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30 January 2020, Version 2.0

Introduction

The MORU Tropical Network recognizes the value of sharing individual level data, software and other outputs generated by our research.

This policy promotes MORU’s overall aim which is to improve health and well-being of people in resource-poor tropics.

We will ensure that data generated from all our research are collected, curated, managed and shared in a way that maximizes their benefit. When sharing data we have an obligation to ensure that the interests of research participants, researchers and other stakeholders are appropriately protected.

We are committed to ensuring that data and outputs sharing is planned for in the inception of a study: including during negotiations with funders and collaborating sites, during evaluation of compliance with local and international ethics and regulatory requirements, and during the design and conduct of consent processes.

From January 2016, data management for all research studies will include preparation for data sharing. Data underpinning research papers will be made available at the time of publication.

Background

MORU was established in 1979 as a research collaboration between Mahidol University in Thailand and University of Oxford in the United Kingdom.  At any one time, MORU has around 60-70 active clinical studies ranging from small single site pharmacokinetic studies to large multi-country projects involving thousands of participants and generating vast amounts of data.

Scope

This policy applies to all clinical research data and outputs generated in studies led by the MORU Network and sponsored by University of Oxford. This includes studies run by the Bangkok Unit, Shoklo Malaria Research Unit, Laos Oxford Mahosot Wellcome Trust Research Unit, Cambodia Oxford Medical Research Unit, Kinshasa Oxford Medical Research Unit and Myanmar Oxford Research Unit. Data and outputs from studies sponsored externally may be subject to other requirements.

Key Principles and Considerations

When sharing research data we aim to maximise its scientific utility through ensuring that data are high quality, shared in appropriate formats and accompanied by relevant and comprehensive metadata files such as protocols, questionnaires and data dictionaries. We aim to minimise potential harms of sharing and protect the interests of relevant stakeholders including research participants, communities and researchers by ensuring that data are released via governance methods with appropriate levels of oversight and conditions of use. MORU remains the custodian of shared datasets and will monitor applicants' uses of data as appropriate. We aim to share data in a fair and equitable manner that does not exacerbate existing inequalities between high-and low-income researchers, and will prioritise the health interests of those resource-poor settings. Our data sharing governance is designed to build and sustain stakeholders' trust in data sharing. Our sharing policies and processes aim to be fair, accountable and transparent as well as proportionate and responsive to the contexts in which the data were collected.

Process

Data Access Committee

Oversight for data sharing within MORU is the function of the Data Access Committee (DAC). Members of the DAC are appointed by MORU’s Science & Strategy Committee according to the MORU DAC Terms of Reference; TOR02 MORU Data Access Committee.

The DAC on behalf of MORU is responsible for:

  • Facilitating data access
  • Determining the access route for individual datasets
  • Reviewing applications for datasets that come through the DAC
  • The custodianship and stewardship of the data, the quality of the data shared, and compliance with funders' policies and with this data sharing policy.

Data access routes

These include:

  1. Online open access: e.g. as supplementary files to a journal article.
    With this method of access, MORU has no oversight or control of secondary uses made of the data.
  2. External repository without case-by-case assessment
    With this method, datasets submitted to a repository (e.g. Figshare) may be accessed by registered users who have agreed to the repository's terms and conditions of use. MORU has no oversight or control over secondary uses made of these data by registered users. Uses made of the data will be restricted by the terms and conditions of the repository.
  3. Application to the MORU Data Access Committee
    With this method, applicants complete an Application Form and a Data Access agreement. Applications are considered by the DAC on a case-by-case basis informed by an assessment criteria, defined in the DAC terms of reference. The type of agreement that applicants are asked to complete will be determined by the DAC. Consideration will involve consultation with PIs, relevant collaborators and other experts. Additional specific conditions of access may be implemented including collaboration and cost-recovery for preparation of datasets.

This is a policy statement and may not be the latest version.

Queries and applications for datasets should be directed to datasharing@tropmedres.ac