International Ethical Guidelines for Health-related Research Involving Humans

protected. It can be acceptable to store personally identifiable data to enhance their value for future
research; by implication, efforts to de-identify data in order to safeguard confidentiality and the
resulting trade-offs in the scientific value of the given data need to be carefully balanced.
Limits of confidentiality. Donors must be informed of the limits to the ability of researchers to
ensure strict confidentiality and of the potential adverse consequences of breaches of confidentiality.
Confidentiality is limited for three reasons. First, even with good governance structures, there is some
background risk that data are leaked or stolen and thus are obtained by unauthorized third parties.
Second, data from different sources (for example, health records, employment records, etc.) may
be linked due to technological advances, which increasingly enable researchers or others to identify
individuals even when working with anonymized or coded data. Identification is also possible when
the context in which the research is conducted is narrow (for example, small hospital) or very specific
(for example, patients with rare diseases). Pooling data from a number of comparable sources may
reduce but not completely eliminate the possibility of identifying individuals. In addition, genetic
information derived through comprehensive technologies (for example, whole-genome sequencing)
increasingly allows identifying individuals. Third, releasing confidential data can be required by law.
For example, some jurisdictions require the reporting to appropriate agencies of certain communicable
diseases or evidence of child abuse or neglect. Similarly, (health) authorities and research ethics
committee accrediting agencies may have the legal right to inspect study records, and a sponsor’s
compliance audit staff may require and obtain access to confidential data. These and similar limits
to the ability to maintain confidentiality must be anticipated and disclosed to potential participants
(see Guideline 9 – Individuals capable of giving informed consent). The more difficult it becomes
to truly anonymize data, the more important it becomes for the participant to retain the ability to
remove personal data from a dataset. Therefore, this is a crucial part of the governance system
specified above.
Mandatory population-based registries. Research projects using data from mandatory populationbased
registries must be submitted for review to a research ethics committee except for data
analyses inherent to the internal institutional research activity of the registry.
Guideline 12: Collection, storage and use of data in health-related research
Return of results and (un)solicited findings. Especially in the context of data collections in which
large data bases are combined (big data research), the informed consent must clearly stipulate
whether return of information derived from analysis of the data is foreseen, if the donor wishes.
The information given to the donor should clearly state that providing individual diagnoses is not the
purpose of the databank or future research project, in order to prevent that donors being falsely
reassured by the absence of unsolicited findings.
There is an emerging consensus that at least some findings in genetic research must be returned
to individual donors if they wish. Tiered consent, meaning the possibility of obtaining packages or
subsets of information, gives donors a range of choices and allows them to choose some options
to give them greater control over the use of their data. In general, the three guiding principles
for return of results need to be followed: results must have analytical validity, clinical significance
and actionability to qualify for being returned. This implies that life-saving information and data of
immediate clinical utility involving a significant health problem must be offered for disclosure, whereas
information of uncertain scientific validity or clinical significance would not qualify for communication
to the donor. The research ethics committee should also evaluate whether individual counselling is
necessary when returning particular genetic findings. Some cases may require making an ethically
responsible management plan for returning (un)solicited findings.
Data-sharing. Researchers, sponsors and research ethics committees must share data for further
research where possible. The conditions for data sharing are spelled out in Guideline 24 – Public
accountability for health-related research.
INTERNATIONAL ETHICAL GUIDELINES FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS
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