Research Data and Materials - Procedures

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Research Data and Materials - Procedures

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Approval authority
Deputy Vice-Chancellor (Research and Innovation)
Responsible officer
Deputy Vice-Chancellor (Research and Innovation)
Designated officer
Director, Office of Research
First approved
3 December 2012
Last amended
16 March 2016
Effective start date
16 March 2016
Review date
21 November 2017
Status
Active
Related documents
Information and Records Management - Procedures
Information Management Framework - Governing Policy
Research - Academic Policy
Related legislation / standards
Right to Information Act 2009 (Qld)
Public Records Act 2002 (Qld)
Queensland Information Standards
Australian Code for the Responsible Conduct of Research (2007)

1. Purpose of Procedures

1.1 These procedures set out the responsibilities for the management of Research Data and Materials in compliance with the 2007 Australian Code for the Responsible Conduct of Research and the implementation of the Research – Academic Policy.

1.2 A key aim of these procedures is to ensure that the roles, responsibilities and authorities defined in the Research - Academic Policy are carried out reliably and consistently. The parties to whom these roles, responsibilities and authorities relate are:

1.2.1 Researchers

1.2.2 Executive Deans and Supervisors of research students

2. Data storage

2.1 Data underpinning research conducted at USC (including electronic data) must be recorded in a durable and appropriately referenced form that is retrievable by the Cost Centre Manager or delegate.

2.2 Researchers must maintain a catalogue of all research data in an accessible form.

3. Obligations of researchers

Researchers are required to:

3.1 Ensure research data and materials retained are sufficient to justify research outcomes and to defend the findings if challenged.

3.2 Familiarise themselves with any legislative and regulatory requirements, as well as any conditions which may be imposed by a funding body or the conditions of collaboration.

3.3 Decide what research data and materials must be retained (in some cases this will be determined by the above provisions or a publisher or by convention in the discipline) and prepare a research data and materials management plan prior to and during the conduct of the research, which addresses:

3.3.1 who is responsible for maintaining and updating the research data and materials

3.3.2 where the research data and materials will be stored

3.3.3 in what form they will be stored (identified, coded or de-identified)

3.3.4 if there is a code key, where will this be stored and who will have access to the key

3.3.5 appropriate retention periods (see further at 3.8)

3.3.6 total size of storage including growth projections over time

3.3.7 if research data and materials are to be transported, in what form they will be transported, and what are the security and back-up precautions

3.3.8 who will have access and

3.3.9 if it is possible that third parties (e.g. funding bodies or law enforcement) might seek access to the research data, what the planned response to such attempted access would be.

3.4 Create and maintain full and accurate records of the research methods and data sources used by way of notes or diary entries and laboratory books, and provide the same level of care and protection to such research records as to analysed research data and materials.

3.5 Manage research data and materials and related records according to protocols approved by the human research or animal ethics committees and in accordance with relevant laboratory and legislative requirements.

3.6 Ensure that adequate backup, archival and monitoring strategies are in place to prevent the loss of research data and materials, and to minimise delays in the completion of the research.

3.7 Afford all research data and materials due care and protection. Regardless of the format of the research data and materials, they must be protected from damage and handled with care. Research data and materials must not be removed from the storage provided without authorisation of the Executive Dean during the active phase.

3.8 Determine the retention requirements giving consideration to the potential value of the research for further investigation and recommend to the Executive when research data and materials should 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.


3.9 Researchers are required to complete a Statement of Authorship and Location of Data and Materials Form in accordance with the Authorship Procedures. This form requires the researcher to identify where the research data and materials and other records are stored.

4. Obligations of supervisors of research students

Supervisors of research students are required to:

4.1 Share responsibility for the management of research data and materials in the conduct of the research by the research students they supervise.

4.2 Familiarise themselves with the legislative and regulatory requirements and funding body or collaboration conditions relating to the research data and materials on the research project.

4.3 In consultation with the student and Director, Research Centre or Head of School or Executive Dean as may be necessary prepare a research data and materials management plan before the research commences.

5. Obligations of Executive Deans

Executive Deans are responsible for ensuring that appropriately qualified staff are delegated responsibility for:

5.1 Keeping a register of where research data and materials are stored both during the active and completed phases of the research.

5.2 Ensuring the appropriate retention of research data and materials.

5.3 Ensuring all research data and materials are maintained securely to prevent unauthorised access, destruction, alteration or removal, accidental or intended damage or destruction.

