Children in Research

The legal age of adulthood (age of majority) varies by state, meaning the legal definition of a "child" depends on where the research takes place. While typically 18, state laws outline specific exceptions where minors can legally consent for themselves. 

Research Conducted in Oregon: Under Oregon law, participants under 18 are considered children requiring parental permission, except in the following circumstances where the minor may provide their own consent:

• Emancipated or Married: Legally emancipated minors or married individuals (regardless of age or type of research).
• Reproductive Health Care: Minors of any age if the research procedures are limited to reproductive health care information or services (such as birth control or the diagnosis/treatment of sexually transmitted infections).
• Mental Health (Age 14+): Minors 14 years of age or older if the research involves outpatient diagnosis or treatment of a mental/emotional disorder or chemical dependency (excluding methadone maintenance).
• Medical Care (Age 15+): Minors 15 years of age or older if the research involves hospital care or general medical/surgical diagnosis or treatment.

Important Note for Investigators: For research to qualify under the medical/mental health exceptions above, the study activities must fall entirely within the scope of clinical care authorized by these statutes. If your study includes procedures that are solely for research purposes (e.g., experimental drugs, non-therapeutic biopsies, or purely scientific surveys), the IRB will likely require parental permission, even if the minor meets the age criteria.

For research involving activities for which Oregon law allows minors to provide their own legally effective consent, the participant does not meet the regulatory definition of a "child" for those specific procedures. Investigators should consult RCS when a study includes both activities that minors may independently consent to and activities requiring parental permission.

When designing research activities, data collection materials, and consent/assent processes, researchers must ensure they are developmentally appropriate for the target age group. The cognitive, emotional, and social maturity of the children should guide how information is presented, the length of the study sessions, and the complexity of the required tasks. 

• Assent Materials: RCS provides distinct assent templates based on age (e.g., ages 7–11 and ages 12–17). Researchers should further adjust the language and format of these templates as needed to ensure their specific study population can easily comprehend the study.

Safeguarding the privacy of pediatric participants and the confidentiality of their data is paramount. Researchers must collect only the minimum necessary information, store data securely, and ensure the physical setting during data collection offers adequate privacy.

• Mandatory Reporting: Researchers must carefully consider and disclose to participants situations where they are legally mandated to break confidentiality, such as in cases of suspected child abuse or if the child poses a danger to themselves or others. See the informed consent guidance (PDF) for recommended language. 

Researchers must justify the inclusion of children in research. Children should not be included merely because they are easily accessible, nor should they be excluded without scientific or ethical justification.

Because of the additional protections required by regulations, research involving children is restricted from qualifying for certain Exempt categories under 45 CFR 46. 

• Category 2 (Surveys and Interviews): Not permitted. Exemptions for survey or interview procedures do not apply to children.
• Category 2 (Observation of Public Behavior): Restricted. This category is only permitted if the observations are of public behavior and investigators do not participate in the activities being observed. 
• Category 3 (Benign Behavioral Interventions): Not permitted. This exemption category cannot be used for research involving children.

Studies involving children that are not eligible for exemption may still be approvable through non-exempt review. 

When conducting research with children, only specific exempt categories may be used, provided the research remains minimal risk and all other regulatory criteria are met:

• Category 1 (Educational Settings): Permitted. Includes research on normal educational practices in established educational settings (e.g., evaluating proven instructional techniques or classroom management already in use). The research must not adversely impact students' opportunity to learn required content or negatively impact the assessment of educators. 
• Category 2 (Educational Tests & Observation): Restricted. Permitted only if the research is limited to educational tests (cognitive, diagnostic, aptitude, achievement) or the observation of public behavior where the investigator does not participate in or interact with the children.
• Categories 4, 5, and 6: Permitted. Research involving secondary data/specimen analysis (Category 4), federal public benefit programs (Category 5), or taste and food quality evaluations (Category 6) can be exempt for children, provided standard regulatory criteria are met.
• Categories 7 and 8: Permitted when all regulatory criteria are met. However, Exempt Categories 7 and 8 require broad consent and ongoing tracking of participant consent decisions which cannot be implemented at this time so these exemption categories are not generally available for UO research. Contact RCS if you have questions about these categories. 

