Medical Writing, Editing & Grantsmanship

An editorial in today’s Philly Inquirer subtitled “Who’s Buying the Science?” concludes that researchers must clearly state: “Here are our results; here’s how we got them; here’s where the money came from; here’s where we work; here’s what we’ve done in the past. Hide any part of that, for whatever hair-splitting reason, and skepticism (which is a good thing, and the backbone of science) is justified if it flares into cynicism.”

Last week, Science magazine announced FASEB’s new COI Toolkit “developed to help the scientific community better navigate financial relationships between academia and industry.” FASEB also recently held a “Call to Action” meeting on July 17th at which participants discussed the development of more consistent policies for disclosing financial relationships between academia and industry. The nicely implemented COI Toolkit derives from 3 guiding principles:

Guiding Principle 1: Investigators must conduct research activities objectively.
Guiding Principle 2: Investigators must operate with transparency.
Guiding Principle 3: Investigators must be accountable to all stakeholders.

FASEB defines stakeholders in the last principle as “including the public, sponsors of research, home institutions, research teams, and human subjects and patients.” The Toolkit includes items organized by stakeholder, and the level of detail includes very specific guidance, such as “Pre-publication review by an industry sponsor should take no more than 60 days.”

A letter in The Lancet suggests creation of a “Conflict Vitae” - “a single document with a single set of definitions for disclosure of financial conflicts of interest.”

And down the road, possibly a COI version of clinicaltrials.gov, where investigators seeking to publish data will need to register all their potential conflics of interst?

First, NIAMS, then NINR … now NIDCR makes 3 NIH ICs that restrict use of the R03 small grant program mechanism for clearly defined new investigators. NIDCR offers up to $150K in direct costs for the 2-year period. NIAMS sticks with the traditional $50K per year but for up to 3 years. NINR seems to be following the parent R03 award of $50K per year for 2 years.

NIDCD offers a special R03 program for young investigators - including postdocs - within 7 years of their doctorate (excluding years of formal clinical training). Applications may be submitted for up to 4 modules of $25,000 each (ie, $100,000 Direct Costs per year), for up to 3 years of support. There are special receipt dates later in the major cycle months (Feb, June, Oct).

Today in Science, Drs. Roberts, Sivaguru, and Yong retract an article published in Feb 2006 about which the editor, Donald Kennedy, published an Editorial Expression of Concern in Oct 2006 based on an ongoing investigtation of possible misconduct. The remaining authors clearly spent some thoughtful time wording this retraction, particularly the apology to the scientific community for not protecting their interests:

“We wish to retract our Report “CDX2 gene expression and trophectoderm lineage specification in mouse embryos” (1). Allegations of research misconduct were received by the University of Missouri-Columbia (MU) Provost, and an investigation found that the first author (K.D.) engaged in research misconduct by intentionally falsifying and fabricating digital images in the preparation of Figs. 4I; 4N; 4S; 2G; 3, J to L; S2, V to X; and S6, I to K accompanying the Science article. In addition, the original raw image files for the majority of the figures in the paper have not been located (the exceptions being the confocal scanning images in Figs. S1, S3, S4, S5, and S6), raising the possibility that the data they represent may also be suspect. We have decided to withdraw the article in its entirety in view of the fact that the paper was founded at least in part on falsified or fabricated images.

The corresponding author (R.M.R.) takes responsibility for placing excessive trust in his co-worker and for not assuring that a complete set of raw data existed at the time the questions first arose about the paper. We deeply regret any scientific misconceptions that have resulted from the publication of this article.

The first author resigned from MU shortly after the allegations of research misconduct were received and could not be found to sign the retraction.”

One wonders if the elusive and suspect author will resurface elsewhere as Eric Poehlman did, slipping across the border to Canada and neglecting to mention the minor ethical shadow overhanging him. Nature reports he has fled the country.

