The Early Development Instrument is an assessment tool used to assess children’s development in kindergarten. It involves collecting information about a child’s physical health and well-being, social capabilities, emotional maturity, use of language and cognitive development and communication skills. According to the Burnaby Now story, the study notice offers brief information on what kinds of data will be collected about the children and that these data will be linked to other kinds of education and health information. It also notes that if parents do not want data collected on their child, they must contact their child’s teacher to indicate this. In other words, the consent, referred to as “passive” in the story, is an opt-out consent.
The letter informs parents about the survey and mentions that data collected can be linked to education and health information. The letter also states that participation is voluntary, and that parents can contact their children’s teachers if they don’t want them to participate.
Ward [a concerned parent] has issues with the use of passive consent, meaning if parents say nothing, their kids will be included in the survey, rather than signing a consent form expressly stating they want their kids involved. Ward is also complaining about what she calls a lack of information on what the data gets linked to.
“They don’t say what they are linking it to,” Ward said. “It violates parents’ rights to informed consent.”
The parents have formally complained about two issues: the use of an opt-out consent and the reported lack of information about how data are being linked to other kinds of datasets, including health information. There’s one more issue here that interests me, in addition to these concerns. I’m wondering if the study researchers have a mechanism in place to report back to parents if serious developmental, social or health issues are identified in their children.
Here’s a few words on each of the issues raised by this story:
1. The use of an opt-out consent process is one that is discouraged across many research contexts. If an opt-out procedure is used, the burden rests with the researcher to ensure that there is thorough and explicit information about what participation really means and how consent, or in this case, non-consent, is expressed. We talk about “obtaining” informed consent in research and this does involve time and energy. It is a clear step that must be revisited and confirmed throughout the life of a research project. Here are three initial questions I would ask about this opt-out process: Are the researchers clear about sending information that is accessible in every parent’s home language and level of reading comprehension? Is it clear what opting-out or passively opting-in really means, to everyone? Is it clear that a traditional informed opt-in consent is impractical? Many potential participants will not fully understand the negative withdrawal option and will simply not make the call to the teacher for either more clarification or to exercise their right to opt out, thereby passively consenting – but this isn’t informed consent. An opt-out clause should never be used as a means to save time and energy of the researcher nor should it be used with a goal of simply “getting more participants”.
2. The notice states that linkages will be made between the data collected and other kinds of data, including health and educational data, considered to be private information. Full and detailed information should be provided to parents about the kinds of linkages being made and the kinds of other data being accessed by researchers. Furthermore, the kinds of strategies put in place to protect privacy should be outlined explicitly and clearly. From the parents’ reactions in this story, the data linkages and privacy measures have not been fully explained.
3. While the study is low-risk, it involves collecting potentially sensitive and very important data about kids. There are very likely to be findings that suggest or demonstrate mild to serious developmental, social or health-related concerns in children. Interestingly, the researchers also note that the information can be used to predict possible future criminality – something as a parent, I’d want to know, I think. The new second version of the Tri-Council Policy Statement(TCPS) discusses the notion of incidental findings, defined as “unanticipated discoveries made in the course of research but that are outside the scope of the research.” (Article3.4). The TCPS is also quite clear that a plan must be in place to inform participants of expected study results and incidental findings. In this case, the goal of the survey tool is to gather information on the development of children so concerning findings are not incidental, per se, but expected. I’m wondering what kind of information gets back to parents about their children.
The story does not include any response from the HELP project or the UBC Research Ethics Board. I found a great deal of information about The Human Early Learning Partnership on the web. I also found a great deal of information about the Early Development Instrument. But it did take time and work to read through a lot of information. If I was a parent getting a study notice like this, I’d be looking for information about the project and giving serious thought about whether or not to participate. However, I’m a researcher. Many parents are not. Many parents have low levels of literacy or are fluent in languages other than English. Many parents work long hours and at multiple jobs. So the burden of seeking information about a study like this should not be transferred to the parents.
The project itself looks like an important and laudable project with goals that are clearly in the interests of multiple stakeholders, including those providing funding to this very large undertaking. At the end of the day, however, even with multiple powerful stakeholders, the interests and the subjective experiences of participants, i.e. those providing the data, must be paramount. When participants are feeling that they are uninformed, unprotected and not being treated in an ethical manner, at the very least it appears that their interests are not being prioritized.