by Michael J. Fitzpatrick, Executive Director
Late last week, The New York Times and The Los Angeles Times broke the news that the prestigious Kreitchman PET Center at Columbia University suspended some current research studies because of “sloppy practices” by researchers. The study under scrutiny involves brain imaging research of people living with mental illness and safety violations that could endanger these individuals.
This disregard for participant welfare is alarming, to say the least. Research is one of the central components of NAMI’s advocacy platform. Research will lead to better treatments and better quality of life for people living with mental illness and, we believe, a cure. It is appalling that after all the advocacy it has taken to promote much-needed research, it could founder upon shoddy practices that threaten the lives of individuals and the future of scientific investigation.
The entire enterprise of research is built upon “the trust implicit between research participants and investigators”—participants know that the treatments or tests may or may not help them directly but the results may help someone like them. The study participants at Columbia’s Kreitchman PET Center—which performs brain research on conditions like schizophrenia and major depression—were acting with the greater good in mind, yet some of these participants were exposed to inappropriately prepared radioactive compounds.
These irregularities were then covered up by “systematic forgeries condoned and approved by the lab director.”
The revelations about ongoing improprieties at the Kreitchman Center scandal suggest that answers must be sought in support of a thorough resolution, among them:
Did the Kreitchman Center’s IRB carry out their responsibilities to protect the best interests of research participants and were its members fully informed of safety concerns raised by the Food and Drug Administration (FDA) in its 2008 review?
Are researchers who have a personal stake in the outcomes of their own research capable of objectively carrying out quality control responsibilities? Shouldn’t quality control be the responsibility of those outside the research enterprise?
In addition to our concern about the safety of the individual research participants, NAMI worries that any family touched by mental illness now or in the future—potentially any family—will pay the price for the corners cut by short-sighted researchers. Investigation into the biological basis of mental illness has had profound implications for people living with conditions. Flawed practices and lack of trust may set back research and prevent important breakthroughs in understanding the nature of serious mental illness and identifying treatments that can foster recovery. This would be tragic indeed.
It is time for the research community, including regulatory agencies and researchers themselves, to step forward and develop and adhere to procedures and safeguards that will protect the interests of participants while allowing important outcomes to proceed and flourish.