Study Initiation and Management: Transfer of Data/Tissues

Back to Study Initiation and Management

Station navigation

Introduction

Data
Normally only anonymised or robustly psuedonymised/linked anonymised data should be passed on. Robust coding is a good way of doing this. If identifiable data is to be transferred, it is important to safeguard confidentiality during transfer and on receipt (e.g. via encryption). Where identifiable data is required from the NHS, for data linking purposes for example, confidentiality should be maintained through the use of Safe Havens.

Where research data are shared with other researchers for new studies, the custodian must ensure that the transfer is carried out with respect for the duty of confidence (i.e. within the terms of consent) and the new group continues to protect confidentiality. A data transfer agreement should be drawn up between the two parties. It may be that the data is shared from a specifically ethically approved Research Database in which case the terms of access to the database must be met.

Where identifiable data will be passed on, the custodian shall not transfer this to a country unless it offers legal protection for identifiable personal data equivalent to that in the UK i.e. within the European Economic Area (EEA). If the custodian does want to transfer identifiable data outside of the EEA e.g. to the USA, or to a developing country, they must first assure themselves that the data will be adequately protected in practice by either:

  • Anonymising the data
  • Obtaining explicit consent from participants to send their data to another country
  • Remaining in control of the use of the data transferred. It is worth noting that this can be difficult to ensure in practice owing to differing legal frameworks and the need for monitoring.

Guidance on re-use of data is available in the Summary of relevant law and Data sharing and publishing sections of the 1st resource below.

Transfer of tissue samples – general principles
In most cases identifiable samples will not need to be shared with third parties, and only anonymised or coded samples sent. Where research results are to be linked to individuals, e.g. for follow-up with clinical outcome or for research diagnostic purposes, this should be done through the custodian of the samples or the individual participant's doctor.

If identifiable data will be shared along with the tissue samples, the samples should be coded for transfer, and any identifiable data required sent separately in line with the requirements outlined above for data.

It is important to have an agreement with the recipient of the tissue samples. This is a two-way process i.e. the third party/recipient may require assurance that consent for their project is in place (in line with Human Tissue legislation outlined in the 2nd and 3rd resources below) and the sender/original custodian of the samples require assurance that the samples will be used within the terms of the consent. The standards that such an agreement should cover are available in the 4th resource below.

Tissue samples - Requirements for export from England, Wales or Northern Ireland
The HTA provide guidance on the import and export of human tissue in their Research code of practice (see 5th resource below). The MRC has developed a summary of these requirements (6th resource).

Resources