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Ethical Aspects of ACGT
Ethical debate regarding the involvement of patients in medical research has a long tradition. Among the principles which have been identified as being applicable to medical research, are the principles of autonomy, beneficence, nonmaleficence, and justice. It is generally accepted that autonomy is one of the most basic principles to be respected in the context of medical research involving patients. This does not only apply to clinical research, but also to research involving data and biological material (cells, tissues, DNA) collected from patients. Derived from the principle of autonomy is the doctrine of informed consent, which has been widely acknowledged in practice.
However, clinico-genetic research addresses new questions regarding informed consent, because data are collected and used not only for specific research questions, but also for future research projects which cannot be defined at the time consent is requested. Facing this demand, doubts have been raised whether consent can be given in advance to future, still unknown research projects.
Even though most scholars still maintain informed consent as an instrument to implement the principle of autonomy, the form and scope of consent in clinico-genetic research is controversially discussed. In order to protect patients' autonomy as the main objective of informed consent, ACGT defines the scope of consent clearly by restricting consent to clinico-genomic research on cancer done within the framework of ACGT.
To consent voluntarily and explicitly to data sampling, storage and usage, potential donors need adequate information. For that reason, given information is comprehensive and understandable formulated and includes the main intentions of ACGT and the range of possible uses of data, measures token to protect donors' personal rights, the possible risks and benefits, and further implications of participation.
Clinico-genomic research may yield research results which could be important for individual patients or even groups of individuals (e.g. family members). Hence, another crucial ethical question to deal with is whether and under what circumstances which data should or must be fed back to persons concerned (and their doctors) in order to enhance treatment and to avoid harm.
From an ethical point of view, it is widely acknowledged that general research results must be accessible for patients involved. Therefore, ACGT makes sure that donors will have access to general study findings on a web-based service. Furthermore, anybody has the right to access personal data stored about him or her. But the right to access such data, which is based on ethical principle as well as on legal provision, is a passive one. Therefore, ACGT provides patients only with information about personal stored data on request.
Furthermore, ACGT provides the technical and organizational resources for feedback processes of individually relevant results initiated by the investigator. However, the relevance of personal research results is - especially in new research areas such as gene expression studies - not easily to approach. From an ethical point of view, it is recommended to give the patients the option to decide about feedback of personal data. Taking this ethical requirement seriously, the ACGT-consent form asks therefore whether the patient wants to receive results which could be important for him or her.