Showing posts with label ethics. Show all posts
Showing posts with label ethics. Show all posts

Thursday, March 24, 2016

Scientific Misconduct at Prestigious Research Centers

On January 23, 2009, the Office of Research Integrity made public their findings of scientific misconduct concerning a doctor who fabricated data for several grants projects funded by the NIH (1). The doctor was a former graduate student in the Department of Pathology, Harvard Medical School, a former research fellow and Instructor of Pathology, at Brigham and Women's Hospital in Boston, a former postdoctoral fellow in the Department of Biology, at the California Institute of Technology, and a former Associate Professor in the Department of Biology and the Center for Cancer Research at the Massachusetts Institute of Technology. He had worked on numerous NIH grants, and was found to have fabricated data supporting applications for five NIH grants. It is difficult to imagine a person better prepared for a life of scientific integrity. From his pre-doctoral training, through his post-doctoral research and his academic appointment, he was nurtured in the finest environments, by some of the most respected scientists on the planet.

The Office of Research Integrity makes its findings a matter of public record. You can visit their web site and read the individual reports of misconduct (2). Here are some findings of misconduct, issued by the Office of Research Integrity, involving prestigious universities:

1. "[A] research program coordinator in the Oncology Center, The Johns Hopkins University School of Medicine, engaged in scientific misconduct by fabricating patient interview data for a study of quality of life measures in cancer patients. Further, the same research program coordinator, "engaged in scientific misconduct by falsifying patient status data by failing to update the status of treated breast cancer patients and misrepresenting data from previous contacts as the updated status for a study." (3)

2. An Assistant Professor in the Department of Psychology at Harvard University was found to fabricate data in a number of different experiments that were described in journal publications. The doctor retracted the published papers in a letter that included the following language, "because I improperly excluded some participants who should have been included in the analyses and that this exclusion affected the reported results. Moreover, the improper exclusion of data was solely my doing and was not contributed to or known by my coauthors." (4)

3. An Assistant Professor in the Yale University School of Medicine "committed scientific misconduct by plagiarizing and intentionally misrepresenting research in an application for Public Health Service (PHS) funded research supported by grant application 1 R24 RR05358-01" (5).

It is easy to find outrageous incidents that occur in the most respected universities and corporations (6), (7), (8), (9), (10), (11), (12), (13), (14), (15), (16). Reign in your astonishment. If you are the kind of person who is motivated by prestige, money and power, then you may gravitate to the places where prestige, money and power are found.

This headline appeared in today's The Guardian, concerning a research scandal at Sweden's famed Karolinska Institute: "'Superstar doctor' fired from Swedish institute over research 'lies'" (17). A renowned scientist and surgeon had committed a variety of scientific frauds, which have called for the retraction of prior "breakthrough" results. In a statement, the Karolinska indicated that the physician's contract would be rescinded for reasons that included apparent scientific negligence and the falsification of his CV." The full extent of the scientist's activities are covered in the article (17). I won't burden you with the sordid details, but The Guardian article is definitely worth reading.


References:

[1] Office of Research Integrity Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-040.html Jan 23, 2009.

[2] Office of Research Integrity. Available from: http://ori.dhhs.gov

[3] Findings of Scientific Misconduct. NIH GUIDE, Volume 26, Number 15, May 9, 1997. Available from: http://grants.nih.gov/grants/guide/notice-files/not97-097.html

[4] Findings of Scientific Misconduct. NOT-OD-02-020. December 13, 2001. Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-020.html

[5] Findings of Scientific Misconduct. NIH GUIDE, Volume 24, Number 33, September 22, 1995. Available from: http://grants.nih.gov/grants/guide/notice-files/not95-208.html

[6] Hajra A, Collins FS. Structure of the leukemia-associated human CBFB gene. Genomics 26:571-579, 1995.

[7] Altman LK. Falsified data found in gene studies. The New York Times October 30, 1996.

[8] Findings of scientific misconduct. NIH Guide Volume 26, Number 23, July 18, 1997 Available from: http://grants.nih.gov/grants/guide/notice-files/not97-151.html

[9] Bren L. Human Research Reinstated at Johns Hopkins, With Conditions. U.S. Food and Drug Administration, FDA Consumer magazine, September-October, 2001.

[10] Kolata G. Johns Hopkins Admits Fault in Fatal Experiment. The New York Times July 17, 2001.

[11] Brooks D. The Chosen: Getting in. The New York Times, November 6, 2005.

[12] Seward Z. MIT Admissions dean resigns; admits misleading school on credentials degrees from three colleges were fabricated, MIT says. Harvard Crimson, April 26, 2007.

