Biomaterial Database

Legal requirements for conducting clinical trials. 2008

Richard Grffith

School of Health Science, Swansea University. richard.griffith@swan.ac.uk

Clinical trials are crucial to the development of new medicines as they test the safety and effectiveness of the drug on human subjects. However, trials do pose a risk to the participants. To minimize this risk all clinical trials must meet the requirements of the Clinical Trials Directive (Council Directive (EC) 2001/20 2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004. In this article Richard Griffith discusses the legal framework that regulates clinical trials in the United Kingdom.

UI	MeSH Term	Description	Entries
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D010344	Patient Advocacy	Promotion and protection of the rights of patients, frequently through a legal process.	Patient Ombudsmen,Patient Representatives,Clinical Ombudsman,Patient Ombudsman,Advocacy, Patient,Ombudsman, Clinical,Ombudsman, Patient,Ombudsmen, Patient,Patient Representative,Representative, Patient,Representatives, Patient
D011637	Public Health Nursing	A nursing specialty concerned with promoting and protecting the health of populations, using knowledge from nursing, social, and public health sciences to develop local, regional, state, and national health policy and research. It is population-focused and community-oriented, aimed at health promotion and disease prevention through educational, diagnostic, and preventive programs.	Nursing, Public Health
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004358	Drug Therapy	The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER.	Chemotherapy,Pharmacotherapy,Therapy, Drug,Chemotherapies,Drug Therapies,Pharmacotherapies,Therapies, Drug
D006113	United Kingdom	Country in northwestern Europe including Great Britain and the northern one-sixth of the island of Ireland, located between the North Sea and north Atlantic Ocean. The capital is London.	Great Britain,Isle of Man
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006805	Human Experimentation	The use of humans as investigational subjects.	Human Research Subject Protection,Experimentation, Human
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults
D013222	State Medicine	A system of medical care regulated, controlled and financed by the government, in which the government assumes responsibility for the health needs of the population.	National Health Service, British,Socialized Medicine,British Health Service, National,British National Health Service,Medicine, Socialized,Medicine, State,Service, British National Health