Archive for March, 2008

Medical Ethics Update 2008

March 31, 2008 at 11:45 pm · Filed under Biomedical Research Ethics

No, I’m not providing such … this was the conference I attended today. Needless to say, one full day wasn’t near enough, but when you don’t have industry sponsorship … The endowed lecture, this year entitled “How Financial Conflicts of Interest Endanger Our Profession”, was given by Jerome Kassirer, MD (Prof of Med, Tufts SOM; Visiting Prof, Stanford SOM; Editor-in-Chief Emeritus, NEJM). An equally fascinating keynote address was delivered by George Lowenstein, PhD (Herbert A. Simon Prof of Economics and Psychology, Dept of Social & Decision Sciences, Carnegie Mellon) on “A Psychological Perspective on Conflicts of Interest in Medicine.”

There was a consensus on the failure of disclosure as a means to remedy COI, despite its perception as the “great disinfectant.” Dr. Lowenstein presented a series of, yes, elegant studies demonstrating motivational information processing (brain processes information differently depending on whether processor wants to embrace or discard the information presented), that physicians are willingly misled even when they know the information being presented is biased, and that disclosure of a COI perversely corrupts the behavior, decisions, & actions of both the discloser and the disclosee. Dr. Kassirer added that disclosure alone requires an assessment of motives (difficult if not impossible) and gives the discloser license to proceed “unconflicted” in an “anything goes” mode.
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Pooling Peer Review

March 26, 2008 at 11:18 pm · Filed under Biomedical Research Ethics, Biomedical Writing/Editing

Two items in Nature journals consider the benefits of a consortium approach to peer review of journal manuscripts (in existence) and grant applications (modest proposal). Nature Neuroscience announced today it is joining the the Neuroscience Peer Review Consortium, which “reduces the overall reviewing workload of the community by allowing authors to continue the initial review process when their paper moves from one consortium journal to another, once the paper has been rejected or withdrawn from the first journal.” The Nature Neuroscience editorial describes the process, voluntariness, and flexibility and notes that the NPRC system will be evaluated at the end of the year … and on an ongoing basis at the journal’s blog, Action Potential.

Separately and quite distinctly, in a letter to Nature, Dr. Noam Harel of Yale makes a modest proposal: a centralized grant proposal repository into which applications could be deposited at the PI’s leisure and that sponsors could search for interesting science to review and possibly fund (no doubt with some encouragement by depositing PIs). The research proposals would only be made available to sponsor agencies, and multiple sponsors interested in the same work could collaborate on a shared funding agreement. As a thought exercise, interesting. As something to actually implement …

And finally, while we’re pondering peer review, Gregory Cuppan, a managing principal at McCulley/Cuppan (which specializes in document development), contributes to the commentary on a prior thread discussing the Publishing Research Consortium survey data. Specifically, he notes that “most people have little or no formal training in the task of review” and would “be interested to know how many readers of this blog have actual formal training in the task of review (here I make a strong distinction from training for the task of editing).” He refers to a 1961 study by the Educational Testing Service in which 53 distinguished reviewers read 300 college student papers but only had a median correlation among reviewer scores of 0.31.

In a separate note to me, he also suggested we look at an article by Mayo et al. in the Journal of Clinical Epidemiology suggesting traditional grant review processes and funding decisions suffer from a high degree of variability due to too few reviewers being involved. The report presents empirical data from intramural review of pilot project applications at McGill University Health Center Research Institute; applications were both ranked and scored (1-5 scale), with poor agreement between the two (kappa value of 0.36, with 95% CI 0.02-0.70). The top-ranked proposals would have failed to meet the “payline” with varying probability depending on who was assigned to provide a scored review. The examined process does not translate to current NIH study section practice, but it lends credence to the recommendation (see pp 4-5 & 38-41) that chartered study section members (not ad hoc reviewers) rank scored proposals at the end of each meeting. Per Mr. Cuppan’s suggestion that manuscript reviewers lack training, see pp 45-46 of the Enhancing Peer Review report for standardizing reviewer, chair, and administrator (officer) training.

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Hellinga Retraction Update

March 24, 2008 at 12:28 pm · Filed under Biomedical Research Ethics, Research News

Latest Discussion can be read/joined here.