• Research that involves no greater than minimal risk to the children.
• Consent Requirements: Requires the assent of the child and permission from at least one parent (unless waivers are justified and approved).

• Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 
• The risk must be justified by the anticipated benefit, and the risk-benefit ratio must be at least as favorable as available alternatives. 
• Consent Requirements: Requires the assent of the child and permission from at least one parent (unless waivers are justified and approved).

• Research involving a minor increase over minimal risk with no prospect of direct benefit to subjects, but likely to yield generalizable knowledge about the subject's specific disorder or condition.
• Consent Requirements: Requires the assent of the child and permission from both parents (Exceptions apply if one parent is deceased, unknown, incompetent, not reasonably available, or if only one parent has legal custody). Assent and parental permission may be waived if specific regulatory criteria are met.

• Research that does not meet the criteria of the other categories above, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
• Special Approval: This category requires special review and approval from the Secretary of the Department of Health and Human Services (HHS) after consultation with a panel of experts.
• Consent Requirements: Requires the assent of the child and permission from both parents (Exceptions apply if one parent is deceased, unknown, incompetent, not reasonably available, or if only one parent has legal custody). Assent and parental permission may be waived if specific regulatory criteria are met.

• Many school districts have their own research review processes and committees. For example, local districts like Eugene 4J require researchers to submit a formal request to ensure the study aligns with district goals, minimizes instructional disruption, and does not overly burden students or teachers. There may also be individual school requirements and approvals necessary. 
• IRB approval does not supersede a school district’s authority to approve or deny research access. When applicable, researchers must obtain a formal letter of support or district approval before initiating the study. See the RCS Permission Chart (PDF) for more information about when documentation of school/school district approval must be documented in the RAP. 

FERPA is a federal law protecting the privacy of student education records. FERPA applies to both adult learners and children who are students. Generally, researchers must obtain signed, written permission from a parent or eligible student before accessing personally identifiable information from education records. While there are limited exceptions to written consent under FERPA (such as specific studies conducted for or on behalf of schools), researchers should generally anticipate needing signed written parental permission to access identifiable education records. Any plans to obtain FERPA protected data without signed written consent will need to be discussed with the educational institution to determine if an exception is allowable. 

Applicability 

FERPA applies when research involves the use or disclosure of education records. For FERPA to apply, these records must be directly related to a student and maintained by an educational agency or institution. 

• Where it Applies: FERPA applies to institutions receiving U.S. Department of Education funding, including public schools, Local Educational Agencies (LEAs), and postsecondary institutions (like the UO). Private and parochial K-12 schools generally do not receive this funding and are exempt, but researchers should always verify with the school.

Key Definitions

• Disclosure: A disclosure under FERPA means accessing, releasing, transferring, or other communication of personally identifiable information contained in education records by any means to any party except the party identified as the party that provided or created the record. When teachers or school officials access identifiable education records for research purposes that are not considered a legitimate educational interest necessary to fulfill their professional duties, that access is FERPA regulated even if they never send identifiable data to external researchers. 
   
• Education records: materials directly related to a student and maintained by an educational agency or institution. These include academic records such as grades, transcripts, and class schedules; applications for enrolled students; attendance records; assignments, discussion board posts; student financial records and special education records such as Individualized Education Programs (IEPs) and related assessments. 
   
• Students: any individual who is or has been in attendance at a school. 
   
• Personally Identifiable Information (PII) includes, but is not limited to:
  • The student's name;
  • The name of the student's parent or other family members;
  • The address of the student or student's family;
  • A personal identifier, such as the student's social security number, student number, or biometric record; Note: biometric records are measurable biological or behavioral characteristics that can be used for automated recognition of an individual. Examples include fingerprints, retina and iris patterns, voiceprints, DNA sequences, facial characteristics, and handwriting.

FERPA Requirements Impacting Human Subjects Research

Unless a formal FERPA exception is granted by the educational institution holding the records, researchers must obtain signed and dated written consent from the parent (or adult student) before accessing records. 