[13] Available from: http://en.wikipedia.org/wiki/Jesse_Gelsinger. Comment. This Wikipedia article recounts the tragic death of Jesse Gelsinger, a volunteer gene theraphy experiment at the University of Pennsylvania.

[14] Salmon A, Hawkes N. Clone 'hero' resigns after scandal over donor eggs. The Times, November 25, 2005.

[15] Wilson D. Harvard Medical School in Ethics Quandary. The New York Times March 3, 2009.

[16] Findings of Scientific Misconduct. NOT-OD-05-009. November 22, 2004. Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-009.html

[17] Oltermann P. 'Superstar doctor' fired from Swedish institute over research 'lies'. The Guardian March 24, 2016. Available at: https://www.theguardian.com/science/2016/mar/23/superstar-doctor-fired-from-swedish-institute-over-research-lies-allegations-windpipe-surgery, viewed March 24, 2016.

- Jules Berman (copyrighted material)

key words: ethics, fraud, scientific misconduct, ORI, Karolinska Institute, Machiavelli's Laboratory, Machiavelli's Lab jules j berman

Wednesday, June 27, 2007

Are human tissues owned?

There's not a whole lot of legal precedent in the biorepository field, and when a case lands in an appeals court, it's very important.

The bare bones of the case are as follows: Dr. Catalano, a prostate cancer researcher at Washington University, saved tissues in a biorepository over several decades. When he took a job at another institution, he sent out a letter to many of the people whose tissues were stored in the biorepository. The letter asked for permission to transfer their tissues to his new employer. He received a number of letters granting the permission. Washington University stepped in and informed Dr. Catalano that the tissues would need to remain in the Washington University biorepository.

Wash. U. asked the court for a declaratory ruling that the tissues were owned by Washington University and could not be taken by Dr. Catalano. The appellate court upheld that the tissues were owned by Washington University.

The text of the ruling is publicly available.

I read over the entire ruling and found myself in total agreement with the court. It was very interesting to read the evidence that the court considered important for their decision.

There was one point in their ruling that I found troubling. The court noted that the tissues were donated to Washington University by patients (which assumes that patients were the original owners of the tissues). Once donated (according to the court), the tissues were owned by Wash U (not Dr. Catalona). The problem here is that there's been a long tradition of not assigning ownership for human tissues. I'm no lawyer, but it's been my impression that removed human tissues carry a variety responsibilities (e.g. render a diagnosis, store in a paraffin archive, provide copies of diagnostic reports as needed) and rights (use tissues for biomedical research). Traditionally, All this is done through an exercise of rights and responsibilities, without an assignment of ownership.

Ownership is a mercantile concept and implies that the owner can sell the property. If you own a cow, that means you can sell the cow. If you own a house, you can sell the house. If you own a tissue sample, that would seem to mean that you can sell the tissue sample. But that is exactly why the tradition has been that tissue samples are never owned. Ethicists have commented that we shouldn't be selling tissues, and that implies that we shouldn't be owning tissues. We can use tissues for different purposes without assigning ownership. An analogy is that we breathe air from the atmosphere, but nobody owns the atmosphere. We also can be required not to pollute the air, even though we don't own the air. Basically, we can have a system of rights and obligations without assigning ownership.

Well, this court decision seems to break a long-held tradition. The court clearly thought it needed to determine who owns the tissues (Wash U or Dr. Catalona), and they ruled that the tissues were property owned by Wash U. So what happens next? Have archived tissues become property [that can be bought and sold]?

-Jules Berman
Science is not a collection of facts. Science is what facts teach us; what we can learn about our universe, and ourselves, by deductive thinking. From observations of the night sky, made without the aid of telescopes, we can deduce that the universe is expanding, that the universe is not infinitely old, and why black holes exist. Without resorting to experimentation or mathematical analysis, we can deduce that gravity is a curvature in space-time, that the particles that compose light have no mass, that there is a theoretical limit to the number of different elements in the universe, and that the earth is billions of years old. Likewise, simple observations on animals tell us much about the migration of continents, the evolutionary relationships among classes of animals, why the nuclei of cells contain our genetic material, why certain animals are long-lived, why the gestation period of humans is 9 months, and why some diseases are rare and other diseases are common. In “Armchair Science”, the reader is confronted with 129 scientific mysteries, in cosmology, particle physics, chemistry, biology, and medicine. Beginning with simple observations, step-by-step analyses guide the reader toward solutions that are sometimes startling, and always entertaining. “Armchair Science” is written for general readers who are curious about science, and who want to sharpen their deductive skills.