The Not So Known History of the Responsible Conduct of Research Regulations
This article will provide some lesser-known history of the RCR regulations including some early versions of RCR education and two cases of misconduct accusations found to be untrue, which helped in the development of RCR as we know it today.
We have all heard the term Responsible Conduct of Research (RCR) but what does that really mean and what exactly are we supposed to do about it? According to the National Institutes of Health (NIH), the idea of RCR should be more about learning how to practice responsible science more than teaching someone that it’s bad to commit research misconduct (Kalichman, 2017). Early training seemed to be of an informal nature and was expected to come from the mentor, but it didn’t seem that this was happening.
The University of Texas Health Science Center at Houston (UTHSCH) in 1984 and Virginia Commonwealth University (VCU) in 1986 had issues arising from ethical dilemmas of graduate students and the seeming lack of guidance from their respective mentors. The course at UTHSCH was built initially to assist graduate students with ethical dilemmas they might face in research (Bulger, Reiser 1993). The initial course was not provided for academic credit, but attendance was mandated by the institution. The initial course offered at VCU was called the “Chairman’s Colloquium,” and was offered as a lecture series not for credit. This initial offering though still seemed to be more interested in politics rather than trying to assist students’ understanding of the responsibility of the ethical conduct of research (Macrina, Munro 1993).
We also know about high-profile cases of research misconduct-- Tuskegee Syphilis Study, Henrietta Lacks, Jesse Gelsinger, and many others. Two cases of alleged misconduct both involved the NIH and drew criticism on the handling of these allegations by the Federal government. In 1991, Dr. Thereza Imanishi-Kari was accused of falsifying data for a scientific paper on immunology and was recommended to be barred from research funding for ten years. Since she was funded by the NIH, the United States Congress reviewed the case. In 1996, though, an appeals panel through the Department of Health and Human Services dismissed the charges against Dr. Imanishi-Kari (Lock 1999). The exoneration called for a widespread review of the oversight of the Federal government and how it handles the investigations of alleged research misconduct.
Dr. Richard Gallo is a well-known researcher and one of the scientists credited with the discovery of the human immunodeficiency virus (HIV). There was a dispute of who should own the patent for a blood test that stemmed from the isolation of the cause of the AIDS virus. Dr. Gallo was accused of stealing the virus from the French scientists working in the same field because they had sent Dr. Gallo a sample from their lab. This led to three separate investigations of scientific misconduct by NIH that started in 1989 and ended in 1993. Dr. Gallo was never found guilty of the misconduct and both groups are credited with work that led to the early discoveries around AIDS and HIV (Vahlne 2009).
It’s not known if these cases and others were the true cause of the creation of RCR education and regulations or that the scientific community as a whole felt that it was needed. Next month, we will look at where we are now with RCR education and regulations.
Authored by Carly Pigg, Research Fiscal Analyst
Louisiana State University Health Sciences Center
SRAI Catalyst Committee
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