Although the NYT has not printed a correction, clarification, editor’s note, retraction, or any other indication that the veracity of Mr. Finder’s reporting has been called into question, they did offer, rightly, the opportunity for VCU to respond in the form of a letter to the editor from President Trani. This letter, although more thoughtfully articulated than his prior memo, continues to downplay the real problems of any university engaging in research service agreements and the even greater ethical problems with this particular research service agreement, setting aside the sponsor for now.
As part of my commentary on this, I disclose that I have been sent a copy of the agreement obtained by a third party through a Va FOIA request (details and downloadable PDF below) and will quote verbatim a few critical points omitted by Trani in his letter and overall response to this story.
For example, secrecy (from the agreement itself):
”19. Neither party shall, without the prior written approval of the other party, (i) advertise or otherwise publicize in a written manner the existence or terms of this AGREEMENT or any TASK ORDER or any other aspect of the relationship between SPONSOR and VCU … If at any time a third party, including without limitation any news organization, contacts VCU concerning SPONSOR, VCU shall make no comment and shall notify promptly SPONSOR of the third party.”
Well then. This restriction goes beyond protecting proprietary data and unapproved publicity/use of names to keep the agreement itself secret along with the relationship between VCU and Philip Morris. What other sponsors might they be protecting in this manner?
Indeed, given that we are talking about a public university, the most important omission from Trani’s discussion about all this is the level of secrecy, both documented in the agreement (and most certainly not a traditional component of any standard research services agreement) and on the VCU campus, as evidenced by the lack of awareness of not only this agreement but a high-level institutional partnership between VCU and Philip Morris.
Worse, consider the ominous reporting by the NYT of “A tenured scientist at Virginia Commonwealth, who would not be interviewed for attribution because he said he feared retribution …” Aren’t we talking about a public university in the US? And yet, tenured faculty are afraid to speak on record – and perhaps are also afraid to challenge this situation at VCU out of fear of retaliation?
One would hope that, given his concern for academic freedom, Trani will allow the faculty to debate this matter openly and abide by whatever decision they may reach with regard to continuing this partnership, begun without their knowledge or input. Such secrecy in relation to a partnership with the tobacco industry is especially egregious given this is an academic medical center with an “emerging” School of Public Health.
Moving back to the letter, Trani’s argument remains, weakly, that “everyone else does it” (like that worked when I tried to convince my mom to let me do something questionable). I refer him to the eloquent explanation by Penn as to why they adamantly do not accept research services agreements, nor should any institution of higher education with a research mission dedicated to advance the social good (versus that of industry). Trani further misleadingly suggests:
“Such agreements [research services agreements], in effect consulting contracts, are similar to those that universities enter into with the pharmaceutical industry and with state and federal agencies.”
Wrong. Here, he is mingling description of this corporate research service agreement with government contracts, which are only awarded through a competitive process [no snickering out there] in which the researcher submits a proposal as to how he or she will perform the required service in response to a request for proposals. There are no government-issued research services agreements of the type raised in the NYT story and being defended by Trani here. He is either unaware of this distinction or is himself intentionally confusing the issue using well-worn tobacco industry tactics. Neither is attractive for a university president.
On the other hand, I’m sure every major pharmaceutical company will be knocking on VCU’s door for these exact same terms in their next agreement. Let’s see, how about a research service such as, invent us a drug that prevents metastases!
Trani next suggests:
“This type of research usually involves gathering data …”
Um, not usually. The point is, work conducted under a research services agreement is not original research: it is a service clearly articulated by the sponsor using material and data provided by the sponsor. Do this, and exactly this. Gathering data? Not likely. If the university service provider needs more data, he or she should go back to the sponsor (client?) for these.
“These agreements [research services agreements] include language to protect the sponsor’s intellectual property, and most assign the intellectual property rights of the work produced to the sponsor.”
True – because, again, work conducted under a research services agreement is narrowly focused exactly because the IP is assigned to the company; no new intellectual property should be generated in the conduct of a genuine research service. The Oklahoma State University Research Services Agreement template serves as an excellent example, and other university research services agreements, such as that used by Auburn University, clearly differentiate between IP related to the sponsor’s product and IP generated incidentally in the course of conducting the service (which is assigned to the University).
In contrast, the VCU-Philip Morris research services agreement states:
“9.2 INVENTION shall mean any … or other intellectual property or know-how discovered, produced, conceived, or reduced to practice by VCU or its PERSONNEL in, or as a result of, the performance of RESEARCH SERVICES … 9.3 SPONSOR shall own all Intellectual Property Rights in Inventions and VCU shall promptly communicate full information regarding INVENTIONS to SPONSOR.”
