foods to be used in intervention studies and also to measure the
amounts of carotenoids ingested throughout the study and thus
gain insight into their effect on the results of the intervention study
(see Note 3).
When food sources containing carotenoids are used, the different forms of preparation/consumption and, where possible, their
bioavailability/bioaccessibility should be considered as these factors affect response and biological activity.
2.3 Participants
Intervention studies must adhere to international principles and
applicable standards in each country regarding bioethics, biological
safety and data protection while also respecting the overarching
principles laid down in the Helsinki Declaration (World Medical
Association) [12], in the Council of Europe Convention on
Human Rights and Biomedicine [13] and in UNESCO’s Universal
Declaration on the Human Genome and Human Rights [14] and
those required by local ethics committees.
Study participants must be provided with information about
the study and must sign an informed consent form before they can
be included. Those documents must show that researchers are
familiar with and commit to upholding applicable laws regarding
personal data protection. In the case of European studies, this
serves as a guarantee that the processing, communication and
transfer of the personal data of all participants adheres to the
provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 and to applicable rules in
force in each European Union country [15].
2.4 Biological
Samples
In human research studies, biological samples are stored (biobanking) and removed after being used for research purposes. At
European level, a set of recommendations has been issued by the
Committee of Ministers of the Council of Europe regarding these
activities. These recommendations also apply to the use for research
purposes of biological materials of human origin stored or previously obtained for a different purpose (i.e., a previous research
project) [16].
2.5 Other
Considerations
Researchers and staff involved in intervention studies must take out
liability insurance before embarking upon a study (see Note 4).
A detailed and duly justified report on the intervention study
must be submitted to the clinical research ethics committee at the
hospital or corresponding research center which must authorize
said study.
Intervention Studies
365
amounts of carotenoids ingested throughout the study and thus
gain insight into their effect on the results of the intervention study
(see Note 3).
When food sources containing carotenoids are used, the different forms of preparation/consumption and, where possible, their
bioavailability/bioaccessibility should be considered as these factors affect response and biological activity.
2.3 Participants
Intervention studies must adhere to international principles and
applicable standards in each country regarding bioethics, biological
safety and data protection while also respecting the overarching
principles laid down in the Helsinki Declaration (World Medical
Association) [12], in the Council of Europe Convention on
Human Rights and Biomedicine [13] and in UNESCO’s Universal
Declaration on the Human Genome and Human Rights [14] and
those required by local ethics committees.
Study participants must be provided with information about
the study and must sign an informed consent form before they can
be included. Those documents must show that researchers are
familiar with and commit to upholding applicable laws regarding
personal data protection. In the case of European studies, this
serves as a guarantee that the processing, communication and
transfer of the personal data of all participants adheres to the
provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 and to applicable rules in
force in each European Union country [15].
2.4 Biological
Samples
In human research studies, biological samples are stored (biobanking) and removed after being used for research purposes. At
European level, a set of recommendations has been issued by the
Committee of Ministers of the Council of Europe regarding these
activities. These recommendations also apply to the use for research
purposes of biological materials of human origin stored or previously obtained for a different purpose (i.e., a previous research
project) [16].
2.5 Other
Considerations
Researchers and staff involved in intervention studies must take out
liability insurance before embarking upon a study (see Note 4).
A detailed and duly justified report on the intervention study
must be submitted to the clinical research ethics committee at the
hospital or corresponding research center which must authorize
said study.
Intervention Studies
365