Ownership and Retention of Data

POLICY NO: RES-17.0

DATE OF APPROVAL: 27 November 2009

AMENDMENTS:

REFERENCE AUTHORITY: Deputy Vice Chancellor and Vice President (Research & Enterprise)

CROSS-REFERENCES:

Responsible Practice in Research (RES 1)
Human Research Ethics Policy (RES 2)
Animal Experimentation Policy (RES 3.1)
Biological Hazards and Genetically Modified Organisms (RES 4)
Ionising Radiation Policy (HR 29)
Non-ionising Radiation Safety (HR 30)
Higher degrees by research (RES-10)
Academic Regulations for Higher Degrees by Research
Code of good practice: research degrees management and supervision
Authorship Policy (RES-12)
Statement of Authorship and Location of Data Form
Public statements by members of University staff (C-5)
University activities - Intellectual Property: Ownership and Commercialisation Guidelines
University activities - Research and Consultancy Guidelines
Staff Code of Conduct
Australian Code for the Responsible Conduct of Research
National Statement on Ethical Conduct in Human Research (PDF file, 1.1BMB)
Australian code of practice for the care and use of animals for scientific purposes 7th edition 2004

Preamble
Policy
Procedures
Definitions

Preamble

The purpose of this policy is to assist the University, and its Researchers fulfil their responsibilities with respect to the storage and retention of Research Data, Primary Material and Research Records associated with, and arising from, research activity in accordance with the Australian Code for the Responsible Conduct of Research (the Code)

The retention of complete, accurate and retrievable Research Records is integral to the research process. Good research practice entails the retention of Research Data, Primary Material and Research Records for the minimum designated period after the publication of results. The Code states that:

'The central aim is that sufficient materials and data are retained to justify the outcomes of the research and to defend them if they are challenged. The potential value of the material for further research should also be considered, particularly where the research would be difficult or impossible to repeat' (The Code, Section 2.1).

Consistent with the aim of the Code, this policy sets out the responsibilities of the University, Executive Dean, Directors of Research Institutes and Centres, and individual researchers for the management and disposal of Research Data, Primary Materials and Research Records.

Policy

1. General

The University will abide by the Code in relation to the ownership, management and disposal of Research Data, Primary Material and Research Records.

2. Responsibilities

2.1 University of South Australia

Under the Code, the University is obligated to:

Identify ownership of Research Data and Primary Materials;
Maintain practices for the retention of Primary Materials and Research Data consistent with practices in the discipline, relevant legislation, codes and guidelines;
Provide facilities for the safe and secure storage of Research Data and Primary Material;
Ensure procedures are in place for the secure and safe disposal of Research Data and Primary Materials when the specified period of retention has expired;
Maintain procedures on Research Data ownership and storage which cover the expected range of research and collaborations that may be undertaken.

2.2 The Executive Dean / General Manager

Subject to any contractual arrangements and/or any or legislative requirements, the Executive Dean / General Manager is obligated under the Code to:

Provide facilities to enable the storage of Research Data and Primary Materials in a manner which enables continued accessibility to the Research Data over time by authorised individuals;
Ensure that University policies and procedures are disseminated to Researchers and Student Researchers;
Provide storage space for Research Data, Primary Material and Research Records that meets security and Confidentiality requirements, particularly in the case of human Research Data, Primary Material and Research Records;
Authorise the destruction of Research Data, Primary Material and Research Records on the recommendation of the Researcher or Student Researcher's Supervisor.

2.3 Researchers

Subject to any contractual arrangements and/or any or legislative requirements, Researchers (including Student Researchers and their Supervisor) are obligated under the Code to:

Decide what Research Data and Primary Materials must be retained. In some cases this will be determined by law, funding agency, publisher or by convention in the discipline;
Ensure Research Data and Primary Materials retained are sufficient to justify research outcomes and to defend the findings if challenged. The potential value of the research for further investigation must also be considered in determining retention requirements;
Ensure that the integrity and security of their Research Data, Primary Materials and Research Records are maintained, and that this material is stored in an identifiable and retrievable way;
Dispose of Research Data after the minimum retention time has lapsed in accordance with the Code and University procedures. When making the decision to dispose of the data, the Researcher must consider professional standards, legal requirements and contractual arrangements. This includes allowing sufficient time for other Researchers and interested parties to make reference to them as well as any allegations made to the validity of the data having being resolved;
Recommend to the Executive Dean that their Research Data be archived (and not destroyed) if they present a significant contribution to the research community, provided that this decision does not breach legal requirements, professional standards or contractual arrangements;
Ensure that a signed agreement is in place prior to research involving multiple parties. The agreement must stipulate where the Research Data and Primary Material will be stored, access rights, ownership, retention and disposal.

