Contents

100. Introduction

200. Glossary and Definitions

300. Research Scenarios and Oversight

400. Approved Screening Procedures

500. Appropriate Study Design and Practices

600. Training

700. Mandatory Reporting

800. Resources

100. Introduction

Research with children and youth is considered a “Youth Program” under Montana State University’s Sponsored Programs for Children and Youth policy. The following procedures further outline guidelines that apply to research involving children and youth. These guidelines support the university’s goal to protect children and serve to provide researchers with expectations to protect children in research, while preserving the integrity of the research. 

The guidelines outlined here are the baseline requirements for conducting MSU research involving children. These guidelines apply when children are thedirect research subjects, when the research is about children, or when the research is about a program delivered to children. Certain requirements may apply for MSU research studies with federal funding or research occurring in conjunction with community partners (i.e., schools, community organizations, tribal nations, etc.). These additional or alternate requirements are at the discretion of the funder, community partner, or applicable regulations.

200. Glossary and Definitions

200.1 Child/Childrenis defined by federal regulations aspersons who have not attained the legal age of majority to consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (45 CFR 46.402(a)).

200.2 Minors is defined by the Montana Code Annotated as any person under 18 years of age.

200.3. Youth is defined as any person under the age of eighteen (18).

In this policy, “children,” “minors,” and “youth” are used interchangeably.

200.4. Not Children is defined as individuals who have been declared emancipated or who are 17 years old while enrolled at MSU; they are exceptions to the general definition of children and may provide consent for their own research participation.

200.5 Work Directly means interaction or participation between the minor(s) and researcher(s).

Research Examples: Face-to-face or virtual interaction, interviews or focus groups, social or behavioral interventions, clinical trials.

200.6 Observational Only Work  means watching children in a group setting with no interaction or participation between the minor(s) and researcher(s) and where another non-researcher adult is responsible for supervision of minors.

Research Examples: Observing and coding participant behavior at a child’s school playground, monitoring curriculum approaches in a classroom where teacher is present, research lab where researcher observes children and parents from another room via live video or two-way mirror.

200.7 Supervised Research refers to research scenarios where, in a group of 1 or more protocol personnel, at least 1 criminal background checked person is present at all times. This Supervisor assumes responsibility over non-criminal background checked protocol personnel.

200.8 Unsupervised Research refers to research scenarios where protocol personnel are not criminal background checked but are subject to other prerequisites before involvement in research with children.

200.9 Care, Custody, or Control of Minors means an adult is present and has primary responsibility for the well being of minors at any given point through the research.

300. Research Scenarios and Oversight

The IRB takes several factors into account when reviewing research with children, including but not limited to:

  • The research setting, privacy, and safety
  • Whether researchers will work directly or conduct observational only work
  • How many researchers will be working with children at any given time
  • Child Assent
  • Parental Consent
  • Risks and preparedness for adverse events
  • Full scope of work and other protocol information

Any researchers who work with children must be appropriately placed based on experience and duties (supervised vs. unsupervised).

  • Supervised protocol personnel may work directly  with children in various settings if approved by the IRB.
  • Unsupervised  protocol personnel may not work directly  with children and cannot be alone with children.
  • Researchers who wish to conduct observational only work may be unsupervised.

PIs must provide appropriate oversight and may conduct periodic unannounced visits of any personnel. At least one adult (supervised protocol personnel or non-researcher like a parent or guardian) must have care, custody, or control of minors at all times during research.

400. Approved Screening Procedures

A criminal background check is required in certain research circumstances. A person whose check result includes a record of sexually based offenses or crimes against children is not eligible to work as a volunteer or employee for University Sponsored Programs for Children and Youth. If criminal background reports include a record of other types of offenses, programs will consult the appropriate offices (University Human Resources, Legal Counsel, or the University Police Chief) to determine if those offenses should preclude participation.

Criminal Background Checks are Required for Supervised Research to Work Directly with Minors. At least 1 Supervisor must be background checked. Such personnel are subject to the following requirements prior to interacting with children:

  1. A criminal background check (required once every 2 years)
  2. Signed acknowledgement and agreement to the Guidelines for University Programs for Children Form.

