The GCAT project is firmly committed to its participants in order to establish, develop and promote research into the health and wellbeing of the population. This commitment is demonstrated by its strict adherence to legal, ethical and social guidelines (ELSI) for all its activities.
All data and samples will be used to carry out biomedical research dedicated to the improvement of health for society according to ethical and scientific principles, with the supervision of a group of experts in scientific ethics. The GCAT policy has been designed in accordance with international guidelines for this type of research and to specifically observe the charter of principles of the Public Population Project in Genomics and Society Project (P3G), which includes the following basic ethical principles:
Respect for people
There is an obligation to respect the autonomy of people participating in research and to protect those with reduced capacities. Respect for autonomy means supplying sufficient information for participants to be able to give their full informed and voluntary consent.
There is a duty to both maximize the net benefits for participants in research and also for society as a whole, while advancing knowledge. Equally there is a duty to minimize harm to participants in research.
Justice and reciprocity
There is a duty to promote trust between researchers and participants in research.
ELSI and particpation
Altruistic and voluntary participation
Participation in the GCAT Project is voluntary and acceptance is via the process of signing an established informed consent form specific to this study. Acceptance to participate means agreement and explicit consent by the participant to give a biological sample and also the data required for the study, which is personal details and information related to health required to carry out the research..
Informed consent to participate in the study
The GCAT informed consent form takes into consideration all the pertinent aspects to protect confidentiality and to promote the integrity of the donor; it provides information about the research project, the procedures for responsible use, the taking of samples and the rights of the participant to know, or not to know.
Model of GCAT informed consent form
Withdrawal of consent and leaving the study
Participant can leave the study or withdraw their consent for particular areas of study. To formally leave the GCAT project participants must sign a specific revocation of their express consent.
Return of results to participants of GCAT
In giving their free consent, the participants in the study accept a limited return of results under agreed conditions.
The results of general interest (research results RR) generated by GCAT research projects will be communicated to all participants using the channels of communication designed for the purpose, such as the GCAT webpage and electronic bulletins. This will give general information about all the research being developed, information about general goals reached and about the participation of GCAT samples and data in research projects.
The return of results of personal interest (Individual Research Results IRR) is strictly limited to individuals whose results have an impact on their reproductive health or personal health. The putative return of results is based on an evaluation of three points:
Analytic validity: the result must be confirmed independently by another technique
Clinical significance: the result must represent a risk to health
Actionable: knowing the result has to have a therapeutic benefit
Access to data and samples
The data and samples of the GCAT project can be used for biomedical research by universities, public institutions and private companies, both profit and non-profit-making. The shared use of the biological samples is one of the objectives.
Due to the limited and exhaustible nature of the samples and because of the strategic value of the associated data, which is the major added value of the collection, access and transfer of data will be controlled by specific data-access committees.