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Last updated: May 15, 2018

Project design and preparation

Key considerations:
  • Researchers must develop an ethically defensible plan (EDP) where the study generates information, which may affect the participants, their family or community. The EDP needs to be implemented practically and must take into the study’s context into account.
  • Different types of studies have a range of risks that demand different levels of attention according to the implications of the research on participants and their relatives.
  • Clinical genomics research is collaborative and requires a multidisciplinary team, including technicians, data scientists and clinical genomics experts.
  • A range of technologies, platforms and methods are available; the biological question, budget, time constraints, availability of staff/expertise, etc. will have an impact on the project design.
  • The value of clinical genomics research increasingly relies on the depth, quality and accessibility of the clinical data available to the study.
  • A data management plan outlines how data will be securely transferred, analysed, managed, stored, accessed, shared (including public data repositories) and/or destroyed and should be in place before the study starts. 

Project design and preparation are key to the success of a clinical genomics study as it can prevent a raft of issues, such as budget blowouts, generation of unusable data, time delays and misconduct. Before embarking on a research project it is recommended to develop a statistically valid experimental design and a data management plan. An ethically defensible plan (EDP) must be created when a study generates information that may affect the participants, their family or community.

This section addresses: