjects.”

As a result of the investigation, the study’s remaining three summers of the study are cancelled and “all of the collected data will be thrown out.” The biomedical institutional review board (IRB) of the University stated in late November that future study applications submitted by Weaver will not be reviewed until she submits a “comprehensive remediation plan,” including training and oversight by an outside mentor, according to the article.

Weaver, the study’s PI, released a statement last Tuesday that said, “I am deeply saddened by the instances that caused Camp DASH to end early. As the principal investigator, I accept responsibility for events that occurred at Camp DASH. The safety and security of research participants always comes first.”

Please visit Undark to read the full article, “Purdue University Mounted a Child Nutrition Study. It Went Very, Very Wrong.


Celia B. Fisher, Ph.D. is the Fordham University Marie Ward Doty University Chair in Ethics and Director of the Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training InstituteFisher’s  Decoding the Ethics Code: A Practical Guide for Psychologist, is now in its fourth edition from Sage Publications.

 

Ethics & Society Newsfeed: World AIDS Day 2017

World AIDS Day, December 1, 2017
National Aids Trust (NAT)

“World AIDS Day takes place on the 1st December each year. It’s an opportunity for people worldwide to unite in the fight against HIV, to show support for people living with HIV, and to commemorate those who have died from an AIDS-related illness. Founded in 1988, World AIDS Day was the first ever global health day.”

The theme of this year’s World AIDS Day, as promoted by NAT,  is “Let’s End It.” This year, NAT is asking everyone to join the fight to end the negative impacts of HIV including isolation, stigma and HIV transmission. According to the World Health Organization (WHO), there were 36.7 million people living with HIV at the end of 2016 and 20.9 million people living with HIV were receiving antiretroviral therapy globally. This year, WHO is advocating for access to safe, effective, quality and affordable HIV services, medicines and and diagnostics other health commodities for all those in need with their slogan “Everybody counts.”

Please visit the World AIDS Day website for more information about the history of the day and how to get involved, support and show solidarity with the millions of people living with HIV.

HIV/AIDS in the News

World AIDS Day 2017 Theme, Facts and Events: Everything You Need to Know

World AIDS Day: I have HIV and I’ll work to end this epidemic until I no longer can

The Global HIV/AIDS Epidemic Explained in 3 Charts

The Global Gag Rule Impacts Hard-Fought Progress On HIV/AIDS Relief

On World AIDS Day, “encouraging signs” seen in fight against HIV

NIH Statement on World AIDS Day 2017

World Aids Day 2017: Donald Trump breaks tradition by not mentioning LGBT community in proclamation

It’s World AIDS Day and this is what the White House page still looks like

Continue reading “Ethics & Society Newsfeed: World AIDS Day 2017”

Fordham University’s Dr. Celia Fisher Weighs in on Researchers Using Real Guns in Study with Children in Mic

In a recent study, researchers asked children ages 8 – 12 years old to watch 20-minute clips of PG-rated movies that either included or did not include gun violence. The objective of the study was to test whether children exposed to gun violence in movie clips would 1) handle a real gun longer and 2) pull the trigger more times than children not exposed to the same clip edited to not contain gun violence.

The children were then placed into a university laboratory containing toys, games and a real, 0.38 caliber gun which was disabled and modified to have a sensor counting trigger pulls with the door closed. A research assistant sat in an exterior greeting room if the children had questions. The study found that children who watched the clip containing guns were more likely to use the guns themselves than the children who watched the clip that did not contain guns (median trigger pulls were 2.8 compared to 0.01 and median number of seconds holding the gun were 53.1 compared to 11.1, respectively). Roughly 27% of children informed the assistant about the gun or handed it over and a small number aimed the gun at other children.

Although this study was approved by the scientists’ institutional review board, many ethicists believe the potential harm of the study was “not worth it,” including Dr. Celia Fisher, director of Fordham University’s Center for Ethics Education. “In any kinds of ethics evaluation, we have to balance the risk against the benefit. I think the study’s results are not of great scientific importance because we already know what the result is going to be. We have decades of scientific research showing that kids will imitate aggressive behavior they view on the TV screen,” Fisher told Mic.
Continue reading “Fordham University’s Dr. Celia Fisher Weighs in on Researchers Using Real Guns in Study with Children in Mic”

What Does Silence Say?

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STUDENT VOICES | CHYNN PRIZE SECOND-PLACE WINNER

By Amy Endres

There had never once been a public opinion poll done in El Salvador until Ignacio Martín-Baró, a Jesuit, set out as the only doctoral-level psychologist in the country to measure the opinion of the people in the 1980s.[1]  He knew this would be difficult.  He had studied at the University of Chicago, and he was certain that he would need to practice very differently than how he had been trained.  But he had still been unprepared for just how difficult it would be.

