Guidance for Obtaining Informed Consent in School-Based Research
Introduction
One common challenge in conducting research in schools is obtaining consent from parents.
Because students in K-12 are almost always under 18 years of age, parental consent is usually
required. A few high schools require the researchers obtain parental consent for all students, even
those 18 years or older.
In most cases, parental consent means that the parents read and sign a consent document before
the child can participate in the study.
Additionally, appropriate assent from the minor is also required, with the particular form of that
assent depending on the development of the participants (e.g., younger children may not be
required to sign for assent but older children might be).
Obtaining Parental Consent
Researchers have developed a number of different techniques for obtaining informed consent from
parents. There is no set list of ways to do this because each research design is different, but in many
cases it is possible to contact parents directly to obtain consent. There are often activities such as
school registration or sporting events when parents can be contacted directly to obtain consent.
Also, some researchers have had success getting consent from parents by giving the class an
incentive if a certain percentage of parent consent documents are returned. There are many other
possibilities.
School districts vary in the policies related to conducting research projects and the written,
informed consent of participants. Some school districts always require signed documentation of
parental consent for all research involving students. The IRB expects that researchers following the
rules of the districts in which they conduct research. The Office of School University Research
Relations (OSURR) can help researchers identify differing policies and practices at various school
districts but the researchers are responsible for finding out about district specific requirements.
“Passive Consent” Usually is Not a Sufficient Form of Consent Under the Regulations
Researchers sometimes ask for approval of what is commonly called “passive consent.” Because the
federal regulations do not include a provision for passive consent, it is more formally considered a
type of a waiver of informed consent. This procedure involves informing parents of the study
through some combination of mail, newsletters, or other channels and then allowing parents to opt
out of the study if they do not want their child to participate. Because there is no way to know that
parents actually receive or read these materials, there is always some uncertainty about whether
the absence of a response from a parent indicates consent or indicates that they have not learned
about the study. Thus, it is unclear in these situations whether consent has actually been given. This
means that the notion of “passive consent” is usually not sufficient. The only way that a purely
passive consent process could be considered actual consent would be if the researchers had some
Guidance for Obtaining Informed Consent in School-Based Research
UIUC IRB
072011
way to be sure that a parent for each child actually saw a consent form (e.g., if the researcher was
able to hand a consent document to a parent for each child). Even in that case, if the researchers did
not collect signed consent forms, the researcher would need a waiver of documentation of consent.
Typically, because it is not possible to know for sure that parents have seen the consent form when
“passive consent” procedures are used, such procedures are not usually considered a viable form of
confirmed consent.
Under certain conditions, however, a ‘waiver of consent’ procedure can be used as part of a consent
process. Still, because passive consent is almost never a viable form of consent itself, the use of
passive consent nearly always requires a waiver of consent.
Waivers of Informed Consent
The federal regulations recognize conditions when consent can be waived, and these conditions for
granting a waiver also apply to parental consent. Most of the time when researchers request
“passive consent” what they really need to apply for is a waiver of consent (because in most cases it
cannot be known for sure that the parents have seen the consent document).
The conditions necessary to grant a waiver of informed consent are:
1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights or welfare of the subjects. In the case
of school based research, this would also include the rights of the parents.
3. The research could not be practicably carried out without the waiver.
4. Whenever appropriate, the subjects (and parents) will be provided with additional pertinent
information after participation.
Factors to Consider about Waivers of Informed Consent
Deciding on whether the four conditions for granting a waiver have been met is not always a
straightforward decision. One reason for this complexity is the various criteria interact. For
example, even within the category of research that can be called “no more than minimal risk,” there
are variations in the extent to which the research has some risk involved. For instance, even though
(depending on the specifics of the design) both might eventually be labeled no more than minimal
risk, there is a difference between a study that involves simply observing students without
recording identifying information and a study that asks students some potentially sensitive
questions. Although risk level is more pertinent to the first criterion, it is also related to the second
one because parents are more likely to believe their rights have been violated if the research
involves some sensitive questions rather than simple observations. Thus, deciding on whether a
waiver can be granted is not as simple as assessing each criterion independently; instead,
researchers and the board have to think about various factors that may be pertinent to multiple
criteria. Some of factors include the following.
Nature of the Activity
Guidance for Obtaining Informed Consent in School-Based Research
UIUC IRB
072011
Researchers need to consider what the research entails. Parents have greater and lesser
expectations that they be directly consulted depending on the nature of the activity. For example, if
the researchers are examining their child’s records that are not normally available to the public,
there is a greater expectation that parents must provide documented informed consent than if the
researchers are simply observing classes without recording identities. Research involving direct
interaction with students (interviews, questionnaires, and so forth) is more likely to require that
parents formally consent than is research not involving interaction with students.
Sensitivity of Topics
Interview and questionnaire research that asks about sensitive topics tends to involve more risks
than research on less sensitive topics. There are different types of sensitivity. Some research
involves asking subjects questions that (if answered in certain ways) could put them at risk of legal
consequences; for example, asking about illegal drug use or underage drinking could put the
participants at risk of legal consequences if the answers were to become known. Another important
type of legal risk is asking students about events that could lead to a mandated report of child abuse
or neglect (e.g., if the questions are likely to elicit specific information about ongoing abuse of a
minor).
The sensitivity of a particular set of questions has to be evaluated on a case by case basis rather
than by general topics. Many general topics can be more or less sensitive depending on what is
specifically asked. For example, if students are asked to confidentially report on their general
perception of whether there is a lot of bullying at their school, it is much less sensitive than if
students are asked to report on their own specific bullying behaviors or are asked to specifically
name bullies and their actions.
