1..Clinical trials shall be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the requirements of these Regulations.

Risks and benefits are considered before starting trials

 2. Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks.

Rights of patients are more important than other factors

 3. The rights, safety, and well-being of the trial subjects are the most important considerations and shall prevail over interests of science and society .

Relevant information available

 4. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the clinical trial.

Scientific basis

5. Clinical trials shall be scientifically sound, and described in a clear, detailed protocol.

Ethics committee MUST approve any trial

 6. A trial shall be conducted in compliance with the protocol that has a favourable opinion from an ethics committee.

Doctor must remain responsible for medical care

7. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist.

Education and training of those involved in trials

8. Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his or her respective task(s).

Informed consent

     9. Subject to the other provisions of this Schedule relating to consent, freely given informed consent shall be obtained from every subject prior to clinical trial participation.

Trial Information

     10. All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

Confidentiality and data protection

     11. The confidentiality of records that could identify subjects shall be protected, respecting the privacy and confidentiality rules in accordance with the requirements of the Data Protection Act 1998 and the law relating to confidentiality.

Manufacturing practice

     12. Investigational medicinal products used in the trial shall be - 
(a) manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and
(b) used in accordance with the approved protocol.

Quality assurance

     13. Systems with procedures that assure the quality of every aspect of the trial shall be implemented.