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.
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