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 Institute. Fisher’s Decoding the Ethics Code: A Practical Guide for Psychologist, is now in its fourth edition from Sage Publications.