Quality of consent forms in pharmacogenetic studies: a survey of research ethics committees in Spain

Objectives: To know the quality of consent forms in pharmacogenetic studies submitted for evaluation to Research Ethics Committees (RECs). Methods: A mail survey to RECs in Spain was conducted; this survey contained questions on the frequency with which different items were included in the consent forms of pharmacogenetic studies reviewed by each REC. Results: A total of 40 out of 69 RECs that answered the questionnaire had reviewed pharmacogenetic studies. RECs considered that information was always or almost always comprehensible in approximately 50% of the forms received. Information regarding reimbursement of patients and commercial interests of the research was scarcely incorporated in the consent forms. In general, RECs estimated that aspects related to the use of samples and genetic information were included in the consent forms with a frequency lower than 50%. The quality of consent forms was considered to be lower by those RECs which had reviewed a higher number of pharmacogenetic studies. Conclusion: Significant deficiencies have been found in the consent forms of pharmacogenetic studies reviewed by Spanish RECs.