The NIH is piloting new Adobe application forms in 3 RFAs with receipt dates in October: RFA-AI-08-020, RFA-DE-09-001 (R01), and RFA-DE-09-002 (R21) (the latter two were originally posted with PureEdge application forms and were reposted on July 1 with the new Adobe forms, which must be used). The SF424 Application Guide for Adobe forms will be available on or before August 1, 2008. Full conversion from PureEdge to Adobe forms is planned for December 2008. A quick summary of the NIH notice on these matters is available from our very helpful friends at NIAID.

In other news (from NIAID), NIH has scheduled the transition to electronic application of the following grant types:

Career development awards (K) — February 12, 2009.
Fellowships (F) — April 8, 2009.
Institutional Training Grants (T) — September 25, 2009.

Still undetermined is the date for moving multiproject grants into the electronic sphere.

From H.R. 2642 (Supplemental Appropriations Act, 2008 - signed into law by our very own Dear Leader on June 30):

For an additional amount for `Office of the Director’, $150,000,000, which shall be transferred to the Institutes and Centers of the National Institutes of Health and to the Common Fund established under section 402A(c)(1) of the Public Health Service Act in proportion to the appropriations otherwise made to such Institutes, Centers, and Common Fund for fiscal year 2008: Provided, That these funds shall be used to support additional scientific research and shall be merged with and be available for the same purposes and for the same time period as the appropriation or fund to which transferred: Provided further, That this transfer authority is in addition to any other transfer authority available to the National Institutes of Health: Provided further, That none of these funds may be transferred to `National Institutes of Health-Buildings and Facilities’, the Center for Scientific Review, the Center for Information Technology, the Clinical Center, the Global Fund for HIV/AIDS, Tuberculosis and Malaria, or the Office of the Director (except for the transfer to the Common Fund).

No word as yet from the Great Zerhouni as to how these funds might be distributed. I’m sure it will be transformative, though.

Now, the NIH is not the only agency celebrating Christmas (or your favorite giving holiday) in July. NASA receives “an additional amount for `Science, Aeronautics and Exploration’, $62,500,000″, while the Department of Energy gets “an additional amount for `Science’, $62,500,000, to remain available until expended.”

The NSF receives a split dividend: “For an additional amount for `Research and Related Activities’, $22,500,000, of which $5,000,000 shall be available solely for activities authorized by section 7002(b)(2)(A)(iv) of Public Law 110-69″ and “For an additional amount for `Education and Human Resources’, $40,000,000: Provided, That of the amount provided, $20,000,000 shall be available for activities authorized by section 10 of the National Science Foundation Authorization Act of 2002 (42 U.S.C. 1862n-1) and $20,000,000 shall be available for activities authorized by section 10A of the National Science Foundation Authorization Act of 2002 (42 U.S.C. 1862n-1a).”

Science provides a nice overview of these goodies as well as current House and Senate versions of the FY09 budget … which won’t see the light of day until well into 2009. For now, a 4% increase for the NIH, and a healthy 13% increase for the NSF. In addition to the big 4 noted above, Science also briefly reviews budget requests for NOAA, NIST, USDA, EPA, and the US Geological Survey.

Update: As noted below in Brendan’s comment , open discussion of this issue continues at Nature Network. Please join in there! The Chronicle is also having a lively discussion of “the oath” … and JAMA has a nice summary of why even well-intentioned folks cannot overcome unconscious bias caused by conflicts of interest, and The Lancet notes this commentary in covering a plagiarism case in the UK. Links to The Gallup Organization report on which this commentary is based can be found at ORI and below.

Nature reports a survey conducted by the Office of Research Integrity that, not surprisingly, finds that most misconduct goes unreported. Sandra Titus et al. found that the “2,212 researchers we surveyed observed 201 instances of likely misconduct over a three-year period. That’s 3 incidents per 100 researchers per year.” (an average of only 24 institutional investigation reports are submitted to ORI each year).

Titus et al. contacted 4,298 scientists holding NIH extramural research funds at 605 institutions.

In 2006, we asked participants to indicate the number of times they had observed suspected research misconduct in their own department in the past three academic years (2002–05). 2,212 scientists provided complete responses to questions concerning research misconduct (51% response rate). Of these, 192 scientists (8.7% ) indicated that they had observed or had direct evidence of researchers in their own department committing one or more incidents of suspected research misconduct over the past three academic years. The 192 scientists described a total of 265 incidents.

