Annual Meeting Reports

Public Access and Reproducible Research: The Journal’s Role, Responsibility, and Contribution

In February 2013, the White House Office of Science and Technology Policy (OSTP) issued a memorandum mandating public access (after a 12-month embargo) to peer reviewed publications and digitally formatted scientific data resulting from federally funded research. Proposals to make publications accessible include broadening PubMed Central to include all US government funding agencies, establishing the Shared Access Research Ecosystem (SHARE) program, and creating the Clearinghouse for the Open Research of the United States (CHORUS). SHARE, proposed by a coalition of higher education and research communities, aims to create a series of interconnected library based repositories to archive a broad array of research materials. CHORUS is a proposal from a coalition of publishers offering a public–private partnership for a technological solution to meet access needs.

The component of the OSTP memo that addresses data accessibility presents serious challenges that include privacy-protection issues and archival characteristics (such as where, how, and how long to store the data). No clear funding support has been presented, nor has instruction about storage duration been provided. Implementing data access will probably be a longer-term project than providing access to research papers.

The Patient-Centered Outcomes Research Institute (PCORI) is a not-for-profit agency authorized by Congress to fund comparative clinical-effectiveness research studies. PCORI’s goals include increasing the quality, quantity, and timeliness of research, but it is also charged with disseminating the results of the work that it funds to a wide variety of audiences and doing so within a short period (apart from the OSTP mandate). PCORI is determining how to disseminate findings to meet its legal mandate and how to ensure that the findings are credible and useful while respecting its funded investigators’ ability to publish in scientific journals.

BMJ (formerly the British Medical Journal) shares the drive to make research data available to the public and is grappling with sharing patient data from clinical trials. There is an understanding between patients and providers that their personal information will remain private and that, when it comes to research, patients may or may not have consented to share their information. The US mandate to provide study data has created concern globally, as expressed by the Wellcome Trust, a global charitable organization, that international collaboration will be damaged if the United States imposes a legal framework that cannot be extended to other countries. BMJ adopted the principle of requiring that anonymized patient-level data from published trials of drugs or devices be accessible to others for purposes of reproducibility. The authors of all eligible BMJ trials have complied with that requirement, and no papers have been rejected for noncompliance.

BMJ has also called for the publication of previously unreported clinical-trial data through an initiative called Restoring Invisible and Abandoned Trials. BMJ published the call, from an international group of academics, for researchers to share “trial documents they have obtained from public sources that need publishing or republishing, and to help us with the writing. We need volunteers to act in place of those who should have but did not make trial reports visible and accessible”.

Another solution that has been presented to make data available comes from GigaScience. This journal and Web resource publishes articles with corresponding data and the necessary tools for analyzing the data, allowing others to attempt to recreate published studies. Reviewers for the journal indicated that repeating the analysis to assess accuracy during a review was time consuming but overall found it very satisfying. Juxtaposing an article with the related data and analytic tools can increase scientists’ efficiency by helping them to retain scientific focus, and it is more advisable to test data before publication than after. However, the process requires time and effort rather than additional funding and is applicable only to particular fields of study. The journal offers the tools to readers, and the data can be cited if they are used in other studies.