Research governance and ethics

Research governance and ethics - All research conducted with MISCH must have gained ethical approval from a certified Human Research Ethics Committee (HREC) before it can commence. Information on the University of Melbourne's HREC can be found at this link.

MISCH recommends adopting these tools in order to optimise the establishment of your research and sustaining Quality by design.

There are a number of internationally recognised resources developed to support research. MISCH recommends adopting these tools in order to optimise the establishment of your research and sustaining Quality by design. These include

  • Equator Network
    • Equator Network: The Equator Website  provides a database of reporting guidelines in order to increase the value of health research and minimise avoidable waste of financial and human investments in health research projects.
  • Research methodologies / protocol development
    • Online checklist to support completion and submission with your manuscript can be found here.
    • SPIRIT 2013 (Protocol template): SPIRIT stands for "standard protocol items; recommendations for interventional trials". SPIRIT is an international collaboration with the objective to improve the quality of clinical trial protocols through defining an evidence-based set of objectives that need to be addressed. These objectives include scientific, ethical and administrative elements that should be included in clinical trial protocols. The intention of SPIRIT 2013 is to promote transparency and a full description what is to occur as part of a particular trial. SPIRIT 2013 is not specific to clinical trials of drugs and devices and can be applied to all studies within its definition. SPIRIT is ICH-GCP consistent and supports international registration of clinical trials.
    • Consort Statement (Research reporting): The CONSORT Statement is an evidence-based, minimum set of recommendations for reporting randomised trials using a 25-item checklist.  It has been developed with a focus on randomised clinical research but is also useful for clinical trial reporting.
    • Consort Extension Randomised Pilot and Feasibility Trials: The CONSORT extension  for randomized pilot and feasibility trials is meant to provide reporting guidance for any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). There are some key differences in pilot and feasibility studies from standard randomized trials, particularly in the type of information that needs to be reported and in the interpretation of standard CONSORT reporting items
    • STROBE Statement (Research Methods): The STROBE statement is an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies, with the common aim of STrengthening the Reporting of OBservational studies in Epidemiology. STROBE publishes checklists for a number of observational methods:  Cohort, case-control, and cross-sectional studies (combined),Cohort studies,Case-control studies,Cross-sectional studies. Although applied to  observational research, the STROBE statement is set in a health research context and uses the language most commonly associated with qualitative research.
    • Standards of reporting results in Qualitative Research: There has been no single or well-accepted international standard for reporting of qualitative results therefore, the 32-item consolidated criteria for reporting qualitative research (COREQ) was developed through the consolidation of 76 items identified in partial checklists from literature reviews. The COREQ focuses on interviews and is largely referenced by health and medical literature. It sets standards across 3 domains: 1. research team and reflexivity, 2. study design, and 3. analysis of findings
  • Systematic Reviews
    • Systematic reviews are needed to research your projects.
    • The University of Melbourne Library offer an Expert Search Service for academic and honorary staff and research students.

    The service provides assistance with the undertaking of systematic reviews, both at the planning and implementation phases. Library staff can develop effective search strategies, recommend appropriate sources and test run and refine strategies.  A charge-back service is also available where library professionals can run searches, collect and de-duplicate records and retrieve articles using University of Melbourne subscriptions and open access resources. Advice can be provided for retrieval of other sources. Up to three hours of advice are supplied free of charge and ongoing support is charged at $60/hr.  A completed systematic review search including retrieval of up to 100 items can usually be performed for $1000-1500.   The library also provides Covidence workspaces for systematic review teams aligned to the University of Melbourne. To find out more or request this service contact Faculty Librarian (MDHS &FVAS) Patrick Condron (Tel : 03 8344 7842 ) or submit a request.

  • Health Economics
    • The Consolidated Health Economic Evaluation Reporting Standard (CHEERS) statement, found on the Equator network site provides key items to think about for a project including health economics.
  • Biostatistics
    • Common misconceptions about data analysis and statistics: Ideally, any experienced investigator with the right tools should be able to reproduce a finding published in a peer reviewed biomedical science journal. In fact, however, the reproducibility of a large percentage of published findings has been questioned. This article provides insights into the pitfalls of reproducibility.
  • NHMRC and ethics
    • NHMRC Health and Research Ethics:  NHMRC issues advice and guidelines on ethics and related issues in the fields of health, human research and animal research.
  • Health Informatics
  • Clinical trials