Pharmacy - Case Study
Monash University makes significant investment in research and is committed to research excellence. Fundamental to high quality research is best practice in data management. Managing research data throughout their life cycle provides benefits to researchers, the institution and wider-community, and covers all aspects of handling, organising, documenting and enhancing research data, and enabling preservation, discovery, access and sharing. In support of research excellence and as a response to the Australian Code for Responsible Conduct of Research (2007), research data management initiatives have come into focus at Monash, which is now seen as a lead organisation in this area.
In 2008, the Research Data Management Advisory Group (RDMAG) was established with representatives from all ten faculties. Discussions at Faculty level initiated by RDMAG representatives identified a number of issues around research data management including the role of Faculty Research Committees, storage and backup, data security, the role of repositories, and data management planning. The impetus for a whole of Faculty research data management project sprang from these discussions. Initiation of the project was led by Professor Chris Porter, Associate Dean (Research) in the Faculty of Pharmacy and Pharmaceutical Sciences.
In 2009, during an iterative drafting, consultation and review process involving the Research Data Management policy framework, the Research Data Management - Pharmacy and Pharmaceutical Sciences pilot (policy implementation) project began. The rationale behind Pharmacy as the likely candidate for the pilot project included its small single-campus/faculty structure, a culture of discoverable records for drug development, recognised early adopters of technological and behavioural change solutions, and the active leadership role taken by the Associate Dean of Research (ADR).
The pilot project's focus was on achievable steps and straightforward solutions. First steps involved establishing a governance structure:
- In August 2009, the Parkville Campus Research Data Management (PRDM) committee was formed.
- The Committee's brief was to consider data storage, LaRDS access, introduction of research data management concepts around secure storage (including the induction of Graduate Research and Honours students), and the implementation of University policy and procedures for research data management at Faculty level.
- PRDM committee representatives include the ADR (chair), researchers, Faculty of IT, research managers; and Library and MeRC representation to assist in the removal of barriers, provide advice and share information.
- PRDM meet four times a year.
- Faculty representation on the Research Data Management Advisory Group (RDMAG).
The governance group mapped local practices identifying good practice and areas for improvement (ranked and prioritised for actioning). The overall aim of the PRDM committee was to create awareness of the University's data management strategy and improve research data management based on best practice.
A review of the Faculty's current research data management practices identified processes already in place including: the Research Office's cover sheet already captured some important information and included a sign off stage; electronic research lab notebooks were used by one research theme with the introduction in 2011 of a standard hard copy research lab notebook (with aims to convert to electronic in the future) for use by all HDRs as part of documentation protocols; degrees of data retention documentation were already undertaken at the administration level for grants/agreements paperwork; and, contracts/agreements paperwork were already being duplicated and stored in the Solicitor's office/University Research Office.
Aims and outcomes
The PRDM committee identified the components of Research Data Management to address, and formulated aims and actions based on each:
1. Awareness raising
- Overarching - to create awareness of the University's data management strategy
- Faculty level -
- All chief investigators/supervisors to have an increased awareness and take responsibility for their data management strategy prior to projects commencing.
- Faculty to embed research data management awareness into existing processes, e.g. staff performance reviews, staff induction, Graduate Research/Honours induction programs, Graduate Research/Honours supervisor training programs.
- Enable quick IT/storage access processes for research data.
- Prepare the University's research data management policy/procedures to reflect faculty specificity and place them on the Pharmacy Faculty Intranet.
- Design a data planning 'checklist' which covers all research data management matters specific to the policy/procedures at Pharmacy.
- Formalise a research staff induction for new staff, with a research data management component.
- Formalise Graduate Research/Honours supervisor training programs with an emphasis on research data management.
- Create an R drive (research folder) for the Faculty's research data usage.
- Provide all researchers with a copy of the 'Managing your research data' brochure available from the Library.
- Ensure the Faculty intranet includes a link to information about research data management.
2. Research data planning
- Data planning is promoted for every research project.
- Chief investigators adopt thorough and compliant research data management practices (responsibility of the Faculty Research Manager).
