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D. Codes of conduct, ethics and professional standards

 

D.1 MRC-funded researchers must be aware of, and adhere to, all legal requirements and relevant codes of conduct required by their employer, place of work and any professional bodies to which they, or members of their research teams, belong, for example General Medical Council, Guidance on Good Practice in Research and related guidance on consent and confidentiality. In some areas of research, for example, for research involving human participants, corporate responsibility is assigned by the research organisation as employers, and in some cases sponsors, to specific individuals to act as health and safety officers, research governance leads, designated individuals on Human Tissue Authority licences, etc. These individuals will work closely with research teams within the organisation and have a responsibility to develop systems that provide accountability that the requirements placed on the employer are being met and to demonstrate that the organisation meets the highest legal and ethical standards.

 

The MRC’s code of conduct for employees is available on the RCUK SSC Knowledgebase alongside other policies which apply when working within an MRC unit or institute.

 

D.2 All MRC-funded research involving human participants, human material, confidential identifiable information or the use of animals or regulated materials must address and comply with all necessary legal and ethical requirements and standards, including governance arrangements outlined in MRC policies and other relevant guidelines (see links to the eight of this page). The expectations and requirements of professional codes of conduct, standards and organisational policies should be addressed in the planning, resourcing and conduct of the study and all appropriate ethical, regulatory and NHS approvals must be in place before any research commences.

 

The MRC ethics series outlines relevant policies and requirements for specific areas, activities and research settings.

 

MRC research units/institutes are required to nominate a research governance representative to lead on the implementation of appropriate systems within the unit.

 

D.3 MRC-funded research involving international partners, or work undertaken outside the UK, must comply with all applicable legal and regulatory requirements. Research involving human participants should have ethical approval both in the UK and the country (or countries) where the work is being undertaken. Further information on ethical reviews in the UK can be found in the MRC Data and Tissues tool kit.

 

D.4 Specific requirements have been developed to support MRC-funded research under the Research Governance Frameworks of the UK Health Departments. The requirements focus mainly on sponsorship and employer’s responsibilities and apply differently to MRC-funded research undertaken within MRC units/institutes and other research organisations; they are consistent with the MRC’s policy on sponsorship under the UK Clinical Trials Regulations 2004 (37).

 

D.5 Specific requirements have been developed to support MRC-funded research under the UK Clinical Trials Regulations 2004. The requirements cover all clinical trials of investigational medicinal products supported by the MRC.

 

Further information and advice on meeting regulatory, ethical and governance requirements in research that involves human participants, their tissues or data is available from the MRC Regulatory Support Centre.

 

D.6. The MRC has high expectations for the design, conduct and reporting of medical research involving animals. Implementation of the 3Rs (replacement, refinement and reduction) is essential to meet ethical standards and to obtain the best possible scientific results. The publication Responsibility in the use of animals in bioscience research was coordinated by the NC3Rs and outlines the expectations of the MRC and other UK research councils and charitable bodies which provide funding for research involving animals. Additional codes of practice and guidelines which relate to the use of animals in research issued by the MRC must also be adhered to.

 

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