5.4 Authorising access to the research data and materials by other researchers during the active phase of a research project. A mechanism must also be defined for requesting a review by a senior member of Faculty, such as Head of School, Director, Research Centre or Associate Dean Research, of any decision to deny reasonable access. Authorising the transfer of research data and materials to an external institution person or entity.

5.5 Providing facilities to enable the storage of research data and materials in a manner which enables continued accessibility over time by authorised individuals.

5.6 Providing storage space for research data and materials and related records that meets security and confidentiality requirements, particularly in the case of human research.

5.7 Ensuring that University policies and procedures relating to research data and materials are disseminated to all researchers and research students.

5.8 Ensuring physical data is stored in accordance with the USC Records Management - Governing Policy.

5.9 Authorising the destruction of research data and materials and related records on the recommendation of the researcher or research student supervisor.

6. Electronic data

6.1 Wherever possible research data and materials and related records should be stored on the University’s network or other allocated research data storage location. USC Information Technology Services or delegated Faculty staff can set up and grant access to each researcher requiring access to the storage location. 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 particular care must be taken to ensure that portable devices are not lost and they must be backed up on the server frequently (daily if possible but at least every 48-72 hours). Files within the folder should be clearly named so that Researchers/Supervisors and appropriate delegated officers can find relevant documents, spreadsheets, analysis and other data.

6.2 Password protection must be used when research data are confidential and restricted to the research team.

6.3 Electronic research data should be stored in at least two locations to mitigate complete loss of one copy. This is not required where data is stored on the university’s allocated research data storage location.

6.4 Electronic research data should be stored with appropriate metadata describing how, when and where it was generated, instrument settings, and software used.

6.5 Researchers with large datasets should consult with Information Technology Services 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, with 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.

7. Limited access databases

7.1 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 records for the project.

8. Human research data

8.1 Human research data should be stored in accordance with the human research ethics application approval requirements (e.g. whether it is non-identifiable, re-identifiable, individually identifiable) and in accordance with the informed consent given by participants (e.g. about access to the data, how the data is published, and whether the data can be used in related or future research projects).

8.2 Protocols relating to access to research data that is individually identifiable or re-identifiable should be clear to participants, all members of the research team and all other people involved in the collecting, handling, storing or analysis of the data.

8.3 Unless there are methodological (e.g. longitudinal studies, projects in which participants wish to be identified) or ethical (e.g. clinical trials) reasons not to do so, researchers should act to make data less identifiable at the point of collection, storage, analysis and publication. This includes replacing individual identifiers with codes and permanently removing identifiers, as well as considering how context clues in published material may allow the possibility of inferring identity.

8.4 Unless specified otherwise in the approved ethics application, data (e.g. interview transcripts, paper based questionnaires, hand signed consent forms etc) must be retained and stored in a secure location (e.g. locked filing cabinets, password protected computers), using secure procedures (e.g. storing codes for re-identifiable data separate from the data itself) and disposed of securely.

8.5 The right of a member of the University staff to access certain information for operational or academic purposes does not necessarily result in there being a right to access this same information for research purposes.

8.6 Where the research methodology involves human research data being handled by third parties before the data goes to the researchers, specific protocols need to be put into place to ensure confidentiality and security of all data.

8.7 The National Statement on Ethical Conduct in Human Research should be consulted in specific cases for advice. This is particularly relevant where human research data is stored in databanks or where the data consists of genetic information.

8.8 Refer to the portal for the USC Human Research Ethics Guidelines information sheet on human research data management for more detailed information.

9. Confidentiality

9.1 It is the responsibility of all USC staff and students to ascertain and comply with any ethics or contractual confidentiality conditions relating to the research data and materials and related records.

10. Access

10.1 Research data and materials giving rise to publications must be available for discussion with other researchers subject to any confidentiality, contractual, privacy or patent protection requirements.

10.2 Requests by another researcher to access the research data and materials should be directed during the active phase of the research to the lead researcher who may refer the request to his/her supervisor and the Head of School, Director, Research Centre or Executive Dean. Transition management plans for provision of research data to and return from other researchers should be considered.

10.3 On completion or abandonment of any research project all requests shall be directed to the Head of School or Director, Research Centre.

