Planning & Funding: Tracking systems

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Introduction

Establishing systems to facilitate the tracing of research participants, or the tracking of samples is needed in many research projects and systems will vary according to the project. The need for, and likely implications of tracking, should be considered in the planning phase of the project so that appropriate costings can be included in any funding submission.

Tracing participants for follow up, or further consent
If conducting a longitudinal study, and further rounds of data or sample collection are planned, it is obviously a necessity that participants are traceable, as considerable loss may compromise the validity of the study. As the study evolves, it may be that additional information comes to light and consent will be needed for new uses of the data or samples already collected.

Similarly, if planning to use an existing collection of data or tissue samples, participant tracing may be required to seek further consent for use in the proposed project, in particular if identifiable information is involved. The necessary time and funding requirements to ensure an adequate tracing and recruitment process needs to be considered in planning new projects. 

It is always best practice to obtain consent whenever this is practicable. However there are legal exemptions to the need for consent, which are outlined in Should consent be sought?

For mechanisms to trace participants, please visit Central NHS and Government Data.

Storage and use of tissue samples
It is good practice, and a requirement of a Human Tissue Authority licence, that:

  • evidence for consent and ethics approval for the use of tissue samples in a research project is producible on request, i.e. there is a sufficient audit trail to be able to demonstrate that consent and research ethics approval was obtained; and
  • all tissue samples donated by an individual for research can be traced, and their storage location, use, transfer or disposal status is known.

This is best managed through standardisation of systems within an organisation that manages collections of tissue samples, including the use of a database to record when samples enter an organisation, their storage location, use, transfer or disposal status. See Collection and Storage of Tissues for further information.