I am registered in the Link2Trials database. Am I required to participate in a trial?
You are never required to participate in a trial. Your registration in the Link2Trials database only indicates you may be interested in participating in a clinical trial. When you see a clinical trial listed on our website that interests you, or if we recommend a suitable trial, you can review the information regarding the research on our website and apply if you like.
I have applied for several trials, but have never been accepted for any. Will I ever be able to participate in a trial?
This problem mainly occurs for those who have a medical condition or are using medication, and are applying for trials requiring healthy volunteers. Even if you feel healthy, certain clinical trials will not accept anyone who has listed a medical condition or medication in their profile.
You can apply for clinical trials that relate to your medical condition. You can usually also apply for other research such as nutritional research, psychological research or medical device testing.
It is important to note that every study has its own selection criteria and your personal details will need to be reviewed for each trial that you apply for.
Should I report the compensation I received for a study as income tax?
Any compensation you may receive is always considered gross fees. In other words, these need to be reported to your tax authority. Depending on your personal situation and other sources of income, you may be required to pay income taxes on the compensation you receive. Any travel costs that have been reimbursed, do not count towards income and do not have to be reported as such to the tax authorities.
How is the amount of compensation determined?
The compensation depends on the duration of your stay at the research facility, number of assessments performed and the associated burden. The amount of compensation does not in any way relate to the amount or extent of the risks involved in any particular trial.
Are there any risks involved?
Participating in a clinical trial is never without risk. For more information please refer to the information pages on safety and risks.
Is there a trial specific insurance?
The research facility will always have taken out study specific insurance, as this is required by law. The regulatory authority and/or medical ethics committee verify that the research facility has taken out the proper cover. Information regarding the insurance policy is generally included in the information pamphlet (informed consent form) you receive prior to consenting to the study. If you have any questions regarding the insurance for your specific study, please direct these questions to your investigator.
Can I still withdraw from the study, if I change my mind halfway?
Yes, volunteers may withdraw from a study at any time and for any reason. You will receive compensation for the period of time that you participated in the study. If you are required to withdraw due to extenuating circumstances or due to side effects (in the opinion of the investigator), the exact fee will be determined by mutual agreement on a case-by-case basis.
What are inclusion and exclusion criteria?
The inclusion and exclusion criteria are medical or social standards that determine whether a person is eligible to participate in clinical trial (or other research). These criteria are based on factors such as age, gender, medical conditions and previous or current treatments. The inclusion and exclusion criteria are meant to select the participants that are eligible for the trials and to guarantee the safety of the trial subjects.
What is a medical ethics committee ?
A medical ethics committee, also referred to as an institutional ethics committee or institutional review board, is an independent committee consisting of medical doctors, pharmacists and lawyers. The committee reviews all study-related materials before and during the trial. The committee assesses the scientific design of the protocol, the safety of the trial subjects and the feasibility. Clinical research cannot be started without the approval of a medical ethics committee.