Scientists were asked to indicate how they became aware of the possible misconduct and were told to report observations and not hearsay. … We used these descriptions to validate whether the observation met the federal definition of research misconduct [fabrication, falsification, plagiarism].

Two people independently coded and evaluated the 265 descriptions to determine whether each met the federal definition of research misconduct. In all, 64 reports (24% of the total) did not meet the threshold of the federal definition — which left 201 observations of potential misconduct made by 164 scientists (7.4% ). These 201 misconduct observations included fabrication or falsification (60% ) and plagiarism only (36% ).

According to our respondents, 58% of the observed incidents had been reported to officials at their institutions.

The authors go on to extrapolate that annually “approximately 1,350 would have been reported [compared with actual number of 24] whereas almost 1,000 could be assumed to go unreported to any official.”

As a fan of work on procedural and distributive justice by Brian Martinson, Melissa Anderson, et al., I was particularly pleased to see the accompanying editorial, Solutions - not scapegoats, address the need to examine the environment as well as the individual:

Meanwhile, misconduct investigations all too often focus solely on an individual offender, and fail to diagnose the environment that has allowed misconduct to flourish. Instead, institutions should seize the opportunity to learn from the experience, and to address the bigger questions. For example, did the atmosphere in the lab create the pressure to cut corners? Or did the intensity of the tenure chase contribute? One way to address such questions might be through internal departmental discussions, in which everyone is free to admit mistakes, and discuss how to fix the problems instead of apportioning the blame.

Indeed, the authors suggest 6 strategies for championing research integrity at an institutonal level:

Adopt zero tolerance: “Social responsibility to the academic community and to the public who fund the research will be strengthened when it is apparent that an institution has a real commitment to integrity.”

Protect whistleblowers: “more than two-thirds of whistleblowers, in a Research Triangle Institute study, experienced at least one negative outcome as a direct result of their actions. Plus, 43% reported that institutions encouraged them to drop the allegation.”

Clarify how to report: Establish “a reporting system that clearly identifies the individuals to whom allegations should be brought, and establishing clear policies, procedures and guidelines related to misconduct and responsible conduct.”

Train the mentors: “Mentors specifically need to become more aware of their roles in establishing and maintaining research rules and minimizing opportunities to commit research misconduct. An institutional investment in building better mentors is an important vehicle to promoting research integrity.”

Use alternative mechanisms: “Auditing research records would be one such means. Mechanisms of review are needed to reduce deficient record keeping, improper protection of human or animal subjects or the utilization of questionable research behaviour.”

Model ethical behaviour: “Institutions successfully stop cheating, for example, when they have leaders who communicate what is acceptable behaviour, encourage faculty members and staff to follow the policies, develop fair and appropriate procedures for handling misconduct cases, focus on ways to develop and promote ethical behaviour, and provide clear deterrents that are communicated.”

In this same issue, Nature also cites the decision of the Ottawa Health Research Institute to suspend Kristin Roovers, whose case ORI closed and reported on last year.

Of course, the lively discussion of the Hellinga retraction is just that - a discussion of the retraction and the science involved, though I suspect we will eventually be discussing more formal issues of misconduct.

As noted here previously, the NIH is developing a new electronic reporting tool called Research, Condition, and Disease Categorization (RCDC). NIAID has a nice summary, as usual. The basic idea is to consistently categorize NIH-funded work according to “nearly” 360 predetermined research areas, conditions, and diseases. Except, that is, projects in such minor areas as women’s health, minority health, AIDS, biodefense, climate change, nanotechnology, and “Networking IT Research and Development.” Hmmm.

To prepare for the February 2009 launch, NIH is hosting a webinar on Wednesday, June 11 at 2 p.m. to introduce the RCDC system. Get the popcorn ready …

Update: Nature provides its brief take on the reforms, as does Science.

Update: In addition, NIAID reports that “This month, NIH will launch some pilots and try some changes, such as shortening the length of R01 and some other applications, developing a new scoring system, and giving applicants more useful feedback.” This month? June???

Today the Great Zerhouni announced “Enhancements to Peer Review” of the sort that would not wind up in your spam folder. The Advisory Council to the Director met today, and Larry Tabak’s presentation to the same about Enhancing Peer Review actually has some meat to it.