Student Researchers are also responsible for:

Signing a declaration that they have complied with the Code and that Research Data, Primary Materials and Research Records collected, used and maintained in the conduct of their research will be retained for the minimum time required according to legislation, from the point of thesis submission unless publication, or public release of the work of research subsequently occurs, in which case the Research Data, Primary Materials and Research Records will then be retained for the minimum time required after publication, or public release, of the work of research. Students must also arrange with their supervisor for the storage of their Research Data, Primary Materials and Research Records in the Academic Unit at the time of thesis submission.

3. Ownership

3.1 Researchers

Research Data, Primary Materials and Research Records created or developed by Researchers and the Intellectual Property in and associated with such Research Data, Primary Material and Research Records are owned by the University, unless otherwise agreed in writing between the Researcher and the University or the University and a third party.

3.2 Student Researchers

Research Data, Primary Material and Research Records created or developed by Student Researchers are owned by the University in the case of University-student projects i.e. projects undertaken by students in collaboration, or subject to commercial agreements, or resulting from projects with pre-existing UniSA intellectual property. In such cases the student will be required to assign ownership of data to the University via a Student Project Participation Agreement at the time of admission into their program.

In all cases, the University will remain the custodian of Research Data and Primary Materials acquired through research in accordance with Sections 2.1 and 2.2 of this policy unless data and materials are owned by a third party or a subject to a formal collaborative agreement as in Section 2.3.

3.3 Research Spanning More Than One Institution

Where projects span several institutions a written agreement must be developed prior to the beginning of the project covering ownership of Research Data and Primary Material.

4. Retention of Research Data, Research Records and Primary Material

Researchers must determine which Research Data and Primary Materials should be retained taking into account conventions in their disciple and /or legislative requirements;
Research Data, Primary Material and Research Records must be maintained for as long as specified by the Code, legislative, contractual and other regulatory requirements.

The Code: Retention time requirements for Primary Material, Research Data and Research Records

Type of Primary Material / Research Data / Research Records	Minimum retention time
Short-term research projects for assessment purposes only	12 months
General research	5 years after publication
Clinical trials (research involving humans)	15 years after publication
Gene therapy (e.g. patient data / records)	Permanent
Significant heritage value data	Permanent (preferably within a national collection)

In addition to the requirements in the table above, researchers should also be guided by the specific provisions of the State Records Act 1997 in relation to retention times for specific materials of heritage or archival value.

5. Storage of Research Data, Research Records and Primary Material

In order to ensure that the University is able to defend challenged research outcomes as required under the Code, it is necessary for the University to remain custodian of Research Data and Primary Materials acquired during research unless the data and materials are owned by a third party. In the event that a researcher or student researcher moves away from the institution, the University will remain the custodian of Research Data and Primary Materials acquired during their formal association with the University;
Research Data, Primary Material and Research Records should be maintained securely to prevent unauthorised access, destruction, alteration or removal, accidental or intended damage or destruction;
Researchers are responsible for maintaining records of where their data are stored. In the event that results from research are challenged, all associated Research Data and Research Records must be retained until the matter is resolved. Research Records that may be subject to allegations of research misconduct must not be destroyed.

6. Access to Research Data, Research Records and Primary Material

Lead Researchers should make their Research Data available for use by other researchers where appropriate unless this is prevented by ethical, privacy or confidential matters (2.5.2 Code);
Researchers given access to confidential data and materials should maintain that confidentiality.

7. Destruction of Research Data, Research Records and Primary Material

Destruction of Research Data and Primary Material must be in accordance with the requirements of the Code and subject to the relevant legislative requirements. Such destruction can only be approved following conclusion of the minimum retention period;
Subject to any contractual arrangements and/or legislative requirements, Researchers must obtain written approval from their relevant line manager for the disposal or destruction of Research Data, Primary Materials and associated Research Records. Destruction of Research Data, Primary Material or Research Records without requisite approval may constitute research misconduct.

