Procedures
While research with minors is not considered a “Youth Program” under current University of Oregon policy, the following procedures outline standards that apply to research involving minors. These standards, as appropriate within the given research context, further support the university community’s goal to protect minors and serve to provide researchers with expectations to protect minors in research while preserving the integrity of the research.
Definitions
Minor is defined as a person under the age of majority where the research is conducted.
Care, custody, or control of minors is defined as when an adult is present and has primary responsibility for supervision of minors at any given point through the research. At least one adult must have care, custody, or control of minors at all times during the research.
Examples:
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In care, custody, or control of minors: Research staff member is the only adult in the visual field of the minor such that they could intervene in a timely manner.
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Not in care, custody, or control of minors: Observing and coding participant behavior in a semi-private setting where there is another adult responsible for supervision (e.g., child’s school playground, small group interactions in a classroom where teacher is present, research lab where parent observes child/researcher interactions from another room via live video or two-way mirror, home visit where a parent or guardian is present).
Standards
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Mandatory Reporting & Oversight:
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Pursuant to the Oregon Child Abuse Reporting Statutes and university Protection of Minors policy, all university employees have a duty to make a report to the Oregon Department of Human Services or a law enforcement agency when there is reasonable cause to believe any child with whom the employee comes in contact has suffered abuse or that any person with whom the employee comes in contact has abused a child. For instances that related to UO authorized research activities, all UO employees are expected to make the report immediately to the University of Oregon Police Department. Therefore, UO employees must provide direct oversight of research involving minors. Volunteers and non-UO employees must be under the direct oversight of a UO employee when the research involves working with minors.
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PIs must use appropriate screening when hiring research team members who will have contact with minors, including incorporating questions to screen potential team members in relation to their ability to work with minors. Human Resources and/or Risk Management are available as a resource when hiring research personnel.
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Research teams who work with minors must be appropriately supervised based on experience and duties. PIs and senior staff must provide direct oversight of team members. Periodic unannounced visits and observations may be important to ensure appropriate conduct of team members when interacting with minors.
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Appropriate Study Design and Practices for Research with Minors:
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Researchers must establish study designs, research methods, and procedures that follow responsible conduct of research practices and ensure the protection of the minor at all times. There must be adequate rationale for the inclusion of minors in the research. Research design and study management considerations that, when carefully planned, offer additional protections for minors typically include:
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A clear organization structure with defined roles and responsibilities, appropriate degree of supervision based on roles and responsibilities, and overall research supervision by experienced personnel. The research design must include adequate supervision of the minors in research based on age and developmental level. The PI is responsible for ensuring sufficient experienced research staff are present during the conduct of the research to protect the minors.
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Appropriate training of all research personnel based on research roles and degrees of responsibilities.
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PI-established standard operating procedures, expectations, and guidelines for the research team in order to foster a protective culture when including minors in research.
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Thoughtful research designs that avoid one-on-one situations with a minor unless the researcher must be in the care, custody, or control of the minor as dictated by the research method. In such circumstances, scientific justification and additional procedures within the research context must be incorporated in the research to ensure the protection of the minor in the research.
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Standard practices to ensure physical and emotional needs of the minor in research are met; this must include ensuring adequate privacy, safety, comfort, and basic needs are met.
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Thoughtful research designs that minimize the possibility of implicit pressure of the minor. Researchers must take into account social, peer, parental, and authoritarian pressures (e.g., teacher, doctor, other adult authority) when designing research recruitment procedures.When designing research with minors, careful attention should also be made regarding any special arrangements for participation (coordination with other activities, child-care provisions of siblings, transportation, parking, reimbursements) and for any compensation to the minor and/or minor’s parent/guardian (monetary or otherwise.)
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Thoughtful research designs that accounts for appropriate assent of the minor, when age and/or developmentally appropriate, and the appropriate permission of the parent or guardian (unless otherwise justified and waived by the IRB). If a child is capable of assent and dissents from participating, even if parents or guardian have granted permission, the child’s decision must prevail unless the IRB has waived the assent requirements under special circumstances. If a child assents to participate in the research, and parental/guardian permission has not been waived by the IRB, the permission of the parents or guardian is required before the child can be enrolled and participate in the research. Continued assent and consent must be obtained throughout the remainder of the research; research team members should make special considerations to incorporate confirmation of continued assent and consent at critical times in the research, as appropriate based on study design.
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Thoughtful research designs that include standard practices and procedures by the research team if researchers discover sensitive information about research participants that is not related to the study itself. This may include information about a minor’s sexual activity, illegal substance use and/or behavior, health status, and/or child abuse or neglect. The research design must account for how such situations will be handled should they arise. Consent and/or assent processes and documents must include adequate descriptions about plans for disclosure, specifying when mandatory, or non-disclosure.
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Thoughtful research design when minors are enrolled in long-term studies, as obtaining new consent may be required for continued participation when the minors reach the age of consenting for themselves.
