Facilitating access to pathology archives as a research resource

It is best practice to have consent for research in place and for the terms of the consent to cover any proposed activity. Ideally this can be done by routinely asking for generic consent for research for all samples collected, processed, analysed and held in Pathology departments (in addition to the consent taken for diagnostic testing). Patients will then be made aware that research may be undertaken using their samples, and understand what this might mean for them. This provides the opportunity for patients to donate samples to ongoing future research or not, as they wish.

It is acknowledged that most routinely collected pathology samples held to date will not have consent for research in place, and that changing practice to ensure that this is taken as part of standard practice may take time. If consent for research is not in place this does not necessarily mean archival material cannot be made available for research. The law does provide specific exemptions to the need for consent (see Using diagnostic archives without consent).

Samples released from the archive should be anonymised (e.g. robustly coded) to protect the confidentiality of donors whenever there is a risk of disclosure (i.e. whenever confidential identifiable information may leave the established care team without consent). Robust coding of samples ensures that although the identity of the donor is kept confidential, samples can still be traced back to donors by the Pathology department (see Anonymisation and Coding).

The release of entire tissue blocks may not be appropriate if patients are still undergoing treatment etc; however, researchers may still be given access to sections cut from diagnostic blocks.

External researchers should discuss their tissue requirements with Pathology departments/ tissue managers early in the planning process to ensure that an appropriate collaboration can be established (see Are you planning to use new or existing sources of Data/Tissues?)

All samples released to external parties should be transferred under an appropriate agreement which defines what the samples can be used for and what the recipient is expected to do with any excess samples once their research has ended, etc (see Transfer of Data/Tissues and Access to Data/Tissues).