Methodological Considerations for Active Information - Passive Consent
From ICE Primer: A Tobacco Control Research Methodology Primer
The TRI Council Policy Statement (TCPS) outlines the requirements for free and informed consent for participation in human research. In general, obtaining free and informed consent from research participants is considered the accepted norm in human research, and is also significantly related to the integrity of the research. Informed consent is considered the cornerstone of the research process with humans and is intended to ensure that: the dignity of potential research participants is respected; known and potential risks associated with the research are fully and adequately communicated to potential participants; agreements to participate in a study is voluntary and brings with it a communicated mechanism to withdraw from the study. Although the TCPS places great emphasis on the importance of the informed consent process in research with humans, it also acknowledges that there may be circumstances under which free and informed consent cannot be obtained. This circumstance might be encountered if a potential research participant lacks competency of capacity to give free and informed consent. A relevant example for purposes of this paper is the case of minors who are not legally able to give their own consent. In the case of minors, parents or legal guardians are asked to give permission on their behalf. Should alternate arrangements for obtaining consent be desired, seven criteria must be fulfilled under the TCPS guidelines. These seven criteria include:
- Research has a set procedure to ensure informed consent
- Research clearly states that participation is on a voluntary basis
- The research involves no more than minimal risk to the participants
- The waiver is unlikely to adversely affect the rights and welfare of the participants
- The research could not practicably be carried out without the waiver of alteration
- Whenever possible or appropriate, the subject will be provided with additional pertinent information after participation
- The waived or altered consent does not involve a therapeutic intervention.
Since the 1998 release of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) by the three major granting councils, there has been a major change in Canada in the guidelines governing ethical approvals for research. The rules that govern procedures for conducting ethics review are increasingly rigorous. Researchers and regulators are concerned that population health research that is conducted under field conditions must balance the utmost concern for what can work under real-life conditions with the rights of those involved.
Additional safeguards can be built in to ensure that parents are well informed about the study in which their son/daughter is being invited to participate and these can address the arguments typically put forth against the use of passive consent (Ellickson & Hawes, 1989).
Schools are key settings for research because it provides an important source of health information, a usual site for conducting interventions and access to a diverse youth population. The type of consent procedure chosen for a research study has both methodological and ethical implications. However ethical issues in school health research are multidimensional and complex because of the very nature of schools and student populations. In particular the type of consent required for a particular study is very critical. The major priority for any ethical consideration when studying students is protection of the rights of students first. It is well documented that the use of active parental consent can cause serious methodological problems including low participation rates (REF), ethnic bias (REF), gender and age bias (REF), personality trait bias (REF), and family trait bias (REF). Further, active parental consent procedures are very costly because of the elaborate methods that must be taken to try to elevate response rates (REFS). These problems are great enough to restrict research in the school setting. Parental consent procedures are broadly classified as being passive or active. This is a stub for new research on consent and student
Types of consent include active consent where an information letter and consent form is mailed directly to the parent and the signed form is returned in a stamped envelope or is sent back to the teachers with the student. Passive consent generally refers to a process in which an information letter is sent home to the parents/guardians of students. Parents are asked to respond if they do NOT want their child to participate. If parents do not respond as instructed in the letter the child is considered to be eligible to participate. Research has shown that there are numerous benefits for using passive consent (Sevenson & Biglan, 1989); passive consent will result in higher participation rates and a larger sample size, thereby reducing the likelihood of a Type 1 statistical error. Finally, passive consent allows either the parent or the student to decline participation, and not just one or the other as is the case with active consent (Sevenson & Biglan, 1989). This is in contrast to traditional procedures in which a parent has to actively provide permission via a signed consent form for their child to participate. Additional safeguards can be built in to ensure that parents are well informed about the study in which their son/daughter is being invited to participate and these can address the arguments typically put forth against the use of passive consent (Ellickson & Hawes, 1989).
A combination of Active information - Passive Consent (AI-PC) provides a response to some ethical issues while addressing methodological rigor. The important distinction between active information – passive consent from the other methods is its value-added component of how consent is applied. The value-added that this procedure offers is its efforts to increase the dialogue between parents, researchers and school administrators. This procedure / method ensures and explicitly communicates that there is an active process to provide information. It is informed consent but not active. It offers the same amount of information that one would receive using active consent procedures except it does not require parental signature. Despite differences in preference among researchers and IRBs regarding parental consent procedures, AI-PC fulfills the requirements outlined by the Tri-Council Policy Statement (1998).
Some key ethical issues surrounding passive consent include level of risk, age, type of consent, student assent, and bias of the study.
Level of risk is often described as minimal and non-minimal risk protocols. Minimal risk is commonly defined as potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in research to be no greater than those encountered by the student in those aspects of his/her everyday life that relate to research. Usually students under the age of 14 may not participate as a research subject in either minimal or non-minimal risk protocols, without parental consent. Students greater than or equal to 19 years of age are considered adults. Vulnerable populations require attention to type of consent required based on the level of risk and as well as the students in schools require strong attention to the rights of vulnerable students[1]
Most school boards require that a research proposal has received university and/or school board/district ethics board approval before they will accept the proposal for review.
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