When passive consent may be the only way

IRBs must find minimal risk, no alternatives

While passive consent may not be the preferred way of obtaining parental permission to survey underage students, researchers say there will continue to be some situations in which it's the best and perhaps only practical choice.

The challenge for IRBs is identifying those situations.

The term "passive consent" does not appear in federal regulations. The Office for Human Research Protections (OHRP) describes a process in which parental permission can be waived or altered when researchers seek to survey underage students.

In order to approve such a waiver, IRBs must find that the proposed study poses no more than minimal risk to participants, that the waiver will not adversely affect the rights and welfare of the students and that the study cannot be practicably carried out without the waiver.

Ronald B. Rapoport, PhD, a professor of government at the College of William and Mary in Williamsburg, VA, says anonymity eliminates much of the risk in a student survey.

"Certainly, if you can do it in a way that is anonymous, that is very important," he says.

In Rapoport's own research on youth obesity, responses were not anonymous — answers about eating habits and height and weight information collected separately had identifiers so they could be linked — but he says identifying information was stripped out almost immediately afterward, so that individual participants couldn't be identified.

"I think that (process) does provide significant protection," he says, noting that researchers need to be able to give the IRB the usual assurances about the security of data and how it is stored.

The other potential risk to students is in the questions themselves. Many student surveys ask about potentially sensitive information such as illegal activity, sexual activity and substance abuse.

Steven Pokorny, PhD, director of health promotion with the Alachua County Health Department in Gainesville, FL, has surveyed 40,000 students in longitudinal studies in middle and high schools.

"Some people will perceive items about sexual behavior as an exposure of risk to the child," he says. "Or even about tobacco and other drugs. There are folks who believe if you ask kids about this, you will stimulate their interest and they'll go out and want to do it. I don't buy that, but that's a concern for some people, including some parents."

He says IRB members need to think about the study from a parent's perspective.

"Is it likely that any parent could become upset about the content of the research?" he says. "If one can be confident — if you can't even think of a friend or a friend of a friend's parent who'd be upset at all by any of this — then it's probably safe (to be conducted with a waiver)."

Researchers say there are situations in which it is impracticable to use active consent in a student survey. For example, the schools themselves may require passive consent, since it is easier for them to administer.

And Rapoport says if the researcher is sampling a small population, it may not be possible to get enough responses using active consent to make any meaningful sense out of the data. This may be particularly true if a researcher is trying to reach a population such as single-parent families or lower-income families, who are harder to reach.

Matthew Courser, PhD, a Columbus, OH-based associate research scientist with the Pacific Institute for Research and Evaluation and IRB member for the institute, says that researchers who want to use passive consent should be able to show an IRB that they have created multiple avenues of communication to parents.

"I might want to see multiple mailings, trying to get hold of parents a couple of different ways," Courser says. "I'd like to see an effort to really try to engage the parents, rather than do what I and other researchers love to do, which is send out a letter and assume if you don't hear back, that they read it, understood it and really don't mind their student doing it."

Pokorny says researchers can go to parent advisory boards or PTOs to discuss the study and take questions.

"If the researcher could demonstrate that (he or she) has presented the full context of the study in that kind of setting and none of the parents thought that anyone would object, then you could feel more comfortable going with a passive mechanism."