Coronavirus disease (COVID-19) technical guidance by WHO Investigation protocol for COVID-19 | Page 8

be separated from whole blood and can be stored and shipped at 4°C or frozen to -20°C or lower
and shipped on dry ice.
Transport of specimens within national borders should comply with applicable national regulations.
International transport of specimens should follow applicable international regulations as described
in the WHO Guidance on Regulations for the Transport of Infectious Substances 2019-2020.
2.7 Ethical considerations
Ethical requirements will vary by country. In some countries, this investigation may fall under public
health surveillance (emergency response) acts and may not require ethical approval from an
Institutional Review Board.
2.7.1 Informed consent
The purpose of the investigation will be explained to all individuals identified for recruitment into
the investigation. Informed consent will be obtained from all individuals willing to participate in the
investigation before any procedure is performed as part of the investigation by a trained member of
the investigation team. Consent for children under the legal age of consent will be obtained from a
parent or legal guardian. Each participant must be informed that participation in the investigation is
voluntary and that s/he is free to withdraw, without justification, from the investigation at any time
without consequences and without affecting professional responsibilities.
COMMENT: The age of consent may vary by country. Check the requirements of local, regional or
national authorities.
Informed consent will seek approval to collect blood and epidemiological data for the intended
purpose of this investigation, that samples may be shipped outside of the country for additional
testing and that samples may be used for future research purposes.
2.7.2 Risks and benefits for subjects
This investigation poses minimal risk to participants, involving the collection of a small amount of
blood. The primary benefit of the study is indirect in that data collected will help improve and guide
efforts to understand extent of COVID-19 virus infection and may prevent further transmission of
the virus.
2.7.3 Confidentiality
Participant confidentiality will be maintained throughout the investigation. All subjects who
participate in the investigation will be assigned a study identification number by the investigation
team for the labelling of questionnaires and specimens. The link of this identification number to
individuals will be maintained by the investigation team and the Ministry of Health (or equivalent)
and will not be disclosed elsewhere.
If the data is shared by the implementing organization to WHO or any agency or institution providing
support for data analysis, data shared will include only the study identification number and not any
personably identifiable information.
Article 45 of the IHR (2005) describes the “treatment of personal data”. 2 Person identifiable data
collected under the IHR should be kept confidential and processed anonymously, as required by
national law. However, such data may be disclosed for assessments and management of public
health risks, provided the data are processed fairly and lawfully.
2
World Health Organization. International Health Regulations (2005)
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