That which adversely affects the interests or welfare of an individual. This may be physical harm, discomfort, anxiety, pain, and psychological disturbance or social disadvantage as well as damage to reputation.
Anything that could cause harm. Risk assessment requires identification of potential hazards and assessing the likelihood and possible impact of each hazard.
Health and Safety
Health and Safety is a discipline concerned with ensuring that the risks in the changing workplace are properly controlled. In the UK it is the role of the Health & Safety Executive to inspect, investigate and enforce H & S legislation.
Health Research Authority approval / HRA approval
If your study is led from England and involves the NHS in England then you may need to apply for HRA Approval. This new approval replaces the NIHR Coordinated System for gaining NHS Permission (CSP) and will ultimately replace NHS permission. Further details on the HRA approval system can be found on the HRA approval webpage.
Persons recruited to and consenting to participate in research not by virtue of the fact they are an NHS patient suffering from a specific condition, but rather as they represent normal, non-diseased physiology.
The Health Research Authority (HRA) was established as a Special Health Authority in 2011 to promote and protect the interests of patients in health research and to streamline the regulation of research. The HRA is responsible for providing the Integrated Research Application System (IRAS) on behalf of the IRAS partners; Research Ethics Committees through the National Research Ethics Service (NRES); the Gene Therapy Advisory Committee (GTAC); and the Confidentiality Advisory Group (CAG).
The HTA licences premises for the storage of relevant material for research purposes in England, Wales and Northern Ireland. There are many exemptions to the need for an HTA licence for research. The HTA also issues licences for human application in the whole of the UK.
Human Fertilisation and Embryology Authority (HFEA)
The Human Fertilisation and Embryology Authority is the UK's independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research.
Human Tissue Authority (HTA)
The Human Tissue Authority is the competent authority for the regulation and use of human tissue e.g. the requirements for consent, licensing and storage of human tissue. For research the HTA has jurisdiction in England, Wales and Northern Ireland. For human application, the HTA has a UK-wide role.