PoPulationand Public HealtH etHics

Case
The PMC has contacted your PHD to participate in a study to validate the new
screening tool against the multiple screening tools used previously. Normally,
all families receive a post-partum call from the PHD to screen for risk factors
that may affect healthy child development. “High-risk” families then undergo
more in-depth screening to determine the level of future intervention and assistance
required, if any. Families may also be identified for screening through
calls to the PHD’s Phone Line or through referrals from other service providers
such as midwives. The screening process is the same for every family.
If your PHD participates in the PMC’s study, PHD staff would screen all identified
families with both their usual screening tool and the new tool. The PMC
plans to use this information to determine the cut-off for “high risk” on the
new tool, but it has not yet developed a data analysis plan. Additionally, although
“low-risk” families would not normally receive any further assessment,
every fifth “low-risk” family will now receive an “in-depth assessment.” (See
Figure 1 for an overview of the current and proposed screening algorithms.)
The “in-depth assessment” contains sensitive questions around parental history,
such as sexual abuse.
Province X does not have a provincial ethics board, and the PMC does not
plan to seek ethics approval through university or local PHD ethics boards.
The PMC does not believe ethics review is required as this is a “program
improvement,” not research, and families would have contact with the PHD
anyway. Your PHD management team has expressed interest in participating
in the study, but some staff members believe that further information is required
to determine if Research Ethics Board (ReB) review is necessary. You
request a copy of the PMC’s literature review, study protocol and associated
tools. You receive a bibliography of references and copies of the study tools,
and are informed that the new screening tool will replace the current ones
within six months; the materials do not contain either a literature review or
the study protocol.
The first question is whether ethics review is required for this study. The
“Tri-council Policy Statement on Ethical Conduct for Research Involving
Humans” can assist with making this decision. 2 The Tri-council uses an ethics
framework with three core principles: respect for persons, concern for
welfare and justice. Generally, research involving living human participants
Research Ethics and Conflicts of Interest at a Local Public Health Department
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