Data research on child abuse and neglect without informed consent? Balancing interests under Dutch law

摘要

According to the Declaration of Helsinki, participation of human subjects in medical research is only acceptable if subjects have given their consent. But in child abuse and neglect, many studies use a design in which subjects do not actively participate. Data in these studies are gathered from sources such as medical records or Child Protective Services. As long as such data are used anonymously, this does not interfere with individual privacy rights. However, some research is only possible when carried out with personally identifiable data, which could potentially be misused. In this paper, we discuss in which situations and under which conditions personal data of children may be used for a study without obtaining consent. In doing so, we make use of two recent studies, performed in our hospital, in which we encountered this issue. Both studies involved collecting personal data. After careful consideration, we decided not to ask informed consent; instead, we arranged for specific safeguards to protect the subject’s and their parents’ privacy as well as possible.Conclusion: Altogether, we conclude that our approach fits within the Dutch legal framework and seems a reasonable solution in situations in which individual privacy rights are at odds with the public interest of child abuse and neglect research. We argue that, although, in principle, data research is only acceptable after informed consent is obtained, the law should allow that, under specific circumstances and safeguards, this requirement is put aside to make research in the field of child abuse and neglect possible. frame="hsides" rules="groups" class="rendered small default_table">> rowspan="1" colspan="1"> >What is known:
• In principle, data research is only acceptable after informed consent is obtained.
• In practice, this is not always feasible. > rowspan="1" colspan="1"> >What is new:
• Under specific circumstances and safeguards, the informed consent requirement can be put aside. class="kwd-title">Keywords: Child abuse, Research, Privacy/legislation & jurisprudence, Informed consent (by minors), Parental informed consent class="head no_bottom_margin" id="Sec1title">IntroductionAccording to the Declaration of Helsinki, participation of human subjects in medical research is only acceptable if subjects (or their legal representatives—e.g., parents) are fully informed of all aspects of the study and have given their consent []. However, in the field of child abuse and neglect, many studies use a design in which subjects do not actively participate. Such studies make use of available data about the children, their parents, and applied (health care) services and interventions to reduce child abuse and neglect. These data are gathered from sources such as medical records [], records of Child Protective Services [], and data provided by community services []. As long as such data are used anonymously, this does not interfere with individual privacy rights of the involved research subjects (which could be both the child and his or her parents). But in some situations, the use of anonymous data does not suffice, e.g., because the data needs deduplication or linking to data from other sources. In these situations, it is necessary to use personally identifiable (or personal) data, meaning that it is reasonably possible to trace an individual’s identity from the data (i.e., without a disproportionate use of means available to identify the person to whom the information relates). The use of such data could potentially cause problems or harm to the subjects or their parents when it is misused or ends up in wrong hands.In research that is carried out in our hospital, we aim at linking data from different sources (medical records, records of Child Protective Services and community services, and self-reported data). This is only possible by using personal data. Whereas, we know that, in principle, all subjects should provide informed consent before their data is used, we experience that this is often not feasible, e.g., because the child and his or her parents are not traceable or—in case of large-scale database studies—it lacks means and time to approach each individual subject. Another problem is that in child abuse research, asking for informed consent may lead to a serious non-response bias [, ]. In this paper, we discuss in which situations and under which conditions a research project could be performed without obtaining informed consent of the research subjects. In doing so, we refer to two recent studies in our hospital in which we encountered these issues.