Data Protection: feedback of data from clinico-genomic research
The latest thinking on legal, ethical and data security issues surrounding clinical trials
Do patients want feedback of data from clinico-genomic research?
ACGT-Poster presentation at the international conference ?Genomics & Society?
In clinico-genomic cancer trials tumor tissue is analyzed to identify genetic components which are involved in cancer development, reaction to treatment and prognosis. Though genetic factors may influence these processes, they do not cause them in the narrow sense of the term. Therefore, the clinical relevance of research findings is difficult to evaluate ? and so are the ethical and social implications regarding the feedback of such findings to patients.
At least in the European context it is indisputable that everyone has the right to make inquiries about personal data which have been collected about him or her. Due to legal provisions, investigators are obliged to disclose such data on request. This is especially applicable if a research process yields information that helps to avoid sickness or adverse drug reactions. But what is about information on genetic polymorphisms and gene expression whose clinical significance has not been fully established yet? Should such information that has only the potential to be clinically relevant be returned to patients? And if yes, should researchers actively approach patients to return study findings that might be or become relevant for him or her?
According to ethical guidelines and legal regulations from Europe and the United States, there exists no obligation for such an individual donor feedback (IDF). In addition, empirical data on patients? perspectives and expectations towards IDF and data protection are rare and mainly limited to the US-health care system. To illuminate what patients in clinico-genomic and clinical trials on cancer want and think about IDF, we are conducting two surveys in the context of ACGT. One survey is a cross-national study on breast cancer patients in several European countries (Germany, Belgium, Greece, and Great Britain) and a Germany-wide survey on parents of children with malignant diseases.
The poster presentation ?Disclosure and confidentiality in clinico-genomic research: Patients? attitudes and perspectives towards Individual Donor Feedback? presented at the international conference "Genomics & Society" (17th/18th April 2008, Amsterdam) discussed central aspects that might affect patients? attitudes and perspectives on IDF: the probabilistic character of genetic information and the pleiotropic nature of genes (what to feed back?); the potential impact of genetic information on family relationships and reproduction (to whom to feed back?); the potential impact on lives and interests of other family members (who feeds back?); and the increasingly prevalence of genetic research in common disorders such as cancer (how to organize feedback?).
The poster presentation convinced by its content and design: it was awarded two prizes. The first one was the one of the audience, and the second award was given to it by the scientific jury composed of acknowledged scholars from different disciplines.