Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

Abstract

BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.ResultsOut of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57 %) of the published studies.ConclusionsThis study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

“…9 There have been calls for audits of access to trial results for performance monitoring and comparison, 8 with several recent examples including trials from individual research centres, [10][11][12] all drugs approved in one year, 13 and all trials approved by individual ethics committees. 14 No attempts have, however, been made to systematically compare funder or sponsor policies on transparency. doi: 10.1136/bmj.j3334 | BMJ 2017;358:j3334 | the bmj We identified pharmaceutical companies' policies on access to information about clinical trials and extracted structured data characterising their commitments to register clinical trials, share summary results, share CSRs, and give access to trial data for current and past trials (box 1); and we assessed concordance with ethical and professional guidance.…”

Determining the level of data sharing, and number of publications, from research databases that have been given a favourable opinion by UK research ethics committees

“…Previous research looking at publication rates of projects reviewed by HRA RECs indicated that most projects take at least 4 years before a resulting publication in a peer-reviewed journal is produced. 7 It might also be expected that the older a research database is the more likely it will be for other researchers to know about it and thus make a data access request. Here, the number of research databases approved per year is shown in figure 4 , although it should be noted that some databases may have been in operation prior to the HRA application date.…”

“…This request formed part of the wider 'transparency agenda' being pursued as a statutory duty by the HRA, but further encouraged by organisations such as the AllTrials campaign 5 and the REWARD Alliance. 6 A previous audit by the HRA showed that only one-third of regular projects reviewed by RECs publish their results, 7 raising a subsequent concern that research database projects may also be underperforming in terms of publishing outputs.…”

Should research ethics committees police reporting bias?

“…10 By cross referencing initial applications with data in clinical trial registries and publication databases, the pilot was able to determine whether projects had published in the scientific literature (32%, 37/116, had) and whether researchers reported their originally stated outcomes (only 43%, 12/28, had).…”