Sunlight in Scholarly Research: A Case Study

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In 2021, the QS World University Rankings noted the existence of 1,002 research universities around the globe.[1] The sheer scope and scale of studies conducted by these institutions, which cut across myriad disciplines and receive funding from public and private entities, necessitates oversight. In the absence of such oversight, negligence and knowingly unethical practices can run rampant, jeopardizing the integrity of knowledge production and, more importantly, the health and safety of research subjects. To deepen our understanding of research ethics, this post summarizes and analyzes the circumstances in one case of misconduct, as reported by the Office of Research Integrity (ORI).

Housed within the U.S. Department of Health & Human Services, ORI issued a summative notice in 2020 concerning the case of Alexander Neumeister, M.D., a former professor of psychiatry and radiology at New York University School of Medicine, Langone Medical Center (NYUSOM).[2] According to the office’s analysis of NYUSOM’s investigation into the matter, Neumeister engaged in misconduct in studies funded by six separate grants from the National Institutes of Health and National Institute of Mental Health. Before outlining the case further, it’s important to note that the case resulted in a Voluntary Exclusion Agreement, where the accused “neither admit nor denie[d] ORI’S finding of research misconduct.”[3] That being said, five out of six of the research studies under question saw funding close to $1.8M in total, which illustrates just one measure of the gravity of the case.[4][5][6][7][8]

The investigation revealed that misconduct occurred in nearly every phase of the research enterprise. Subjects’ eligibility for inclusion in studies was based on assessments that were too old to be appropriately used. Neumeister claimed that those on his research team conducting assessments had earned the necessary licenses, certifications, and training to do so, when in fact they had not. The lead researcher also compelled members of his team to alter, leave out, and intentionally overlook specific assessment data. Knowing misrepresentation of data corrupted the integrity of the studies and data reported in past publications were integrated into the “results” of later clinical research trials. 

The consequences of these violations are particularly acute, I’d argue, considering the potential vulnerability of the studies’ primary research subjects: those suffering from post-traumatic stress disorder and/or anorexia, the latter of which Neumeister’s grant proposal described as a “chronic psychiatric disorder associated with the highest mortality rate of all psychiatric disorders.”[7] In a 2016 expose of the researcher’s unethical practices in a Pfizer-funded study, The New York Times illuminated the suffering endured by one of Neumeister’s subjects who had survived childhood sexual abuse:

[Diane] Ruffcorn, who writes a popular Facebook blog on trauma called A Little Bent, said the most unsettling part of the experience was not the loose monitoring, but the preparations for the trial. To participate, the N.Y.U. team told her, she first had to stop taking all her medications. But the study had several false starts, requiring her to stop taking medication, then restart, then stop again — and restart.

“It was horrible,” she said. “I had flashbacks, returning nightmares, every symptom coming on full force, not to mention the withdrawal. After going off and back on four or five times, I told them, ‘I can’t do this anymore.’”

Carey, B. (2016, June 27). An N.Y.U. Study Gone Wrong, and a Top Researcher Dismissed. The New York Times. Retrieved from https://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html

The Department of Psychiatry at N.Y.U. School of Medicine forced Neumeister to go on leave following reports of his misconduct and the researcher later resigned. This disciplinary action is reassuring given the pain Ms. Ruffcorn and perhaps additional subjects experienced. But the fallout from these cascading violations yields numerous unnamed consequences and unanswered questions.

First, the agreement that concluded ORI’s case required Neumeister to retract or correct four publications that were affected by his unethical practices. While a vital step, this action doesn’t rectify the downstream manifestation of corrupted findings in publications that cited Neumeister’s work. Since a focus of his research was novel, if not considered taboo by some–marijuana in mental health treatment–Neumeister’s misconduct jeopardizes the legitimate efforts of researchers at the frontier of this niche in experimental drug studies. Additionally, there’s the opportunity cost that was incurred. What about fledgling studies that didn’t receive the $1.8M+ that Neumeister was ultimately awarded? How could the results of those unfunded studies have improved public health?

We live in a time when higher education is the target of widespread mistrust among a large contingent of the U.S. population, which closely hews to partisan lines. A 2017 Pew Research study revealed that “58 percent of Republicans and GOP-leaning independents believe higher education has ‘a negative effect on the way things are going in the country,’ versus just 19 percent of those on the left who say the same.”[9] And those numbers on the right are only increasing. Considering this, wrongdoing among unethical researchers is particularly damaging at a time when universities must demonstrate their contribution to the public good, more than ever. Fortunately, units like the Office of Research Integrity work diligently to ensure that transparency and accountability are upheld in the scholarly research. For, in the words of past Supreme Court justice Louis D. Brandeis on the subject of corruption, “sunlight is said to be the best of disinfectants.”[10]

Notes

[1] QS World University Rankings 2021 Supplement. (2020, June 9). In QS Top Universities. Retrieved from https://www.topuniversities.com/student-info/qs-guides/qs-world-university-rankings-2021-supplement

[2] Case Summary: Neumeister, Alexander. (2020, January 7). In Office of Research Integrity. Retrieved from https://ori.hhs.gov/content/case-summary-neumeister-alexander

[3] Ibid.

[4] CB1 Receptor PET Imaging Reveals Gender Differencesin PTSD. (n.d.). In Grantome. Retrieved September 26, 2020, from https://grantome.com/grant/NIH/R01-MH096876-01A1

[5] KOR Depression. (n.d.). In Grantome. Retrieved September 26, 2020, from https://grantome.com/grant/NIH/R01-MH102566-01A1

[6] Kappa Opioid Receptor Imaging in PTSD. (n.d.). In Grantome. Retrieved September 26, 2020, from https://grantome.com/grant/NIH/R21-MH096105-01A1

[7] Kappa Opioid Receptor Imaging in Anorexia. (n.d.). In Grantome. Retrieved September 26, 2020, from https://grantome.com/grant/NIH/R21-MH102035-01

[8] A mGlu2/3 agonist in the treatment of PTSD. (n.d.). In Grantome. Retrieved September 26, 2020, from https://grantome.com/grant/NIH/R34-MH102871-01

[9] Vyse, G. (2017, July 13). Liberals Can’t Ignore the Right’s Hatred for Academia. The New Republic. Retrieved from https://newrepublic.com/article/143844/liberals-cant-ignore-rights-hatred-academia

[10] Brandeis, L. D. (1913). What Publicity Can Do. Harper’s Weekly. Retrieved from http://louisville.edu/law/library/special-collections/the-louis-d.-brandeis-collection/other-peoples-money-chapter-v