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Safety risks
In what way is my safety secured?
The ethical end legal regulations, which apply for the performance of the medical science, also apply for medicine research. Each initiated medical research must be approved by an independent Medical Ethical Committee. This committee operates independently from the assigning industry, contract research organizations, which guide the research, the examining physician, the research institute and from Link2Trials.
The institute carefully examines the nuisance you could encounter during the examination and the financial compensation, which you could receive for your participation in the clinical trial. If you would like to have more information on The Medical Ethical Committee, please visit the website of the CCMO, www.ccmo.nl. All the rights and duties of the volunteers, researchers, researching institutes, are laid down in The Declaration of Helsinki 1994 and The European Guidelines of April 2, 2001. WMO The law Medical-Scientific Research(WMO) deals with scientific research, during which volunteers have to cooperate during the research and the rules of conduct that apply.
The WMO (issued March 1, 2006) is in force as of December 1, 1999. The main importance of the WMO is: Protection of a volunteer. The WMO was incorporated to provide a maximum of protection (also legal protection) of the volunteer:
- the volunteer must be informed in writing of the research.
- a physician, who is not involved (independent), must be available to inform the volunteer.
- the volunteer must give his approval in writing for participation in the research.
- an insurance must be made available in case a volunteer encounters damage.
- the law dictates requirements relating to the obligatory testing of the research.
- the law dictates extra requirements regarding children participating and adults that are not able to give informed consent.
Implementation of the EU-guideline 2001/20/EG On April 4, 2001 the European Guideline Good Clinical Practice (2001/20/EG) was published. The essence of this guideline is: the harmonization of clinical medicine research in the European member countries. The guideline should have been implemented in the Dutch law before May 1, 2003. The Dutch legislator chose to make certain amendments in the WMO(Medical-Scientific Research law). On November 22, 2005 the amended WMO passed Dutch Parliament. The amended WMO became in force on March 1, 2006.
What are the risks?
Notwithstanding the fact, that the researches are construed and executed with the highest carefulness, risks are involved:
- lacking of efficacy, you don’t seem to benefit from the clinical study.
- depending on the kind of clinical study you are participating in, this could be time consuming, this could implicate that you would have to participate in more than one treatment, that you would have to stay in a hospital or in a research institute more than one day, probably several days.
- there is a possibility that you encounter unpleasant or even serious side effects.
Specially, the moment that a medicine is not yet registered and you would like to participate in an early phase of research regarding that medicine, there is a possibility that before you participate, only a few volunteers have been treated with that medicine. Of course the outcome and results of research with laboratory animals will make decide the assigning industry, a research physician, the medical ethical committee of a hospital or research institute, that the risks are acceptable for the volunteer.
You must bear in mind that the regulations are very firm! There have been cases in the past in which something went wrong, because unexpected events occurred. If this happens, this is only the case in Phase I studies, with a new class of strong medicines. The institutes that deal with Phase I studies with these kind of strong medicines will apply all possible safety measures to bring back the risks to a minimum.
Very known and most recent was the Phase I study, which had a very unsuccessful course, was the Phase I study in London in March 2006. It must be said, that these kinds of unsuccessful events occur very rarely. What happened in London triggered consequences for Phase I studies and results are applied in the mean time all over the world to enhance the safety of Phase I studies. Since the start of modern medicine research, only a couple of these kinds of events are known. Phase I studies will test the safety of a medicine and are meant to show and register possible side effects.
