Rules and regulations concerning clinical trials
Rules and regulations
Strict rules and regulations apply to clinical trials. Those rules and regulations are in place to ensure that clinical trials are safe and sound. All trials by ICON must comply with these rules.
Which laws and regulations apply?
The most important rules and regulations that apply to clinical trials are:
- The Declaration of Helsinki: guidelines and basic principles for medical-scientific research involving human subjects, drawn up by the World Medical Assocation.
- Good Clinical Practices: International guidelines for the design, implementation, reporting and archiving of clinical research on human subjects.
- The Dutch Medical Research Involving Human Subjects Act (WMO): Dutch legislation specifying the requirements for volunteer-based clinical trials.
Your safety comes first
These laws state among other things that a participant's safety always comes first. It is also legally stipulated that your participation in a trial is always voluntary. In other words, you can always withdraw from the trial at any time.
Approval by an independent committee
In addition, these laws state that all clinical trials must be approved by an independent committee. In the Netherlands, that is the Medical Ethics Review Committee (METC). This committee monitors participants' safety and privacy, among other things. ICON is only allowed to recruit participants for a trial once the METC has approved it.
The METC is supervised in turn by the Central Committee on Research Involving Human Subjects (CCMO).