By Gary Evans, Medical Writer
In a recent study, parents in a pediatric ICU (PICU) were approached to give consent to storage of their children’s specimens in a biobank for future research. In surveying parents afterward, the researchers found that almost half of those asked about the biobank did not seem to understand that storage of clinical specimens was a research pursuit.1
“Despite the research team’s approaching all 80 parents with a modified consent form to enroll their child in a pediatric biobank, only 54% indicated that they were approached to enroll in any research during their child’s current admission to the PICU,” the authors reported.
This finding raises issues of informed consent for biobanking at a time when vast troves of genetic material are being gathered and stored for research, such as in the National Institutes of Health’s All of Us project. Indeed, a follow-up study is underway to see if a video explaining biobanking could improve the informed consent process, says lead author Erin Paquette, MD, JD, MBe, associate chair of the Ethics Advisory Board at Ann & Robert H. Lurie Children’s Hospital of Chicago, and a critical care pediatrician at Northwestern University.
“It is important that we communicate effectively when we ask people about their willingness to participate in biobanks, that they understand that it is not for clinical purposes but for research purposes — even if those research purposes are not known at the specific time that they are enrolling,” she says.
Paquette and colleagues conducted a survey of parents of hospitalized children in a PICU to assess perceived barriers to research. A prime objective is to improve recruiting, both in numbers and diversity of children enrolled. As a baseline assessment based on prior studies, they reported that parents who typically enroll their children in research may be motivated by a sense of altruism, the perceived benefits of the trial, and an existing relationship with the clinicians and researchers. Established barriers include risk to the child, the perceived added burden of research, and the timing and approach of requesting participation.
The latter concern was a prime focus as Paquette and colleaues assessed how parents preferred to be approached, and by whom. “Of the 80 parents who completed the study survey, 45% indicated that they (or their child) were involved in research prior to this PICU admission,” the authors reported.
About half were confused about the biobank consent. However, of the 43 parents who said they were approached during the study period about any research, 93% agreed to enroll their child in a study. Of the 76 respondents who said they had been asked to enroll in research during their child’s current PICU stay or a previous admission, 56 reported that they felt respected, and 50 said they had adequate time to make a decision.
Of those who answered questions about motivators, 84% said it would help children in the future. The majority said the research was low-risk and the process was not burdensome.
Barriers were reported less frequently, with the most common answers being perceived risks to the child, and feeling their child was too sick to participate. Eight of 17 respondents cited the burden of research as a barrier.
A Need to Be Explicit
IRB Advisor sought further comment from Paquette in the following interview, which has been edited for length and content.
IRB Advisor: Can you elaborate on the apparent confusion among respondents about whether biobanks are a part of research?
Paquette: In the study, all patients were eligible for enrollment in a biobank. Despite this, only about half of them actually acknowledged that [biobanking] was a research approach. That taught us how people see biobanking research, particularly if they are approached in a general fashion rather than as part of a research study. That has some implications for how we think about biospecimen research, particularly when we are approaching parents of children. There is a need to be explicit about the fact that it is a research activity.
The other thing that was interesting — with respect to diversification among people who indicated they had been approached about research. We had lower rates of Hispanic individuals indicating that they were approached. Despite the fact, that as I said, all individuals in our PICU were approached about this biobank study over the same period.
IRB Advisor: Was there a language barrier to informed consent?
Paquette: Depending on the study, the consent forms could be in English, or short forms in different languages. There were eight studies recruiting in our PICU at the time that we did this investigation. Different studies had different language requirements. The forms for the biobank study that everybody was approached about were available in English and Spanish. We don’t think it was a barrier in terms of getting the consent form in a language that was understandable, at least for the biobank study.
IRB Advisor: Biobanks are a little bit of an abstraction from what people may normally consider human research.
Paquette: We learned that maybe people don’t think of that as research in the same way. It is not about a particular research question. It is more about having samples available for research in the future. The implications are that it is collected not for clinical purposes, but for research studies.
One of the follow-ups that we have done in response to this finding is create a research video on biobanking. We are in the process of rolling out a study where we will add the video to the consent form for biobanking to see if it improves people’s comprehension of it as research, and that research may follow from it. We will test the video in the context of a study recruiting for a biobank.
One of the things we are paying attention to is whether it impacts enrollment across diverse populations. We’re tracking not only enrollment, but sociodemographic data, literacy levels, trust in the healthcare system, and trust in research.
IRB Advisor: Can you elaborate on the responses from parents about being approached to enroll their child in research?
Paquette: One thing that we were particularly interested in was whether approaching an individual regarding multiple studies would create a burden on them, making them less likely to participate. We actually found that the more studies people were approached for, the more they agreed to participate in research. One could say that they were potentially compelled to participate because they were asked, so we probed for factors like whether they felt burdened or overwhelmed by being asked. Some people reported that, but it was not an overwhelming number that said it was a barrier to participation. We found that our sample was quite amenable to research participation.
Respondents didn’t seem to be particularly burdened by having our research team approach them about having their child eligible for more than one study.
IRB Advisor: Did you find that most parents preferred a single contact for multiple research requests, although that may not be a common practice?
Paquette: Yes. The majority of people prefer to be approached by one contact for multiple studies rather than having each individual research team approach them. Most people preferred either their treating doctor to approach them or a single research staff contact. We are doing some prospective data collection about factors related both to recruitment and retention in research in our PICU. We are looking at a variety of interaction-related variables between researchers and parents. These include the timing, who is doing the approach, how many studies are they approaching for, and how many times are families approached. This could help develop some best practices.
I think that, historically, individual study teams have made research approaches. For people in one place who might be approached by multiple teams, it might make more sense to have a more streamlined, single point of contact. We are testing some of those approaches within our unit.
- Paquette E, Shukla A, Davidson J, et al. Burden or opportunity? Parent experiences when approached for research in a pediatric intensive care unit. Ethics Hum Res 2019;41:2-12. doi:10.1002/eahr.500014.