Subjects have the right to information and to ask questions. Not just prior to, but also during the research. The sponsor of the study is responsible for providing this information and answering difficult questions. He/she is also compelled to appoint an independent doctor or other independent expert to whom the participant can go to with questions.
The WMO states a ‘doctor not involved in the execution of the research or an expert who is able to provide the subject adequately with clear information and advice regarding the research though who is not involved in the execution of the research’ (section 9) (non-official translation).
An independent doctor or other independent expert is:
- preferably not employed as partner of the sponsor, and
- not employed by the sponsor’s company, and
- if employed by the institution where the research is being carried out, then should not be involved in the research.
The expert may not have personal interests in the (inclusion of patients in the) research. He/she must be adequately knowledgeable in the field of the specific research and be easily contacted by the participants.
It is sometimes difficult to determine when an expert is independent. When in doubt try to gather well-founded arguments for your choice. The reviewing committee ultimately decides if the expert can indeed be determined to be independent.