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PROJECT DESIGN During the first phase, it is important to keep in the mind some important questions ( Summary box 13.1 ). Summary box 13.1 Questions to answer before undertaking research /uni25CF /uni25CF /uni25CF /uni25CF /uni25CF /uni25CF /uni25CF /uni25CF /u...

Peer review Once the protocol is finalised, formal peer review is needed. In the UK, evidence of peer review will be needed before submitting an application to a research ethics committee and for HRA approval. Many funders of research will undertake their own...

Regulatory approvals Interventional clinical or device trials are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Researchers are encouraged to use an existing and established international register such as ISRCTN or Clin...

Regulatory framework In the UK, the implementation of the UK Policy Framework for Health and Social Care Research provides a framework Regulatory framework In the UK, the implementation of the UK Policy Framework for Health and Social Care Research provides ...

Research integrity In 2013, Universities UK, in collaboration with major funders of research, developed The Concordat to Support Research Integrity , which sets out key commitments to ensure a high standard in research. It highlights the principles and profes...

SUNRR that enhances the integrity of the study and includes require ments for sponsorship by an institution to ensure the following: peer review , independent ethics review , compliance with data protection principles , financial probity , dissemination and ma...

Sample size Calculating the number of patients required to perform a satis - factory investigation is an important prerequisite to any study . An incorrect sample size is probably the most frequent reason for research being invalid. Often, surgical trials are...

Study protocol Now that the research question has been decided, and it has been checked that su ffi cient patients should be available to enrol into the study , it is time to prepare the detail of the trial. At this stage, a study protocol should be constructed...

ADUL TS: PEOPLE 18 AND ABOVE Capacity in adults is presumed, but this may be challenged on the basis of a reasonable belief that they are incapacitated. Incapacity in England and Wales is established (in those aged 16 years and over) by a two-stage test. Fir...

CHILDREN AND YOUNG PEOPLE In England and Wales, a person is a child until their 18th birthday; older children are distinguished from their younger counterparts, since 16- and 17-year-olds are additionally described as ‘young people’. Citizens under 16 years ar...

CONCLUSION Surgeons have combined duties to their patients: to protect life and health and to respect autonomy , both to an acceptable - professional standard. The specific duties of surgeons are shown to follow from these: reasonable practice concerning infor...

CONFIDENTIALITY BALANCED AGAINST THE RISK OF SERIOUS CONFIDENTIALITY BALANCED AGAINST THE RISK OF SERIOUS

CONFIDENTIALITY BALANCED AGAINST THE RISK OF SERIOUS

DECISIONS IN THE BEST INTERESTS OF INCAPACITATED PATIENTS We are all well aware that adults with capacity must make their own treatment decisions. There is no justification or need to determine the best interests of such patients since they can (by definition) d...

DECISIONS IN THE BEST INTERESTS OF INCAPACITATED PATIENTS We are all well aware that adults with capacity must make their own treatment decisions. There is no justification or need to determine the best interests of such patients since they can (by definition) d...

DISCLOSURE PRIOR TO CONSENT In surgical practice, respect for autonomy translates into the clinical duty to obtain informed consent before the commence ment of treatment. It is easy to underestimate the gap in understanding between 2 a surgeon and his or her ...

DO NOT ATTEMPT RESUSCITATION? Furthermore, the decision to discontinue life-sustaining treat ment may go hand in hand with a decision not to attempt cardiopulmonary resuscitation, in the event of cardiorespi ratory arrest. In England, it is settled law that b...

DOCTRINE OF DOUBLE EFFECT Surgeons could find themselves involved in the palliative care of patients whose pain is increasingly di ffi cult to control. There may come a point in the management of such pain when e ff ective palliation is possible only at the risk...