For Priority 1, Engaging the Best Reviewers, we have recommendations to spread a 12-session reviewer commitment over 4-6 years; allow “duty sharing by colleagues as appropriate”; establish a policy of service requirement for certain classes of awards (Merit/Javits, Pioneer, Type 2 renewal with >$500K in DC, PI on 3 or more R01 equivalents); rank proposals at meeting’s conclusion (to provide feedback to study section members); allow reviewers who have served a minimum of 18 full study section members (chartered member or equivalent) to apply for administrative supplements of up to $250K in TC and/or request that they be considered for Merit/Javits on a competitive basis; and develop an NIH-wide standardized core curriculum based on best practices.

For Priority 2, Improve the Quality and Transparency of Reviews, we have - shockingly - a new 7-step scale (vs the 41-step scale currently in use) in which assigned reviewers provide individual scores (1-7) for each of the 5 review criteria (impact, investigator(s), innovation/originality, project plan/feasibility, environment) and a preliminary global score. Applicants who are streamlined would receive 5 scores, one for each criterion representing an average from all reviewers. For applications that are not streamlined, all study section members, based on the discussion of each criterion, will provide a global score of 1-7; after initial scoring, all proposals within relevant categories will be discussed as a group & ranked (ranking at the conclusion of the meeting then allows for “recalibration” of global scores).

The summary statement then would be realigned with the explicit rating criteria, with a template allowing a prescribed amount of space for each criterion. Optional fields would be available to reviewers who wish to provide additional advice (”mentoring”), including the helpful suggestion that the proposal not be resubmitted unless fundamentally revised as a new application.

The application itself would be shortened and redesigned as well: 12 pages for R01s, with “other mechanisms to be scaled appropriately”, and structured to align with the explicit review criteria. Appendices will be limited to 8 pages and will only be permitted “for specific information that is deemed critical on the basis of NIH-defined criteria (e.g., elements for a clinical trial or a large epidemiologic study)”.

For Priority 3, Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages, they talk about both early stage investigators (ESI) and new (to NIH) investigators, with an intent to “cluster review, discussion, scoring, and ranking of ESI within a study section, pilot percentiling ESI across all study sections, and … ensure that the number of fully discussed proposals from ESI is not disproportionately reduced”. Clinical research applications would enjoy the same clustering of “review, discussion, scoring, and ranking”. Reviews for more experienced investigators would “place equal emphasis on retrospective assessment of accomplishments and a prospective assessment of what is being proposed”.

“Transformative” research will be encouraged by expanding the Pioneer, EUREKA, and New Innovator awards until these comprise ~1% of R01-like awards. The Pioneer & Junior Pioneer (aka New Innovator) pot will be >$500M over 5 years, while the EUREKA pot will be >$100M over 5 years. These programs will be joined by a “new, investigator-initiated ‘transformative’ R01 pathway using the NIH Roadmap authority & funding” with >$250M over 5 years. (so, yeah, we’re talking close to $1B for these 4 programs)

Another component of Priority 3 seeks to reduce burden on applicants, reviewers, and NIH staff. Here, the goal is to reduce resubmissions both from applicants with a high likelihood of funding based on their A0 review (hallelujah!) and from applicants with low or no likelihood of funding based on their A0 review (thank you straight talk express). This component also seeks to “rebalance success rates among A0, A1, and A2 submissions to increase system efficiency” and to include statistics on cumulative success rates as a function of score or percentile in the summary statement. This section is accompanied by some incredible figures, including a bar chart and table of unsolicited R01 applications funded by percentile and by status [Ao, A1, A2] for 4 years [1998, 2004, 2005, 2006]; the bottom line is that “almost twice as many rounds of applications required today … though most are still ultimately not funded.” Cheery data, eh?

For Priority 4, Develop a Permanent Process for Continuous Review of Peer Review, suggestions include piloting 2-stage reviews (editorial board model) and “prebuttals” as well as high-bandwidth electronic review, different methods for ranking the relative merit of applications, and monitoring performance of review. On the issue of percent effort, an alternative approach to requiring a minimum percent effort is suggested: applicants would be required to complete a subfield in the Environment section of the application in which they indicate if they have NIH RPG (research project grant) support in excess of $1M at time of anticipated funding. If so, they must justify why additional resources are needed.

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 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.

Trani continues:

“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.

