Regulation

There are two overriding concerns at the heart of all the laws, guidelines and frameworks which govern the conduct of clinical trials in the UK:

  • To protect the rights, safety and well-being of participants
  • To ensure the quality of the data collected

The standards that apply to all UK research are:

Research Governance Framework

The Research Governance Framework for Health and Social Care (2005) sets out the high standards required for all research in the NHS.

Upon becoming a Non-Departmental Public Body on 1 January 2015, the Health Research Authority (HRA) took responsibility for issuing guidance for research in England in place of the Research Governance Framework.

The new UK Policy Framework for Health and Social Care has now been drafted and issued by the HRA for comment.

Good Clinical Practice

The ICH Guideline for Good Clinical Practice (1996) and the Declaration of Helsinki (1996 version) supports the conduct of high quality clinical research.

EU Regulations

The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States

UK Laws

There are UK laws that apply to all clinical trials such as the Freedom of Information Act (2000) and the Data Protection Act (1998).

Local NHS Trust Policies

Individual NHS Trusts often have their own local policies regarding research that must be adhered to.

Clinical Trials involving Medicinal Products

If a trial involves testing a new medicine or medical device, it must also meet the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004.

Ethics

All NHS research involving people has to be approved by a Research Ethics Committee (REC).

It is the job of these committees to protect the rights and interests of the people who will be in the trial.

Each NHS Research Ethics Committee is made up of between 12 and 18 volunteer members.

At least one-third of the members must be 'lay'; half of the lay members must be 'lay plus' members.

Lay members are people who are not registered healthcare professionals and do not conduct clinical research.

Lay plus members are people who have never been care professionals, researchers in a care field, or chairs, members or directors of care service bodies or organisations providing care.

The remainder of the committee are expert members, who are specialists including doctors, other healthcare professionals and academics.

Each Committee has a Chair, a Vice Chair and an Alternate Vice Chair.

Each year, RECs review around 6,000 research applications.

On average, they give an opinion in less than 40 days: well within the maximum allowed of 60 days.