J2. Financial compensation for investigators and participating centres

Only applicable if the information in the ABR form is not sufficient. This could include, for example, the financial paragraph in the contract between sponsor, investigator and research institution.

There are no detailed instructions regarding the amount of the compensation for investigators and centres 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 CCMO uses the statement as a starting point for the review of proposed financial compensation. The statement is guiding for the accredited MRECs.

The most important elements used in the review of a proposed financial compensation for investigators or centres are:

• any expenses are always reimbursed;
• the financial compensation is based on time invested and the going hourly rate for the professional group;
• any extra financial compensation is not desirable;
• personal gain is not acceptable;
• gain for the centre or research institution is acceptable within reasonable limits;
• agreements on financial compensation between the sponsor, executing party and participating centre must be laid down in a contract. This contract can be provided upon request during the review of the research protocol.