Читать книгу Fundamentals of Pharmacology - Группа авторов - Страница 92

The legal and ethical standards which govern research into pharmacological treatments are very specific to the context of clinical drug trials. During the Second World War, Jewish prisoners in Nazi concentration camps were used as subjects in medical experiments against their will, leading to permanent disfigurement, disability, trauma and in many cases death. In response to these atrocities, the Nuremberg Code (1947) was developed as international guiding ethical principles for the conduct of research involving human participants. They include principles of informed consent, non‐coercion and the right to withdraw, as well as the importance of robust protocols underpinned by beneficence. These principles were later encapsulated within the Declaration of Helsinki (World Medical Association, 2008) and further legislation has evolved to ensure the safety of human participants in clinical trials including: Data Protection Act (2018), Human Tissue Act (2004) and the Medicines for Human Use (Clinical Trials) Regulations (2004) as well as the Human Rights Act (1998).

Research is an important mechanism for healthcare professionals to ensure that the drug treatments we offer patients are thoroughly tested for safety and efficacy. Additionally, there is strong evidence emerging that research‐active hospitals have better patient outcomes, highlighting the importance and the responsibility healthcare providers have to offer their service users the opportunity to be involved in clinical trials (Ozdemir et al., 2015). It is essential that legislation enables clinical researchers to conduct clinical trials in the endeavour of medical advancement, while ensuring that participants are fully informed of the potential risks and benefits, are not coerced into consenting to participate, and are aware of their right to withdraw from participating at any time. The guiding principle is that the wellbeing and safety of the participants is paramount and takes priority over any other consideration.

Research Ethics Committees (RECs) have the remit to review any proposed research that involves human participants. Made up of a number of lay‐people and professionals experienced in their own field, it is the responsibility of the REC to interrogate the research protocol and to identify any aspects of the research consent and treatment processes which may pose an unacceptable risk to participants or the public. Approval from a REC is essential before a trial can go ahead. As the trial progresses, researchers will also need to seek ethical approval to make any amendments to the protocol, which may be something as minor as a change of wording within a participant information sheet, to something more substantial such as a change in the dose of medication to be administered. These changes will be implemented in line with Good Clinical Practice (GCP) principles (MHRA, 2012).

Despite these safeguards, there are notable incidences that have occurred in recent years related to the conduct of some clinical trials. For example, in 2006, volunteers in an early phase drug trial at the Northwick Park Hospital became seriously ill. The story became headline news after six participants reacted badly to the medication, suffering a severe immune response leading to organ failure and one participant requiring the amputation of his fingers. This led to a full investigation and the resulting report changed a number of practices in the running of drugs trials which sought to prevent this from happening again (Expert Scientific Group on Phase One Clinical Trials, 2006).

Fortunately, however, the ethical and legal frameworks which surround clinical research, limit these incidents and provide principles and guidance for the safe conduct of research and researchers.