1.2.3 Clinical and basic science research
High quality surgical research has been instrumental in expanding the range of procedures that can be performed safely. It has made operations safer, less invasive and more effective.
Surgeons are in a unique position to undertake clinical research vital for surgical innovation and improvement of patient care, and should strive to participate in research and innovation initiatives related to their practice. Surgeons must be able to understand the relevance of research, critically appraise published research and apply it to practice. If you undertake research, you should:
- Submit full protocols of proposed research and details of intended new technical procedures to the local NHS research/ethics committee before starting. All clinical trials should be registered and all trial results should be published, including negative results or results where the outcome is different to what was expected.
- Treat patients participating in research as partners, respecting their dignity and unique clinical circumstances and ensuring that research outweighs any anticipated risks.
- Fulfil the regulations of the World Medical Association Declaration of Helsinki 1964/2013 on the ethical principles for medical research involving human subjects.
- Fully inform research participants about the aims, intentions, values, relevance, methods, hazards and discomforts of the proposed research. Inform participants how their confidentiality will be respected and protected.
- Fully inform patients in randomised trials about the procedures being compared and their risks and benefits, and record this in your notes.
- Accept that a patient may refuse to participate or withdraw during the programme, in which case their treatment should not be adversely influenced.
- Seek guidance from the local ethics committee regarding the need for consent for the use of tissue removed during an operation for research purposes (as opposed to routine histopathology). Seek permission to remove tissue beyond that excised diagnostically and therapeutically. Acquire specific permission to use any removed tissue for commercial purposes, for growing cell lines or for genetic research.
- Discourage the publication of research findings in non-scientific media before reporting them in reputable scientific journals or clinical meetings. Ensure that any information regarding the research project that may be published on the internet or elsewhere follows ethical principles.
- Disclose any personal affiliation or other financial or commercial interest relating to your research and its funding. This includes, for example, private healthcare companies, pharmaceutical companies or instrument manufacturers.
- Report any fraud that is detected or suspected to the local research/ethics committee.
- Recognise and be familiar with the Human Tissue Act 2004 regulations and obtain appropriate licences where necessary.
- Ensure that you have a good understanding of the standards regarding clinical trials on human subjects. It is best practice to have obtained a certificate of Good Clinical Practice.
- For surgical research that involves animals, fulfil the strict regulations of the Animals (Scientific Procedures) Act 1986/2013.
|Good Practice in Research||GMC||2010|