Now, I received the agreement from Jeanne Lenzer who filed the FOIA request on behalf of BMJ (British Medical Journal), who paid VCU over $200 for the privilege of receiving this information. I am only pulling out quotes that provide full coverage of the issues raised in the NYT article to confirm the reporter has accurately portrayed the agreement and to allow officials from other universities to get beyond the generalities being tossed around to look at the actual terms (ie, this is not what “everyone” agrees to when they sign research services agreements). This is a huge complex legal document (21 pages plus “exhibits”), well beyond my expertise to interpret further - though others may wish to submit their own FOIA requests to examine the actual terms closely, perhaps even in consultation with a lawyer.

And ask for the titles of the task orders (projects) while you’re at it. The titles and nature of the work were not provided by VCU to the NYT (”Dr. Macrina would not discuss many details of the research”). However, Pam Lepley named them in the cover note to Ms. Lenzer, and both titles reflected human research (including the lung disease project), with absolutely no hint - not remotely - that any of the work might have anything to do with learning how to remove nitrogen and phosphorus from wastewater. (I opt not to cite the actual titles provided in case this is part of additional journalistic investigation.)

So, were Drs. Solano and Macrina mistaken? Misleading the reader? Worse? Ms. Lepley was given her information from the VCU Office of Research (which Dr. Macrina oversees), so one wonders which version he is disseminating is correct … and whether what anyone involved with this agreement “says” in the future can be trusted.

Much more on all this must be considered, such as the ethics of the President of both a University and an academic health system having fiduciary responsibilities to the success of the tobacco industry and demonstrating decades of staunch support for Philip Morris in his roles as President (and of course there is the entire prior discussion to consider as well).

So, last October I had a little fun working out the logic for my office pool picks for the next CTSA sites. Today we learn that 14 new sites have joined the consortium:

Albert Einstein College of Medicine of Yeshiva University (New York City)
Boston University (Boston)
Harvard University (Cambridge, Mass.)
Indiana University School of Medicine (Indianapolis)
Northwestern University (Chicago and Evanston, Ill.)
The Ohio State University (Columbus, Ohio)
The Scripps Research Institute (La Jolla, Calif.)
Stanford University (Palo Alto, Calif.)
Tufts University (Boston)
The University of Alabama at Birmingham (Birmingham, Ala.)
University of Colorado Denver (Aurora, Colo.)
The University of North Carolina at Chapel Hill (Chapel Hill, N.C.)
The University of Texas Health Science Center at San Antonio (San Antonio)
The University of Utah (Salt Lake City)

I only missed Scripps, but they have a heck of a lot of collaborating sites (including, interestingly, the Center for Applied Genomics at CHOP - Children’s Hospital of Philadelphia …)

Only 22 spots remaining in the Consortium. Who’s left?

UCLA, UMd, UMinn, Georgetown, Medical College of Wisconsin, NYU, SUNY Stony Brook, U Cinncinati, U Florida, U South Florida, U Tennessee, Baylor, Penn State, UCSD, U Vermont , U Illinois-Chicago , MUSC , U Missouri, UNM, Dartmouth, LSU, U Arkansas, U Hawaii, U Kansas, U Kentucky, U Louisville, U ND, U Oklahoma, UVa

Plus, I’m sure, at least a dozen or so not named here, such as an Arizona contingent, U Nebraska, a Mountain State rep, (never mind - the KY & TN sites would cover Appalachia), et al. (and then there is VCU with their corporate partner Philip Morris USA)

Update: I’ve discussed President Trani’s letter to the NYT above. And perhaps this NYT article explains how this all could have happened.

Update: Outstanding Blog Entry by an VCU Adjunct Professor summarizing the many (& snowballing) unethical activities going on in Richmond (and a great follow-up commentary here as well).

The NYT today reports on an astoundingly unethical and outrageous research agreement between VCU (Virginia Commonwealth University) and Philip Morris USA. The need to deny existence of this agreement if asked by the press … the ability of Philip Morris to remove everything but prepositions from journal manuscripts and any other form of dissemination … the pre-assignment to the company of intellectual property generated. Jiminy Crickets.

This would be unconscionable no matter who the corporate sponsor was, but the fact that the largest tobacco company in the US has secretly garnered such power over academic researchers (& that this agreement has been kept secret from VCU’s academic community itself no less) is almost beyond belief. And that such agreements have been secured with other universities as well is truly alarming.

An April 24 NEJM editorial notes “Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies.”

So well said. What happens when you add the qualifiers that the tobacco company is given the IP, can block publication, and requires the University to deny even the existence of the contract and individual projects supported under it? (UPI summary nails the important points.) I think we’re well beyond questioning advisability.