- Embed the submission of a customised data planning checklist (adapted from the Library developed research data management check list for Graduate Research students) in the process at the grants submission stage. A copy of the checklist is stored in Faculty Research office files.
- Focus on improved data planning by creating an administrative support folder on the R drive (for grant / award letter / checklist).
- Review the University data planning checklist template for the following specifics:
- Copyright and IP matters
- Ethics requirements
- Funding source
- Funding category
- Size of data
- Time line for storage and destruction of records
- Describe how the data will be archived
- How will the data be disposed of at the end of the retention period?
- How will the data be accessed and what security access issues are relevant?
- Faculty Research Manager to ensure an audit of the 'closing off of projects' occurs with respect to the data management process in combination with a review of the checklist.
3. Retention of research data and primary materials
Adopt a standard Faculty policy around retention periods and the use of hard copy lab notebooks.
- Use research lab notebooks (electronic and hard copy) in the documentation process.
- Educate Faculty researchers about the University's retention and disposal guidelines.
- Identify a faculty expert on research data retention and disposal.
- Create clear guidelines for Pharmacy and Pharmaceutical Sciences specific to research data.
- Faculty audit review processes to ensure the data life-cycle happens.
- Embed responsibility for audit reviews in the Faculty Research Manager's position description.
- Information about mandatory retention periods is added to the Faculty intranet.
4. Ownership, copyright and intellectual property
Educate research staff about who owns their data and how copyright and IP (with respect to data storage) is considered for current and future data usage.
- The checklist /training and induction sessions have basic questions drawing the CI's attention to matters such as -
- How ownership and storage will be handled if a researcher leaves Monash
- Acknowledgement of copyright issues
- Check NHMRC guidelines regarding collaboration paperwork.
- Ensure compliance to existing Copyright and other IP regulations and guidelines.
- Ownership of research data is identified and documented at the start of a research project, where current and future data usage needs are considered.
- Faculty-produced agreements are reviewed to ensure data ownership is covered.
- Grantees are aware of any data management protocols included in their agreements.
- Seminars/induction sessions highlighting IP issues are promoted and conducted as required.
- The Solicitor's Office to insert a clause into the standard/specific University research contract. For example, "a research data management plan is stored with the project and the chief investigator has full responsibility for this document and its implementation."
- Promote Supervisor Masterclass 4 on Copyright and Intellectual Property to staff.
5. Ethical requirements
Most ethical requirements relating to data management are covered through existing ethics procedures, particularly at Research Office cover sheet stage.
Ensure consideration of privacy, confidentiality and cultural sensitivities in relation to de-identification of data as per the Code, data security and access control, storage (short and long-term), and disposal.
- As mentioned in section 2: establish an 'admin research' folder adjacent to the research data folder on the R drive for storage of ethics / controversial / 'never to be released' data.
- The checklist, training and induction process should cover privacy issues, particularly with respect to where and how the data is stored, for example accessibility. Can the system be established to 'block' and 'unblock' people as necessary, based around consent and accessibility to the data in the future?
6. Storage, record-keeping and backup
To use LaRDS as the storage site for all research data, and to have an effectively functioning R drive to capture data and send it to LaRDS.
- Faculty storage allocations to research staff and students reviewed
- Faculty R drive captures data ('staging posts'), with overnight transfer to LaRDS
- LaRDS as the storage site for all research data, including an evident link from the Faculty intranet to LaRDS.
- Faculty R drive is structured around strict guidelines/protocols: use, storage, filing, and nomenclature.
- The use of a shared space on the R drive is mandated for all Honours research projects.
- The use of hard-copy research lab notebooks as part of documentation processes/protocols (electronic in the future).
- Ensure the checklist has clear start/end dates for confidential data; labelled to reflect confidentiality.
7. Exit planning
Embed within University contracts and agreements, 'memorandum of understanding' clauses relating to exit planning. This must blend with the checklist and be auditable and retrievable.
- Checklist has clear start and end dates, with consideration to what is occurring to the data in between these times.
- Retention and disposal information is kept near or linked to the data in an adjacent administration folder on the R drive.
