According to the Belmont Report principles, respect of persons requires that subjects be both fully informed and fully autonomous in participating in research. This means certain demographics will require special concerns for their participation in research, especially those who are reduced in their ability to make an informed and educated decision. Children are of high consideration, moreso when students, and further, prisoners are subjected to extensive policy safeguards as well. Further, international concerns need to be addressed for researchers, as well as how to report unanticipated problems.
Learning Outcomes
Children
Children as human research subjects are one of the most commonly involved vulnerable populations and as such there is a great deal of consideration to give. A child is defined as someone under the age of consent – while this is 18 for the majority of the US (except for Alabama and Nebraska, where it is 19, and Mississippi, at 21), special attention must be given in other jurisdictions. If an area does not have an age of consent, local customs and norms must be weighed in assigning one.
All considerations for “consent” are the responsibility of their legal guardian, as a child is someone who is under the age of consent. However, a secondary agreement to participate is required to attained from the child, called “assent,” if the child is old enough to be able to reasonably do so. Federal regulations are broad in describing the assent process yet for accountability it may be in the best interest of the IRB to provide a separate agreement document like the informed consent for the child to sign. This must be in language understandable for the child. Generally, consent documents can be signed by one parent, but in studies that involve more than minimal risk without direct benefits to the child, it is required to have both parents sign. Any amendments to this process must be approved by the IRB and essential to the study procedure (such as needing to use deception to attain accurate results), the safety of the participants (such as waiving parental consent and waiving documentation of child assent for studies about children perceiving marital abuse) or otherwise absolutely necessary.
Under almost all circumstances, research with children is not eligible for exemption and must obtain informed consent and child assent. A list of exceptions include:
In most circumstances, the child is a ward of the state or other organization, they are not permitted to be participate in research. Exceptions must be research specifically related to the child’s status as a ward, or conducted in settings such as schools or camps where the majority of other participants are not wards. Further, the IRB must require that each child who is a ward must have a designated advocate.
Also, remember, if a child reports any form of abuse or neglect, inside or outside study parameters, it is mandated that this be reported to the appropriate authorities immediately. This supersedes informed consent, confidentiality procedures and studies given a certificate of confidentiality.
Research in primary and secondary schools
Studies taking place in schools with minors, such as primary (elementary) or secondary (high school), has an additional set of considerations that must be weighed when doing research. Firstly, the Family Educational Rights Protection Act (FERPA) protects the educational records of students from being disclosed without parental approval. While in certain circumstances this may be waived,, such as studies run by a school district or research in private schools with no funding from the Department of Education, on the whole, it is a federal law that must be abided by. Even if a researcher is an employee of the school and normally has access to these files, they must understand the dual role of a researcher and employee, where they may not access these records as a researcher even if they can as an employee. Directory information is generally not covered by FERPA. Further, the Protections of Pupil Rights Act (PPRA), gives parents rights in controlling the participation and consent requirements for studies their children participate in.
PPRA regulations give parents control over their children’s participation in surveys and experimental instructional methods. If a survey involves eight sensitive topics, parental consent must be attained and cannot be waived and they have the right to review the study instruments. These eight topics are:
Further, all schools funded by the Department of Education (which includes all public schools) are required to notify parents about third party surveys, allowing them to review them and request their children not participate. This can be done even if the parental consent is waived.
Parental consent is not able to be waived unless five criteria are met. This may be advisable when parental consent forms may present a barrier to attaining an accurate and representative sample. The criteria are:
Research is eligible for exemption for only a narrow subset of criteria. This includes observational studies in public areas (such as playgrounds) if the researcher does not interact with the subjects, research analyzing educational tests (unless disclosure may pose harm to subjects), using aggregate data such as system wide performance information or recorded data without identifiers, and finally, research conducted with “normal educational practices that are not likely to adversely affect student’s opportunity to learn. An example of this last criterion would be studying the difference in performance between two classes both using different but widely accepted English curricula, to assess their effectiveness or the importance of their methodology.
Finally, in regards to the child assent process, special care must be given to not pressure students. Students may fear their teachers will be angered by non-participation, and it would be beneficial to advise them this is not the case. Further, students may feel isolated or alienated if they are one of the few class members not participating in the study, which would be rectified by providing alternative activities to study participation. Students will likely feel pressured to participate in the study if doing so in a group setting and should be given privacy in deciding whether or not to participate. Finally, students may be swayed to give “correct” answers in studies and it is advisable to inform them there is no “right or wrong” answers in the study.