10.4 In considering authorising access or transfer of research data and materials and related records, the Head of School or Director, Research Centre shall:

10.4.1 consult with the researcher and his/her supervisor

10.4.2 consider the ethical, privacy, contractual, confidentiality and patent protection issues

10.4.3 consider the potential value of the research data and materials and related records for further research particularly where the research would be difficult or impossible to repeat

10.4.4 ensure the independence of the research project and

10.4.5 optimise areas of synergy with other USC research projects or research collaborators.

10.5 Access authorisations may be reviewed by the Deputy Vice-Chancellor (Research and Innovation) on the written request of any researcher.

10.6 Researchers given access to confidential research data and materials must maintain that confidentiality.

11. Right to information

11.1 Researchers should be aware that under the Right to Information Act 2009 (Qld), under defined circumstances, the University is required to allow persons access to documents which are its possession. Further information may be sought from the Director, Information Services.

12. Research collaborations with other institutions

12.1 Where projects operate across other institutions a written agreement must be developed prior to the beginning of the project covering ownership of research data and materials.

13. Retention at USC

13.1 The University shall be responsible for storage of the research data and materials and related records as stipulated in the Queensland State Archives University Sector Retention and Disposal Schedule and any additional legislative or contractual requirements.

13.2 In the event that results from research are challenged, all associated research data and materials and related records must be retained until the matter is resolved.

13.3 Research data and materials and related records that may be subject to allegations of research misconduct must not be destroyed.

13.4 The minimum retention requirements under the Australian Code for the Responsible Conduct of Research are:

Type of Primary Material / Research Data / Related Records Minimum retention time
Short-term research projects for assessment purposes only (for example undergraduate or postgraduate coursework projects) 12 months
General research, including that undertaken by higher degree by research students 5 years after completion or 5 years after publication whichever is the latest.
Clinical trials (research involving humans) 15 years after publication
Gene therapy (eg. patient data/records) Permanent
Significant heritage value data Permanent (preferably within a national collection)

14. Retention of duplicate copy by researchers

14.1 Researchers who leave the University may negotiate with their Head of School, Research Centre Director or Executive Dean to take copies of research data and materials and related records for research projects which they have conducted during their time at USC for their own use.

14.2 Subject to any contractual arrangements, privacy or confidentiality considerations, researchers may retain copies of research data and materials and related records. These duplicate 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 materials and related records.

14.3 As a general rule all original research data and materials and related records will remain at USC.

15. Research data or primary material transfer

15.1 Before transferring any research data or materials to or from USC, a Material Transfer Agreement or a collaboration agreement defining the rights and obligations of both parties in respect of the research data or materials must be entered into between USC and the entity providing or receiving the material. This applies to material being transferred domestically or internationally.

15.2 Prior to importing or exporting any material researchers must familiarise themselves with and ensure compliance with all Customs, Australian Quarantine Inspection Service rules, regulations or laws.

15.3 If a researcher transfers from USC to another institution or from another institution to USC, a written agreement must be entered into between both institutions and the researcher in respect of ownership, custodianship, transfer of responsibilities and any desirable ongoing access to the research data and materials by USC.

16. Changes to storage location within USC

16.1 Where the location of research data and materials and related records is changed within the University the Location of Data and Materials Form must be updated by the person responsible to reflect the new location.

17. Destruction and disposal of research data and materials

17.1 Destruction of research data and materials must be in accordance with the requirements of the Australian Code for the Responsible Conduct of Research and subject to the relevant legislative requirements. Such destruction can only be approved following conclusion of the minimum retention period.

17.2 When making the decision to dispose of the research data and materials 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. Research data and materials and related records that may be relevant to allegations of research misconduct must not be destroyed.

17.3 Researchers must obtain written approval from their Head of School or Director, Research Centre for the proposed disposal or destruction of research data and materials or related records.

17.4 Research data and materials and related records will not be disposed of from any central storage repository without the written consent or knowledge of the relevant researcher and Head of School or Director, Research Centre.

17.5 In the event that results from research are challenged, all relevant research data and materials and related records must be retained until the matter is resolved.

17.6 Destruction of research data and materials and related records without requisite approval may also constitute research misconduct.

18. Further advice

18.1 Further advice about these procedures may be obtained from the Executive Deans, Associate Deans (Research), Heads of School or the Director, Office of Research.

18.2 The University's Records Management team coordinates a range of training and information sessions and can assist a School seeking to establish or review their recordkeeping and archival storage procedures.

FORMS

Location of Data and Materials Form (Word doc)

END

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