Route Maps

The Route Maps are designed to guide you through the legal and good practice requirements surrounding the use of personal information or tissue samples when setting up, running or closing a research project. Before using the Route Maps, take time to think about your project and its setting. Consider the following:

  • The research question and design of your study. In particular, consider if you will be using information or tissue samples, or both in your project; whether you will be contacting participants directly or using existing sources of data and/or tissues and contact is not required; whether you will need access to anonymised or identifiable data and/or tissues.

  • Where you are in the project. There are 4 main Route Maps and 2 sub maps covering different stages in the project. The key stages are identified as "stations." Click on a station and you will find helpful information and, where relevant, one or more "resources". Resources provide advice and links to other sites. Each station and each resource is categorised (see below).

  • The expertise of your research team and organisation. Some resources on this site are addressed to the needs of Researchers, others will be of particular interest to Research Managers.

You can access the Route Maps in either Map view or List view and you can download your chosen map in PDF format (you will need to do this if you wish to print the maps). You can select the List view at any stage; and you can download each map from the relevant Route map or Sub map page. You will need Acrobat Reader to read PDF documents (Acrobat Reader can be downloaded below).

  • Planning & Funding

    This Route Map takes you through the planning process from the initial research question to finalising documentation for approvals submission. It gives access to sub maps on Consent arrangements and Confidentiality arrangements.

  • Seeking Approvals

    This Route Map takes you through the permissions and approvals process, outlining which approvals are needed for which studies; and when Licences are required.

  • Study Initiation & Management

    This route map looks at recruitment of participants and the conduct of the study.

  • Study Closure & Archiving

    This Route Map looks at the end of the study or analysis point, including requirements for archiving and sample disposal.

Using the maps

You have 4 main Route Maps, which are described above.

  • Move along each map from left to right. That is the direction in which the processes flow.
  • Some processes can be done in parallel.
  • Not all stations will be relevant, it depends on the project. All information is provided so that you can exclude stations on an informed basis.
  • Click on a station and you will be taken to an introductory section on the topic, and a list of relevant resources (not all stations have resources). Some stations (Consent arrangements and Confidentiality arrangements) have a sub map.
  • To print the maps you will first need to download the PDF, this can be done from each Route map or Sub map page.

Station and resource categories

  • Each station and each resource is colour coded, to distinguish between legal requirements (red); good practice (blue); and standard processes (black). In some situations, good practice can be considered mandatory (e.g. by the NHS) although it does not have statutory force.
  • It is also indicated whether the resources are applicable to data; tissues; all research; or specific research projects.

Download route maps for printing.

You will need Acrobat Reader to read PDF documents.

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