Research governance: the broad range of regulations, principles and standards of good practice that ensure high quality research

What should research governance cover?

• Research proposal - publicly available
• Expertise of researchers
• Transparent consent process if involving humans
• Information governance (transparency on use of data)
• Funding
• Indemnity arrangements
• Reporting results - registration of of trial on website
• Publication

Declaration of Helsinki

• Statement of the ethical principles for medical research involving human subjects, including research on identifiable human material and data
• 'The health of my patient will be my first consideration'
• Duty of the physician to promote and safeguard the health, wellbeing and rights of patients, including those involved in medical research
• Medical progress is based on research that ultimately must include studies involving human subjects
• Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights
• While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects
• Medical research involving human subjects mst be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications
• Groups that are underrepresented in medical research should be provided appropriate access to participation in research
• Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects