Research Governance Framework
The Research Governance Framework (RGF) aims to cohesively present the principles of good practice and seeks to improve research quality. It describes arrangements to define and communicate principles, requirements and standards; delivery mechanisms to ensure that these are met, and arrangements to monitor quality and assess adherence to standards nationally.
The RGF sets out a national standards framework for research participants involved in health and social care research. Adherence to the framework ensures that participants and research partners are linked in with learning networks and research networks. It enables effective management of research to national standards and continuing training and education in research management. This leads not only to dependable local delivery of research and increased patient and public involvement, but also monitored research standards and adverse events reporting.
The RGF contains the responsibilities of participants, researchers, investigators, research funders, the Sponsor, universities and others employing researchers, organisations proving care, care professionals and research ethics committees. In practice, the framework aims to provide principles and requirements for different aspects of research governance, these covering five different domains as follows: ethics, science, information, health safety and employment and finance and intellectual property. The RGF provides guidance regarding requirements in legislation and regulations, standards required by the Department of Health and other established principles of good practice from recognised international authorities and professional organisations.
For a full example of the Research Governance Framework please see the NHS Health Research Authority website.
Good Clinical Practice
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, recording and reporting of research involving humans. It provides international assurance that:
- rights, safety and confidentiality of participants in clinical research are respected and protected
- data and reported results of clinical investigations are credible and accurate.
GCP principles apply to all clinical investigations that could affect the safety and well-being of human participants and GCP training is a legal obligation for researchers participating in Clinical trials of Investigational Medicinal Products.
At NELFT we strongly recommend all Principle Investigators and relevant members of the team have attended GCP training for all research carried out at the trust so as to ensure high quality research practice in keeping with the GCP principles below.
GCP - 13 Principles
- Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented.