covers a broad spectrum of different types of information depending on the discipline. In the scientific community research data is the information that is gathered and recorded to support/validate a research undertaking
can be in the form of a database, platform or architecture used to store data within an institution. It can also be the source from which the data is collected such as the research participant or research
is the process of how the data will be gathered, stored, analyzed, protected and whether it can be shared at a later stage
broadly includes collecting, storage and processing of large volumes of data in databases that have capacity for complex data sets and data streaming. Big data is significant for use and reuse in analysis and mapping but there are still challenges concerning big data
is a formal document that outlines how you will handle your data both during your research, and after the project is completed. It is good practice to have a data management plan prepared at the start of the research project
simply stated data ownership refers to who has the right to own, control and use the research data. Ownership of data is complex matter that requires careful consideration regarding the risks and benefits associated with the use of data. The control of information includes not just the ability to access.
• Control of information includes a partners ability to create, modify, package, derive benefit from, sell or remove data, and also the right to assign these access privileges to others (Loshin, 2002).
• Ownership refers to who owns the rights in relation to the relevant data
• Control refers to any restrictions or conditions that apply to use of the data
• Management and maintenance of the data refers to the practical systems and capacities required to store, archive and manage the data
• Access and use refers to the terms and conditions under which access to and use of the data is permitted
is often confused with ownership. Data access depends on the nature of the research undertaking and each research partners contribution. It refers to the use of research data often available through a gatekeeper, on provision of a licence to use, with certain restrictions/conditions. It is helpful to understand that providing access to data and samples should be done in a controlled manner. For example, following the standard procedures of a research partner institution where it involves sensitive data
is the method applied by the research partners to make available and accessible the research data within the research undertaking or to outside researchers
is a new concept. According to Meriam Webster dictionary, custodian is 'one that guards and protects or maintains; especially : one entrusted with guarding and keeping property or records or with custody or guardianship...'
Data custodianship may refer to the ethical rather than legal framework of data rights. In an effort to ensure equitable research collaborations, the custodian is to ensure that all legislative mechanisms, ethical review processes, accessibility and management practises are complied
is the protection of (clinical trial) data which has been submitted to a regulatory authority for the purposes of marketing approval, from ‘unfair competition’
careful consideration regarding research data should be held regarding
• nationals laws
• ethical and practical implications
• ownership and access or sharing
• management (maintenance) and
• use of research data
Partners should consider developing an institutional data sharing and access policy if there is none in existence. A policy can help guide how you negotiate with partners on data sharing issues.
Researchers should have a full understanding of various issues related to data ownership to be able to make better decisions regarding data ownership. These issues include paradigm of ownership, data hoarding, data ownership policies, balance of obligations, and technology. Each of these issues gives rise to several considerations that impact decisions concerning data ownership.
where the ethical, legal and social implications of research data relating to -
• rights of ownership
• sharing of data
• conferring/assigning rights to others
• negotiating access, use and control, and
• storage and management of the data.
This also highlights issues of equity and fairness with respect to the capacity of researcher from a developing country to collect, analyse, manage and store such data in ways which also maximise the benefits and minimise risks to themselves, their institutions and their study populations. Partners should thus discuss ways in which capacity of research partners in poorly resourced settings can be strengthened for full and fair benefit from the research activities.
as well as having added value as a by-product of information processing . At the core is the the degree of ownership (and by corollary, the degree of responsibility) is driven by the value that the partners derive from the use of that information.
The consensus of the research partnership should be on emphasizing the principle of openness.
Sharing data has a number of benefits to society in general and protecting the integrity of data in particular.
Thus, researchers should clarify at the beginning of a project if data can or cannot be shared, under what circumstances, by and with whom, and for what purposes.
can be established in a partnership arrangement as stand-alone agreements or as relevant clauses in a larger contractual agreement. The conditions regarding access, use, control, confidentiality or commercial arrangements can be included in an overarching research contract or established in the form of a stand-alone agreement between partners. For example:
• Material Transfer Agreement (MTAs) -
is a contract governing the transfer of tangible research materials between parties involved in a research project, when the recipient intends using these materials for their own research purposes
• Confidentiality Agreement -
is a contract which covers the transfer of confidential data/information between partners for certain purposes, but which restricts the disclosure of such data to third parties
• Access Agreement -
is a contract which outlines the terms under which access/permission to access will be granted to data and the purposes for which the data may be used, when a decision has been made to share such data with one or more parties. This may include terms preventing the transfer of access rights to third parties
“Having a data sharing policy in place helps you when establishing terms for data sharing in research collaboration. For example, the INDEPTH policy provides template license agreements to use in the case of data producers making data available for sharing on the INDEPTH Data Repository. As well, it provides a template for data use agreements between the Network and a secondary data user.
Before the policy was established, there was a long-standing discussion amongst INDEPTH members, starting as early as the 2005 Annual General Meeting of the Network in Durban, South Africa, on how to responsibly, efficiently and widely share public health research data within and beyond the Network in a sustainable manner. This process culminated in the appointment of the INDEPTH Data Access and Sharing Committee (iDASC) at the 2009 AGM in Pune, India, which was tasked with drafting a data sharing and access policy under the auspices of the INDEPTH Board. A primary input to the policy were the discussions held during a joint INDEPTH and COHRED meeting in Nairobi, 28-29 July 2011 which was attended by 22 INDEPTH member centres.
The outcome of the meeting was an INDEPTH and COHRED position paper on sustainable data sharing in public health research. The INDEPTH data access and sharing policy builds on existing Network and centre-specific data access and sharing policy documents and identifies various categories of data and access levels associated with each. It also stipulates the terms, conditions, scope and time frame for accessing and sharing the different data categories equitably, ethically and efficiently. The scope of this Network policy is restricted to the sharing of those data (falling under different data types mentioned in this policy document) that are submitted by member centres to the Network.”
– Kobus Herbst (Principal Investigator) INDEPTH iSHARE2 Project, INDEPTH Network
The Malaria Genomic Epidemiology Network (MalariaGEN) is a partnership of malaria researchers in over 20 countries supported by the Grand Challenges in Global Health Initiative. In MalariaGEN, a number of attempts have been made to address the more exacting challenges of data sharing, in addition to material transfer agreements and research contracts.
(Taken from De Vries et al., 2011)
For further help to better understand issues of data sharing and ownership, the ‘Data Release Policy for Genome-wide Association Data’ may provide some answers concerning the following:
Available at http://www.malariagen.net/sites/default/files/content/terms/files/GWAS-Data-Release-Policy_v1.1.pdf
Data Sharing and Intellectual Property in Genomic Epidemiology
From Biodiversity to Human Genetics
Access to Research Data from Public Funding
Open Data Report
Managing Intellectual Property Rights over Clinical Trial Data
Who owns what?
Indigenous knowledge and struggles over representation
Ownership of field research records ... informants and subject communities
Research ethics in the Kalahari:
Issues, contradictions and concerns
Innovation for Poverty Action
Building the Infrastructure for Data Access and Reuse...
An Analysis of the Legal Context
Data Access and Sharing Policy
Fair Research Contracting