[Deficiencies in consent forms for genomic research].
BACKGROUND
whenever biological samples are requested for genomic research consent from donors is always needed. in this process, appropriate information offered to participants is essential. the aim of this study is to assess the information included in consent forms from genomic studies.


METHODS
a 51-item checklist was used to perform a content analysis of consent forms offered to sample donors. We included all consent forms used in genomic research projects approved by an Ethics Review Committee between 2004 and 2007.


RESULTS
consent forms from 68 genomic studies were reviewed. 58 (85%) of those were international studies and promoted by the pharmaceutical industry. We found some important deficiencies in the consent forms on the information related to the sample's use: less than 50% mentioned aspects related to the ownership of the sample, the free donation of the sample or the place of sample storage. There have also been frequent omissions related to the genetic data such as the right to know the results of the research, the disclosure of information to family members or the length of time during which these genetic data will be stored.


CONCLUSIONS
important omissions have been found in the assessed consent forms on aspects related to the use of samples and genetic data. Therefore, a substantial improvement should be undertaken in the consent forms in order to comply both with the requirements established in the Spanish biomedical law and the ethical demands.
Sáenz de Tejada López
M
M
Hospital Clínico San Carlos, Madrid. martalst@yahoo.es <martalst@yahoo.es>
Valle Mansilla
J I
JI
Ruiz-Canela
M
M
D032962:Consent Forms / Q000592:standards*; D056726:Genetic Association Studies / Q000941:ethics*; D006801:Humans; D010597:Pharmacogenetics / Q000941:ethics*