Response from PLOS One editors to requests for more information about the PACE trial:
Several readers have raised concerns regarding the analyses reported in this article. We are also aware that there have been requests for the data from this study.
The article was published in 2012; the PLOS data policy that applies to the article is that for submissions prior to March 3, 2014, which is outlined here: The policy expects authors ‘to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research’. The policy also notes that access to the data should not compromise confidentiality in the context of human-subject research.
PLOS ONE takes seriously concerns raised about publications in the journal as well as concerns about compliance with the journal’s editorial policies. PLOS staff are following up on the different concerns raised about this article as per our internal processes. As part of our follow up we are seeking further expert advice on the analyses reported in the article, and we will evaluate how the request for the data from this study relates to the policy that applies to the publication. These evaluations will inform our next steps as we look to address the concerns that have been noted.
The Medical Research Council funded the PACE trial and they also have a policy of open access to research data:
MRC policy on research data sharing
Our policy on data sharing builds on the principles developed of the Organisation for Economic Co-operation and Development (OECD). The report “Promoting Access to Public Research Data for Scientific, Economic and Social Development” identified that publicly-funded research data are a public good, produced in the public interest and that they should be openly available to the maximum extent possible.
The OECD Principles and Guidelines for Access to Research Data from Public Funding (2007) promotes a culture of openness and sharing to increase “the return on public investments in scientific research,” exchange of good practice, awareness of the costs, benefits and restrictions on sharing.
The MRC policy is also consistent with the Research Councils’ Common Principles on Data Policy which in turn reflect the OECD principles.
Our data-sharing policy applies to all MRC-funded research. It does not prescribe when or how researchers should preserve and share data but requires them to make clear provision for doing so when planning and executing research. The policy was approved by the Council in 2005. This September 2011 version includes some minor changes that do not alter the intent of the policy.
The MRC expects valuable data arising from MRC-funded research to be made available to the scientific community with as few restrictions as possible so as to maximize the value of the data for research and for eventual patient and public benefit. Such data must be shared in a timely and responsible manner.