Study Initiation and Management: New uses of Data / Tissues

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Introduction

If new (aka secondary) uses of already collected data and/or tissues are proposed, this raises issues of consent, particularly where identifiable information is to be used. Do the terms of the original consent cover the proposed secondary use? If not, then the general principle is to obtain consent or anonymise.

The legal situation for secondary uses of data, differs to that for tissues.

Re-use of Data
Whether or not consent is required for the re-use of data is a complex area, addressed in a number of guidance documents and articles available below (1st to 5th resources). See also Should consent be sought?

New uses of Tissues
Under the Human Tissue legislation there are specific requirements for consent, see 6th and 7th resources below. It is worth noting that for tissues, consent/authorisation can be broad both in duration and scope i.e. consent does not need to be only project-specific. When tissues are collected for diagnosis, consent can also be taken for research (i.e. both for specific research projects as well as more generally by seeking broad generic consent for future research).

If tissues will be stored for uses not covered by an existing NHS REC approval, then an HTA licence may be needed (see HTA Licence).

Data and Tissues
The arrangements for new uses of data and/or tissues may require NHS Research Ethics Committee review. Depending on the proposed project this may be as a new application or amendment to a previous application. Please see Protocol amendments for information on amending a previous application.

Where secondary use is proposed from collections of data and/or tissues originally obtained for non-research purposes, this should be classed as a new research project. In these cases please follow the Route Maps from the beginning (see Planning & Funding).

Resources