The UK Human Tissue Act and the Use of Tissue for Research, Issues for Research Ethics Committees

The cosmetics, detergents and food industries trial development products using healthy human volunteer studies. They also use human tissue for in vitro investigations. Hitherto, the ethics of such work has not been regulated. The UK Human Tissue Act will have legal implications on current arrangements for such studies within the industry, especially with regards to informed consent and seeking ethical review of research proposals. At present, however, it is unclear who will fund ethical review for use of ‘relevant material’ in non-medical research, and on the required status of ethics committees to review such work. The principles behind the sampling, storage and processing of ‘relevant material’ are largely identical whether it be for medical or non-medical investigations. It is argued, therefore, that this is further justification for industry and professional bodies to adopt best practice of ethical review for all studies in ‘grey areas’ outside the scope of regulations. This would follow closely those standards applied to biomedical research.

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12. Organ Transplantation

Medical Law ◽

10.1093/he/9780198825845.003.0012 ◽

2019 ◽

pp. 625-690

Author(s):

Emily Jackson

Keyword(s):

Informed Consent ◽

Organ Transplantation ◽

Human Tissue ◽

Similar System ◽

Uterus Transplantation ◽

Organ Retrieval ◽

Opt Out ◽

Tissue Act ◽

Human Tissue Act ◽

The Uk

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing students with a stand-alone resource. This chapter discusses organ transplantation. It first considers cadaveric donation, looking at who may become a donor, and which organs can be taken. It also includes discussion of the issues raised by novel transplants, like face and uterus transplantation. The chapter summarizes the system of organ retrieval in the UK, looking at the consent-based model adopted in the Human Tissue Act 2004; the introduction of an opt-out system in Wales, and the government’s plan to introduce a similar system in England. It then turns to living organ donation, looking at informed consent and the legitimacy, or otherwise, of incentives. Finally, it considers the ethical, practical, and legal obstacles to xenotransplantation, i.e. transplanting animal organs into human recipients.

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Human Tissue Act 2004: The age of consent arrives in the UK

Journal of Commercial Biotechnology ◽

10.5912/jcb146 ◽

2005 ◽

Vol 12 (1) ◽

Cited By ~ 1

Author(s):

Gillian Johnson ◽

Alex Wilson

Keyword(s):

Human Tissue ◽

Royal Infirmary ◽

Criminal Sanctions ◽

Age Of Consent ◽

Regulatory Approach ◽

Tissue Act ◽

To Come ◽

Alder Hey ◽

Human Tissue Act ◽

The Uk

The organ collection scandals of Alder Hey and Bristol Royal Infirmary in the UK were the driving force for a comprehensive overhaul of the legislation and regulation of the handling and use of human tissues in the UK. The Human Tissue Act 2004 is due to come into force in April 2006 and will resolve a number of uncertainties for researchers. The adopted regulatory approach is not dissimilar to that adopted for the use of embryos in the UK. The legislation provides the framework but a body established under the Act â€“ the Human Tissue Authority (HTA) â€“ will be responsible for granting licences, determining what constitutes 'appropriate consent' and providing detailed guidance and regulations. The advantage of this approach is that it will allow the board of the HTA, whose members include experienced professionals in the medical and research communities, to adapt the system to keep up with scientific developments and possibly changes in public opinion more rapidly than would have been possible where guidance is set out within the legislation. Even before the HTA issues its first guidance, researchers can be clear that certain activities, such as those relating to cell lines, are not covered by the Act. Other processes, such as the anonymising and de-linking of patient data could be subject to additional regulation by the HTA although any guidelines must also conform with the provisions of the Data Protection Act 1998. This paper discusses the new regulatory framework and identifies the challenges for researchers in complying with an Act, which provides for criminal sanctions for breach.

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Research approvals iceberg: helping it melt away

BMC Medical Ethics ◽

10.1186/s12910-019-0434-2 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Simon E. Kolstoe ◽

David Carpenter

Keyword(s):

Clinical Research ◽

Research Ethics ◽

Health Research ◽

Ethics Committees ◽

Research Network ◽

Regulatory Environment ◽

Research Ethics Committees ◽

The Uk ◽

Governance Processes ◽

Local Research

Abstract Background In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. Discussion As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network.

