• It is vital to define research adequately to follow the appropriate guidelines.
• Informed consent must be obtained from all participants. This includes adequately providing information of the benefits and risks involved. The only exception to this is if the patient has impaired mental capacity.
• Clinical research must be approved at national and local levels by ethics committees. The NHS site (R&D department) must also be made aware of, and approve any projects or investigations.

• Doctors have a duty to do good for their patients: the principle of beneficence. Medical research (involving patients directly or indirectly) is vital to promote and improve existing healthcare in the present and also in discovering therapies and treatments.
• Patients' autonomy must be respected. 'The relationship between a doctor and a patient is based on trust, and the participants' rights to make a decision on their involvement in any research must be protected'.^[1] Hence, any participants must be informed if they are to be involved in any research, in order to get consent.
• However, informed consent is only valid if patients are given honest information about the research and are informed fully about all the benefits and risks.
• The principle of non-maleficence must also be adhered to. As mentioned, the primary aim of research is not intended to directly benefit the current participants, and so they may not get any benefits from it. BUT, measure must be taken to ensure that all risks are minimised- and again, patients are informed of this when you get consent.

Defining Clinical Research

4 key discriminants are, as laid out in 'Defining Research (2010)' by the National Research Ethics Service (NRES): intent, treatment/service, allocation and randomisation. ^[2]

• Intent. The primary aim of research is to derive new knowledge2, which is beneficial to future patients and the wider population. This is different to service evaluations or clinical audits, where the aims are to judge and evaluate current standards of care.

  If a project has multiple intentions, it may be harder to define what it is. In this case it may necessary to seek clarification and judgement, either from a Research Ethics Committee (National or Local), or even the Research and Development office located at the NHS site where the project is taking place.

• Treatment/Service. "Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community." (Defining Research, 2010) ^[2]
• Allocation. Allocation of Treatment follows protocol and a defined framework in research. In audits and service evaluations, no allocation takes place. Treatment is chosen jointly by the patient/clinician before either take place.
• Randomisation. Research may use randomisation. Audits and Service Evaluations do not.

Applying for Research Approval:

After the project is designed and informed consent is obtained, the following procedure needs to be followed to obtain approval:

• Applications need to be made using the Integrated Research Applications System- IRAS (https://www.myresearchproject.org.uk/).
• Applications then need to be booked in for review with an appropriate REC, either to via the central allocation system, or directly via the local allocation service. Once a booking is made, the application and supporting documents need to be submitted to the allocated REC within 4 days.
• Once a valid application is received, the REC has 60 days to return an opinion on whether the research complies with the current ethical regulations.

• General Medical Council: http://www.gmc-uk.org/guidance/ethical_guidance/research.asp
• 'Defining Research': National Research Ethics Service, 2010.