Research Rules: They Are There for a Good Reason

I have just read a most fascinating book. It is about how one woman’s cancer cells developed into the entire field of cell biology and virology. But even more importantly, it is a book about the development of human subject controls and protection in all areas of medical research. I very highly recommend The Immortal Life of Henrietta Lacks, by Rebecca Skloot. The book describes the life of Henrietta Lacks, a black woman who grew up outside of Baltimore, how she developed cancer and was treated at Johns Hopkins Hospital at a time when it was still a segregated facility with separate operating rooms, hospital beds, and water fountains for “colored” people. Her cells were taken without her permission (which was not unusual at that time) and used for research. Her cells were very useful in teaching  researchers about growing cells cultures and the cells  was successful in helping to develop the polio vaccine among other things. They were grown and sold without  her family’s permission and her family, who could not afford medical care, did not receive any of the income that the sale of her cells produced.


Clinical Research

As a clinical researcher, I confess to having experienced annoyance at all the rules I needed to follow in order to do research. I knew I had to get permission of parents, and kids, when they were old enough. But all that paperwork with the Institutional Review Boards. Is this really necessary? I will NEVER ask that question again after reading this book.

In their attempt to understand how cancer cells grew, researchers injected cells from Henrietta Lacks into people to see what happened. Some of the subjects were asked to volunteer. However, since they were prisoners, it is not clear how much  they were actually volunteering. Some subjects were cancer patients who had these cancer cells injected into them as part of the hospital’s research. Then there were researchers at a hospital for chronically disabled patients who wanted to inject cancer cells into their patients, but three physicians refused to participate and eventually this became public. The three doctors were Jewish and their awareness (and everyone else’s) had been heightened by the horrors of Nazi Germany. The Nuremberg Trials had set as its first principle that nothing could be done to a patient without his or her consent. Obviously this was not current practice.

How could this be justified?

As this information became known, there was outrage. Some of the physicians involved argued that since the subjects of the research were receiving free medical services it was legitimate to do  research without their permission. Fortunately, not every one agreed. The two physicians who had done the most outrageous work  lost their licenses to practice. Although the  NIH had a rule requiring consent from any research subject, it discovered that most of the programs to which they had awarded grants failed to get the consent of their subjects. In 1910, the AMA had developed guidelines for doing research on animals but, amazingly, not on  humans.


How did this change research?

NIH clamped down on research involving their grants. Institutional Review Boards were organized at every program doing research to oversee all research. They required patient consent before doing any research and returned  to the “do not harm” rules that we all thought were part  of every day practice. Patient protection and privacy rules were developed, and now if physicians or other health care workers do not observe them, punishment  is severe. Things have changed and we are lucky they have. I promise never to complain again about research rules (well that may be going too far.)


About Jane Madell

Jane Madell has a consulting practice in pediatric audiology. She is an audiologist, speech-language pathologist, and LSLS auditory verbal therapist, with a BA from Emerson College and an MA and PhD from the University of Wisconsin. Her 45+ years experience ranges from Deaf Nursery programs to positions at the League for the Hard of Hearing (Director), Long Island College Hospital, Downstate Medical Center, Beth Israel Medical Center/New York Eye and Ear Infirmary as director of the Hearing and Learning Center and Cochlear Implant Center. Jane has taught at the University of Tennessee, Columbia University, Downstate Medical School, and Albert Einstein Medical School, published 5 books, and written numerous books chapters and journal articles, and is a well known international lecturer.