However, no doubt VCU President Trani’s status as a major stockholder (personal shares - and likely the University as an institutional investor) and Board of Directors member of an international tobacco leaf dealer and the prior affiliation of VCU VP for Research Macrina (author of the RCR textbook “Scientific Integrity” no less) with Philip Morris may have clouded some judgment down there. So might the $2.2 million donation to the Schools of Engineering and Business and unnamed amounts donated to the Massey Cancer Center … plus the endowed chair of international business ($1 million at least), $250K to the Rice Center for Environmental Science and multiple donations over the years to the VCU Career Center. Who knows about the special interests of officials at other Universities that might have inspired participation in this egregious secret arrangement.

I’ve been trying to limit these off-topic posts on academic medical centers that cooperate with the tobacco industry (which I do believe is a special case - not the start of a slippery slope), but this particular situation easily spills over into broader issues of research integrity, no matter the sponsor. The reporter correctly notes that the dire need for money fuels this sort of “turn a blind eye” reliance on any funding opportunity, no matter the source. (The reporter incorrectly suggests VCU takes in $227 million in research awards: this total, inflated by contributors such as ~$25M from Qatar for their School of the Arts, is for sponsored programs of all types; the NSF ranks VCU 104th [wow, after Univ Alaska Fairbanks, at 102] with total R&D expenditures from all sources of $149M , $65M of which is from the NIH.) On the other hand, VCU seems to have sold its soul for not much money unless there is a significant “gift” under negotiation as a quid pro quo.

John Frangioni at Harvard recently noted in a Nature Biotechnology commentary about greed at academic medical centers (AMCs) that “US citizens and taxpayers expect that AMCs maintain their hard-earned status of independence from external forces and place the public good higher than any other motivation.”

I cannot imagine a situation in which the public good is abandoned more than in this agreement binding a public institution of higher learning and academic medical center to conduct secret research for the tobacco industry.

Yawn. The May edition of Peer Review Notes includes exciting job opportunities (folks looking to leave the lab: SROs wanted, not to mention a director for the new Translational & Clinical Sciences Division … perhaps a glimmer of hope, Whimple), an asynchronous electronic discussion review anecdote, updates on IRG realignments, and the story of a $10 grant awarded to a 10-year-old in 1957 (project had NO public health significance no less!).

I’m still wondering how the following peer review recommendations (a la Great Zerhouni) - apparently to be phased in via a pilot program in JUNE - represent a significant enhancement of the process:

Restructured Applications: The recommendations also [in addition to shorter R01 application length] call for R01 applications that are structured according to the review criteria with an emphasis on an application’s impact and significance in advancing scientific knowledge. Each application would be rated against individual criteria and also given an overall score. Applications would then be ranked, and any necessary adjustments in scoring made. [okay, the ranking is new - so you would get priority score, percentile, and rank?]

More Focused Reviews: Reviews themselves would be shorter and more specifically address how applications fared in terms of the criteria—impact, investigator, innovation/originality, research plan and environment. This set of changes will emphasize the impact of the application, versus the methodology, allow reviewers to read more applications and give applicants, councils and staff clearer feedback. [hmmm]

Enhanced Training: The recommendations also call for enhanced training for Scientific Review Officers, chairs and members and incentives for reviewers. [don't hold back folks - let them know what might incentivize you!]

Notice is hereby given that the Office of Research Integrity and the Acting Assistant Secretary for Health have taken final action in the following case:

Lois Bartsch, PhD, former postdoctoral research trainee, Department of Genetics, Cell Biology, and Anatomy, University of Nebraska Medical Center, engaged in scientific misconduct in research supported by grants P30 CA36727, R01 CA77876, and P20 RR016469. Specifically, PHS found that Dr. Bartsch:

Falsified DNA sequence files by deleting a nucleotide and changing nucleotide designations and reported the altered file as the ACI rat p16Cdkn2a sequence with a CpG dinucleotide polymorphism in the upstream region to GenBank, in grant application CA118151, and in the poster presented to Cold Spring Harbor Laboratory;

Fabricated the claim in grant application CA118151 that GenBank entries for the human p16Cdkn2a gene had a CpG polymorphism near the transcription start site;

Falsified the differential methylation of CpG dinucleotides near the transcription start site of p16Cdkn2a DNA and reported that tumor tissue was more methylated than normal tissue in ACI rats treated with estrogen and that the ACI allele was more methylated than the BN allele in tumor tissue from (BN x ACI)F1 animals treated with estrogen in grant application CA118151.