Much of Martín-Baró’s early conclusions were made on the fact that very few people would speak to him.  Only 40% percent of the rich felt safe enough to speak their opinion.  And the poor? Less than 20% of the poor would do the speak to him.[2]  Less than 20% would speak to him about their lives, what they thought of the government, or anything that could get back to someone who could hurt them.

In his case, silence stood for more than an inconvenience to answer a pollster.  It stood for more than a passive distrust of someone collecting data.  In his case, silence told a story of gripping fear, of generations of pain, of mothers mourning children slain by an oppressive and violent government.

Silence says a lot, and it’s important that researchers take that silence into account.

I do not present my essay from El Salvador, though, much less an El Salvador in the throes of civil war like my introduction remembers.  Instead, I present my essay from the United States.  Martín-Baró was attuned to the differences between the countries.  He remarked to an American colleague once that, “In your country, it’s publish or perish. In mine, it’s publish and perish.”[3]  Indeed, Martín-Baró would later be killed, one of eight martyrs, in November of 1989.

I do not propose that he was mistaken.  He was an American-trained researcher after all; he would know the dynamics between the countries.  There is far more protection in the United States, particularly for the researchers today, than there was in Martín-Baró’s time and region.  However, I do want to turn my gaze to those who cannot freely speak their mind in the United States, and posit that researchers can (and, I argue, should) take on their behalf, if they are to act in the heroic way that Martín-Baró did.

What does silence say in the United States?

Continue reading “What Does Silence Say?”

“She Can’t Help The Choices She Makes”

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STUDENT VOICES | CHYNN PRIZE FIRST-PLACE WINNER

By Madeleine Cardona

I will never forget the day my mother got diagnosed. I could swear that just yesterday I was thirteen years old waiting anxiously to be called in from the waiting room of some fancy New York State doctor’s office. I was young, but I had some idea of what was going on. I knew my parents and I were there because they were going through a divorce and fighting for custody of me. What I did not know was that we were about to endure a court-ordered psychiatric evaluation and that the results were going to change my life forever.

“Madeleine, your mom is very sick,” the psychiatrist attempted to explain to me. I did not understand. I did not know a sick person could look perfectly healthy. “It’s not a physical sickness, it’s in her head. She has a mental disorder called Paranoid Schizophrenia.” She went on using big words to explain how my mother’s brain “wasn’t like other people’s brains.” I sat there listening closely, hanging on every word the woman was saying to me. “She can’t help the choices that she makes, it’s not her fault that she is the way that she is. She needs help.” Every day since that day in the doctor’s office, that remark replays in my head over and over. “She can’t help the choices she makes.”

That is what gave me the most trouble. I sat around for years and years watching the choices that my mother was making, unable to intervene. If she cannot help the choices she makes, why could my dad or my mother’s other family not make the choices for her? Why could nobody make her take medication? I eventually learned that it was because my mother was sick, but “not sick enough.” The court ruled in favor of autonomy and said that my mother still had the right to make her own medical decisions. According to them she was functional and was not posing an immediate danger to herself or others. I understand autonomy. Autonomy is defined as “a principle in which a person should respect the rights of other individuals to freely determine their own choices and decisions” (Jonas). I understand how important free will and the ability to make choices about your own body are. It is hard for me, however, to understand how you can continue to honor a person’s right to make their own decisions, when every decision they make is only hurting them. It is hard to sit there, as a loved one, and not want to just make them take the medication they need to get better, or force them participate in that research study that just might help.

Continue reading ““She Can’t Help The Choices She Makes””

Ethics & Society Newsfeed: August 18, 2017

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Politics

Neil Gorsuch Speech at Trump Hotel Raises Ethical Questions
“Justice Neil M. Gorsuch, President Trump’s Supreme Court appointee, is scheduled to address a conservative group at the Trump International Hotel in Washington next month, less than two weeks before the court is set to hear arguments on Mr. Trump’s travel ban.”

Trump’s Washington DC hotel turns $2m profit amid ethics concerns
“Donald Trump’s company is said to have taken home nearly $2m in profits this year at its extravagant hotel in Washington, DC – amid ethics concerns stemming from the President’s refusal to fully divest from his businesses while he is in office.”

3 representatives want to officially censure Trump after Charlottesville
“In response to Donald Trump’s controversial remarks about the violence in Charlottesville, Virginia, three Democrats want to censure the president.”

Does Trump’s Slippery Slope Argument About Confederate Statues Have Merit?
“NPR’s Robert Siegal talks with Ilya Somin, a professor of George Mason University, about President Trump’s warning that pulling down Confederate statues may lead to a slippery slope in which monuments to the Founding Fathers are torn down.”