Procedures

1. General

The University will monitor procedures for the storage, retention, recording and disposal of Research Data , Primary Materials and Research Records.　

2. Storage of Research Data, Research Records and Primary Material

Researchers will create and maintain throughout the research project, full and accurate records of the research methods and data sources used, by way of notes/diary entries and laboratory books etc;
All data and materials must be afforded due care and protection. Regardless of the format of the materials/data, they must be protected from damage and handled with care. Research Data or Primary Materials must not be removed from the storage provided without authorisation during the active phase;
When Research Data has been obtained from limited access research databases or in a contracted project it may not be possible to store the Research Data in accordance with the above requirements. In such cases, a written description of the location of the original Research Data or key information regarding the limited access research database from which it was extracted should be kept as part of the Research Records for the project;
At the point of publication of research, Researchers are required to complete the University's Statement of Authorship and Location of Data Form (RTF file). This form requires the Researcher to identify where the Research Data, Research Records and Primary Material are stored.

2.1 Physical data

Physical data must be stored in accordance with the University's Records Management Policy (currently in draft form);
Wherever possible Research Data, Primary Materials and Research Records should be stored in the Academic Unit in which the Research Data were generated. Where this is not feasible use should be made of the University's off site storage facilities.

2.2 Electronic data

Wherever possible Research Data, Primary Materials and Research Records should be stored on the local Academic Unit server drive. Research folders can be installed by the University's Information Strategy and Technology Services Unit staff and access granted to each Researcher requiring access to the folder. The data in the folder are backed up nightly. Standard practice should be to store all data on the local server. Working files may be stored on an individual's computer hard drive, USB drive or personal laptop but must be backed up on the server frequently (48-72 hours). Files within the folder should be clearly named so that Researchers/supervisors can find relevant documents, spreadsheets, analysis etc;
Password protection must be used when Research Data are confidential and restricted to the research team;
Electronic Research Data should be stored in at least two locations to mitigate complete loss of one copy;
Electronic Research Data should be stored with appropriate meta-data that is information about each Research Data set describing how, when and where it was generated, instrument settings, software used etc;
Researchers with large data sets should consult with the University's Information Strategy and Technology Services Unit (ISTS) to determine the appropriate current mechanisms to store such data sets. Large data sets should have data management plans, risk assessments and transition or disengagement plans, the latter particularly necessary where the Research Data are created from data owned by a third party. Large data sets may need risk assessments to include risks associated with long term storage.

2.3 Human research data

Human Research Data should be stored in accordance with the human research ethics application approval requirements (non-identifiable, re-identifiable, individually identifiable). If Research Data are to be accessed and/or used by others, the data must be non-identifiable due to privacy and confidentiality requirements (unless the participants have agreed for their data to be accessed and used for a purpose other than the reason for which it was collected);
Unless specified otherwise in the approved ethics application, the original data must be retained and stored in a secure location (e.g. audio tapes of interviews, hand signed consent forms, paper based questionnaires etc).

3. Access to Research Data, Primary Material and Research Records

Research Data should be made available for use by other Researchers unless this is prevented by ethical, privacy, confidentiality or contractual reasons. Transition management plans for provision of Researchers data to and return from other Researchers should be considered;
Requests to use Research Data and Primary Materials for further research should be directed to the lead Researcher or Student Researcher;
The final decision on access to Research Data and Primary Materials will reside with the Deputy Vice Chancellor (Research & Enterprise);
When Research Data involving human participants has been collected for research, only the nominated Researchers can have access to these Research Data and Research Records unless otherwise approved by the University's Human Research Ethics Committee;
Researchers should be aware that under the Freedom of Information Act 1991 (SA), the University, under defined circumstances, is required to allow persons access to documents which are in the University's possession. Further information may be sought from the University's Freedom of Information Officer

4. Removal or Movement of Research Data, Primary Material and Research Records

Lead Researchers, who leave the University, may negotiate with their Executive Dean / General Manager to take copies of their Research Data, Primary Material and Research Records for their own use. As a general rule original Research Data, Primary Material and Research Records are to remain in the University as per Section 4 (i) of this Policy;
Where Research Data, Research Records or Primary Materials are moved within the University the Statement of Authorship and Location of Data Form (RTF file) must be updated by the person moving this data to reflect the new location.

