Steven B. Pokorny talks about the issues to consider when choosing between passive and active consent.
Q: What is the difference between active and passive parental consent?
A: Active and passive consent methods differ in important ways. A passive consent procedure typically involves distributing a letter to the children’s parents or guardians explaining the nature of the study and providing a method to retract permission. In an active consent procedure, the introductory letter explains the nature of the study and provides a method to document permission. The important distinction between these two procedures is that the passive consent procedure assumes that the parent or guardian has consented unless some action is taken, whereas the active consent procedure requires the parent or guardian to signify in writing their permission for the minor to participate in the study.
Q: What issues do researchers need to consider when deciding between active and passive consent?
A: Researchers face considerable ambiguity and controversy regarding the issue of obtaining informed consent for minors. Terms such as “active” and “passive” are not part of the regulations, and the definition of minimal risk is vague. However, some guidelines have been developed for research involving children (OHSR, 1993). Your decision may depend on your funder and/or your IRB as well. The Department of Education now requires active parental consent for surveys, analyses, and evaluations they fund, and while some IRBs allow passive consent under certain circumstances, many do not. So before you make a decision, familiarize yourself with the current regulations, and discuss specific concerns with your IRB.
Q: What are some of the arguments for allowing passive consent in research with children?
A: One advantage for using passive consent procedures is that they typically result in a very high response rate, and may also yield a non-biased sample for population-based surveys (e.g., all of the enrolled students at a school). In the 1st year of our study (Pokorny, et al. 2001), we sent parent consent letters to over 7,000 6th – 8th graders, giving parents the opportunity to decline permission for their child to participate by contacting the principal or project director. Our participation rate was 89% and representative of the enrolled students.
Q: What are the concerns related to using passive consent?
A: One of the major criticisms of using passive consent procedures is that the parent/guardian may not get the information they need about the study. For example, information that is sent home through the children may never make it home, or may be accidentally discarded when it arrives with other information sent by the school. The researcher has no documentation that the parent/guardian had exposure to the information. Even if they received the information, there is no guarantee that they read it and understood that they had to notify someone if they did not want their child to participate.
There is also the issue of “minimal risk,” especially in studies of sensitive issues like tobacco and drug use. If the study involves more than minimal risk, then active consent is required, but the definition of minimal risk isn’t clear. Although highly unlikely, for example, it is possible that a minor could become upset when presented with a question about his/her tobacco or other drug use.
Q: What are the advantages or reasons behind using active consent?
A: Some researchers and parents believe that obtaining active parental consent is more ethical than passive procedures, especially when the study involves sensitive issues with youth. Many families are upset with corporate America’s use of passive consent in marketing practices. For example, some companies entice people to accept a free trial period of a product and then begin billing the consumer at the end of the period unless the consumer notifies the company that they do not want to purchase the product. With active consent, you are assured (as much as is possible), that the parent has read the information, understands the study, and has given approval for the child to participate. School administrators may also feel more at ease with the research knowing that they are less likely to get complaints from parents/guardians regarding their children’s participation.
Q: Any disadvantages to active consent?
A: It can be more labor intensive to get a satisfactory return rate, and some studies show that active consent procedures can result in a biased sample, which affects your ability to generalize the results. However, good participation rates and representative samples can be obtained by collaborating with school administrators.
Q: When you collaborated with school administrators, what active consent methods did you end up using, and how successful were they?
A: We used 3 methods of obtaining active consent, based on each principal’s idea of which method would yield more consents. Interestingly, they varied quite a bit in their success rate. Version 1 involved sending the consent packet with the student report card, which required a parent/guardian’s signature. Minimal follow-up was needed, and our return rate was 85%.
For Version 2, the consent packets were sent directly to the students’ homes, and parents were required to sign and return the form. This procedure required the school staff to do follow-ups, and we got mixed results. Return rates varied from 55% to 82%. When we looked closely, we found that the key to getting better response rates with this method was administrative support. When administrators actively encouraged the teachers to get consents back from the parents, the return rate was higher.
In the 3rd version, which we used in only 1 school, the consent packet was mailed directly to students’ homes with a self-addressed stamped postcard to be mailed to our research team. This version did not work well at all, with only 33% of the parent/guardians returning the form.
Q: What suggestions do you have to increase response rates for active consents while maintaining a non-biased sample?
A: We found that the most effective method was sending the consent packets home attached to the child’s report card (when the report card required a parent/guardian’s signature). By making the consent form a part of an already required and familiar procedure, a successful response rate was achieved without placing additional burden on school staff or the research team. The next best method for us was sending the consent packet directly to the children’s homes, and having teachers follow-up with reminders. However, this method was successful only when combined with strong administrative support.
Q: Any other advice for researchers involved in the process of obtaining parental consent?
A: Decisions about the use of passive versus active consent are complex, and they can involve cultural and religious value issues that exist within the research setting, normative practices within the IRB, guidelines from funding agencies, and norms within the community. While it is possible to elicit high participation rates with active consent, more resources are often needed to accomplish this goal, and you might exclude those at highest risk. Investigators can be confronted with a dilemma if funding agencies require active consent and high participation rates, but do not provide the funding infrastructure to accomplish this goal. In addition, while some school administrators will welcome active consent procedures, others will see it as burden because more time and energy needs to be devoted to gaining consent.
We suggest that researchers seek creative ways to obtain active consent without overwhelming the school staff. Collaborate with the school administrators and faculty; seek their advice on what will work best with their population. Look for multiple methods to inform the target population about the study. For example, we go to major school events like walk-in registration, open house, parent-teacher conference nights, and report card pick-up events. We become part of the school’s existing processes. We also communicate through school newspapers, principal letters to parents, and even parent-teacher organization groups. When parents are adequately informed and see the research team as part of the school community, they will be more likely to return consent forms.
This transcript is based on personal communication with researcher in February 2005 and published article. 1 Pokorny, J., Jason, L., Schoeny, M., Townsend, S., & Curie, C. (2001). Do participation rates change when active consent procedures replace passive consent? Evaluation Review, 25(5), 567-580.