Bioethics/Medical Ethics and Research Ethics

Vaccination: Costly clash between autonomy, public health
Bioethical principles in conflict with medical exemptions to vaccinations

CRISPR and the Ethics of Human Embryo Research
“Although scientists in China and the United Kingdom have already used gene editing on human embryos, the announcement that the research is now being done in the United States makes a U.S. policy response all the more urgent.”

Exclusive: Inside The Lab Where Scientists Are Editing DNA In Human Embryos
“[Critics] fear editing DNA in human embryos is unsafe, unnecessary and could open the door to “designer babies” and possibly someday to genetically enhanced people who are considered superior by society.”

The Ethics Issue Blocking Organ Transplant Research
“The ethics of so-called donor-intervention research are incredibly fraught. How do you get informed consent and from whom? The dead donor? The live recipient—or possibly dozens of live recipients getting tissues or organs from a single donor, fanned out across the country at different hospitals each with their own ethics review boards? All this would unfold against intense time pressure. Every minute of delay is a minute in which the organ is deteriorating.”

NSF reiterates policy on teaching good research habits despite its limitations
“The National Science Foundation (NSF) in Arlington, Virginia, has decided to double down on its implementation of a congressionally mandated policy aimed at reducing research misconduct among NSF-funded scientists, despite a new report that notes problems with the agency’s approach.”

What do revised U.S. rules mean for human research?
“Following a contentious 5½-year process, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a revised “Common Rule,” which governs federally funded research involving human subjects (1). The updated rule includes a number of welcome changes for U.S. institutions and researchers, and their scientific collaborators abroad.”

Technology and Ethics

The Ethics of Doxing Nazis on Social Media
“The important question is: does any of this help?”

The importance of building ethics into artificial intelligence
“Understand ethical AI and its role in the future of work, recruit talent that understands AI – and its power to address workplace challenges, develop AI that runs on data reflecting the diversity of its users…”

The Ethics of Artificial Intelligence
“Establish an ethics committee, pursue innovation safely, create a solid foundation, choose autonomy, not regulation…”

“We have made more progress in artificial intelligence (AI) in the last three years than in the preceding three decades. AI is transforming from handy little applications that make our lives easier (from Alexa and Siri to Uber and Netflix) to something more powerful…”


Philosophy and Business Ethics

Are corporations becoming the new arbiters of public morality?
“After Charlottesville, CEOs have become our public conscience. Here’s what that says about capitalism in America.”

How to be Ethical in the Workplace, According to 3 Philosophers
“Whether you’re a journalist, banker, salesman, chef—whatever your career path may be—you’re obviously going to want to be a good professional. A key factor in being “good” in any profession is to be ethical…”

User Beware: Privacy Settings just a Facade

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By Brenda Curtis, Ph.D.

Social media platforms continue to improve and refine their privacy settings as the demand for advanced user protections increases. Although enabling catered privacy settings to online profiles allows users to indicate who they would like share personal information with, it does not necessarily protect them from the platforms – i.e. websites and apps – themselves. Since social media accounts provide users with a sense of control over personal data, users assume that their information is safe. However, no matter what settings or privacy protections are applied to personal profiles, users do not generally have control over the online platform itself. What this means is the website or app being used usually shares information from accounts with third parties like advertising agencies or other databases. This data sharing is widespread throughout the industry, but it is not generally known by the public. This is partly because the disclosure of this sharing is done in the social media platform’s “Terms and Conditions” Which are often skimmed over or ignored.

Aside from social media websites, there are several other websites and apps that access your personal information via this information sharing to create a single database for everyone in the country. This is generally called data aggregation. One such site that has been in the news recently is FamilyTreeNow.  FamilyTreeNow is explicitly a genealogy site, and compiles information from various legal online sources to create a database full of personal information for genealogical research. This site pairs information from public records such as police records and court documents with the information collected from social media and address databases to create a sometimes way too revealing profile. Not too long ago, most of this information would only be accessible after exhaustive research, but Now FamilyTreeNow makes this information as easy to find as a click of a button, and publicly accessible.

Although the website might be fascinating for someone with genuine curiosity about their own family tree, the danger of anyone having access to information to a person’s age, birth year, address, family members and even public records is something that cannot be ignored. In today’s world, access to this type of personal information makes crimes like identity theft much easier to conduct and can provide the basis for access to financial accounts, credit records and other accounts and assets. For years we have been cautioning users against posting too much information online, but increasingly, due to data aggregators like FamilyTreeNow, this information is being posted without our knowledge or consent on publicly accessible sites.

Continue reading “User Beware: Privacy Settings just a Facade”