Medical Writing, Editing & Grantsmanship

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:

Based on the findings of an investigation conducted by Huntington Memorial Hospital and information obtained by ORI during its oversight review, the U.S. PHS found that Scott E. Monte, LVN engaged in scientific misconduct by knowingly and intentionally falsifying and fabricating clinical research records in cancer prevention and treatment protocols supported by awards U10CA69651, U10CA12027, U10CA32012, and U10CA86004.

Specifically, Mr. Monte knowingly and intentionally: (1) Entered falsified and fabricated laboratory data or physical examination results on five research protocol case report forms; (2) Falsified a gynecological examination report in a physician’s progress note and entered the falsified document in the patient’s research chart; and (3) Fabricated progress notes for four patients and a case report form for one of these patients.

Stop the presses!

The Chronicle of Higher Education reports, stunningly, that “an overwhelming majority [of academic scientists] believe peer review in journals is necessary.”

I would have expected to read this at The Onion, not at The Chronicle.

The survey report, paid for by the Publishing Research Consortium, “found that the average peer review takes 80 days, that the average number of manuscripts each reviewer reads yearly is 8, and that each reviewer tends to spend 5 hours on a manuscript over the course of 3-4 weeks.” Which explains a lot …

Update: Perhaps these reviewers should read the book reviewed in JAMA this week, Peer Review and Manuscript Management in Scientific Journals: Guidelines for Good Practice.

Update: The Lancet comments both on the Publishing Research Consortium survey noted above and the egregious behavior of the NEJM reviewer of the meta-analysis of rosiglitazone’s cardiovascular risks (see comment below).

Update: We already have an article retraction resulting from use of this database, and both Deja Vu and the underlying tool, eBlast, were mentioned (though apparently not used) in conjunction with a massive case of fraud (70 articles published over a 4-year period retracted).

In Nature this week, we have a Tale of Two Citations. A tale with which most of us are all too familiar. Best of times and worst of times and all that. A tale, um, retold in The Chronicle for Higher Education (though as a report about the Nature commentary).

In a nutshell: “Although duplicate publication and plagiarism are often discussed, it seems that discussion is not enough. Two important contributing factors are the level of confusion over acceptable publishing behaviour and the perception that there is a high likelihood of escaping detection. The lack of clear standards for what level of text and figure re-use is appropriate (for example in the introduction and methods) is a well known problem; but the belief that one can get away with re-use is probably the single most important factor.”

In addressing the latter issue, the authors, Mounir Errami and Harold Garner (both from University of Texas Southwestern Medical Center), used the search engine eTBLAST to look for similar language among papers and found 70,000 hits in Medline. These and duplicate citations from other scientific literature databases are deposited in Deja Vu. The authors have manually read through 2,600 abstracts from these hits and would like help from the scientific community in sorting through this repository. Dr. Garner has received a Research on Research Integrity R01 award to support this work.

In the Nature article, the authors suggest that if journal editors “use more frequently the new computational tools to detect incidents of duplicate publication — and advertise that they will do so — much of the problem is likely to take care of itself.” Perhaps, especially as manuscripts were returned and word spread along the grapevine.

Unfortunately, one possible source of high duplicate hit rate could be the increasing tendency for e-pub ahead of print, which could account for identical (or near identical) abstracts and authors within months of each other in the same publication. However, this would not be a problem for journal editors considering a newly submitted manuscript. Perhaps the International Committee of Medical Journal Editors would consider addressing this possibility (use by journal editors of electronic tools to flag plagiarism, self or otherwise) in a future update of their guidelines. Perhaps the folks involved with the NIH Public Access Policy and PubMedCentral might consider taking a look-see at their own repository.

Literally … the Jan 08 issue, complements of the Center for Scientific Review. Seems as though the big news is that formal recommendations on enhancing peer review will be made to the Great Zerhouni et al. in February 2008. In the meantime, you can check out the revolutionary ideas in the Insider’s Guide to Peer Review for Applicants prepared by current and retired study section chairs. Seriously, though, nice concise compilation of sound advice.

Also of possible interest … study sections can expect to have one meeting a year held somewhere other than Bethesda/Rockville & environs, specifically in Chicago, Seattle, Los Angeles, or San Francisco. SROs (scientific review officers, formerly known as SRAs) can seek approval to use other major west coast cities.

The newsletter also reports improvements in speed, ease of use, and convenience of the online message board-based review system (asynchronous electronic discussion) … and the availability of reports for individual open house workshops on re-aligning various integrated review groups and the promise of a comprehensive final report soon.

Speaking of which, CSR replaced the current Division of Clinical and Population-based Studies with a new Division of Healthcare, Population and Behavioral Sciences and split the current Health of the Population IRG into two new IRGs. Altogether, the Division will have 5 IRGs: Biobehavioral and Behavioral Processes; Risk, Prevention and Health Behavior; AIDS and Related Research; Epidemiological and Population Sciences; and Healthcare Delivery and Methodologies.

