HRA pilots first ever surplus tissue sample tool

Last updated on 30 Mar 2023

The Health Research Authority (HRA) is looking for volunteers to help test a new tool that’s designed to make it easier for researchers using human tissue.

The tool will provide guidance and support to researchers planning to use surplus human tissue samples in the absence of consent.

Surplus human tissue from a living person may be stored and used for research without consent provided researchers cannot identify the donors and the research is ethically approved by a Research Ethics Committee (REC).

The tool is the first of its kind and was developed in response to calls from the research and biobank community to ensure there is consistent guidance for researchers and RECs to deal with ethical issues relating to how these types of samples are used.

The tool also aims to get researchers to consider the use of surplus tissue where there is an absence of consent at an earlier stage of their research project, which would help to better facilitate the research ethics review approval process.

As part of the pilot, we are encouraging researchers who plan to use tissue samples, where consent hasn’t been requested, to test the tool before it’s rolled out widely.

'The new tool will ensure there is greater consistency and guidance in place to support researchers using surplus tissue samples in the absence of consent.

At the moment there is inconsistency with what is considered to be ethically acceptable on how to use surplus tissue samples where consent has not been provided, which can mean that researchers get different outcomes at the research ethics approval stage.

The tool will also help researchers to consider ethical issues and possible alternative safeguards at a much earlier stage of their research design, which will mean that they are better prepared and equipped to discuss these during the ethics review meeting.  We believe this will help help ensure their application is processed smoothly and in a good amount of time.

The use of human tissue is an important part of research, and we want to be sure that the tool works efficiently for the benefit of the research community, patients, and the public. This is why we are encouraging researchers to get involved and use the tool, which will help support our work to make the UK an even more attractive place to do research.'

Dr Catherine Blewett, senior development manager at the HRA

The tool guides researchers through a series of questions which encourages them to provide more information about why they are using surplus tissue without consent and to think about the steps they need to follow to have the right safeguards in place.

To get involved, researchers need to complete the tool and submit a copy of their responses to the questions along with their application to the research ethics review, which is conducted by the REC.

Following the research ethics review, the HRA will request feedback from researchers and the REC on the tool’s usability and the consent process.

What is surplus human tissue samples

Human tissue samples are the material that comes from a human body and consists of human cells taken from the skin or body organs.

Surplus human tissue samples are removed for clinical purposes or research and are not required for other purposes directly related to the person from which the tissues was removed or are left over from the research project.

Get involved

To find out more about the tool and to join the pilot, please contact the HRA Co-ordination and Standardisation team.

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