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Ethical issues in genomic research: Proposing guiding principles co-produced with stakeholders

Clinical Ethics ◽

10.1177/1477750918802420 ◽

2018 ◽

Vol 13 (4) ◽

pp. 194-198

Author(s):

D Carrieri ◽

L Jackson ◽

C Bewshea ◽

B Prainsack ◽

J Mansfield ◽

...

Keyword(s):

Research Ethics ◽

Support Groups ◽

Healthcare Professionals ◽

Ethical Issues ◽

Ethics Committees ◽

Genomic Research ◽

Research Ethics Committees ◽

Patient Support ◽

Research Teams ◽

The Uk

Ethical guidance for genomic research is increasingly sought and perceived to be necessary. Although there are pressing ethical issues in genomic research – concerning for example the recruitment of patients/participants; the process of taking consent; data sharing; and returning results to patients/participants – there is still limited useful guidance available for researchers/clinicians or for the research ethics committees who review such projects. This report outlines the ethical principles and guidance for genomic research co-produced with stakeholders during two workshops which took place in the UK between November 2016 and May 2017. The stakeholders involved in these workshops included: healthcare professionals, genomic research teams, academics, patients, biobank managers, and representatives from the Health Research Authority (HRA), NHS Research Ethics Committees, patient support groups, pharmaceutical industry, and health policy think tanks. The co-produced principles and guidance are specifically aimed at researchers/clinicians and members of NHS Research Ethics Committees, and are formulated with the intention to be clear and accessible, both in terms of content and language, to these groups.

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Organ Donation and Transplantation

A Medic's Guide to Essential Legal Matters ◽

10.1093/med/9780198749851.003.0007 ◽

2018 ◽

pp. 87-98

Author(s):

Keith Rigg

Keyword(s):

Organ Donation ◽

Human Tissue ◽

Regulatory Authority ◽

Living Donor ◽

Deceased Donor ◽

Golden Thread ◽

Living Donor Transplantation ◽

Tissue Act ◽

Human Tissue Act ◽

The Uk

The organ donation and transplantation sector in the UK has a comprehensive legal and regulatory framework, with some important differences between England, Scotland, Wales, and Northern Ireland. The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 are the key pieces of primary legislation, with the Human Tissue Authority being the regulatory authority. Consent, or authorization in Scotland, is the golden thread that runs through the legislation and is key for the removal, storage, and use of organs for transplantation. The specific aspects of the legislation that cover deceased donor transplantation are: (1) consent/authorization; (2) when the wishes of the deceased take precedence; and (3) preservation of organs for transplantation whilst awaiting consent. For living donor transplantation, the legislation governs: (1) the regulations pertaining to all living donor transplantation; (2) paired/pooled donation; (3) non-directed stranger donation; and (4) the illegality of commercial dealings in human organs.

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The legal justification for donor optimisation procedures

Clinical Ethics ◽

10.1177/1477750916657665 ◽

2016 ◽

Vol 11 (4) ◽

pp. 122-129 ◽

Cited By ~ 2

Author(s):

Sarah-Jane Brown

Keyword(s):

Human Tissue ◽

Organ Procurement ◽

Legal Framework ◽

Mental Capacity ◽

Best Interests ◽

Tissue Act ◽

Legal Justification ◽

Mental Capacity Act ◽

Human Tissue Act ◽

The Uk

Current organ procurement policies in the UK include ante-mortem interventions to facilitate organ donation. However, a clear and unambiguous legal framework for these procedures does not currently exist. The Human Tissue Act (HTA) 2004 does not provide authority for donor optimisation procedures before death, and there are a number of difficulties in encompassing these procedures within the Mental Capacity Act (MCA) 2005 provisions on best interests. This article proposes a system of specific advance consent to enable best interests to take on its ascribed role as the legal justification for donor optimisation procedures.

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