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J1. Financial compensation for research subjects

This is only applicable when the information in the ABR form is not sufficient.

There are no detailed instructions regarding the amount of compensation for research subjects for participating in a clinical trial. The CCMO has various models which have been described in field literature and has gone over the possible criteria and discussed this with the accredited MRECs. The CCMO finally came to a consensus together with the accredited MRECs. This is described in the CCMO statement on financial compensation for research subjects and investigators.

The most important elements for the review of a proposed financial compensation for the research subjects are:

  • any expenses made are always reimbursed;
  • financial compensation is based on invested time, on the basis of the minimum wage and the burden of the research;
  • a higher financial compensation is not ruled out, as long as there is sufficient reason for doing so;
  • the compensation is not based on the risks;
  • the type of research (therapeutic or non-therapeutic) and the phase of research can be used for determing the amount of the financial compensation deemed acceptable for/appointed to the patients.