And elsewhere … Nature Neuroscience has an editorial that does a nice job recapping the peer review review & revamping effort.

Update: JAMA has a nice summary of the true impact of COI, even on well-intentioned investigators.

In the same issue of Accountability in Research as the report on the effectiveness of RCR education, Kevin Elliott raises concerns about “Scientific Judgment and the Limits of Conflict-of-Interest Policies.” He notes that “these worries are aggravated by the fact that many universities are currently seeking to bolster their research portfolios and boost local economies by developing more extensive partnerships with private industry.” The abstract of this well-crafted and insightful article says it all:

This article argues that the three major elements of typical university conflict-of-interest (COI) policies (i.e., disclosure, management, and elimination of conflicts via divestiture or recusal) are likely to be insufficient for screening out many worrisome influences of financial COIs. Current psychological research challenges the effectiveness of disclosure, management plans are unlikely to address the wide range of ways that financial COIs can influence scientific judgment, and it is often impractical to eliminate conflicts. Identifying the limits of these policies highlights the importance of considering alternative strategies, such as encouraging more independently funded research, in order to maintain the integrity of science.
Read the rest of this entry »

Update: NYT reports on poster child of why the NIH cannot rely on Universities to police their researchers, as does the Harvard Crimson itself (quite thoroughly). Nature takes a look as well, noting that Duke now plans to step up internal monitoring so they don’t show up on the NYT A1. Science notes that attention has turned to Stanford and has a longer piece examining the investigation and broader issues. JAMA has a nice summary as to why COI does matter.

At the institution where I now hang my, um, bike helmet, the research administration is passionately determined to ensure all work conducted serves the greater good rather than the almighty dollar. They’ll turn away or not pursue (or not allow faculty to pursue) money that may involve any conflict of interest (including pharma dollars on the health system side, but that’s another story). This is a very good thing, though it’s a bit spooky that those to whom I report seem to know better even than Santa who’s been naughty & nice, and they know even before I’ve seen an application narrative what sort of COI I should watch for and report as needed - including once to our RIO (research integrity officer), who puts the fear of God in investigators, probably because that’s who it sounds like on the phone.

So it was with more than a passing interest that I noted the Office of the Inspector General has released its report on NIH: Conflicts of Interest in Extramural Research. Unfortunately, they seem to have failed in their two stated objectives:

1. To determine the number and nature of financial conflicts of interest reported by grantee institutions to the NIH.

Finding: NIH could not provide an accurate count of the financial conflict-of-interest reports that it received from grantees during fiscal years 2004 through 2006.

Finding: NIH is not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported and most conflict-of-interest reports do not state the nature of the conflict.

2. To determine the extent to which NIH oversees grantee institutions’ financial conflicts of interest.

Finding: Many Institutes’ primary method of oversight is reliance on grantee institutions’ assurances that financial conflict-of-interest regulations are followed.

Okaaaay. The OIG recommends that the NIH Read the rest of this entry »

I had to cobble something together for the health sciences faculty here (an intimate group of a few thousand of my closest friends) on how the NIH Public Access Policy actually works, and I thought I’d share the wealth here. Hope this is helpful.

All peer-reviewed articles that arise from work funded in part or in whole by grants or contracts awarded by the NIH must be made publicly available no later than 12 months after the official date of publication.

This mandatory requirement applies to all grant and cooperative agreements awarded on or after October 1, 2007 and to all contracts awarded on or after April 7, 2008. Principal Investigators are responsible for ensuring compliance with the Policy even if they are not an author or co-author of a publication arising from their NIH-funded work.

Compliance is a three-step process: address copyright when submitting a manuscript to a journal for review, submit the accepted manuscript to the NIH, and cite the manuscript using the PubMed Central reference number.

Address Copyright. As an NIH-funded author, you must ensure that any copyright transfer or other publication agreements allow the article to be submitted to NIH in accordance with the Policy. If you submit your manuscript to a journal that already cooperates with the NIH on this, you need not do anything further to ensure compliance with the Policy.

If you wish to publish in a journal not on this list, you must inform the journal that the article is subject to the Public Access Policy when submitting the manuscript. You must then communicate with the journal before any of your copyrights are transferred to ensure that all conditions of the Public Access Policy can be met. Some journals ask authors to transfer copyrights when a manuscript is submitted for review, so please be careful not to transfer rights during the submission process without confirming the journal’s ability to comply with the Public Access Policy. Please remember that this Policy is mandatory for all NIH grantees, and avoid signing any agreements with publishers that do not allow authors to comply.

Submit Manuscript to NIH. If your journal does not submit the accepted manuscript to the NIH on your behalf, you or your designee can deposit a copy of the peer-reviewed manuscript via the online Manuscript Submission System (tutorial available). The submitted final, peer-reviewed manuscript must include all graphics and supplemental materials that are associated with the article. Please note that not all open-access journals automatically submit manuscripts to the NIH; you are responsible for ensuring your manuscripts are deposited in compliance with the Policy.

