Here’s a quick look at some of the privileges and regulatory approvals our group had to seek before we could begin the project that I am currently running. These all had to be met before we could start our first experiments.
The National Instututes of Health Center for Scientific Review Special Emphasis Panel on New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases (NIH ZRG BST-Z50): Our ‘Non-viral gene therapy for sickle cell anemia’ grant will receive funding for two years at $249,990 per year in direct costs and up to three additional years of funding at $495,920 per year in direct costs.
The Recombinant DNA Advisory Committee (RAC): Our lab is allowed to use and create artificial DNA strands and to use chemical, electrical, or physical means to introduce them into organisms.
The Institutional Biosafety Committee (IBC): We also allowed to culture living human, animal and bacterial cells and tissues and to genetically manipulate the same, provided we maintain BSL-2 and BSL-1 procedures and equipment.
The Nuclear Regulatory Commission (NRC): We will retain and have access to 500 micro Curie quantities of radioactive phorphorus-32, sulfur-35, and chromium-51. I will also have access to a 320 kV x-ray irradiation unit and/or a 1.02 Gray per minute cesium-137 source.
The Drug Enforcement Agency (DEA): We will retain for use in animals one-hundred gram bottles each of sodium pentobarbital, ketamine, and xylazine. For laboratory purposes, we are allowed to purchase reasonable quantities of the drug precursor chemicals methylamine, barbital and acetic anhydride.
The Institutional Review Board (IRB): We are allowed to receive and conduct experiments on deidentified human tissues including umbilical cords, cord blood, and peripheral blood collected from sickle cells patients. Approval is pending for waste units from exchange transfusion, the release of backup stem cell units in transplant patients and directed donation of umbilical cords from sickle cell children.
The Institutional Animal Care and Use Committee (IACUC): This year I will be allowed to house and use up to 512 mice for Pain Class B tissue harvest, in which I will anaesthetize them, drain their blood and cut out their bones for stem cells as outlined in the submitted protocol. A further 104 mice can be used for Pain Class C surgical procedures, where they will be dosed with radiation, transplanted with mouse or human stem cells, and implanted with dorsal skin fold vascular viewing windows. Subjects surviving the procedure in good health are authorized for the induction of sickle cell crisis and observation for up to four days at which time they must be euthanized.
That’s a pretty full summary of the various acronymically named bodies I and most other medical scientists need to get permissions from to conduct research. Without that approval most of the things I do each day could land me jail. I have to scientifically justify why we need those permissions, but it’s mostly rote because I’m already a scientist. I’m already official. The presumption is that I and the people I work for know what we’re doing. Without that official stamp of approval that list above would probably read: defrauding the government, bioterrorism, nuclear smuggling, drug trafficking, battery, theft, and animal cruelty.
Obviously a great deal of this course will be discussing who gets to do what and for what purpose and is allowed have that be accepted as legitimate or scientific. I get to speak from a position of privilege and legitimacy; one I don’t really have to worry about losing that anytime soon, but that I feel compelled to defend. There are good reasons why we grant scientists these things generally, but there are probably a range of reasons each scientist seeks it.
For me, science is very much about empowerment. After all of the drudgery with paperwork and approvals, a project like mine, a smaller grant where I am the principal person at work in the lab, takes on a thrill-of-the-hunt quality. There’s enjoyment in the pursuit of discoveries and new ideas. The end point of the project is to develop a potential cure for sickle cell anemia that is fit for human trials. It’s more or less up to me and my boss to figure out how to make that happen.
We are only a year into the grant and I’ve already departed significantly from the original plan in the grant. This happens to many so-called ‘high risk high reward’ projects and often the real skill seems to come in overcoming and improvising around obstacles rather than creating a perfect master plan. Projects are always breaking down because some assumption or technique fails in practice, but that first draft plan is based on the best information from other investigators in other circumstances.
The blackboxing process that Bruno Latour conceives of, for scientists, is really a labor saving device and a didactic tool. It makes it easier for ideas to be understood and learned by others. One of the traits of successful scientists is to understand the internal mechanisms and know when one can rely on them and when one must reject them. Scientists, almost like a craftsman or artisan, develop an intuitive understanding of their field and methods on which they rely. It’s often when scientists see that understanding in a novice that they begin to accept them as a peer.
It is that initial acceptance as a scientist, securing that initial NIH money, and getting approval from IRB that are the highest hurdles. On the other side of those barriers there are far easier institutional obstacles, but this is all to merely begin the physical, laboratory-driven side of the process that most scientists truly enjoy. I've worked for years to be able to have the privileges that scientists get in our society. Now that I have gotten there for the most part, I'm trying to challange my assumptions before I get too comfortable.
Wow. Data and a profoundly important idea--law totally informing the science-making process.
ReplyDeleteThe famous 'paradigm shift' book (Thomas Kuhn's 'Structure of scientific revolutions') says the 'politics,' variously, influences 'problem selection' and thus partly determines the course of science (what gets worked on).
Lucas shows us 'Science in Action.'