Consent forms in genomics: the difference between law and practice

- European Journal of Health Law
Author/s: -Boddington, Paula -Curren, Liam -Kaye, Jane -Kanellopoulou, Nadja -Melham, Karen -Gowans, Heather -Hawkins, Naomi
Journal: European Journal of Health Law
Year: 2011
Volume: 18
Issue: 5
Pages: 491-519

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Stud- ies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant informa- tion and consent documentation in the future studies.