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Researchers must adhere to all university policies, applicable civil rights laws and policies and conduct requirements, including university respectful workplace requirements. Researchers should conduct themselves in a courteous and respectful manner, be an appropriate and positive role model for minors, adhere to and enforce other rules, policies, and guidelines established for the research by the PI, and strive to provide a safe, comfortable research experience for the minor.
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Staff Training for Research with Minors:
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Training for all research personnel who are conducting research with minors must occur prior to conducting the research activities. Training must include instruction specific to the IRB approved protocol, research team procedures and instructions, and instruction around protecting minors in the research context. Generally, topical training for the protection of minors should include the following elements, as determined appropriate for the research setting:
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Expectations, including appropriate interactions, behavior standards, conversations, and boundaries-including scenarios based on the research methods and setting. Human Resources offers additional information on behavioral standards for interacting with minors.
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Child abuse awareness and prevention, safety, and privacy.
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Mandatory reporting requirements and research procedures when there is suspected child abuse or neglect.
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Appropriate conduct requirements, incorporating expectations for interacting with minors, including age-appropriate considerations.
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Other related University policies and procedures.
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Alternatively, the PI may elect to require all research personnel to complete the UO online-training available through HR at https://hr.uoregon.edu/hr-programs-services/youth-programs-protecting-minors/youth-programs-training-staff; this may also be used supplemental to PI-led training.
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Criminal Background Checks
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For researchers in the care, custody, or control of the minor for research, a criminal background check must be performed prior to engaging in research with minors. The criminal background check must be current, within 2 years, and must be documented in the research records. The PI is responsible for working with HR in obtaining appropriate documentation for the research records, and for maintaining current (within 2 years) background checks for all research personnel in the care, custody, or control of minors for the research. The PI must also have a current criminal background check in the research records. The PI is responsible for working with HR and his/her supervisor if a criminal background check reveals information that could affect the individuals’ suitability for their role in the research with minors.
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For NIH-funded research (and potentially other federally-funded research):Additional information is solicited from PIs in their proposal to address how the research team is prepared to responsibly conduct the research with children. This offers further protection of minors in research.
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Additional protections, as mandated by Federal regulations governing human subject research, are included in IRB approved protocols to mitigate risks associated with the individual risks of the research study and include specific directives of the IRB as well as the requirements to obtain appropriate assent of the minor (unless waived by the IRB) and appropriate parental permission (unless waived by the IRB).
Assent of the child
Assent must be obtained from the child if the child is 7 years old or older. However, the Committee for the Protection of Human Subjects (CPHS) may waive the assent requirement if some or all of the children lack the capacity to give meaningful assent, or the research holds out the prospect of direct benefit that is important to the health or well-being of the children that is available only in the context of the research.
The federal regulations do not set a minimum age at which a child's assent must be solicited but instead say that assent is required whenever in the judgment of the CPHS the children are capable of providing assent, taking into account their ages, maturity, and psychological state. The CPHS has set this age at 7 years based on consultations with a child development expert on the University of Oregon faculty. Therefore, when research subjects are younger than 7, their assent does not have to be solicited, but the committee encourages researchers to explain to younger children what they will be asked to do in the course of the research and to secure their agreement to participation if possible.
Please also see the UO assent form templates for children ages 7-11, UO assent form templates for children ages 12-17, and our assent form supplemental guidance.
Permission from parent(s) or guardian
If the research involves only minimal risk, or it poses more than minimal risk but promises to benefit the child directly, permission must be obtained from at least one of the child's parents, or the child's guardian. If the research poses more than minimal risk and no direct benefit to the child, both parents or the child's guardian must give permission for the child to participate in the research. However, the permission of a parent who is deceased, unknown, or incompetent, or not reasonably available, or who does not have legal responsibility for the care and custody of the child is not required.
If a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the children (for example, neglected or abused children), the committee may waive the requirement that parental permission be sought, provided that there is an appropriate alternative mechanism for protecting the children which is not inconsistent with the law. The choice of an appropriate alternative mechanism depends on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the children, and their age, maturity, status and condition. In such cases the researcher should propose an alternative mechanism, explaining why it will protect the children. The committee will then review the adequacy of this proposal.
When parents or guardians are asked for permission and children are asked for assent, they must be given the same basic information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing.
The assent form for children should be written in language appropriate to their age and understanding. If the parents are not also research subjects themselves, it may be appropriate to have them sign the same form their children sign. If the parents are also research subjects, ordinarily a separate form should be drafted for them, addressing their own participation as well as that of their children. See the sample consent forms for examples.
In circumstances in which the usual requirements for securing and documenting informed consent may be waived when the subjects are competent adults, the CPHS also may waive or alter the requirements for seeking permission and assent with a "passive parental consent" or opt-out consent procedure when children are subjects.