Researchers say human tissue regulation is necessary to ensure informed consent - new report

Human Tissue Authority media release

Issue date: 30 September 2009

The Human Tissue Authority (HTA) today launches an independent evaluation of how regulation and requirements affect researchers working with human tissue.

The HTA worked with an external consultancy, Opinion Leader, to ensure that the results were independent. 295 people took part in the evaluation via telephone and online interviews. The evaluation was carried out between January and April 2009.

Main findings

Researchers had an awareness of the broad roles of the HTA, such as issuing licences for storing human tissue for research (97% aware) and producing codes of practice (93% aware). Most participants report that the HTA performs well on delivering against these roles (giving an average score of 3.9 out of 5.0 for providing licences; 3.8 out of 5.0 for producing codes).

Despite this high level of awareness of key parts of the HTA's role and remit, half of the participants do not make a distinction between the regulatory framework based around human tissue legislation and a broad range of governance or regulatory activities outside remit of the HTA - including ethics committee approval, funding and NHS Research and Development approval. For this reason, views of the impact of the regulatory framework for human tissue are closely correlated with general views about the wider legislation, regulation and governance in the research sector. Findings from the survey should therefore be read in this context.

Researchers reported that wider legislation, regulation and governance around the use of human tissue for research:

• is necessary to ensure that human tissue is used appropriately (75% agree)
• is necessary to ensure that human tissue is used with informed consent (75% agree)
• has raised standards of research processes and storage (65%)
• has ensured that informed consent is given by donors (70%)
• has made it more difficult to get hold of samples (68%)

A smaller number said that:

• wider legislation, regulation and governance did not hold up research unnecessarily (20%)
• requirements are easy to comply with and that wider legislation, regulation and governance is streamlined (17% and 16% respectively)
• requirements are uncomplicated and easy to understand (9%)

There are some key differences of opinion across sub-groups. Most notably, those who are more aware of the HTA's role and remit, and those who are broadly in favour of regulation, are less likely to say human tissue legislation and subsequent regulation by the HTA has had a negative impact.

Dr Shaun Griffin, Director of Communications at the HTA, said:

"The HTA began regulating the storage of human tissue for research in September 2006. It is inevitable this new regulation would impact on how research is conducted; for example the requirement for informed consent would be expected to have an impact on access to human tissue samples. We took the brave step of asking researchers for their honest perceptions about the impact of this regulation, warts and all.

"The evaluation showed that researchers could not separate our regulation from the regulation and governance of other organisations. Although this means the results do not directly relate to the HTA, it gives us valuable insight into how the wider regulatory and governance framework is perceived by researchers.

"We were pleased to see that a large proportion of researchers see the link between regulation, the appropriate use of tissue and informed consent as being important. We also know that they credit regulation with driving up standards. But their perception is that the regulation and governance framework is not streamlined and makes it harder to get hold of samples.

"It was good to see there was high awareness of the broad roles of the HTA and that we performed well on delivering them. However, more work is needed to understand why some researchers believe access to tissue is more difficult; and to work with them and other stakeholders to overcome any unnecessary barriers.

"We work very closely with other organisations to play our part in streamlining regulation and helping researchers to navigate the regulatory and governance requirements. For example, we worked with others on the UK regulatory route map for stem cell research and manufacture. We will also continue to strive to provide clear advice and guidance for researchers to help them understand the regulation and minimise the impact on their work. Our new code of practice for research, published earlier this month, is just one recent example."

ENDS

For further information, please contact Claire Bithell, Senior Media Advisor at the HTA on 0207 211 3439 or claire.bithell@hta.gov.uk

Notes to editors:

• The report is available on the HTA website
• The Human Tissue Authority (HTA) is an independent watchdog that supports public confidence by making sure human tissue is used safely and ethically, and with proper consent. We license and inspect organisations that store and use human tissue for purposes including teaching about the human body, carrying out post-mortem examinations, using human tissue to treat patients, carrying out research on human tissue and displaying human bodies or tissue in public. We also give approval for donations of organs and bone marrow from living people.
• The HTA licenses organisations that store human tissue for research in England, Wales and Northern Ireland.
• If a research project has approval from a recognised ethics committee it does not need an HTA licence. A large amount of research on human tissue, therefore, does not require a licence from the HTA.
• Consent is required for research on human tissue from deceased patients (autopsy tissues) unless the project has recognised ethics committee approval or was obtained before 1 September 2006.
• Consent is not required for research on tissue from living patients (biopsy tissues) if the samples are anonymised or coded and the project has recognised ethics committee approval, or if the tissue samples were obtained before 1 September 2006.
• The HTA has a new Research code of practice that gives researchers practical guidance on the Human Tissue Act 2004. The interactive code is available on the HTA website.
• In June 2009 the HTA launched a new and improved website
• In July 2009 the Better Regulation Executive published its report of the Hampton Implementation Review of the HTA. The review  praised the HTA for using the principles of Better Regulation to ensure we are risk-based, proportionate and transparent. The review team rated the HTA highly on provision of advice and guidance and minimisation of inspections and data collection burdens. The full report can be found online
• More information about the Interim UK regulatory route map for stem cell research and manufacture can be found online
• Opinion Leader is a research-based consultancy which works with clients across national and local government, the voluntary and not-for-profit sectors, and private sector businesses. Opinion Leader combines its experience in engagement, dialogue and insight, with a wide range of research techniques to examine and evaluate complex and controversial issues.