• No Passive Consent: Opt-out or passive consent does not meet FERPA requirements. However, exceptions may be possible.
• Electronic Signatures: Must identify and authenticate a specific person as the source of the consent.
• Required Consent Elements: In addition to standard IRB requirements, a FERPA consent form must specify:
  1. The specific education records to be disclosed.
  2. The purpose of the disclosure.
  3. The specific party or class of parties receiving the records.
  4. A statement that the school will provide a copy of the disclosed records to the parent/student upon request.
• Requesting a FERPA Review: All studies involving FERPA protected data associated with UO students will need review by the UO registrar. For non-UO institutions, the official responsible for conducting the FERPA review may vary. The RCS/IRB cannot grant a FERPA exception; it must be granted by the educational institution holding the records. 
  • For UO Records: Contact the UO Registrar (email both registrar@uoregon.edu and kaira@uoregon.edu).
  • For Non-UO Schools: The decision-maker varies (e.g., Principal, District Privacy Official, or Registrar).

PPRA applies to programs funded by the U.S. Department of Education and dictates how researchers may administer surveys, evaluations, or analyses that touch on sensitive topics. 

PPRA Applicability

PPRA applies when the local educational agency or the research is funded by the U.S. Department of Education (ED) and students will complete a survey, analysis, or evaluation that reveals information about one of the 8 protected topics. Note: A Local Educational Agency includes elementary schools, secondary schools, school districts, or local boards of education. It does not include postsecondary institutions like the UO. 

8 Protected Topics

1. Political affiliations or beliefs
2. Mental or psychological problems
3. Sexual behavior or attitudes
4. Illegal, anti-social, self-incriminating, or demeaning behavior
5. Critical appraisals of close family members
6. Legally recognized privileged relationships (e.g., lawyers, physicians)
7. Religious practices, affiliations, or beliefs
8. Income (other than as required by law to determine program eligibility)

PPRA Requirements Impacting Human Subjects Research

Researchers must work directly with the local educational agency to ensure PPRA requirements are met.

• Right to Review: Parents/guardians (or adult/emancipated students) must be notified of their right to review the survey and instructional materials before the research is conducted.
• Consent and Waivers: The IRB cannot overrule a school district’s PPRA policies or issue a waiver of consent for protected topics unless proper PPRA notification occurs.
  • Passive Consent: May be permissible under an IRB waiver if parents receive notification and an opportunity to opt out of the survey.
  • Active Consent: If the research is Department of Education-funded and the survey is mandatory, active written consent is required by federal law. The IRB cannot issue a waiver of informed consent under these circumstances.  

• Permission vs. Consent: Because children are legally unable to provide informed consent, researchers must obtain permission from parents/guardians and, when appropriate, assent from the child (See Assent section below).  
• Mutual Agreement: If both parent/guardian permission and child assent are sought, both must agree. In most cases, a parent's denial overrides a child's assent, and a child's dissent overrides a parent's permission. The child cannot participate unless both agree. A child's refusal should be respected in most circumstances. However, the IRB may determine that assent is not required under limited circumstances permitted by the regulations.
• Information Requirements:
  • Non-Exempt Research: Parents must be given the same basic information that is generally required for adult subjects. A study must meet specific criteria in order to receive a waiver or alteration of parent/guardian permission (see Waiver or Alteration of Parent/Guardian Permission section below).  When parent/guardian permission is sought, permission must be documented in writing with a signature unless documentation is waived (see Documentation of Parent/Guardian Permission section below).
  • Exempt Research: The information in the permission form can generally be more limited. However, if other regulations apply (like FERPA or PPRA), specific written consent elements may still be required.

While obtaining parental permission is the standard requirement for research involving children, the IRB may approve a waiver of parental permission or alteration of informed consent under specific regulatory conditions. 