So, if a VCU faculty member incidentally makes a discovery (say, a new and improved method or algorithm for analyzing the data) in the course of accomplishing a research service for Philip Morris, the IP automatically and preemptively is assigned to Philip Morris. No, I cannot imagine “most” universities signing up for this IP giveaway and placing their tax-exempt bond status at risk.
“Disclosure sections in research services agreements are for the protection of intellectual property — not the suppression of data.”
True. But what Trani is leaving out is that the final decision to permit publication in this particular research services agreement (not of those used at most other universities) lies with the company. This restriction comes up not in the discussion of publication (where the longer than typical review period arises) but in the definition of Sponsor Proprietary Information, which was clearly articulated in the original NYT story (so the claim of being unfairly portrayed does not hold muster):
“10.1 SPONSOR PROPRIETARY INFORMATION shall mean … including without limitation all work product or other material created by VCU and/or its PERSONNEL in connection with this AGREEMENT and all SPONSOR MATERIALS. … All information provided by SPONSOR or its representatives shall be presumed to be SPONSOR PROPRIETARY INFORMATION …”
And what does this mean for publishing or presenting (or even talking about) any results from research services performed?:
“8.2 VCU shall remove from the proposed publication that material which SPONSOR identifies as SPONSOR PROPRIETARY INFORMATION …”
Which would leave the articles and prepositions and punctuation marks, I think.
So VCU can’t publish any data conducted under this master research services agreement unless Philip Morris rules it isn’t proprietary. Yet apparently, overnight:
“V.C.U. investigators already are at work preparing manuscripts connected with a project on pulmonary disease financed under the Philip Morris research services agreement. These manuscripts will be submitted for publication in peer-reviewed medical journals in the near future.”
First, why didn’t Solana or Macrina mention these in the NYT article or Macrina in the RTD “article” or even Trani last week in his open letter to the VCU community? Seems like the sort of evidence of freedom to publish the University would have trumpeted from the very start. What a coincidence that these manuscripts seem to have just been started this weekend. Remarkable. I’m sure they’ve at least created empty Word documents entitled PM MS #1 and PM MS #2, just to make an honest man out of Trani.
And so, eventually, when these manuscripts are ready, they’ll have the “discussions” with Philip Morris noted by Macrina in the NYT story, and the company might agree to maybe permit submission … of something, but who knows what (& what will be pulled out as “proprietary”). What if Philip Morris flags some unflattering data as proprietary and dictates that they need to come out of the manuscript? What if the removal of these data alters the conclusions drawn? We cannot possibly know, nor could the reviewers at these journals. Thus, the integrity of the research record is at risk. Nothing should be published from work conducted under the restrictions of this agreement.
(whole ‘nuther blog entry … especially considering VCU has multiple research services agreements – could other manuscripts generated under one of these restrictive agreements be [have been?] submitted for review with selective undesirable results potentially – and invisibly to reviewers – withheld at company request due to their proprietary nature?)
Further, considering again this example, what proprietary data on pulmonary disease would Philip Morris own – and be at liberty to give to VCU researchers to analyze? Shouldn’t the mere fact of a tobacco company owning intellectual property related to the early signs of lung disease raise some alarm bells, particularly at a university with an academic medical center?
And who are these unknown, unnamed “multiple parties”? Why do they have rights above those of the university researchers? The agreement is between VCU and Philip Morris but apparently extends to … whom? Again, the secrecy at play here does not belong on the campus of a public university.
“the V.C.U. scientists involved do have the final say in choosing their work — including the design of their studies, interpretation of results and the publication of findings.”
Except under a research services agreement, both the one of concern here and the other unnamed agreements also in effect at VCU. No research service work confers such freedom to the faculty or students, most especially in study design (sponsor defines the service), yet again Trani either doesn’t understand this distinction or purposely obfuscates it in his closing comment.
What he omits throughout his rationalization for this abomination of university ethos is the fact that this is a Master Research Services Agreement. This agreement covers every project – every “task order” – conducted. Most research services agreements are linked to a specific project, again to ensure that the terms apply to narrowly defined and appropriate product-testing type services. Here we have blanket coverage of all future (& secret) work with these outrageous restrictions. Perhaps the individual task orders are even more restrictive – who knows, because no documented details (& possibly, see below, no accurate information) are being released on these.
If Trani would like to be able to accurately claim that VCU ‘s research is “consistently conducted under the highest ethical standards”, I would urge him to emulate outstanding role models such as the University of Pennsylvania than settle for the lowest common denominator, “everyone else does it” approach.