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.

 

Welcome 2017 HIV and Drug Abuse Prevention Research Ethics Training Institute Fellows!

The Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI) is pleased to announce that the following individuals have been selected as 2017 fellows:

Cook
Dr. Stephanie Cook, New York University
Estreet
Dr. Anthony Estreet, Morgan State University
Fielding Miller
Dr. Rebecca Fielding-Miller, University of California, San Diego
Guta
Dr. Adrian Guta, University of Windsor
Pagano-Therrien
Dr. Jesica Pagano-Therrien, University of Massachusetts 
Pasipanodya
Dr. Elizabeth Pasipanodya, University of California, San Diego
Philbin
Dr. Morgan Philbin, Columbia University
John_S
Dr. John Sauceda, University of California, San Francisco

The Fordham University  HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI), now in its 7th year, is a training grant sponsored by the National Institute on Drug Abuse (NIDA) (R25 DA031608-07), Principal Investigator, Dr. Celia B. Fisher, Director, Center for Ethics Education). The RETI provides early-career investigators in the social, behavioral, medical and public health fields with an opportunity to gain research ethics training. In doing so, RETI addresses the urgent need for HIV and drug use investigators who can identify and address ethical issues, engage drug using and other at-risk communities in the construction and evaluation of population sensitive research protections, and generate empirical data to inform ethical practice and policies for HIV prevention science. Through their funded Mentored Research Projects (MRP), RETI fellows generate empirical data, publish their findings in a variety of high-impact academic journals, and are trained to apply for increasing grant opportunities.

The program’s aims are to: (1) increase trainees’ knowledge of and capacity to address key ethical issues in HIV and drug abuse prevention research; (2) increase trainees’ capacity to ethically engage participants and communities in the construction of participant protections that reflect the values and merit the trust of all stakeholders in HIV and drug abuse prevention research.; (3) increase trainees’ capacity to conduct research that will generate data to inform HIV and drug abuse prevention research practices and policies; and (4) create and sustain an information and communication network for trainees, faculty and others in the field for enhancing ethical knowledge, ethical dialogue and future professional collaborations in HIV and drug abuse prevention research ethics.

Please visit our Institute Fellows page for the biographies of both this cohort and earlier cohorts of RETI Fellows, as well as read more information about their mentored research projects (MRP) and publications.

We look forward to welcoming our new fellows to the Institute in July!

Ethics & Society Newsfeed: October 14, 2016

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Health Care and Bioethics

DNA database highlights need for new medical privacy protections
Creation of a national repository of genetic information is seen by some as crucial to reducing medical costs and improving people’s healthcare.

‘Big data’ could mean big problems for people’s healthcare privacy
Public and private insurers are spending millions of dollars on systems that can predict people’s future healthcare needs.

Colorado Wrestles With Ethics Of Aid In Dying As Vote Looms
Colorado man says he would like the option to end his life rather than face a painful death and advocates for Colorado’s Proposition 106  or “death with dignity.”

The NIH needs to review the ethics of research on primates
Congress asked the National Institutes of Health to review “its ethical policies and processes” on nonhuman primate research “to ensure it has appropriate justification for animal research protocols.”

Breast Cancer Death Rates Are Down, But Racial Disparities Persist
Women are less likely to die of breast cancer than they were a decade ago, but not all women are benefiting from that trend.

Continue reading “Ethics & Society Newsfeed: October 14, 2016”

Will Research on 10,000 New Yorkers Fuel Future Racial Health Inequality?

Image via Flickr.
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By Celia B. Fisher, Ph.D.

A 20-year, multi-million dollar study of more than 10,000 New Yorkers scheduled to begin next year claims that it will enable the development of theories, therapeutics, and policies to improve the health and quality of human life.  Although still in the planning stages, the breadth of the data collection proposed (including health habits, biological data, and geospatial mapping) combined with the lack of detail accompanying such a widespread publicity effort raises questions regarding the extent to which the research risks of such an endeavor have been well thought out.

Continue reading “Will Research on 10,000 New Yorkers Fuel Future Racial Health Inequality?”

Best intentions, worst outcomes: Ethical and legal challenges for international research involving sex workers

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Central America hosts a thriving sex work industry that is a key source and transit region for sex trafficking and undocumented migrants engaged in sex work. Sex workers – particularly those who are migrant – are at high risk for HIV and other sexually transmitted infections as well as physical abuse and in some cases murder. However, the existing network of international, national, and local criminal and human rights policies applicable to sex workers can be confusing and contradictory, not only in the context of access to sexual health preventions and interventions, but also for investigators seeking to conduct that can lead to effective sexual health services.

Continue reading “Best intentions, worst outcomes: Ethical and legal challenges for international research involving sex workers”

Ethics & Society Newsfeed: March 4, 2016

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Via NYPL Digital Collections.

NIH vowed to move its research chimps from labs, but only 7 got safe haven in 2015
Nearly three years after the National Institutes of Health announced that hundreds of chimpanzees held for invasive medical experiments would be retired to a sanctuary, relatively few have been so lucky. Only seven made the trip in all of 2015.

The Brain Gets Its Day in Court
A new study found that the number of judicial opinions referencing neuroscience as evidence more than doubled between 2005 and 2012.

The Consequences of Poor Science Education in Kindergarten
A majority of low-income and minority kindergarteners come in with poor general science knowledge—and closing that gap may be crucial for ensuring academic success later on.

A Baby, a Baboon Heart, and the Transplant Heard Round the World: The Story of the First Neonatal Cardiac Xenotransplant in History
Stephanie Fae Beauclair, better known to history as Baby Fae, was born October 14, 1984 with hypoplastic left heart syndrome. Baby Fae needed a heart transplant to survive but a human heart was not available to her. What happened next challenged the boundaries of medical science and bioethics.

Continue reading “Ethics & Society Newsfeed: March 4, 2016”

Ethics & Society Newsfeed: February 19, 2016

Photo via Naitonal Archives Catalog
Participants in the Tuskegee Syphilis Experiment. | Photo via National Archives Catalog

Voices for Our Fathers Keeping Memory of Horrific Study Alive
The Tuskegee syphilis experiment recruited poor men with “bad blood” from rural Macon County, Ala., as test subjects. The study went on for decades, despite its ethical issues.

‘Government only pays for the positive outcomes.’ A strikingly new approach to social problems.
Two states announced Tuesday that they would experiment with an unusual method of financing human service programs that allows governments to pay nothing unless the programs are successful.

Needle Exchanges Can Now Get Federal Funding
Lifting the ban underscores a growing recognition that needle exchange programs can help reduce the the spread of infectious diseases

A First-Aid Class for Mental Health
Most people know how to help someone with a cut or a scrape. But what about a panic attack?

Continue reading “Ethics & Society Newsfeed: February 19, 2016”