- Communication of expectations
All Baker Institute researchers have a responsibility to themselves and their colleagues to ensure the veracity of the data they obtain in research. This includes the collection, analysis and interpretation of these data. Principal investigators who lead research teams must also take responsibility for those data and assume responsibility for close and regular supervision of their teams and their adherence to the principles of responsible authorship.
- Organisational support
We have increased investment in our research support function and have recruited an experienced scientist and research administrator to head a new Research Strategy and Operations office. The new office encompasses the responsibilities of what was previously known as the ‘Research Office’ as well as research supervisory activities (including clinical research support, research management and research governance). The Head of the Research Strategy and Operations office reports directly to the Director of the Baker Heart and Diabetes Institute.
- Registry of Baker Institute studies
The existing central registry of human research studies is being further developed using a new data management system. All studies have a study number, and checks relating to training, mentorship, start-up and closure lists (see below) will be possible. This will build on our existing research database and we plan to develop and implement this in 2016.
- Clinical trials
In keeping with the requirements of the Alfred Human Research Ethics Committee, clinical trials and studies now require the active involvement and close supervision by clinicians and health professionals. In addition, it is now a requirement that trial participant bookings involve more than one person (e.g. a booking system at the Baker Institute, or if relevant, another facility). The Data and Safety Monitoring Board (DSMB) processes that are part of clinical trials have been strengthened and extended to non-pharma trials. This will provide a timetable of reporting and review.
- Research training
All new laboratory and clinical staff will continue to receive induction information including all of the Codes of Research Practice. Laboratory heads are responsible for disseminating these codes of conduct to their teams. Good Clinical Practice training is required for the principal investigators, study coordinators, other staff and students for all studies.
- Mentor system
Every study — clinical and laboratory — now requires a designated mentor, external to the group, who act on behalf of the Institute. This person (who could be part of the DSMB) will be a source of independent oversight and should be provided with progress reports (usually quarterly, but this may vary by study). The mentor should be able to review source documentation on request and a record of these reviews will need to be filed in the research database.
The objective of the mentor system is to provide an additional level of oversight for early identification of potential problems. Mentors will be sourced from the new Research Strategy and Operations Office for Randomised Control Trials, and from a separate lab group for other studies (organised at Domain level).
- Start-up checklist
At the commencement of each new human research study, investigators need to sight and sign a checklist of investigator responsibilities, acknowledging their obligations. This includes a data plan for both data storage and analysis. Specific data management plans are now included for clinical data (e.g. Access or Redcap database). A single investigator should never be responsible for all aspects of the study.
- Internal audit program
We are implementing an internal system of regular spot checks of source data as well as monitoring of recruitment rates and case report forms. This will be facilitated by the implementation of electronic lab books and an equivalent process for clinical trials. It will be overseen by the Research Strategy and Operations Office.
As per the Institute’s Research data and primary materials management policy, clinical trial data must be retained for 15 years, observational and laboratory studies for five years. We have increased efforts to ensure that records are backed up and stored securely, and electronically in a central location.
- Completion checklist
A Completion Checklist must be filed when a paper is submitted for publication by a Baker Institute investigator. This will enumerate the aspects of the study that have been cross-checked and by whom. In addition, the research database will be logged with the Research Strategy and Operations office at the time of paper submission.