Because the sensitivity of questions must be evaluated on an ad hoc basis, it is impossible to list all
the topics that are considered sensitive, but there are certain topics that often are associated with
more sensitive questions. These include questions about abuse of children or the elderly, sexual
assaults, bullying, illegal behaviors, risky behaviors, sexual activities, and thoughts about suicide.
Research on any of these topics is often (but not necessarily) considered fairly sensitive. In such
cases, the bar for granting a waiver of consent is higher than it would be with less sensitive
questions.
It is also important to recognize that even if a study asks about sensitive topics, there are steps that
can be taken to mitigate the sensitivity of the study. For example, if there are some particularly
sensitive questions, the right to refuse to answer them can be highlighted by including a response
option such as “I do not want to answer.” Alternatively, having multiple reminders that questions
can be skipped is preferable to having that information stated only one time in the assent
document. In cases when the sensitivity of a research topic is mitigated by the specific design
features of the study, this increases the chances that a waiver of parental consent may be
appropriate.
Guidance for Obtaining Informed Consent in School-Based Research
UIUC IRB
072011
Developmental Stage of the Children
The level of development of potential participants is relevant in various ways. First, as children get
closer to the age of legal consent, they typically become more capable of understanding what they
are assenting to than are younger children. This is important because such children are more likely
to be granted some autonomy in their decision-making and therefore if they assent to a study that
their parents have not actively consented to, this is less likely to be considered a violation of the
parent’s rights than with a younger child. To be clear, this in no way implies that minors under 18
can give consent in some cases; instead, it simply means that norms about what parents have a
right to know about is somewhat influenced by the age of the child. All other things being equal, the
younger the child, the less likely it will be that a waiver of parent consent can be granted.
It is also important to note that the importance of developmental stages is not necessarily linear.
For example, there may be periods during preadolescence when children are particularly
susceptible to pressure from their peers or from authority figures. This would impede on their
ability to freely refuse to participate or to withdraw from the study. If there is reason to believe that
a particular group or cohort is particularly susceptible to such pressures, it is less likely that a
waiver of parental consent will be appropriate.
Because the waiver requires making a case that all the conditions for the waiver have been met,
researchers desiring a waiver of the parents’ consent should provide evidence that the participants
in the study are at a developmental stage where they can reasonably be expected to be able to
refuse or withdraw assent.
Protections for Privacy and Confidentiality
The measures taken to protect privacy and confidentiality influence the risk level, even within the
category of research that is considered no more than minimal risk. If a study gathers no identifying
information, it generally reduces the risk of the study and therefore increases the changes that a
waiver of parental consent may be appropriate. If the research collects identifiable information, the
appropriateness of a waiver depends on other factors such as the sensitivity of the questions and
how secure the measure taking to ensure confidentiality are. Privacy and confidentiality are, of
course, particularly crucial considerations if the data gathered are somewhat sensitive (see above).
Sufficiency of Efforts at Contacting Parents
Short of watching a potential participant (or parent) read a consent form and then quizzing him or
her over its contents, it usually is not possible in most research to know if a participant has truly
given informed consent. This problem in all research is compounded by circumstances when
parents are sent information about the study and then asked to opt out. In an opt in procedure, one
can at least be certain that the parent has seen the document (even if one cannot be certain that the
parent has read it). Because of the uncertainty inherent in an opt out procedure, the key question
becomes whether the researchers have made sufficient efforts to provide the parents a chance to
see the information about the study so that it is clear that their rights have not been violated.
Guidance for Obtaining Informed Consent in School-Based Research
UIUC IRB
072011
There is a wide range of ways that information about a study can be made available to parents, and
some are more likely to be considered a violation of rights than others. For instance, if researchers
choose to make the information about the study available only on the school webpage, it is very
likely that many parents would not see this, even though it was technically available for any parent
to see. In such a case, going forward with a study using an opt out procedure would generally be
considered a violation of the parents’ right to know that the research is going on.
The general principle is that researchers should use a method that is reasonably likely to contact
the parents of all the children. This can be accomplished in different ways, but one method that is
often appropriate is a mailing to the parent or parents’ home address. Although one cannot be sure
that the parent will open and read the mailing, the researcher can be reasonably sure that the
parent at least had the opportunity to see it (i.e., the parent’s rights to have access to the
information were not violated). If researchers do not use the mail, the IRB typically expects that
researchers use multiple methods for trying to inform parents such as going to registration or open
houses, having survey questions available for parents to review at the school, including information
about the student in newsletters, and so forth.
Because documents given to students to take home often do not make it to the parent or parents,
“backpack mail” is not sufficient by itself. If backpack mail is used as a way to contact parents, there
must be other additional means used to contact the parents about the study.
There is no firm list of approved and disapproved methods for contacting parents, but the key
question is always whether there is a reasonable likelihood that the means of providing information
will successfully make it available to a parent or parents of all potential student participants.
Ease of Opting Out
For a waiver of consent to be granted, it must be easy for parents to opt out if they wish for their
child not to participate. The ideal is for parents to have multiple options for opting out (such as both
by email or by phone). Providing an opt out procedure that is onerous to parents violates their
rights by implicitly pressuring them to allow participation.
Also, it is unreasonable to expect that parents would review materials about the research and reply
immediately. Therefore, the researchers should give ample time for parents to opt out. In most
cases, the IRB has expected that parents be given at least two weeks to opt out from the time they
are likely to have received the information about the study.
Guidance for Obtaining Informed Consent in School-Based Research
UIUC IRB
072011