Good practice in research
The World Health Organization defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes phase I to phase IV trials.
The National Research Ethics Service provides definitions of research, clinical audit, service evaluation and surveillance.
Research ethics committees (RECs) have a responsibility to safeguard the rights, safety, dignity and wellbeing of people participating in research. They review applications for research and give opinions about the proposed participant involvement and whether the research is ethical. Guidance on whether research requires ethical review under either the law or the policy of the UK health departments can be found on the National Research Ethics Service website.
Update to: World Medical Association Declaration of Helsinki, 2013
Restricting research participants to subgroups of the population that may be defined, for example, by age, gender, ethnicity or sexual orientation, for legitimate methodological reasons does not constitute discrimination.
A sponsor is the person, individual or group that takes responsibility for the initiation, management and financing (or arranging the financing) of the research. All research undertaken in the NHS must have a sponsor. You should refer to the Medicines for Human Use (Clinical Trials) Regulations 2004 for a full definition of a sponsor and its responsibilities in clinical trials of investigational medicinal products.
Medicines and Healthcare products Regulatory Agency
Further advice is provided in the publication Notes for Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive Sources (Administration of Radioactive Substances Advisory Committee, 2006).
Further advice on responding to incidents and complaints is set out in paragraphs 44-45 of Management for doctors.
Personal Information in Medical Research (pdf) (Medical Research Council, 2000) provides further advice on how long research records should be kept. The NHS Code of Practice: Records Management (Department of Health, 2006); Records Management: NHS Code of Practice (Scotland) (Scottish Government, 2008); Welsh Health Circular (2000) 71: For The Record (National Assembly for Wales); and Good Management, Good Records (Department of Health, Social Services and Public Safety, Northern Ireland, 2005) all include schedules of the minimum periods for which research records should be kept.
The EQUATOR Network website provides advice on good practice in reporting health research.
Further information on publication and authorship is provided in section 3.15 of the Code of Practice for Research: Promoting good practice and preventing misconduct (UK Research Integrity Office, 2009).