Background

In common with clinical governance and other quality assurance systems, the framework provides:

• Arrangements to define and communicate clear quality standards.
• Delivery mechanisms to ensure that these standards are met.
• Arrangements to monitor quality and assess adherence to standards nationally.

Co-operation from all members of the multi-disciplinary team is essential in producing high quality research. With this in mind, the Department of Health is working with patients, service users, carers and care professionals, the public and its research partners to develop and implement the research governance framework to ensure quality in health and social care research.

Key requirements of the Research Governance Framework

The framework has identified five main areas so that legislation, standards and guidelines can be applied across the wide range of health and social care research; these are:

I. Ethics - the dignity, rights, safety and well-being of participants must be the primary consideration in any research. Processes must be in place to ensure appropriate ethical review of research projects.

2. Science - systematic reviews must be considered prior to undertaking research, so that time and money-wasting duplication of research does not occur. Experts in the relevant field should review proposals.

3. Information - there should be free access to information in research being conducted and its findings and it must be presented in a format understandable to the public. Critical review should be sought through accepted scientific and professional channels.

4. Health and Safety - the safety of participants and research staff must be a priority. Staff should be adequately experienced and trained in their speciality to safely conduct research and must be able to demonstrate this by keeping a training log.

5. Finance - all research must have compensation mechanisms in place to cover against harm as a result of negligence. All research must be clearly costed, taking into account all aspects of the study process so that resources are appropriately allocated and paid for.

The roles and responsibilities within the Research Governance Framework are outlined below for nurses and midwives (Responsible Care Professional), research nurses/midwives (Researchers), senior nurses/midwives or nurse managers (Employing Organisation), research leads (Chief Investigators) and trusts (Sponsor or Care Organisation).

As a nurse/midwife (Responsible Care Professional):

You retain the responsibility for the care your patients participating in research, even if you have nothing to do with the search study.

You must make sure a researcher has Trust approval and Ethical approval before they approach any of your patients.

If you are unsure whether the research has received approval, or you are concerned about informed consent or the way the research is being conducted, you must contact the chief investigator (person leading on the research) or the Research and Development Office, by telephone immediately.

As a research nurse/midwife (Researcher):

You have a responsibility to ensure the day-to-day running of the study.

You must ensure that the research being undertaken follows the agreed protocol.

You are responsible for helping other care professionals to ensure that participants receive appropriate care whilst involved research.

You must protect the integrity and confidentiality of clinical and other records, and data generated by the research.

You must report any failures in these respects, any adverse reactions and other events and suspected misconduct through appropriate systems (clinical risk, ethics committee, sponsor and research and development).

As a senior nurse/midwife nurse manager (Employing Organisation):

You must ensure all research active nursing or midwifery staff within your

area have clear lines of management and support.

You must ensure that any research that utilises staff under your management has appropriate Ethics and Trust approval.

You must ensure that all staff within your department are aware of their responsibilities towards patients participating in research trials.

You must ensure that research active nursing or midwifery staff have access to professional development to promote good standards of research practice.

You are responsible for the conduct of the research at a site, and are accountable for this to your employer, and, through them, to the sponsor (organisation responsible for management, monitoring, audit, financial review and resources) of the research.

You are directly accountable to the care organisation(s) within which the research takes place, ensuring that indemnity has been sought from the care organisation.

You must have suitable experience and expertise in the design and conduct of research so that you are able to either; undertake the design, conduct, analyses and reporting of the study to the standards set out in the research governance framework, or, to lead and manage others with delegated responsibility for some of these aspects.

The study must comply with all legal and ethical requirements and must be carried out in accordance with the Research Governance Framework.

Each member of the research team, including those at collaborating sites, must be qualified by education, training and experience to discharge his/her role in the study, and their qualifications must be documented.

Each investigator involved in a research study must be aware of his/her legal duties, ensure that students and new researchers have adequate supervision, support and training, and all staff members have Trust contracts.

The research must follow the protocol or proposal approved by the relevant ethics committee and the sponsor.

Procedures must be in place to ensure collection of high quality, accurate data and the integrity and confidentiality of data during processing and storage.

The Chief Investigator accepts a key role in detecting and preventing scientific misconduct by adopting the role of guarantor on published outputs.

All data and documentation associated with the study must be available at the request of the inspection and auditing authorities.

Retain the responsibility for quality of all aspects of patient care whether or not some aspects are part of a research study.

Be aware of, and maintain, a record of all research work being undertaken through or within the organisation, including research undertaken by students as part of their training.

Ensure that an appropriate research ethics committee has approved all research.

Permit and assist with any monitoring, auditing or inspection required by relevant authorities.

Monitor research to ensure it is carried out in accordance with the approved protocol.

Deal with all cases of suspected research misconduct.

Ensure that written agreements are in place for all research involving external partners that clearly detail each partner's responsibilities under the research governance framework, and that affiliated/employing universities also have agreements in place.

Ensure that only research of high scientific quality is undertaken.

To ensure compliance with the Research Governance Framework, the following essential documentation is required by the Research and Development Office prior to final Trust indemnity being granted. All applicable documents must be supplied before any research can proceed.

Local support

In response to the Research Governance

Framework and new laws for research into medicinal products and medical devices, Barts and The London NHS Trust is setting in place a number of processes to ensure that it meets the standards and legal requirements.

Full-day teaching sessions on GCP in Clinical Trials are available (contact Gary Roper). Information leaflets on research governance have been circulated throughout the Trust and Medical School; information is also available on the Research and Development intranet site.

Training in Understanding Research Ethics' is also available to provide insight into the processes and requirements.

A checklist for ethics submission is also available on the Research and Development intranet site.

Research and Development Office - who  does what

Staff are also available in the Research and Development Office to assist with any questions or concerns.

• Assistant Director of R&D, Strategy & Quality -  General enquiries.
• Research Governance & GCP Manager -  Research governance and Good Clinical Practice (GCP) questions, support and training.
• Ethics Interface Facilitator -  Ethics and indemnity information, training and support.
• Research Governance Support Officer-  Project registration, research governance and ethics enquiries.
• Research Facilitator for Nurses, Midwives and Allied Health Professionals)  Advice on designing research, training & funding opportunities, and finding collaborators.
• Finance Manager -  Financial management and research costings.
• RAB Grants Administrator - Research Advisory Board-- (RAB) enquiries.
• Statistician - Statistical support.

Useful websites

References

1. Department of Health. Draft Research Governance Framework for Health and Social Care, 2nd Edition, (Autumn), London: Department of Health. 2003.

2. The European Parliament and the Council of The European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 2001.

4. House of Commons. The Royal Liverpool Children's Inquiry Summary and Recommendations, House of Commons. January 30th 2001.

6. Department of Health and European Commission ICH Harmonised Tripartite Guideline for Good Clinical Practice. (E6) 1st May 1996. Department of Health and European Commission.