Publishers have been the whipping post for those who feel that reports deriving from taxpayer-funded research should be made available free of charge to taxpayers. This has occurred despite the fact that there are alternative ways to get the directly funded research results to the taxpaying public. In most cases, these alternatives depend on the researchers themselves fulfilling the terms of their grants by filing reports and data with their funding agencies, which then make the reports available online via government Web sites. They also depend on the funding agency enforcing its own policies.
But what happens when studies reveal that NIH-funded researchers aren’t depositing their reports or their data within the time allotted to them? What happens when the NIH itself doesn’t chase down the reports it requires from its taxpayer-funded researchers?
Very little, it seems, despite the fact that on its face, this seems like a pretty egregious abrogation of duties. As H.R. 3850, Food and Drug Administration Amendments Act of 2007 (FDAAA) is explained on the ClinicalTrials.gov site:
‘Applicable clinical trials’ generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).
There are at least three studies showing low rates of compliance — two of these (one focusing on publication after registration in ClinicalTrials.gov, and the other focusing on mandatory reporting requirements for the same) were covered recently here. A third study of publication events, published in PLoS Medicine in 2009, was highlighted in our comments on an earlier post covering the first two studies.
After a week of spirited comments about open access, taxpayer-funded research, heartless publishers, and so forth, it was surprising to hear the virtual equivalent of crickets on a soft summer night when we published a post summarizing these findings.
Maybe Rick Anderson is exactly right — we only hear comments at the pitch and rate we’ve seen in some instances when we argue about “should” and not “is.” In that mode, and to get the conversation going, this is more a post about “should” — that is, researchers should keep their promises to the taxpayers funding their research by actually sharing the data, writing up the reports required of them, and depositing both with their funding agencies when the terms of their funding require such actions.
. . . the ICMJE will not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication.
Many publishers also support authors in this regard, including the oft-maligned Elsevier, which will help authors deposit their materials.
Despite this and the mandatory nature of the reporting requirements, not only were publication rates of trials registered at ClinicalTrials.gov surprisingly low, but perhaps most alarming was the low rate of compliance with mandatory reporting requirements.
Not all trials registered with ClinicalTrials.gov are subject to mandatory reporting requirements, and the researchers performing the recent study of reports being filed limited their scope to those grants that required their recipients to report their findings within 12 months of trial completion.
Of the 738 trials that were interventional (that is, patients were put at risk) and which required reporting within 12 months, only 22% had reported results. A full 78% had not. By comparison, trials not required to report their findings still reported them 10% of the time, so there’s only a 12 percentage point gain by having mandatory reporting requirements in place and agreed to upon trial inception.
Let’s make this clear — these are researchers who applied for and received taxpayer funds on the condition that they report the results of the trials that were funded within 12 months of the trial ending. These were also interventional studies, meaning patients were put at risk.
Why isn’t there a hue and cry about this abrogation of duties to taxpayers and patients alike? Where are the police when you need them?
As for the lack of NIH publishing practices around the required reports, it’s interesting to contemplate that while perhaps they can’t manage to enforce their policies with researchers, they can spend time building out the likes of PubMed Central, while also putting in place unfunded mandates on publishers, who have to share their online infrastructure without further compensation. Some may call this crafty, but it seems like more of a misappropriation of effort and influence. Shouldn’t the NIH be worried about directly fulfilling its duty to taxpayers, enforcing its mandates with researchers, and doing justice to the patients put at risk in the interventional studies it has funded?
But where is the outcry? The shock? The dismay? The calls for justice?
I think the reason for radio silence on these gaps in reporting is sad and simple — the most vocal critics of what happens to government-funded research have fixated on publishers for more than a decade. It’s a hard habit to break. Publishers are an easy target because they are perceived as “the other” in the scholarly and research world (despite the fact that most publishers are run by academic societies, universities, or academic researchers); because publishers have consolidated operations and well-known names (Elsevier, Wolters-Kluwer, Springer); and because publishers have a relatively small and coordinated set of direct payers.
Researchers, on the other hand, are a diffuse group with diffuse funding. As a US taxpayer, it’s hard for me to be upset at anyone in particular because NIH or DOE researchers are pretty anonymous, don’t function as a corporation, and are hard to tag with individual blame. Also, how much of my taxes are being misspent because of this? Probably a small amount, but definitely an unknown amount. Again, unless this becomes a bigger deal, I can only be exasperated alone and in the abstract.
That doesn’t make the fact that researchers are apparently taking money from taxpayers and then breaking their promises to taxpayers any more acceptable. If one concern at the heart of the open access (OA) movement is that taxpayers deserve to get what they’ve paid for, then a major problem is upstream of publishers — it’s in the 78% of grant agreements that are being abrogated by researchers every year, researchers who accepted taxpayer dollars, completed the research, and then blew off their reporting requirements. Sorry, their mandatory reporting requirements.
Where are the cries of outrage at “researchers keeping data under lock and key” or “researchers breaking their fundamental bargain with the system”?
Until we know what we’re trying to do in clearer terms, we’ll continue to have anger, dismay, and moral outrage erupting predictably, but perhaps not when and where it should.