Guiding Principles for the Regulation and Governance of Health Research
1. Safeguard the well-being of research participants
2. Facilitate high-quality health research for public benefit
3. Be proportionate, efficient, and coordinated
4. Build and maintain confidence in the conduct and relevance of health research through transparency, clarity, accountability, and contestability
The goal of health research—encompassing experimental medicine, clinical trials, and epidemiology—is to improve and sustain the public’s health. Whether involving healthy volunteers, patients, or the public more widely, the Academy of Medical Sciences (2011) has enunciated four fundamental principles (see Box 1) that should underpin the regulatory environment for health research.
In the United Kingdom, however, none of these principles is fully (and in many instances even partially) met. Even Principle 1— safeguarding the well-being of research participants—is undermined by the mindless controls that are too often imposed and that lead to a false sense of security. Principles 2, 3, and 4 are observed in the breach. Yet we know that the public, in the United Kingdom, has an appetite for research. Most patients, given the opportunity, want to take part in clinical trials. Half a million members of the general public have contributed their personal details (in anonymised form), as well as blood, urine, and saliva, to UK Biobank. In order to meet the aspirations of patients, the public, and the health research community (including both the life sciences industries and academic investigators), the following measures are being taken:
1. In response to the advice of the Academy of Medical Sciences’ report, the government has created (as of December 1, 2011) a Health Research Agency (HRA). In line with the academy’s proposals, it is intended that this new body fulfill two functions. First, it will bring together the current disparate arrangements for providing ethics approvals for health research. The National Research Ethics Service has already moved into the HRA and other bodies will do so shortly. Some of the arrangements for ethics review are enshrined in primary legislation and will take a little time to unravel, but there is a real determination, on the part of the government, to ensure that rapid progress is made. Second, the Academy of Medical Sciences expects the HRA to coordinate the research