Advice about Industry-funded Projects
Posted on November 21, 2007
Alan F. Schatzberg (bio) discusses right-to-publish and intellectual property.
So industry grants generally speaking, if it’s a trial that the company is doing, they’ll own the intellectual property even though some universities try to own it, but it’s impossible otherwise you’d never get the study. For other kinds of grants, there’s kind of a sharing of intellectual property potentially. In general though, universities really want to have a right to publish. They may give the sponsor the right to look at it for a month, or whatever, but they generally maintain the right to publish and that’s because there have been some abuses historically where companies pocket vetoed the study and just said they couldn’t publish it.
The two big issues are right to publish and potential intellectual property that need to be discussed; the mechanisms vary. At one point you could get unrestricted grants from pharmaceutical industries to do whatever you want. Those don’t happen much, and they don’t happen in clinical departments because of the concern that there’s a kind of quid pro quo arrangement that could be occurring to use a particular product. So, now things are really kind of geared around studies and specific protocols. And frequently the paying now is done based on piecemeal basis so for a work product. Pay for X patients studied, you get a certain amount of dollars, you finish the report, and that makes it more of a business like arrangement. But it also kind of gives it a rigidity and requires some degree potentially of help, either the person has some resources, or the division, or the department because there has to be some risk for hiring the staff to get going, et cetera.
So, it’s important for young people to monitor the progress here of the study, because otherwise there is a fixed cost that’s going to in fact come land on somebody’s budget. And chairs in general are not very happy with getting suddenly stuck with covering a deficit based on somebody’s grant that they hadn’t anticipated. They don’t like that ‘cause it’s a cost over and it in fact hampers their ability to kind of manage their program, so it’s very, very important, on the young investigator’s side to manage that.
But one way of dealing with that is to get with the program chief who may have some other resources that could be a back up that could at least get a project going that then could be paid back rather than hiring staff. There are ways around that that can be helpful, maybe some guarantee about a potential deficit up to certain point.
And then at the same time, one needs to kind of structure the protocol so that it’s doable. I think that one of the problems that people have is that they inclusion exclusion criteria are so strict that in fact patients can’t get enrolled. You can’t find the particular kind of patient, the patient doesn’t get studied, and now what happens? You’ve in fact had fixed cost, you haven’t studied the patients, you’re not getting paid ‘cause now you’re getting paid per patient and per five patients and per ten patients and then you have a big loss. So, try to structure the study so that you can get it done.
Excerpted from interview with researcher at the 2007 Career Development Institute for Psychiatry in Palo Alto, CA.
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