We are conducting an online longitudinal survey involving children as research participants. Adolescents will enter data via their own registered portal. Should parents be allowed to view the data; and if so, until what age?
-CEO, Research Foundation
When research involves children, federal regulations require parental permission. These regulations define a child as: “… persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” i
If there are research specific statutes indicating when a minor can consent on their own behalf, the IRB would default to those provisions. However, most states do not have research specific statutes and therefore we will apply the statutes related to when a minor can consent to healthcare to determine when the child will be treated as an adult. If the child is considered an adult for a particular treatment or service, the child will be able to consent for themselves and this also means that they will have control over who can have access to the information from that treatment or service. All states have provision for allowing minors to consent on their own to healthcare related to pregnancy and sexually transmitted infections (STIs) and some states allow minors to consent for themselves for substance abuse and chemical dependency. Likewise, most states will allow a minor who is married and/or in the military to consent for their own healthcare.
With respect to treatment related to pregnancy and STIs, some states will set a lower age limit at which the minor can consent and others do not. If the state has set a lower age limit, such as 13 years old, a minor younger than that would need parental consent for the treatment. In this case, since the child does is not treated as an adult, the parents would have access to the information. If on the other hand, the child is 13 years old, they would be able to consent to the treatment. In this case, the child is able to say that they do not want their parents to have access to the information.
Outside of the limited situations where the state will allow the child to consent for themselves, the expectation is that the parents/guardians will consent for the child to be in the research and as such, the parents/guardians would have access to any information collected on the child and the survey results.
If the above referenced study is one where the child could consent to participant on their own, then the parents/guardians would not be able to get access to the information or survey results unless the participant agreed that the parents could see it. One approach that the sponsor could consider is requiring the parents to have access to the information and survey data in order for the participant to be part of the study. Based on the above description, the participant is not receiving care directly through the research, rather they are just answering survey questions. If the participant decides not to allow their parents to have access to their information or the survey results, the participant will not be enrolled. This approach will not impact the participant’s ability to get treatment if the states allows them to consent on their own behalf but it will be administratively easier to manage the study as it does not stratify the study by participants who have agreed to allow their parents to see their data, those who have not agreed to allow their parents to see their data, and those who are not able to consent for themselves.