BAREC wishes to provide clear guidance on the reimbursement of contraception-related expenses in the context of clinical trials, emphasizing the principle that sponsors should cover these costs when a participant is required to use contraception as part of the study protocol.
The mandatory or recommended use of contraception should generally be regarded as study-related. In line with this perspective, we assert that sponsors are expected to cover the costs associated with obtaining and using contraception methods, ensuring that participants are not burdened with these financial obligations. The study-related contraception should be either reimbursed (if paid in advance by the participant) or compensated for (if a reasonable fixed lump-sum has been agreed upon). This principle is applicable to all clinical research irrespective of the sponsor’s nature (commercial or non-commercial) or the type of participants involved (patients or healthy volunteers).
Not meeting these requirements for studies submitted under the framework of CTR/MDR/IVDR, should result in a negative opinion as far as the research ethics committee (REC) is concerned. The purpose of this advice is to contribute to the harmonization of Ethics Committees.
For more information we refer to the BAREC “Guidance on fair compensation of subjects for their participation in clinical research in Belgium.