I wanted to thank David for his many comments in the ongoing discussion of the Dwyer et al. retractions, including his pointing out that the 2007 Journal of Molecular Biology article from this group was also formally retracted and, most recently, two enlightening electronic letters to Science (particularly the one from Dr. Richard at SUNY Buffalo) on this case.

And yet another update via David in the main thread on this retraction:

“One very interesting section of Andrea’s [Gawrylewski, The Scientist] blog entry that has not appeared online before is that “Shortly after the original paper appeared in Science in 2004, Hellinga went to give a seminar in Berkeley to present his new findings. [Jack] Kirsch said he brought up the issue with the Km and asked to see Hellinga’s data but never received it.” Yet another lesson to learn from this whole fiasco.”

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Greatness of Zerhouni

March 23, 2008 at 8:37 pm · Filed under Research News

A heads up in case you missed this journalistic biopic of the Great Zerhouni in the National Journal … including gems such as “Partly prompted by a relative, he specialized in radiology, which seeks a clearer image of the body’s internal workings. That defined focus distinguishes radiologists from many other biological scientists, who spend their days incrementally exploring narrow niches, such as the digestive tract of C. elegans — a worm one-quarter of an inch long.”

I can’t say I have ever heard radiology described as a vocation in quite these terms, or, for that matter, radiologists described as biological scientists.

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222 Grants to 22 PIs

March 19, 2008 at 4:14 pm · Filed under NIH Advice

BB brings to our attention the “item in the latest Nature re 222 NIH grants going to 22 investigators.”

As Nature notes, the first two PIs with the most awards are conference organizers (including Keystone Symposia) juggling lots (n=32 to Keystone) of little R13 grants. Busy but not necessarily abusive to the system.

The big question is whether big names go on applications to secure the NoA, with the actual work completed by others in the lab. Consider, for example, Nobel laureate and former NIH Director (& budget doubler) Harold Varmus holding on to 8 awards worth $13.1M. John Reed, as director of a 35-person lab and PI on 11 NIH awards (~$10.9M), feels he deserves all his awards. The question is would those 11 awards still go to the Burnham Institute if the person who did most of the work were the PI on the application. If the science is sound, the answer should be yes. So why not let the science and the actual investigator running the show stand on their own merits and apply directly?

And then there is Sten Vermund at Vanderbilt (11 grants, $24.1M), who bluntly “acknowledges that a former stint at the NIH overseeing a $50-million grant portfolio in AIDS vaccine trials taught him a lot about how successful grant applications are packaged and marketed. “I don’t want to make myself sound like a grant-writing technician, but let’s be honest: that is a nontrivial part of success in biomedical research.””

The NIMH currently does not want its funded PIs coming back to ask for a 5th award without prior approval, and I feel the 20% PI effort requirement is a good step toward equitably allocating limited NIH resources, certainly as applied to research project grants (including projects that are components of P mechanism awards, U54s, and the like). As I’ve noted previously, Brian Martinson et al. suggest this would be a welcome shift from the perspective of procedural and distributive justice.

The US DHHS Office of Inspector General is very interested in effort reporting, so it could be they will offer indirect help to the NIH’s movement toward limiting awards per applicant PI. Harold, John, and Sten clearly have a few obligations to their institutions outside the lab for which they are paid. Aside from fairness in allocating resources, managing – and maintaining funding for – so many projects and people can take its toll on even the most vigorous researcher, as Eric Poehlman can probably attest (falsified/fabricated data on 17 grant applications to the NIH).

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NIH Grant Cycle – Tips on Application through Renewal

March 19, 2008 at 1:27 pm · Filed under Grantsmanship, NIH Advice

NIAID (who else) has a handy new NIH Grant Cycle tutorial/resource guide that steps you through the entire process of developing, preparing, submitting, resubmitting, managing, and renewing an NIH grant application/award.

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Scientific Method Humor

March 17, 2008 at 5:06 pm · Filed under Biomedical Writing/Editing, Grantsmanship

Well, 18 months after relocating to Baby It’s Cold Outside, I’m still unpacking boxes & rifling through forests worth of files. Pay dirt! A few yellowing, crumpled mimeographs (okay, not that old & lacking that distinctive smell – but certainly photocopies of lists tapped out on manual typewriters) that I’ve managed to keep with me for nearly a quarter of a century, so heaven knows the original source. Suffice it to say, not me. The list of useful research phrases can be found online. I’m not sure I’ve seen this explanation for scientific method though:

The cornerstone of modern science is the scientific method. Scientists first formulate hypotheses, or predictions, and then perform experiments to test their hypotheses. There are two forms of scientific method, the inductive and the deductive.

