Research Ethics Blog

In the most recent issue of the American Journal of Psychiatry, editor Franklin Miller comments on the work of Zeanah and colleagues who conducted a randomized controlled trial (RCT) on orphaned and abandoned children in institutions in Romania. Institutionalized children were randomized to either continue in institutional care or sent to family foster care. After a period of time, pyschiatric outcomes between the two groups were compared.

Here is Miller’s editorial: The Randomized Controlled Trial as a Demonstration Project: An Ethical Perspective

It might be argued that this research is deficient, and hence unethical, on grounds of both social value and risk/benefit ratio. Do not we already know that institutional care is deleterious and inferior to foster family care, especially for very young children? Indeed, in their opening paragraph the authors list features characteristic of institutional care “which all contribute to an adverse caregiving and social environment.” Although this is the first randomized trial comparing outcomes for children who remain within institutional care versus those who receive foster care, randomized trials are not the only source of reliable knowledge. For example, we know that heart transplants and dialysis save lives despite the absence of randomized trials. Critics might contend that since the answer to the research question was already known, based on prior observational research and the extensive experience of child welfare agencies, there is no social value in conducting the research…

At first glance, I was very surprised that this RCT was deemed ethically sound and allowed to be conducted. After all, don’t we already know that foster care is preferable to institutional care for vulnerable children? Aren’t we therefore exposing children who are randomized to continue living in an institution to what we know to be a “worse-off” condition? My intial concerns were twofold: I wasn’t sure that there was clear clinical equipoise and I wasn’t entirely clear that the risk/benefit balance was favourable. Overall, I wasn’t clear on the social value of this project – what would the researchers have found out that we likely didn’t already know?

Miller’s editorial touched on my own concerns and raised further interesting questions for consideration. Here’s what I found most thought provoking:

Context counts. While there may be agreement that foster care is preferable to institutionalized care in North America (the researchers clearly agree on this in the introductory remarks of the article), this was not the case in Romania — prior to this study. The predominant belief was that institutionalization was, in fact, the preferred way of raising abandoned or orphaned children. With no foster care in Romania, the researchers knew that they had to have some very compelling evidence in order to open up the discussion with policy-makers to establish a foster care system in their country. An RCT seemed to be the way to demonstrate that foster care resulted in improved psychiatric outcomes and thus provide demonstrable evidence for policy-makers favouring foster care. As Miller reiterates, while RCTs are not the only way we can “know” things, it’s clear that policy-makers still look to this “gold standard” in order to influence their decisions.

My first gut reaction was to question the social value of this RCT based on the fact that the question I assumed the researchers wanted to ask had already been answered, i.e. is family foster care better for children than institutional care? However Miller notes that we must look carefully to determine what the research question really is before we decide on a project’s social value or lack thereof. This point is a very important one for anyone assessing the ethical soundness of research to remember. In this case, the researchers were specifically aiming to determine whether children who were initially institutionalized had better outcomes after a shift to foster care. That specific question had not been answered before the researchers set out to do this study.

I think that there are two good take-away messages here for those who review research from an ethical perspective. The first is that the specific research question must be clarified before making an assumption regarding the social value of a research project. Too often, we assume that research questions are already answered without first considering two things. First, we often don’t look as carefully as we should at what the researchers really want to achieve, explore or uncover with their study. Second, we often neglect to thoughtfully consider context or to even question our own assumptions on what is the “norm”, especially in research projects like this one that involve other countries or jurisdictions in which markedly different sociocultural, economic and political forces shape norms and values that are also, in turn, quite different. In his discussion of research projects that involve more than one country with different norms, Miller asks, “Whose equipoise counts?” Not an easily answered question. However it is one that must be, at the very least, asked and reflected upon.

~ by Nancy Walton on July 19, 2009.

Posted in Uncategorized