GCAT: your data legally safe and protected
The GCAT Project has a firm commitment to its participants and its researchers to establish, develop and promote health research for the benefit of society. To do this it must comply with the law on the Ethical, Legal and Social Implications (ELSI) of all aspects of GCAT activities.
Data and samples will be used according to ethical and scientific principals, supervised for a committee of experts in scientific ethics. Participants must be informed and signed a consent form.
The GCAT policy has been worked out within the international guidelines for biomedical research, in particular within the Charter of Principles of the Public Population Project in Genomics and Society Project (P3G) this covers the following basic ethical considerations:
Respect for People
It is an obligation to respect the freedom of participants in research and protect people with reduced capacity. Respect for freedom implies providing sufficient information to participants for the to be able to make an informed decision and give their consent voluntarily.
It is an obligation to maximize the net benefits for participants in research and for society as a whole when expanding our knowledge. Equally it is an obligation to limit possible harm to participants in research..
Fairness and Mutual Understanding
It is an obligation to encourage trust between researchers and participants in research.
What does ELSI mean for the participants in the GCAT Project?
Altruistic and voluntary participation
Participation in the GCAT Project is voluntary and acceptance is indicated by the signature on the informed consent form specific for that study. The acceptance means that the participant explicitly agrees to give a biological sample and the personal and health information needed for the study.
Informed Consent to participate in the study
The informed consent form for the GCAT considers all the relevant aspects to protect confidentiality and respect the privacy of the participant and provides information about the research, procedures collection of samples as well as the right to know and the right not to know.
The local blood donor centres of the Blood and Tissue Bank of Catalonia taking part in the project will provide copies of these documents.
Withdrawal of consent and leaving the study
Participants can leave the study or withdraw their consent for particular areas of research. To formalize leaving the GCAT participants must sign a retraction of their consent and specify their express wishes.
Returning results to GCAT participants
The participants in the study accept that the terms of the agreement include a limited return of results when they agree to participate.
Results of general interest (Research Results, RR) produced by the research projects of the GCAT will be communicated to participants through the website, a bulletin etc. The contents will be general information on the research as a whole, information about goals reached or about the participation of data and/or samples in other studies.
The return of results of individual interest (Individual research results, IRR) is strictly limited to results that would directly impact on the reproductive health or general health of that person. Whether results are returned depends on them meeting three criteria:
Analytical Validity: the result must be independently confirmed by another technique
Clinical significance: The result must represent a threat to health
Action: knowing the result must make a treatment possible
Access to data and samples
The samples and data of the GCAT Project can be used for biomedical research by universities, public institutions and non-profit and profit-making private companies. Sharing the use of the samples is one of the objectives of the GCAT.
Because of the limited and finite nature of the samples and the strategic nature and added value of the associated information access and transfer of data will be controlled by specific committees.