• Waiver and/or Alteration (including "Passive" or "Opt-Out" Consent): The IRB can waive or alter the requirements for parental permission (such as using a "passive" or "opt-out" consent process). A complete waiver or a waiver of one or more of the required elements of consent (alteration) may be granted if the study meets the following regulatory criteria:
  1. Research involves no more than minimal risk to the subjects;
  2. Research could not be carried out without the requested waiver/alteration 
  3. If the research involves using identifiable private information or identifiable biospecimens, the research could not be carried out without using such information or biospecimens in an identifiable format;
  4. The waiver/alteration will not adversely affect the rights and welfare of the subjects; and
  5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation
• Additional Information about "Passive" or "Opt-Out" Consent
  • In human subjects research, passive consent (also called opt-out consent) is a process in which potential participants are informed about a study and are considered to have agreed to participate unless they actively decline or opt out. This is not considered a valid consent process by the regulations and requires all criteria for a waiver of consent to be met (see above). 
  • Required Documentation: 
    • The investigator must provide the parent(s) with a written document in a language understandable to them containing the required elements of informed consent. Parents must have sufficient information to determine if they do not want to allow their child to participate in the research. If a parent/guardian and a child are both participants, one consent document can be used to obtain both permission for the child and consent from the parent/guardian. 
    • The research plan should explain how the written document will be distributed to parents/guardians. Consider what would be the most reliable method to get the information home to the parents/guardians. For example, you may choose to work with the schools to have them send an email directly to the parents/guardians. As information sent home with children may not be reliably provided to parents/guardians, it is good practice to have multiple ways of providing the information to the parents/guardians and not relying solely on information sent home with children.
    • Parents/guardians must be given sufficient time to decide whether they want to opt their children out of the research and communicate this back to researchers. In the research plan, explain how much time will be allowed for parents/guardians to make a participation decision and justify why this timeframe is adequate given the nature and complexity of the study. 
  • Some school districts require active parental consent regardless of whether IRB waiver of documentation of consent is appropriate, so it is a good idea for the researcher to check in with the participating school districts and schools prior to the development of a passive consent process.
• Waivers to Protect the Child (e.g., Abuse or Neglect): If requiring parental permission is not a reasonable requirement to protect the subjects (e.g., research involving neglected or abused children), the IRB may waive the requirement.
  • Alternative Mechanism Required: To utilize this waiver, the researcher must propose an appropriate alternative mechanism for protecting the children that is consistent with state and local laws. The appropriateness of this alternative is based on the study's risks, benefits, and the age, maturity, and condition of the children.

Researchers must obtain and document parental or guardian permission in writing prior to a child’s participation in a study, unless the IRB has approved a waiver of documentation.

Number of Required Signatures:

• One Parent: Sufficient if the research involves minimal risk (404) or presents a prospect of direct benefit to the child (405).
• Both Parents: Required if the research poses more than minimal risk with no direct benefit (406/407). Exceptions apply if a parent is deceased, unknown, incompetent, not reasonably available, or lacks legal custody.

Form Structure:

• Combined vs. Separate Forms: While parents and children can technically sign the same document, using separate forms is generally recommended to ensure the child's assent form remains written in age-appropriate language. However for older children (12-17), it may be appropriate to obtain assent using the same form but a separate signature line for children on the parent/guardian permission form. 
• Parents as Subjects: If parents are also participating as subjects in the research, a separate consent form may be used for their own participation. However, a combined parent/guardian permission and adult consent form may be appropriate if the form is clear which population is doing which activities (you/your child). 

• Defining Assent: Assent is a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. 
• Requirement: For non-exempt research, child assent is required whenever the children are capable of providing it, unless specific regulatory criteria for a waiver are met (see Waiver of Child Assent section below).
• Mutual Agreement: If both parent/guardian permission and child assent are obtained, the parent(s) and the child must agree to participation or the child cannot participate.
• Dissent and Ongoing Assent: Assent is an ongoing process rather than a one-time event. Investigators should respect a child's willingness to participate initially and throughout the study and seek renewed assent when appropriate because of changes in age, maturity, or study activities. If a child shows signs of dissent (behaviorally or verbally), their wishes should be honored. 
• Child Participants Who Reach Age of Majority: Individuals enrolled in research as children may reach the legal age of consent during the course of a study. If these participants will continue to participate in the research, investigators should obtain the participant's own informed consent for continued participation once they are legally able to consent for themselves. Researchers should plan for this possibility when designing longitudinal studies involving children. 