Students on a research project involving minors who will not  work directly with children, who will be under supervision, or who will conduct observational only work  will not need to complete a criminal background check. Responsibility for ensuring such personnel do not work directly  with children or are under supervision will rest with the PI. However, such personnel will be subject to the following requirements:

  1. A sex offender registry check and violent offender registry check, conducted by the PI (required annually). A person whose check result includes a record of sexually based offenses or crimes is not eligible to work as a volunteer or employee for University Sponsored Programs for Children and Youth.
  2. Signed acknowledgement and agreement to the Guidelines for University Programs for Children Form.

PIs are responsible for maintaining all records.

500. Appropriate Study Design and Practices

Researchers must establish study designs, research methods, and procedures that follow Responsible Conduct of Research (RCR) practices and ensure the protection of children at all times. There must be adequate rationale for the inclusion of children in the research. Research design and study management considerations that, when carefully planned, offer additional protections for children. Such plans typically include:

  1. A clear organizational 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 children in research based on age and developmental level. The PI is responsible for ensuring that sufficient experienced research staff are present during the conduct of the research to protect children.
  2. Appropriate training (see Section 600) of all research personnel based on research roles and degrees of responsibilities.
  3. PI-established standard operating procedures, expectations, and guidelines for the researchers in order to foster a protective culture when including children in research.
  4. Thoughtful research designs that avoid one-on-one situations with children unless the research personnel meet the work directly definition and has satisfied the screening and oversight requirements of this guidance. In such circumstances, scientific justification and additional procedures within the research context must be incorporated in the research to ensure the protection of children.
  5. Standard practices to ensure physical and emotional needs of the children in research are met; this must include ensuring adequate privacy, safety, comfort, and basic needs are met.
  6. Thoughtful recruitment design that minimizes the possibility of implicit pressure of the children. Researchers must take into account social, peer, parental, and authoritarian pressures (e.g., teacher, doctor, other adult authority) when designing research recruitment procedures.
  7. Appropriate Assent and Consent Procedures: Research designs must account for assent of the children, when age and/or developmentally appropriate, as well as include the consent of the parent or guardian (unless waived by the IRB).
  8. Thoughtful research designs that include  standard practices and procedures by study personnel if researchers discover sensitive information about 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, child abuse, or neglect. Red flags may also include mentions of:
  • Harming self or others
  • Abuse of any kind or neglect
  • Elder abuse

The research design must account for how such situations will be handled should they arise. Response plans may vary based on the age of the child. The IRB recommends that any such matters are referred to the PI and addressed same day before the subject departs. Consent and/or assent processes and documents must include adequate descriptions about plans for disclosure, specifying when mandatory, or under what circumstances non-disclosure of sensitive information would be allowable.

  1. Thoughtful research design when minors are enrolled in long-term studies, as obtaining new consent may be required for continued participation when the children reach the age of consenting for themselves. Incorporate confirmation of continued assent and consent at critical times for long-term research.
  2. 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 children, 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 children.

600. Training

Training for all research personnel who plan to work with children in research must occur prior to conducting those research activities. Training plans should be included in the IRB protocol submission and must include instruction specific to the protocol, research personnel procedures, and instruction around protecting children in the research context. PIs are responsible for creating an appropriate training plan and then carrying this out upon IRB approval. Generally, topical training for the protection of children includes the following elements:

  1. Expectations, including appropriate interactions, behavior standards, conversations, and boundaries describing anticipated scenarios based on the research methods and setting.
  2. Appropriate  conduct requirements, incorporating expectations for interacting with children (with age-appropriate considerations) and adherence to established common sense University guidelines for working with children.
  3. Child abuse awareness and prevention, safety, and privacy.
  4. Reporting requirements and procedures when there is suspected child abuse or neglect.
  5. Supplemental CITI Training courses focused on research with children are available.
  6. Other related University policies and procedures as applicable.

700. Mandatory Reporting

All university employees are expected to make a report per Montana Code Annotated 43-3-201 to the Montana Department of Child and Family Services or a law enforcement agency when there is reasonable cause to believe any child with whom the employee, student, or other personnel comes in contact has suffered abuse or that any person with whom the employee, student, or other personnel comes in contact has abused a child, as those terms are defined in the M.C.A. 41.3.102.

For instances that relate to MSU authorized research activities, all university employees are expected to also report immediately to their Director or Department Head. The Director or Department Head will work with Legal Counsel to determine if further reporting or action needs to be taken. If the incident may also be a crime (e.g., assault, sexual misconduct, etc.), the matter will also be reported to the University Police Department.

800. Resources

Many federal regulations apply to specific circumstances and are utilized by the IRB for specific case reviews. Resources include: