What are the risks?
“Find out how to earn 3,247 euros in 27 days.” You may be familiar with these kinds of advertisements that recruit test subjects: people who test drugs or treatment methods. Is this easy money making, or are there risks involved? The facts and story of a test subject.
It is logical that medicines do not just come onto the market. To make sure they are safe, they are first extensively tested. This is first done on laboratory animals. At a later stage, people are also needed to try out the drugs.
Types of medicines
It can be all kinds of drugs: against depression, obesity, diabetes, thrombosis, et cetera. For example, they look at the side effects and how the body absorbs and breaks down a medicine.
Who can be a test subject?
Some studies require patients suffering from the condition for which the drug is intended. But there is also a great demand for healthy volunteers.
Preference is usually given to men between the ages of 18 and 65. Hormone levels fluctuate too much in women of childbearing age; this makes it difficult to determine the effect of a substance.
Researchers clearly indicate in advance who is eligible to participate in a study. Dangerous drugs, for example against cancer, are only tested on terminally ill patients.
Legal protection of subjects
Drug research takes place in specialized commercial clinics. Of these, four are in the Netherlands. The clinics need several hundred healthy volunteers for each drug, spread over several years. In total, between five and ten thousand people participate in this type of medical studies every year.
The researchers are not allowed to just test everything on humans. They must request permission in advance from an independent review committee. He or she assesses whether the study is meaningful and medically justified.
Subjects are also protected in other ways, through the Medical Research Involving Human Subjects Act (WMO). This law states, for example, that you must always receive complete written information about the examination in advance and that you must be insured against any damage to health.
Health risks
According to the Dutch research centres, it very occasionally happens that someone suffers from serious side effects. By serious they mean that the health of the test subject is at risk. The investigation will of course be stopped immediately.
Minor discomforts do occur regularly; between ten and twenty percent suffer from nausea, headache or diarrhoea. Whether you have side effects or not, as a volunteer you can always stop whenever you want. That is also laid down by law.
Financial compensation
There is usually a financial compensation for participation. For some people, it is even the main reason to sign up as a test subject. The amount of the reimbursement is based on the minimum wage and depends on the number of days you have to be in the clinic. Sometimes it only takes a day, while other investigations take several weeks.
The amount of the compensation has in any case nothing to do with the risks. You are also not allowed to participate unlimitedly in all kinds of studies in order to earn a higher amount. There must always be at least three months between two examinations.
Once you have decided to register as a test subject, you will undergo a medical examination. This way the clinic knows for sure that you can safely undergo the tests, that you are not pregnant or have an illness. The clinic can also request your file from the general practitioner for additional medical information. Then you sign a document stating that you have understood everything and that you understand what you are getting into. From that moment on you are officially a test subject.
Personal experience
Karin (34) has now participated in drug research 15 times. She has never found it scary: “I have always prepared myself well. First you will receive an extensive information package at home. When you report to the center afterwards, someone will receive you who will guide you during the entire investigation. Usually there are several volunteers who participate in the same research, so you can support and help each other.”
“You always have to report for certain actions. For example, to give blood, for checkups, or to take the medicine. This has to be very precise, on the minute. But there is also quite a lot of time to do something for yourself. That’s why there is a living room, there are computers and you can borrow books and DVDs.”
“Nevertheless, not everything is pleasant. For example, a kind of IV needle is inserted that has to remain in place for a while. And you can get side effects. I have had about four side effects myself: from nausea to headaches and diarrhoea. So you have to think carefully. what you’re getting into.”
