It is the responsibility of the Research Organisation (RO) to ensure that the research is organised and undertaken within a framework of best practice that recognises the various factors that may influence or impact on a research project. Particular requirements are to ensure that all necessary permissions are obtained before the research begins, and that there is clarity of role and responsibility among the research team and with any collaborators. The Research Councils expect research to be conducted in accordance with the highest standards of research integrity and research methodology.
The sections are:
Medical and health research
Health and Safety
Misconduct and conflicts of interest
Research ethics - The RO is responsible for ensuring that ethical issues relating to the research project are identified and brought to the attention of the relevant approval or regulatory body. Approval to undertake the research must be granted before any work requiring approval begins. Ethical issues should be interpreted broadly and may encompass, among other things, relevant codes of practice, the involvement of human participants, tissue or data in research, the use of animals, research that may result in damage to the environment and the use of sensitive economic, social or personal data.
Use of animals in research - Wherever possible, researchers must adopt procedures and techniques that avoid the use of animals. Where this is not possible, the research should be designed so that:
the least sentient species with the appropriate physiology is used
the number of animals used is the minimum sufficient to provide adequate statistical power to answer the question posed
the severity of procedures performed on animals is kept to a minimum. Experiments should be kept as short as possible. Appropriate anaesthesia, analgesia and humane end points should be used to minimise any pain and suffering.
The provisions of the Animals (Scientific Procedures) Act 1986, and any amendments, must be observed and all necessary licences must have been received before any work requiring approval takes place.
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Medical and health research - The RO is responsible for managing and monitoring the conduct of medical and health research in a manner consistent with the Department of Health’s Research Governance Framework for Health and Social Care (or equivalent). There must be effective and verifiable systems in place for managing research quality, progress and the safety and well-being of patients and other research participants. These systems must promote and maintain the relevant codes of practice and all relevant statutory review, authorisation and reporting requirements.
Research involving human participants or data within the social sciences that falls outside the Department of Health’s Research Governance Framework must meet the provisions and guidelines of the ESRC’s Research Ethics Framework. While this research may involve patients, NHS staff or organisations, it is defined as research that poses no clinical risk or harm to those who are the subjects of research. RO must ensure that appropriate arrangements are in place for independent ethics review of social science research that meets local research ethics committee standards.
Significant developments must be assessed as the research proceeds, especially those that affect safety and well-being, which should be reported to the appropriate authorities and to the Research Council. The RO must take appropriate and timely action when significant problems are identified. This may include temporarily suspending or terminating the research.
The RO is responsible for managing and monitoring statutory requirements for which it accepts responsibility, for example, in relation to legislation on clinical trials, use of human organs, tissues and data.
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Guidance by the MRC on the conduct of medical research, and by ESRC on the conduct of social science research, provided on behalf of all Research Councils, must be observed.
Health and Safety - The Research Organisation is responsible for ensuring that a safe working environment is provided for all individuals associated with a research project. Its approach and policy on health and safety matters must meet all regulatory and legislative requirements and be consistent with best practice recommended by the Health and Safety Executive.
Appropriate care must be taken where researchers are working off-site. The RO must satisfy itself that all reasonable health and safety factors are addressed.
The Research Councils reserve the right to require the RO to undertake a safety risk assessment in individual cases where health and safety is an issue, and to monitor and audit the actual arrangements made.
Misconduct and conflicts of interest - The Research Organisation is required to have in place procedures for governing good research practice, and for investigating and reporting unacceptable research conduct that meet the requirements set out in the Research Councils’ Code of Conduct and Policy on the Governance of Good Research Conduct (2009) and any subsequent amendments.
The RO must ensure that potential conflicts of interest in research are declared and subsequently managed.