Study Initiation and Management: Transfer of Data/Tissues

Introduction

Data
Normally only anonymised or robustly psuedonymised data should be passed on. If identifiable data is to be transferred, it is important to safeguard confidentiality during transfer. Encryption is a good way of doing this. Section 5 of the 1st resource has more information on safeguarding confidentiality.

Where research data are shared with other researchers for new studies, the custodian must ensure that the group accepts a duty of confidence and protects confidentiality.

Where identifiable data is passed on, the custodian must ensure that these are not passed to a country without legal protection for identifiable personal data equivalent to that in the UK, unless the custodian first assures themselves that the data will be adequately protected in practice. Under the terms of the Data Protection Act 1998, there are no special restrictions on transfers of identifiable data within the European Economic Area (EEA).

Outside of the EEA, e.g. for data sent to the USA, or to a developing country, the custodian must either:

• Anonymise the data
• Obtain the individual explicit consent to send their data to another centre
• Remain able to control the use of the data transferred, however, this is not always possible to ensure owing to differing legal frameworks and the need for monitoring.

Guidance on re-use of data is available in MRC Ethics Series Personal Information in Medical Research (2nd resource). It is important to have an agreement with the third party. The MRC guidance includes issues to cover in such an agreement.

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's doctor.

If identifiable data is required to be shared along with the tissue samples, 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 such that the third party/recipient may require assurance that consent for their project is in place in line with Human Tissues legislation (the consent requirements are outlined in the 3rd and 4th resources below) and the sender (original custodian) of the samples has assurances that they will be used within the terms of the consent. The standards that such an agreement should cover are available in the 5th resource below.

Tissue samples - Requirements for export from England, Wales or Northern Ireland
The Human Tissue Authority has issued a code of Practice on Import and Export of human tissue samples, this is available in the 6th resource below. MRC has developed a summary of these requirements (7th resource below).