Question relating to Nuremberg Code and Scots Law: FOI release

Information requested

"How is it recorded on Scottish Government systems that the Nuremberg Code is enshrined in Scots Law".

Response

As a general principle, health ethics is not devolved to Scotland and therefore the Nuremberg Principles are not part of Scots Law. However, research conducted in NHS Scotland is regulated and governed through a UK wide system which observes those principles. The Research Ethics Service in Scotland is a part of the UK-wide national service, facilitating research whilst simultaneously protecting the rights, safety, dignity and well-being of people participating in research in the NHS. The Ethics Service:

1. Provide robust and responsive ethical review of research by RECs.
2. Provide ethical guidance and management support to RECs.
3. Deliver a quality assurance (QA) Framework for the research ethics service.
4. Deliver training and support for researchers and REC members.
5. Work with colleagues in the wider regulatory environment to streamline the processes for approving research.
6. Promote and support transparency in research.

Phase 1 studies in healthy volunteers are assessed by RECs which are recognised to review this type of research. ‘Recognised’ RECs are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of Clinical Trials of Investigational Medicinal Products (CTIMPs), in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004.

Governance of the Research Ethics Committees (RECs) in Scotland is provided by the NHS Health Board, the Chief Scientist Office (CSO), the Health Research Authority (HRA) and the United Kingdom Ethics Committee Authority (UKECA). Research Ethics Committees operate entirely independent of researchers, sponsors and funders, with each REC consisting of up to 18 volunteer Lay and Expert members. This ensures they are able to put participants at the heart of their review; and the UK health research ethics legislation respects the principles outlined in the code and in the legislation https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governancearrangement-research-ethics-committees/.

However, any legislation is only as good as the way in which it is implemented. We require research staff to undertake Good Clinical Practice training before they can start research and this training must be regularly updated. Further information on this can be found here Research Governance |NHS Research Scotland |NHS Research Scotland. In addition, the Ethics Service works to a Framework agreed among all Four Nations of the UK, the UK research governance framework Governance Arrangements for Research Ethics Committees.

This UK policy document describes how NHS/HSC Research Ethics Committees function and specifies when review by an NHS/HSC Research Ethics Committee is required. https://www.legislation.gov.uk/uksi/2004/1031/contents/made.

Full details of all legislation and agreed policies followed by RECs is available on the HRA website at https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-service/ and the NHS Research Scotland website at Research Ethics |NHS Research Scotland |NHS Research Scotland.

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