Coronavirus disease (COVID-19) technical guidance by WHO Household transmission investigation protocol | Page 18

2.6.1 Informed consent and assent
The purpose of the investigation will be explained to all known household contacts of a confirmed
COVID-19-infected patient. Informed consent will be obtained from all cases and household contacts
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 he or she 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, respiratory samples 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.
2.6.2 Risks and benefits for subjects
This investigation poses minimal risk to participants, involving the collection of a small amount of
blood and respiratory specimens. The direct benefit to the participant is the possibility for early
detection of COVID-19 infection, which would allow for appropriate monitoring and treatment for
themselves and their household contacts. The primary benefit of the study is indirect, in that data
collected will help improve and guide efforts to understand transmission of 2019-nCoV and prevent
further spread of the virus.
2.6.3 Confidentiality
Participant confidentiality will be maintained throughout the investigation. All subjects who
participate in the investigation will be assigned an identification number by the investigation team,
for the labelling of questionnaires and clinical 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 are shared by the implementing organization with WHO or any agency or institution
providing support for data analysis, data shared will include only the investigation identification
number and not any personally identifiable information.
Article 45 of the International Health Regulations (2005) (IHR) describes the “treatment of
personal data” (21). Personally, 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.
2.6.4 Terms of use: Go.Data
If groups implementing the investigation opt to use open-source Go.Data as a tool to run this
investigation (17), several options are available for Go.Data hosting in countries. Detailed
information is presented in Appendix C of this document. The group implementing the
investigation will need to consider the best approach for the investigation setting.
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