From NEJM: Since he was adopted by staff members as a kitten, Oscar the Cat has had an uncanny ability to predict when residents are about to die. Thus far, he has presided over the deaths of more than 25 residents on the third floor of Steere House Nursing and Rehabilitation Center in Providence, Rhode Island. His mere presence at the bedside is viewed by physicians and nursing home staff as an almost absolute indicator of impending death, allowing staff members to adequately notify families. Oscar has also provided companionship to those who would otherwise have died alone. For his work, he is highly regarded by the physicians and staff at Steere House and by the families of the residents whom he serves.

Notice is hereby given that the ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the findings of an inquiry report by UCLA and additional analysis and information obtained by ORI during its oversight review, the U.S. PHS found that James David Lieber, Staff Research Associate, Semel Institute for Neuroscience and Human Behavior, Integrated Substance Abuse Programs, UCLA, engaged in research misconduct in research funded by grant R01 DA15390.

Mr. Lieber knowingly and intentionally falsified and fabricated multiple follow-up interviews, urine samples, and urine sample records of human subject study participants and entered such false and fabricated data into the study’s data base. A total of 914 follow-up interviews of opiate users were planned to be completed as part of a study of gender differences in a follow up of opiate users in California. Mr. Lieber was assigned to interview 53 of the 132 subjects located for the follow-up study. Over a six-month period, Mr. Lieber falsely claimed to have conducted face-to-face interviews for the study while subsequent contacts with the subjects revealed that they had not been interviewed for the study. A review by the institution determined that the respondent fabricated interviews for 20 of the 53 interviews assigned to him. In addition, he falsified the urine specimens for those 20 subjects and caused the entry of false information into the study tracking and locating data base for 11 subjects. Aggravating factors included the theft of $5180 for incentive payments to subjects and travel expenses.

That would be the new Director of the Office of Portfolio Analysis and Strategic Initiatives (OPASI), Alan Krensky. Nature has a nice recap of his initial days on the job and plans for the future, which apparently will include moving on at the end of 2008 to direct the Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI), of which OPASI will be a member (so will the Office of AIDS Research and the Office for Research on Women’s Health). Maybe he’ll be promoted to run something with even more letters in its abbreviation by the end of his tenure. Seems promising that he’ll make some sense of the Roadmap in the meantime.

My main advice in this task is that investigators discuss authorship and “credit” at the outset when projects are being planned and implemented (& as new team members come on board) so no unspoken assumptions are made that erupt at manuscript time. A short piece in Nature has some potential merit - but good heavens, I have no idea who would have the time to do this for each paper generated:

“Using a multi-criterion decision making (MCDM) approach, a group of potential co-authors decides on a set of items — such as figures, tables, text and ideas — that comprise a manuscript. They score each person’s contribution to each item as a percentage. Types of contribution vary across publications, but a group of co-authors is well placed to make judgements. As they may not always agree exactly, a range can be assigned that they can ‘agree to disagree’ on.

The group should then assess the relative importance of each item and put them in categories, in order of importance to the manuscript. For example, category A (the most important) might constitute a 15% weighting, category B 10% and category C 5%. This way, each item is given a weighting that represents its importance to the whole work. Finally, each author’s relative contribution to each item is calculated.”

Of course, this would at last explain something I see in many grant applications - the incorporation in research project timelines of 6 months of support at the end of the project period for publication …

Exceptional, Unconventional Research Enabling Knowledge Acceleration … an RFA co-sponsored by NIGMS, NIDA, NIMH, NINDS, and NIAID to provide non-renewable R01 support to “investigators who are testing novel, unconventional hypotheses or are pursuing major methodological or technical challenges. … Several key features of the EUREKA FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s.” So - read the RFA carefully, and then read very carefully between the lines. LOI due Sept 24th, application receipt date is Oct 24th.

Confirming a suspicion I’ve had for years … Scans reveal a fluid-filled cavity in the brain of a normal man.

So pleased that the Washington Post published a short piece honoring Odile Crick, who drew the double helix for the April 1953 issue of Nature. Would have been nice to see at least a brief mention of Rosalind Franklin (and possibly even Odile’s perspective on the controversy, if that is known), but overall a nicely done and intimate recap. The NYT added their tribute as well.