With the hiring of our research coordinator, Joe Voros at Johns Hopkins, there has been a noticeable uptick in our research discussions and activities. Our initial focus is putting in place the infra-structure to transport human tissue to UCLA, Hopkins, and Boston Children’s. With this process in place we can then ship tissue to the institutions actively conducting research on RE. This process is governed by regulations that are well-intended, but in fact are today controversial. The regulatory regime is referred to as IRBs, International Review Boards. IRBs are a fact of life for every researcher involved in human disease.
The federal requirement for the procedures governing human tissue research stems directly from experiences in the Tuskegee Study. The Tuskegee Study was a federally funded study that took place from 1932 to 1972. In that study a large number of low income, African-American men with syphilis were studied for several decades to determine the natural history of untreated syphilis. The study took place before treatments for syphilis were available and the men were not offered treatment with penicillin even after it became available. The men were not told they were subjects in a research study and many of them died of the complications of syphilis. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was exposed in a newspaper story, and it became a political embarrassment.
When this breach of ethics became publicly known in the middle of the 1970s, the federal government put in place legal requirements for a process that reviews and approves human tissue research that uses federal funds. These rules led to the establishment of institutional review boards at hundreds of institutions receiving federal funding for research.
Today’s problems with IRBs can be summarized as follows. “It seems that a frenzy is building over the behavior of many IRBs. Increasingly, we hear horror stories about IRBs that are imposing incredible burdens on researchers, creating bureaucratic nightmares and otherwise hindering the progress of research. Many are charging that, rather than protecting the safety and welfare of research participants, IRBs have become too focused on protecting their institutions from exposure to liability or bad press.”
We are working diligently to put in place the necessary IRBs. We are in need of RE tissue including blood, spinal fluid, and brain tissue, especially from patients that are pre-hemispherectomy. Please ask your neurologists and neurosurgeons to contact me or Joe Voros at jvoros1@jhmi.edu to learn about what the RE Children’s Research Consortium and our plans for a tissue bank and registry.
February 29th is Rare Disease Day. March 26th is Purple Day. Purple Day is an international grassroots effort dedicated to increasing awareness about epilepsy worldwide. On that day people in countries around the world will be wearing purple in support of epilepsy awareness. Rasmussen’s encephalitis is the rarest of the rare affecting a few hundred people a year and marked by incurable epilepsy. Please mark your calendar and support RE awareness as well as other rare diseases by wearing purple on both dates.
Grace and I show our true colors at the fundraiser.
At Ellen's Stardust Diner in New York City.
