Study Initiation and Management: Access to Data/Tissues

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Introduction

The collaborative nature of much research means that other research teams, not directly involved in a project, may ask for access to its data and/or tissues for their own research.

MRC policy is to promote the sharing of useful collections of data and/or tissues with researchers undertaking high quality research, provided that confidentiality is maintained or appropriate consent is in place, and that such use is not against the interests of the donor. Guidance is available in the 1st, 2nd (data) and 3rd (tissues) resources below.

How to manage such requests for access may depend on the following:

Anonymised data or tissue samples
The terms of the original consent and ethical approval are important. Participant Information Sheets and the NHS REC application should state that tissues and/or data may be shared with collaborators or third parties and that these may be in the UK or abroad, whenever it is anticipated that this might occur. Explicit consent for storage and future uses should also be in place, where this is anticipated.

It is not a legal requirement to have explicit consent for research use of anonymous information, or anonymised tissues from the living (as long as NHS REC project specific approval is in place for the tissues). However, throughout the UK, it is a legal requirement to have consent/authorisation for the research use of anonymised tissues from the deceased (for samples that were collected from the deceased on or after 1 September 2006).

If collaborators will have access to data and/or tissues in one specific ethically approved project, these collaborators should be named on the NHS REC application. If collaborators were not included in the original application, a simple notification to the main REC who originally approved the project should be made.

It is possible, via IRAS, to apply for generic Research Database ethical approval for establishing a data resource that you wish to share with others. Ethical approval of this kind allows researchers to make applications to the database management committee for use of the data held, without the need to apply for further ethical approval as long as the data provided is anonymised (see Section 11, in 4th resource).

For custodians of tissues and associated data already collected and held in a Research Tissue Bank or Pathology archives, the management of requests for access is fundamental to the running of the bank. For such banks, a formal application process with committee review may be required. The National Cancer Research Institute has created a Template for Access Policy development to facilitate sharing of samples and associated data (5th resource below).

More information on the management of collections of human tissues is available in section 5 of the 3rd resource below.

Please visit Transfer of Data/Tissues to find out more about import and export, and transfer agreements/standards.

Identifiable data
Wherever possible, data that is shared should be anonymised. If third party access to identifiable data is essential for the proposed research, then consent should be in place. It is reasonable to expect that existing datasets can be shared with other researchers as long as this is consistent with the terms of the original consent agreed by participants. Arrangements for access and securing confidentiality should be reviewed by a Research Ethics Committee.

If consent for third party access to identifiable NHS patient data is not in place, or is not feasible in England and Wales, Section 251 approval from the Confidentiality Advisory Group (CAG) of the Health Research Authority (HRA) should be obtained, for more information please see 6th resource and Section 251 approval.

Information on how to transfer identifiable data is available in Transfer of Data/Tissues.

Identifiable tissue samples
Whenever possible it is good practice for research to be conducted on coded or completely anonymised samples. In the event that identifiable information is requested by third parties or collaborators it should be ensured that any duty of confidence is not be breached. The terms of the original consent should be checked to see whether the proposed use by third parties is covered and if not, then consent should be sought if necessary (see Should consent be sought?). It should be stressed that identifiable tissue should not be passed on unless consent is in place. Good practice suggests that donors provide explicit consent for third parties to access their samples, and that these arrangements are approved by an NHS REC. If information is to be fed back to participants this should be ethically approved, and managed appropriately, e.g. by a qualified clinician. More information can be found in Information to participants.

Import of tissue samples into England, Wales or Northern Ireland
The HTA provide guidance on the import and export of human tissue in their Research code of practice (see 7th resource below). The MRC has developed a summary of these requirements (8th resource).

Resources