Tired. Brain still hurts.
Today was the second day of our two-day seminar on the legal aspects of basic science and clinical research. Here are some of the highlights:
Export Controls: Intellectual property can be considered an export. As can all that wonderful information rattling around inside your gray matter. Sending an email with technical information in it is no different than sending a FedEx package with technical information in it. If you send information to embargoed states, you are potentially violating the embargo depending on what you sent. If you go to an embargoed state for the purpose of disseminating information, you are potentially violating the embargo.
Good Clinical Practice: Don't do an "Enron." Don't tellthe federal investigator that you lost the records because of (pick your favorite): fire, flood, natural disaster, shredder malfunction. Basically it's the federal equivalent of "The Dog Ate My Homework" excuse. Your third grade teacher didn't buy it, and the feds don't either - and they can do a lot more than just give you an "F" on the assignment.
I'm not sure that our general counsel anticipated what was going to come up in this session. He was a bit pale when we began asking questions about Blackboard and knowledge-sharing. Not long after that he declared the session "privileged." He also looked a bit gray after the session was over. As in "what did I get myself into??" One problem with academics - if there is information to share - we generally share it first, then worry about the implications of it afterwards. Worrying about the implications of information sharing first is a bit new to many of us.
Sigh. Brave new world - especially for me. One foot in law student mode, the other firmly in educator mode. The law student wanting to chase down the implications. The educator in me wanting to go and hide under the bed and pretend it was all just a bad dream.
T-minus 2 months, 19 days, and counting.
Saturday, January 13, 2007
Thursday, January 11, 2007
With Intent.....
Hello Everyone~
I've been busy the last several days orienting into my new position at the School of Nursing and learning what everyone's needs are with regards to our Blackboard educational suite and their skill level when it comes to learning new software programs.
Today I sat through "Survivor: Research Island" - the first day of a two day legal seminar covering the Do's and Don't's of research - especially with regards to money. What I learned the first day - don't mess with the money. The first three presentations could easily have been retitled "False Claims 101." Gaaah! Something can be a false claim, even when it isn't intended to be a false claim. And the fines/penalties are steep - even for just a civil settlement. There wasn't anything settled for less than 500K total, and many were multi-million claims. The biggest loser was one that settle for 38 million, and the attorney that briefed that case said that it could have been a lot worse.
Then there was the researcher who "inflated" his resume, got the go ahead to sponsor his own clinical drug trial through the University he was teaching at, falsified data on his grant application, and (if I'm remembering correctly) falsified some of the study data that he submitted to the FDA to get approval for his clinical trial. The FDA didn't even go after the University in that case. The criminally charged the researcher for falsifying data and a handful of other offenses also related to clinical trial research.
Moral of the story: Don't lie to the government. Don't mess with the money. Don't even give the appearance of messing with the money, or it will be BAD for you. Very Very BAD. Even if you had no intention of defrauding, or just made a mistake, it will still be BAD for you.
The good out of all of this is that I now have a jump on false claims tort. I have just received several hours of training from one of the big names in Federal false claims defense. For free, no less. And, I had the added benefit of not having to travel all the way to Washington DC in order to get it. Waaay cool.
They told us that today was the "scary story" day, and that tomorrow they will give us tips on how to plan and execute studies so that when we face an audit we will be ready.
Brain hurts. Going to bed now.
I've been busy the last several days orienting into my new position at the School of Nursing and learning what everyone's needs are with regards to our Blackboard educational suite and their skill level when it comes to learning new software programs.
Today I sat through "Survivor: Research Island" - the first day of a two day legal seminar covering the Do's and Don't's of research - especially with regards to money. What I learned the first day - don't mess with the money. The first three presentations could easily have been retitled "False Claims 101." Gaaah
Then there was the researcher who "inflated" his resume, got the go ahead to sponsor his own clinical drug trial through the University he was teaching at, falsified data on his grant application, and (if I'm remembering correctly) falsified some of the study data that he submitted to the FDA to get approval for his clinical trial. The FDA didn't even go after the University in that case. The criminally charged the researcher for falsifying data and a handful of other offenses also related to clinical trial research.
Moral of the story: Don't lie to the government. Don't mess with the money. Don't even give the appearance of messing with the money, or it will be BAD for you. Very Very BAD. Even if you had no intention of defrauding, or just made a mistake, it will still be BAD for you.
The good out of all of this is that I now have a jump on false claims tort. I have just received several hours of training from one of the big names in Federal false claims defense. For free, no less. And, I had the added benefit of not having to travel all the way to Washington DC in order to get it. Waaay cool.
They told us that today was the "scary story" day, and that tomorrow they will give us tips on how to plan and execute studies so that when we face an audit we will be ready.
Brain hurts. Going to bed now.