research The Research Governance Framework sets out standards for healthcare research under the following five domains:

RG standards

Ethics

Research should:
  1. When it involves NHS patients, service users, care professionals or volunteers, or their organs, tissue or data, be reviewed independently to ensure ethical standards are met (i.e. it respects the dignity, rights, safety and well-being of participants). The ethical review process is a legal requirement.
  2. Have an identified sponsor, who will take on responsibility for initiation, management and financing of a study. It is a legal requirement for clinical trials. The sponsor must, amongst other things, be satisfied ethical standards are followed. Please see our section on sponsor responsibilities for more information.
  3. Have arrangements for obtaining informed consent. This will be assessed during the ethical review process.
  4. Use human tissue or organs carefully. Consent from patients or relatives of the deceased is important. Such research must comply with the Human Tissue Act 2004, which came into effect in 2006. 
  5. Use and protect patient data appropriately. All those involved in research must be aware of their legal and ethical duties.  Particular attention must be given to systems for ensuring confidentiality of personal information and to the securit y of those systems.
  6. Involve service users and carers of their representative groups, wherever possible, in design, conduct and reporting.
  7. Respect the multi-cultural nature and diversity of human society and conditions.
  8. Take account of risks to participants. Risks must be in proportion to the potential benefit, and risks, pain and discomfort must be kept to a minimum. Risks must be explained clearly to the relevant Research Ethics Committee and to participants. 
  9. Arrangements for compensation must always be explained to participants in the unlikely event of non-negligent harm.
  10. Follow three principles if it can be conducted only with animals:
  • Replace a nimals by non-animal methods wherever possible
  • Reduce numbers to the minimum necessary to obtai n valid results when replacement is not possible
  • Refine all procedures to minimise adverse effects

Science

Research should:
  1. Consider existing sources of evidence, especially systematic reviews. Research which duplicates other work unnecessarily, or is not of sufficient quality to contribute usefully to existing knowledge, is unethical.
  2. Be peer reviewed by experts in relevant fields, to offer independent advice on its quality.
  3. Be approved by the relevant regulatory bodies. The Medicines for Human Use (Clinical Trials) Regulations 2004 regulate trials of medicines in people. Authorisation by the MHRA is required to proceed.
  4. Meet regulatory requirements governing the use of human embryos, the release of genetically modified organisms, food and food processes, as appropriate. 
  5. Retain the data collected for an appropriate period to allow further analysis by the original or other research teams, subject to consent and support monitoring by regulatory and other bodies.

Information

Health and social care research is conducted for the benefit of patients, users, care professionals and the Public.  There should be free access to information on research being conducted and on the findings of research, positive or negative - once subjected to appropriate scientific review. Information should be understandable to the public.

For commercial development of medicines, medical devices and aids for disabled persons etc. consideration must be given to the protection of intellectual property or commercial confidentiality. The timing of the publication of research findings should take account of this.

Those conducting health and social care research must open their work to critical review through accepted scientific and professional channels. 

Findings must be made accessible to those participating and those who could benefit from them (including the relatives of deceased patients who have consented to the use of organs/tissue in research).

Health, safety and employment

Research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The safety of participants and research and other staff must be a priority at all times. 

Health and safety regulations must be strictly observed - including the provision of information, containment, shielding and monitoring, as required.

Finance and intellectual property

There must be transparency and accountability in the use of public funds to support health and social care research. Organisations, such as the College, who employ researchers must be able to compensate anyone harmed by their negligence. If any organisation offers to compensate participants in the event of non-negligent harm, it must be able to do so. Please see our section on insurance for more information about indemnity cover. Consideration must be given to the appropriate exploitation of intellectual property rights.

The standards combine information from relevant UK legislation and international guidelines where appplicable.  However, no single document can capture the full range of requirements for healthcare research, more specific regulations, standards and guidelines exist across the domains.