8. Review and destruction
Adopt a standard Faculty practice around review and destruction.
- Roles and responsibilities identified - Chief Investigator has full responsibility for review and destruction of data (with support from Faculty Research Manager).
- Training is provided for secure destruction of data records.
- Faculty Research Manager is responsible for audit processes.
- Check list includes and addresses review and destruction as a separate item.
Outcomes so far
The policy implementation pilot has resulted in small but significant steps, not the least, faculty-led training and cultural change manifested in a drive for continued improvement in research data management practice. Other outcomes include:
- Formation of a faculty-level Research Data Management committee, including two sub-groups to address:
- Digital storage
- Protocols for file structures and naming.
- Procedures mapped to local practices identifying current good practices, areas for improvement, and priorities.
- Faculty-led training:
- Induction training of early career researchers
- Research Data Management component included in the research staff induction process
- Emphasis on Research Data Management in HDR/Honours supervisor training.
- Adapted Research Data Management policy and procedures specific to the Faculty.
- Central storage for research data, with the provision of 'staging posts' and overnight transfer to LaRDS.
- Mandated network storage for Honours students.
- A shared network drive (R) with articulated file structures and naming protocols for funded projects:
- 'Admin support' folder for grant/award letter/checklist
- 'Admin research' folder for storage of ethics data.
- Hardcopy research lab notebook protocols (electronic in future).
The value of these preliminary steps should not be underestimated. Many Honours students become PhD students, who then become early career researchers and ultimately PhD supervisors. Small changes over time have big impacts.
Disseminating the message university-wide
Traditional change management strategies are not supplanted by the approach taken at Pharmacy, but rather complement them with both top down and bottom up strategies running concurrently. The Research Data Management Communications Plan identifies the University's senior management as critical stakeholders in the policy implementation strategy, requiring dissemination of the message at this level, but not in isolation. Because Monash has multiple campuses in different countries, a diversity of cultures and methodologies, and researchers who often identify with their global disciplinary communities more than with the institution, partnering with researchers at a faculty and/or unit level helps mitigate some of the complexities, creates an environment for mutual exchange and understanding and builds up a portfolio of real-life examples of the benefits of research data management.
The lessons learned from the Pharmacy case (RDM policy implementation pilot project) are predominantly to celebrate achievements and value all improvements no matter how simple or small. Cultural and behavioural change through policy always takes time, but clarity of purpose through policy implementation provides incentives for good processes, behaviours and attitudes. Researchers want to improve practice and 'know' there are benefits.
Concurrent and continuing activity
In 2010, the Research Data Management Policy and Procedures for Staff, Adjuncts and Visitors was endorsed by the Academic Board, followed in 2011 by the Graduate School Committee's endorsement of the Research Data Management Procedures for Higher Degree by Research Candidates. From policy development to implementation, the Monash University Library in collaboration with the eResearch Centre (MeRC), eSolutions and the Faculty of IT are working towards the development of improved research data management practices across Monash University.
As part of a program of initiatives, the Research Data Management policy framework will be promulgated university-wide to address high-level and operational aspects of research data management at Monash University. The implementation process necessarily considers research data management issues and highlights the benefits of good research data management practice to researchers, faculties and units, and the institution.
Further developments in research data management at Monash have seen the recent release of the Research Data Management Strategy and Strategic Plan 2012-2015 [pdf 196kB], which outlines Monash's aims for research data management, and is grouped around the five themes: Excellence and Impact, World Class Infrastructure, Skills and Knowledge, Integrity and Professionalism, and Leadership and Collaboration.
Use case analysis
Think over the approach taken by the Pharmacy and Pharmaceutical Sciences Faculty to research data management issues and policy implementation. Compare the commonalities and differences to experiences of data management practice within your own Faculty/Unit.
Identify what is already happening relative to research data management in your Faculty.
What research data management issues stand out as requiring significant attention?
What strategies from this use case would work in your Faculty?
What other strategies could be included?
Suited to your own Faculty, what approach for implementing the Research Data Management policy framework would you suggest taking?