I am more than ready to obtain blood samples from our subjects, but we are still waiting on approval from the IRB (its been nearly a month!). Our protocol is now in “expeditied review” which means that any IRB board member can just pick it up, read it, and approve it. (This is supposed to be quicker than waiting for the next board meeting.) I have no idea how long this will take; but for now we wait…
Last week’s seminar with Colleen Deeny was a good introduction to the ethics and policy behind research. It was interesting to see how history’s ethical disasters and dilemnas were used to establish the current regulations researchers use today. Using humans in clinical trials is a very valuable practice yielding significant benefits to society, provided rules are followed. I have noticed that scientists often times view consent forms and IRB approval of new protocols as road blocks that delay schedules and create stress. We must, however, be grateful for the extensive measures taken to protect our study subjects.
I found the NY Times article very interesting, as I had never heard of a researcher fabricating data. Poehlman, clinical researcher at the University of Vermont, was caught and charged for this crime. He cheated rather boldly, initially using his authortitative position to deny his misdeeds. I give my kudos to Water Denino, the UVM student who courageously confronted his boss after asing the advice of many colleagues. Denino faced the possibilty of permanently damaging his career but knew it was the responsible thing to do. Poehlman brought up the issue of writing grants to obtain federal money to conduct research. My mentor once told me that as long as you have ”good data and good results”, getting funding is not that bad, just time consuming. It was noted that for one of Poehlman’s later studies, even a false hypothesis would have been a contribution to science.
I enjoyed And the Band Played On although I was saddened to learn that many ethical barriers prevented the CDC and Reagan administration from investigating AIDS sooner than they did. The most obvious ethical misdeed was done by Dr. Gallo, an egotistical researcher who wanted the credit for isolating the disease first done by French researchers. The subject of obtaining government funding to run a lab was also touched on in this movie. Dr. Curran of the CDC explained how time-consuming and competitive grants were- reasons his lab lacked adequate research equipment.
Ok, I’ve finally been assigned a project! I’ll be investigating whether or not it is possible to predict whether certain cancer patients who clot are susceptible to subsequent clotting. We’ll begin by collecting the blood of two groups of patients, performimg RNA and microarray analysis to identify a metagene for predicting which patients will clot again and which ones won’t. Results will hopefully lead to developing a personalized medical strategy for better treatment. As I mentioned in a previous post, we are currently waiting on the approval of the protocol, but meanwhile I’m running RNA extractions and getting comfortable with the procedure. I’ll make updates as this study progresses.rnrnrn
I had no idea there was such a profession as a research nurse. Yesterday, I had the opportunity to shadow 2 research nurses who both are recruiting subjects for participation in two different studies. So, what exactly do they do? They are the backbone of clinical research- they work in an office setting but also frequent the Duke North Hospital and Duke South clinics to see about potential subjects for currrent hematological studies. Donned in a white lab coat that I borrowed from Sheree, we headed off to 9th floor, oncology. Their department is primarily concerned with cancers of the blood like lymphomas and leukemia. She and I checked up on the platelet counts of three different patients to see if they were still elligible for PLADO, a nation-wide study that is looking for a more cost-effective way to tranfuse platelets. Meanwhile, Robin was working on an observational study on Heparin-Induced Thrombocytopenia that follows cardiac bypass patients. The anticoagulant heparin has the disadvantage of increased clotting in certain patients. Part of her job includes giving these patients the spiel of the study and asking them to sign a consent form to donate their blood. She did this task with reservation, saying that it was difficult approaching people in the ICU who were often in a lot of pain; “I feel like a salesperson”, she told me.Recruiting these patients is the first barrier to clinical research, apart from awaiting approval of the protocol from the IRB, whcih can take a few weeks-which is what I’m kind of doing right now.
As I mentioned, I am working in the Hematology/Oncology lab with Dr. Tom Ortel. His research focuses on rare diseases of the blood involving thrombosis (severe clotting) or hemorrhage (severe bleeding). He just finished a study on Antiphopholipid syndrome, an autoimmune disease characterized by excessive blood clotting. Just yesterday, I went to a talk he gave to his colleagues about his findings. He shared a few patient case studies and was able to recommend more up-to-date treatments for APS patients. I enjoyed how he was able to apply his research to real patient care. The study I’ll be helping out with involves a condition called Heparin-Induced Thrombocytopenia. It sounds just like its name: a drug called heparin produced unintended platelet aggregation leading to thrombosis in cardiac bypass patients. To investigate, we will be performing RNA extractions from human blood and analyzing gene expression patterns with microarray analysis. I had a nice introdcution to the lab setup this week and I’m eager to begin the real extractions on Monday! Here is a picture of my mentor and one of me:
