The trusted source for
healthcare information and
Active or passive: Gaining consent from parents for student surveys
Regulations, IRBs favor obtaining active consent
When researchers want to survey underage students in school settings, it's obviously necessary to get permission from the children's parents. But exactly how that permission is best obtained has been a matter of debate.
Many researchers support a process known as "passive consent," in which parents are notified about a study and given a means to let the school or researchers know if they don't want their child to participate. If the parents do not act, consent is assumed.
According to the Office for Human Research Protections (OHRP), such a procedure does not comply with the regulatory requirements for seeking parental permission and many IRBs strongly discourage the practice. Researchers often are told to either use active consent — in which a parent must return a consent form in order for a child to participate in a study — or seek a waiver of parental permission.
In addition, the U.S. Department of Education now requires active consent for the research it funds, says Steven B. Pokorny, PhD, director of health promotion with the Alachua County Health Department in Gainesville, FL. Pokorny previously served as senior project director on an NCI-funded study of youth tobacco use.
But studies over the past 10 years show that requiring active consent results in significantly lower response rates.
In addition, some researchers note that active consent processes lead to under-sampling of minorities and of certain groups of at-risk children, potentially biasing studies. In most cases, they say, parents who don't return consent forms don't actively oppose their children's participation, they simply didn't see the form or didn't have time to fill it out and return it.
"The ones who return the form, they're a unique segment of the population that are on top of things," Pokorny says. "They're able to process things that come through the house. But there may be folks who are in the riskier classification for some of our research, who aren't capable of doing that, for various reasons."
The situation leaves IRBs with a delicate balancing act — weighing the importance of a parent's right to decide about a child's research participation against the potential impracticability of conducting research about important youth health issues such as drug, tobacco and alcohol use.
"From the perspective of the scholar, you're clearly giving up a lot when you go to active consent," says Ronald B. Rapoport, PhD, a professor of government at the College of William and Mary in Williamsburg, VA. "People who are not responding tend to be of lower socioeconomic status, they're more likely to be non-white, and they're more likely to be on the school lunch program."
They are, in short, the people researchers often most want to reach, he says.
Pokorny says active consent can raise another problem — many schools won't allow research that includes it, because of the increased staff burden associated with administering it.
"Many times, if you go to a school and tell them you have an active consent requirement from your IRB, they'll shut the door on you right there," he says.
But he and others argue that it's not impossible to achieve success with active consent, if researchers are willing to be creative and to work with schools to craft a process that fits the student population being studied.
Parents 'not paying attention'
Matthew Courser, PhD, a Columbus, OH-based associate research scientist with the Pacific Institute for Research and Evaluation, set out to study risky student behaviors such as alcohol and drug use in 14 Kentucky school districts. He was able to compare the demographics and the results from two different groups of schools: Seven school districts administered his survey using active consent while seven demographically similar districts used passive consent procedures.
In each case, packets of information about the survey, including a consent form, were sent home with students about three weeks before the survey was scheduled. In an effort to boost participation in the active consent group, incentives such as gift cards or free refreshments were offered to students who returned their forms, regardless of whether their parents gave consent.
Despite the incentives, the active consent schools only averaged a 29% response rate, compared to a 79% response rate for schools assigned the passive consent procedure.
Students who participated in the study in the active consent schools were on average younger, less likely to be male and less likely to say that they had used drugs or alcohol than those in the passive consent group.
With those kinds of numbers, you'd expect Courser to be a strong advocate for passive consent procedures. But Courser, who also serves on PIRE's IRB, says his thinking was changed by a post-study survey and focus groups he held with parents.
In the survey, he asked parents whether they remembered getting the consent form. Very few parents in either the active or passive consent arm of the study did remember getting the form, but they over-reported returning the forms.
"Parents thought if they were a good parent, they would have returned the form," Courser says. "It reinforced the growing view — and it's my own view as well — that passive consent isn't consent at all.
"When I started the project I had hoped to make the argument that IRBs are out of whack on this one and that they needed to relax," he says. "But then hearing from parents that they're not paying any attention at all — I just don't think at the moment that there's any way I can make a general sort of call to support going to passive consent and still being within the regulations."
Pokorny had a similar reaction after conducting a study on tobacco use in schools using passive consent. He says a parent called him, upset about the passive consent procedure. The parent wasn't necessarily concerned about the harm of the child participating in the study, but was angry at the assumption that he was consenting unless he took action.
Pokorny says the school district backed his team and didn't require a change in the consent procedure, but he still felt the parent's concerns should be addressed.
"One way we approached our work on this project was we didn't want to do any harm in the community in the process of trying to do good with the research," he says. "We looked at it very closely and said, can we move to more of an active consent process and how can we do it in a way that doesn't overburden our staff or the school system in trying to get that consent?"
Improving response rates
Pokorny has worked with dozens of school districts trying to craft smart approaches to active consent that produce more than the usual lackluster response rates.
He meets with school administration to see how schools get parents' signatures on other necessary documents — a report card, for example, or a statement saying they've read the student handbook. And then he tries to incorporate the research consent form into that existing process.
At one school, he inserted a consent statement into an all-inclusive school permission form that addressed items such as handbooks and students' Internet use. "We had a 90-something% return rate on the consent form and it was no additional work for them or us to do that."
He's attended school registration events, and assigned staff to stuff consent information into student packets to eliminate any potential burden and win the school districts' approval for the active consent.
Pokorny says one reason active consent has such a bad reputation is because researchers often implement it in the least effective ways possible.
"They have this notion of a standard procedure — how do you get this form to the house and back — and they send it in the mail. But I'm sorry, that's just not appropriate for some populations," he says. "Or they stick it in a kid's backpack. Well, you've never been a parent if you think that's a viable way to get something home and have a parent look at it. It's not going to happen."