INDUCTIVE:

  • Formulate hypothesis
  • Apply for grant
  • Perform experiments or gather data to test hypothesis
  • Alter data to fit hypothesis
  • Publish

    • DEDUCTIVE:

  • Formulate hypothesis
  • Apply for grant
  • Perform experiments or gather data to test hypothesis
  • Revise hypothesis to fit data
  • Backdate revised hypothesis
  • Publish

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    Best Places for Postdocs

    March 10, 2008 at 10:51 am · Filed under Research News, Research Resource

    The Scientist has an annual feature I’ve followed with interest since it’s inception: the annual survey of the best places for postdocs to work. You can go directly to the tables and survey methodology. Rankings for US and international sites are broken out, but the lists combine academic, private, government, and industry employers (click on the “Type” column to sort them accordingly – clicking on all the column heads sorts the data thusly).

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    NIH Public Access Explained

    March 7, 2008 at 4:08 pm · Filed under Biomedical Writing/Editing, NIH Advice

    Today the Association of Research Libraries offered a Webcast (viewable via archive) on the recently mandated NIH Public Access Policy. The presentations by Kevin Smith, JD (Scholarly Communications Officer, Duke University), Jim Siedow (Vice Provost for Research, Duke University), and Tony Waldrop (Vice Chancellor for Research & Economic Development, UNC) were quite useful and raised awareness about the need for academic authors to protect and manage their copyrights more broadly. I think this is an hour well spent, especially for anyone actively involved in facilitating and monitoring institutional compliance with this directive.

    Similarly helpful (especially to PIs without an hour to spare) and much appreciated are the resource links to materials from Duke and UNC, such as Duke’s sample letter to publishers to protect author rights to comply with the Public Access policy.

    Finally, the NIH is seeking public comment on the Public Access policy. As with Enhancing Peer Review, written comments are due by Monday, March 17th. You can submit a comment to be presented at the Public Meeting to be held on Thursday, March 20th from 10 a.m. to 4:30 p.m. (NIH Natcher Conf Ctr); approximately 30-40 of these comments will be presented. If you want to attend, you must register by March 17th. The Great Zerhouni himself is on the agenda. The NIH has issued a formal Request for Information as well.

    Update: Summary from the NIH Public Meeting: “The NIH received comments from representatives of universities and other NIH grantee organizations, publishers from commercial organizations and professional societies, journal editors, patients, public health advocates and the general public. The NIH received 451 comments in advance of the meeting. Preliminary analysis indicates more than 60% of these pre-meeting comments expressed support of the policy as implemented; approximately 15% said the 12-month delay period was too long; and 15% had concerns that a mandatory policy would be detrimental to scientific publishers.”

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    Clinicaltrials.gov Expansion

    March 7, 2008 at 3:01 pm · Filed under Biomedical Research Ethics, Research News

    Zarin and Tse (from NLM) have published in Science a thoughtful commentary, Moving Toward Transparency of Clinical Trials, in which they discuss problems of reporting bias against negative trials and review Section 801 of the FDA Amendments Act (”FDAAA 801″), which was enacted on Sept 27, 2007 and “expands the scope of required registrations at ClinicalTrials.gov and provides for the first federally funded trial results database. It mandates registration of a set of controlled clinical investigations, other than phase I trials, of drugs, biologics, and devices subject to regulation by the FDA. The law applies to research for any condition regardless of sponsor type (e.g., industry, government, or academic).”

    This is a massive undertaking of great import, and they conclude that “FDAAA 801 should transform the degree of public access to critical clinical trial information from publicly and privately funded clinical research” but also discuss several challenges to its implementation related to potential loopholes and issues of IP, validation, and interpretation by the public. For example, the “NIH and FDA are directed by the law to conduct a pilot quality-control project to determine the optimal method of verification” of the completeness and accuracy of submitted data. Whoa. And double whoa when it comes to balancing the need to protect IP while also protecting and promoting public health (particularly those who volunteer to participate in clinical research). Stay tuned.

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