The IRB may waive the requirement to obtain child assent under specific circumstances outlined in federal regulations. A waiver may be granted if any of the following apply:

• Lack of Capacity: The IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted. This is determined by taking into account the ages, maturity, and psychological state of the children involved. 
• Direct Benefit: The research holds out the prospect of direct benefit that is important to the health or well-being of the children, and this benefit is available only in the context of the research.
• Waiver Criteria are Met: Even if children are capable of assenting, the IRB can waive the assent requirement if the study meets the same regulatory criteria required for a waiver of informed consent (as listed in the Waiver or Alteration of Parent/Guardian Permission section above).

When the IRB determines that child assent is required, it must also determine whether and how that assent must be documented.

Age Requirements and Capacity (UO Policy):

• Federal regulations do not set a minimum age for assent. Instead, the development of the child (age, maturity, and understanding) should be considered. Experts in child development have generally recommended that children 7 years of age or older participate in a formal assent process.
• Children Under 7: Formal assent does not have to be solicited. However, the IRB encourages researchers to explain to younger children what they will be asked to do in simple terms and secure their agreement to participate if possible. 
• Children 7 and Older: Assent must generally be obtained unless specifically waived by the IRB.

Form Language and Structure:

• Developmental Appropriateness: The assent form must be written in language appropriate to the child's specific age, maturity, and understanding.
  • Resources: Please see the UO assent form templates for children ages 7-11 (Word), UO assent form templates for children ages 12-17 (Word), and assent form supplemental guidance (PDF). 
• Combined vs. Separate Forms: If the parents are also research subjects themselves, it may be appropriate to have them sign the same form their children sign. For example, combined parent/guardian permission and adult consent form may be appropriate for older children if the form is clear which population is doing which activities (you/your child). 

• A "ward of the state" (which may also be referred to as the "ward of the court" in state law) is a child who is under the legal custody or guardianship of the state, or any other agency, institution, or entity. This may include children in the foster care system, those under the protective care of child welfare agencies, or youth in state-run facilities where the government has assumed the legal rights and responsibilities of a parent. 
• Because legal custody is governed by state and local laws, the exact criteria for who qualifies as a ward depend on the specific laws of the jurisdiction where the research takes place.
  • Under Oregon Revised Statutes (ORS) 419B.328, a juvenile court legally makes a child a "ward of the court" once it determines it has jurisdiction over the child's welfare. This legal mechanism typically occurs under ORS 419B.100 when a child is found to be abused, neglected, abandoned, or otherwise lacking capable parental care, necessitating government protection.

• For research approved under 45 CFR 46.406 (greater than minimal risk, no direct benefit) or 45 CFR 46.407 (greater than minimal risk research requiring HHS Secretary approval), wards can only be included if the research is:

1. Related to their status as wards; or
2. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

• Additionally, when wards are included in these higher-risk categories, the IRB must ensure that an advocate is appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. The advocate must be independent of the research, the investigators, and any guardian organization, acting solely in the best interests of the child.

• 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. 
  • 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.
  • 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).

Mandatory Reporting & Oversight

• 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.
• 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.
• 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.
• Appropriate Study Design and Practices for Research with Minors:
  • 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:
    • 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.
    • Appropriate training of all research personnel based on research roles and degrees of responsibilities.
    • PI-established standard operating procedures, expectations, and guidelines for the research team in order to foster a protective culture when including minors in research.
    • 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.
    • 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.
    • 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.)
    • 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.
    • 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.
    • 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.
  • 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.

Staff Training for Research with Minors

• 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:
  • Expectations, including appropriate interactions, behavior standards, conversations, and boundaries-including scenarios based on the research methods and setting. 
  • Child abuse awareness and prevention, safety, and privacy.
  • Mandatory reporting requirements and research procedures when there is suspected child abuse or neglect.
  • Appropriate conduct requirements, incorporating expectations for interacting with minors, including age-appropriate considerations.
  • Other related University policies and procedures.
• Alternatively, the PI may elect to require all research personnel to complete the UO online-training; this may also be used supplemental to PI-led training.

Criminal Background Checks

• 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.
• 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.
• 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).