The purpose of clinical and healthcare research is to investigate human diseases or conditions and their treatment, diagnosis and prevention. It may involve current or former patients, or healthy volunteers, as well as patients’ health data, biopsy material, or blood. The evaluation of new drugs in clinical trials is an important part of clinical research, as is the scientific study of factors affecting the health and illness of individuals. Non-clinical or healthcare related human research can include surveys, questionnaires, interviews or focus groups, as well as research involving healthy volunteers.
Below are some guidelines for conducting research involving humans. The College has a Joint Research Compliance Office whose remit is to help the College and its researchers meet the requirements of research governance, ensuring that the College fulfils the legal, ethical and scientific obligations of the healthcare research process. For more information, please visit the website of the Joint Research Compliance Office.
- Subjects should not be deceived either by the withholding of information or by intentional misleading regarding the procedures or purposes of research unless there is a valid methodological reason for doing so. Such methodology should always have the approval of an ethics committee.
- Any studies that involve human tissue, NHS data or facilities should be approved by an NHS Research Ethics Committee. For non-NHS studies that do not involve human tissue, NHS data or facilities, ethics approval should be sought from the Research Ethics.
- It is unethical to conduct poor quality research on human subjects. Researchers should therefore ensure that all such research is properly designed and conducted.
- To enhance the validity of the research, any substantial amendments to the conduct of the study should be approved by the sponsor before being submitted for approval as required in the guidelines or regulations of the Research Ethics Committee that originally reviewed the study and, following this approval, should be explained to all research participants by the investigator. Such amendments should also be submitted to any relevant authority from which approval to conduct the study has been obtained.
- To improve the scientific quality of research, studies should be subject to scientific peer review before being submitted to an NHS Research Ethics Committee for approval. For externally funded studies this is usually done as part of the application for funds. For internally funded research, the study should be peer reviewed by a person or persons completely independent to the research team with appropriate expertise in the subject area. Evidence of this peer review should be submitted with the ethics application. See the College Peer Review Service.
- All staff members engaged in clinical or healthcare research are required to register their research projects with the appropriate NHS Trust(s), including projects involving private patients being treated in Trust facilities. No research activity should occur without Trust approval being in place as this will breach the terms of ethics approval. Any clinical or healthcare research conducted outside the UK should always be carried out according to UK ethical and Good Clinical Practice standards, but should also adhere to any local requirements in place in the country where the research is being conducted.
- The College requires all those undertaking clinical or healthcare research to obtain approval for their work from the appropriate external bodies, e.g. the NHS Research Ethics Committees, the Medicines and Healthcare Products Regulatory Agency, etc.
- Research involving clinical medicine students must be approved by the Imperial College Medical Education Ethics Committee.
- Any tissue research on human-relevant material (that which will or may contain one or more whole human cells) must only be conducted under NHS ethics approval or with a valid Human Tissue Licence authorised by the Human Tissue Authority.