Cite PubMed Central Reference Number. Beginning with the May 25, 2008 receipt date, your applications, proposals, and progress reports sent to the NIH must include the PubMed Central (PMCID) or, if the PMCID is not yet available, the NIH Manuscript Submission reference number (NIHMS ID) when citing applicable articles that arise from your NIH-funded research.

You’ll find additional information and details on how to comply with the Policy at:

NIH Public Access Policy Notice

NIH Public Access Policy

NIH Manuscript Submission System

PubMed Central

But first … an NYT Magazine feature on The Moral Instinct. And in February, check out The Scientist for a discussion by C. Neal Stewart Jr. and J. Lannett Edwards on their approach to teaching a successful research ethics class. In the meantime, some additional perspective by Edyta Zielinska.

Gradually, the data are coming in regarding whether required RCR training and/or real-world ethics “lessons” affect the behavior of researchers. Most recently, McGee et al. offer results from a qualitative study of doctoral students and postdocs before and after a formal RCR course at the Mayo Clinic. Interestingly, none of the authors are from the Mayo.

Interviews were conducted ($40 compensation, but only 30 of 127 class matriculants participated in the study) to learn whether prior experiences influence how a scientist reacts to and is or is not influenced by a formal (weekly lecture) RCR course. Of the 30 study subjects, 13 reported having already taken a formal RCR course (in one interview, a participant says he/she has “done this … five or six times”!), and 15 had “informal” RCR training (not defined, but I assume via mentor, perhaps workshops or seminars or even online modules … this irritates me because I’ve seen “informal RCR training” used elsewhere without being well defined).

The authors opted to focus on two lectures based on results of a small pilot study: Authorship (RCR students expressed strong opinions & frank disagreement about material taught) and Conflict of Interest (RCR students had little prior knowledge & displayed much confusion about this concept). At the Mayo, 2 different instructors presented these lectures. Read the rest of this entry »

JAMA also reports the shocking (or not) news that Philip Morris, RJR, et al. continue to deceive the public with false advertising about tar and nicotine levels in their cigarettes. “At the November 13 hearing, Sen Frank R. Lautenberg (D, NJ), who chaired the session, said he had uncovered a lengthy history of false and deceptive cigarette ratings and marketing practices. “It is now clear that the tobacco industry has been aware of the inaccuracy of these ratings for more than 3 decades,” said Lautenberg. … Cigarette manufacturers Altria Group Inc (Philip Morris International) and R. J. Reynolds Tobacco Co were called to the hearing but refused to attend.” The Supremes will take a listen next.

Today’s issue of JAMA has a commentary on the meaning of translational research by Steve Woolf, one of my favorite people and someone I respect tremendously. He is concerned at how few resources are devoted to T2 (bedside to community) translation. He knows that T1 (bench to bedside) translational research is more expensive due the the infrastructure that must be supported and the crap shoot involved in such research. T1 comprises everything from histone ubiquitylation to Phase III clinical trials plus all in vitro and in vivo work in every conceivable species between. Without the T1 part of the equation, there is no T2. Plus, we need the hope made possible through and the excitement generated by T1 research.

But I work both sides of the aisle, so I understand Steve’s frustration on the T2 side. Personalized medicine to a family doc does not mean taking blood to run a genomic profile (see commentary on why not in NEJM) … it might mean automated alerts in a patient’s electronic health record regarding the need to ask about dietary salt/sodium intake, side effects from a recently prescribed drug, or Hemoglobin A1c screening; for the pharmacist, perhaps an alert that a prescription has not been filled on schedule. More difficult is how, upon learning the patient with diabetes does not routinely check blood sugar, to motivate such behavior. How to get a morbidly obese 12 year old to eat sensibly and become more active when nothing in the social environment supports adherence to this advice. How to convince politicians to ban smoking in public spaces (Viva La France!). The solutions seem so common sense that funding them does not.

T1 research keeps getting funded because it generates measurable, reproducible, statistically significant, and scientifically valid results. It succeeds, which in turn allows NIH ICs to justify their budget requests. T2 efforts all too often … do not. And they’re hard to distill into an attention-grabbing sound bite (”Impact of Medicare Part D and Racial Disparities in Treatment and Outcomes for Hypertension”). Sometimes the T2 side of the equation does come out ahead, such as NYC’s impressive success in reducing smoking rates among teens and adults (and commentary as to why Connecticut does not do as well). As the disease-of-the-month lobbies have learned, the key is to capture headlines, hearts, and then pocketbooks and budget line items. This is easier when you can say you’re funding work to cure disease XYZ than when you say you’re funding a Markov decision processes model for optimizing statin start times for patients with Type II diabetes.