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Study
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Informed Consent
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IC 1
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General / Questions
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General principles:
All reasonable measures are to be taken for minimisation of risk and burden for the research participant.
- Human studies including collection of samples and genetic data are only carried out after the person has given free and informed consent.
- A human study involving persons who are not able to consent can only be carried out if it is for their benefit. Consent must be given by a guardian in accordance with the disabled's wish.
- The participant has the right to withdraw the consent at any time without any consequences.
- Information and consent must be documented.
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The study includes the collection of samples and genetic data
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The study population includes people who are not able to consent
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IC 2
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NuGO Guidelines
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Information during consent process:
It should be provided to the person in an adequate and comprehensive manner and should be documented. It is preferable to seek advice of experts in social sciences and communication, i.e. sociologists or psychologists, to optimize information process.
The consenting process has to assure the participant understands:
- him or her being asked to participate in a nutrigenomics research project
- the voluntary nature of participation
- the differences between research and medical treatment and the limitation of the personal benefit - necessary commitments involved in the participation in the research project.
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Topics to be covered:
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the overall plan of the project (study design, sampling, sample and data processing)
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a statement whether the sample will be stored after the study has finished
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possible risks involved in the participation (medical, social, legal1)
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opinion of the Ethics Committee
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where applicable: rights and safeguards prescribed by law for the protection of those who are not able to consent to research
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right to withdraw authorization at any time without being subject to any form of discrimination particularly regarding medical care
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the form in which research and test results will be communicated
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any provision for State access to samples and data
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whether or not payment of expenses (e.g. reimbursement of costs for transportation) will take place
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circumstances under which the individual will be re-contacted to renew the consent or under which circumstances no renewal of consent would be necessary respectively
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where applicable, any commercial prospects of the proposed research (including the possibility of filing patent applications on the results)
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IF [study includes samples...]: If it is planned to anonymize samples and data unlinked (see glossary, figure 1 and 2), the participant needs to be informed that future potential benefit from study results due to participation of individual genotype information would not be possible.
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Link: COREC guidance on information sheets and consent forms v2.0 22/11/05.
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Link: COREC information paper on informed consent in clinical trials of investigational medicinal products v1.1 26/09/05.
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Techniques to increase understanding the features of nutrigenomics research:
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having the potential participant take information home
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having a relative or friend present during discussions with the researcher
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using videotapes, question and answer pamphlets, drawings, computer modules, or other educational tools to provide information about the research
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having a research nurse or another qualified person also talk to the potential participant and offer to answer questions
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sending out newsletters about the status and results of the study and what have been done with their data and samples.
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phoning the participants asking whether any question regarding the participation came up (possibly more appropriate for smaller studies)
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IC 3
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tailored NuGO Consent Form Template, based on answers on page IC 1 and probably checked topics on page IC 2.
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Informative Item
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Additional Ressources