Medical Research and Research Governance
Research is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole. 1

A number of different activities come under the umbrella term of 'medical research'. This ranges from working in a laboratory with a microscope and cells, to investigations based on humans and patients in hospitals.

Medical Research can be grouped into 3 main categories:

  • Clinical Audits
  • Research (Clinical or Laboratory)
  • Service Evaluation

  • Clinical Audits: Aim is to see whether current standard of care is following pre-defined standards. Requires submission to RECs (Research Ethics Committee)
  • Research: Aims to produce new knowledge to benefit patients in the future, and does not intend to directly benefit participants. Does not require REC approval.
  • Service evaluation: Designed to define or measure current practise. Is not intended to be generalised beyond the setting at which the evaluation takes place. Does not require REC approval.
Clinical Audits
Clinical audits investigate the care received by a patient (includes all aspects, from procedures used for diagnosis, treatment received and the outcome on their quality of life), and evaluates this against the current recommended guidelines for practice.

General Medical Council (UK): 'You must work with colleagues and patients to maintain and improve the quality of your work and promote patient safety. In particular, you must take part in regular and systematic audit(s)'. 3

Clinical Audits are important to optimise current knowledge and literature, in order to improve the quality of practice and outcomes for patients.

Clinical Audits require access to medical records of patients. Patient records may be used for an audit by the medical team caring for the patient, and:

  • Consent:
  • Consent from the patient is not required
  • Patient consent is implied as long as the patient is 'aware that the audit may exist'. 4
  • Additionally, audits may be carried out by people outside of the care team if the data is anonymised, and consent is still not needed).
  • Consent is needed if a researcher, who is not part of the medical care team, wished to use non-anonymised data. However, Health and Social Care Act 2001 recognises that this may be quite difficult if large numbers of records are being used, and makes allowances for research to proceed in such circumstances, strictly only if it is in the wider public interest.

  • Ethical Review
  • Does not require ethical review or approval from the NHS research ethics service (NRES).
  • However, the NRES may be consulted for advice if there is some confusion over what defines an audit. (Guidance on what is an audit or research is available at http://www.nres.npsa.nhs.uk/applications/is-your-project-research/)
  • If the NRES determines that no approval is necessary, the research and development offices, at the NHS site where the research is carried out, still need to be notified.
Clinical Research
Legal Aspects

All research projects must adhere to certain guidelines in order to make them legally acceptable

GCP (Good Clinical Practise) is an international ethical and scientific quality standard for the design, conduct and record of research involving humans. Previously it was recognised as best practise but with the advent of Medicines for Human Use Regulations 2004 and the EU Directive on GCP, compliance with GCP is now an legal obligation in UK for all trials involving medicinal products.

  • 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 research ethics committees (RECs). The NHS site (where the project is taking place) must also be made aware of, and approve any projects or investigations.

  • Medicines for Human Use (Clinical Trials) Regulations 2004: It is against the law to start or conduct a clinical trial or to recruit participants unless there is a favorable opinion from an ethics committee and authorization from the licensing authority
  • Human Tissue Act 2004: Regulates storage and use of human tissue. Consent is required for lawful retention and use of human tissue. It is an offence to have bodily material with the intention of analysing the DNA without consent.
  • EU Clinical Trials Directive 2001: Sets standards for the protection of clinical trial subjects, including incapacitated adults. Requires trials to be conducted in accordance with the principles of GCP.

Ethical Aspects

Declaration of Helsinki: Is a statement of ethical principles developed by the World Medical Association to: "provide guidance to physicians and other participants in medical research involving human subjects" 5

The Declaration includes principles on:

  • Safeguarding research subjects
  • Informed consent
  • Minimising risk
  • Adhering to an approved research plan/protocol

    • 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.

In addition to the principle of beneficence, other key ethical principles must be upheld:

  • Patients' autonomy must be respected. The doctor-patient relationship is based on trust, and the participants' rights to make a decision on their involvement in any form of research must be protected. 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 clinical 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.
Clinical & Research Ethics
Clinical Ethics

  • CECs are multidisciplinary groups
  • Are advisory bodies (only)
  • Provide support for decision making on ethical issues
  • Offer ethical input into NHS trust policies (e.g. issues that arise from provision of healthcare within the individual trusts, or discussing individual cases referred by professionals within the trust) as well as other healthcare institutions.
  • Although the exact function of each CEC varies between different trusts, according to the individual needs and resources of each trust or healthcare institution.
  • Currently there are 85 such committees in the UK.
  • Topics discussed by CECs include Confidentiality, Consent, Capacity, Refusal of Treatment, Advanced Directives, End of Life Decisions, Genetic Testing and Resource Allocation.
Research Ethics

  • The National Research Ethics Service (NRES) is the main body in the UK which regulates research involving any patients or users (including staff) of the National Health Service (NHS).
  • Taken over activities and roles of Central Organisation of Research Ethics Committees (April 2007).
  • Dual Mission of NRES 6:
    • "to protect the rights, safety, dignity and well-being of research participants."
    • "to facilitate and promote ethical research that is of potential benefit to participants, science and society."
  • Research involving patients and users with in the NHS needs approval from the NRES.
  • However, all research within the NHS also needs individual governance approval from the research and development offices at the NHS sites where the individual research will be carried out.
Making an NRES Application
  • Guidelines for applications for research approval can be found at the NRES website application page (http://www.nres.npsa.nhs.uk/applications/).
  • 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.
References