5. Destruction of Research Data, Primary Material and Research Records

Research Data, Primary Material and Research Records will not be disposed of from any central storage repository without the written consent or knowledge of the relevant Researcher/s and Academic Unit;
Subject to any contractual arrangements, privacy or confidentiality considerations, Researchers may retain copies of Research Data, Primary Materials and Research Records. These copies may be disposed of at any time by the Researcher. Permission to dispose of copies and duplicates is not required, However, due care must be taken to ensure that disposal is secure and takes account of the confidentiality and possible sensitivity of the Research Data and Primary Materials;
In the event that results from Research are challenged, all relevant Research Data and Research Materials must be retained until the matter is resolved. Research Records that may be relevant to allegations of research misconduct must not be destroyed.

Further advice

Executive Dean / General Manager
Ethics and Compliance Officer (Tel: 8302 3118)
Compliance Officer (Tel: 8302 3523)
Deans of Research
Academic colleagues/Supervisors/Fellow student Researchers

The University's Records Management team coordinates a range of training and information sessions, and offers a consultancy service to the Academic Unit seeking to establish or review their record-keeping procedures and archival storage.

Definitions

For the purposes of this policy the following definitions are used:

Term	Definition
The Code	The Australian Code for the Responsible Conduct of Research (2007)
Confidential Research Data and Research Records	includes identifying information such as names and addresses, signed consent forms, master lists of names or matching codes for a current study or similar listings which may be held for a period of time for a follow up study; Research Data and Research Material and Primary Material which contains Personal Information and Research Data and Research Records deemed to be commercially sensitive through approved contractual processes.
Confidential Information	includes, but is not limited to, trade secrets, drawings, know-how, techniques, source code and object code, business and marketing plans and projections, arrangements, and agreements with third parties, customer information and customer list, research participant information and research participant lists, concepts not reduced to material form, inventions, designs, plans and models and any other information that is marked confidential or notified to be confidential.
Electronic Research Data and Research Records	means Research Data and Research Records created and maintained by means of electronic equipment and which may also be communicated through electronic means.
Intellectual Property (IP)	includes all copyright and neighbouring rights, all rights in relation to inventions (including patent rights), plant varieties, registered and unregistered trade marks (including service marks), designs, Confidential Information, circuit layouts, and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields
Personal Information	means information or an opinion (including information or an opinion forming part of a Research Database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion (as defined in the Privacy Act 1988).
Primary Material	includes, but is not limited to, ore, biological material, photographs, artwork, questionnaires or recordings acquired through undertaking research from which Research Data are derived.
Research Record	includes the media on or in which Research Data are stored e.g. laboratory notebooks, fieldwork notebooks, graphs, charts. Importantly, Research Records also include other documents or media containing information associated with the research process. Examples of such information are: correspondence (including e-mail), project files, grant applications, ethics applications, signed consent forms, documents describing methodology, instrument calibration Research Records, computer programs, mathematical formulae used for Research Data analysis, details of purchases of equipment and laboratory consumables, formal agreements with third parties, technical reports, student and other internal reports, presentations, and many other possibilities.
Research	means an original investigation undertaken to gain knowledge, understanding and insight (as defined in The Code). For a broader definition see Box A.1 of the Code
Researcher	means any University staff member who in the course of their employment conducts research or if not employed, is affiliated with a research project conducted with the University (and cannot be specified as a student Researcher).
Statement of Authorship and Location of Data form	The register of recording the locations of Research Data and Research. Research Records gathered by the University's Researchers and Student Researchers in the conduct of Research.
Student Researcher	means any honours, postgraduate, undergraduate, student undertaking research and enrolled at the University or if not enrolled, is affiliated with a research project conducted with The University (and cannot be specified as a Researcher).
University-Student project	are research activities undertaken by students in collaboration, or subject to commercial agreements, or result from projects with pre-existing UniSA intellectual property.