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Avoiding high-risk authors: Should Corporate Integrity Agreements recommend searching the Retracted Publications database?
Abstract   Peer reviewed

Avoiding high-risk authors: Should Corporate Integrity Agreements recommend searching the Retracted Publications database?

L C Carey, A Seth, Mark Woolley and Karen L Woolley
Current Medical Research and Opinion, Vol.32(Supplement 1), pp.S5-S6
Annual Meeting of International Society for Medical Publication Professionals (ISMPP), 12th (National Harbour, United States, 11-Apr-2016–13-Apr-2016)
2016
DOI: https://doi.org/10.1185/03007995.2016.1152850
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https://doi.org/10.1185/03007995.2016.1152850View
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Abstract

Clinical Sciences
Objective: Corporate Integrity Agreements (CIAs), which can address authorship practices, typically require sponsors to check if individuals have been debarred, but don't yet recommend checking if these individuals have authored retracted publications. Authors with misconduct retractions can be serial offenders (highrisk authors). We investigated 1) the feasibility of cross-matching debarment and retracted publications lists, and 2) how well debarment searching could detectretracted authors. Research design and methods: For this quantitative and qualitative assessment, we exported (11/08/2015) data from the US Food and Drug Administration (FDA) Debarment List and the MEDLINE Retracted Publications database (both freely accessible). Every debarred individual was checked against all authors of all retracted publications. Potential matches were further investigated to ensure cross-match validity. Searching time was recorded. A case study was conducted on the cross-matched author with the highest retraction record. Results: Cross-matching was feasible; each debarred author could be checked within 5 minutes. The FDA Debarment List (n = 139 entries; US focus) was less comprehensive than the Retracted Publications database (n = 4013 entries; global focus). There were only 2 (1.5%) matches between debarred individuals and retracted authors; both retracted authors were serial offenders for publication misconduct. The case study showed debarment didn't occur until 2 years after 18 publications had already been retracted. Conclusions: The Retracted Publications database, more global and 30-fold larger than the FDA Debarment List, could provide sponsors and agencies with a free, practical, timely, relevant, and comprehensive way to help avoid high-risk authors. Future CIAs, as well as Good Publication Practice guidelines and company policies, could consider recommending a Retracted Publications search before author engagement.

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