Appendix D

Checklist of Requirements for School Studies

1. Information to be provided to school officials:
   • Full copy of protocol including all measures
   • Logistics of data collection-when and where:
   • Estimation of intrusiveness
   • length of individual sessions
   • Length of entire study
   • Handling of students who do not consent to participate. Who will be responsible for alternate activities?
   • Listing of all research personnel, their roles on the project and qualifications
   • Anticipated benefits to the school including timing and certainty of delivery
   • Any risks of the study:
   • Possible disruptions to school both during and after data collection
   • length of individual sessions
   • Length of entire study
   • Any responsibilities of the school—collecting consents, monitoring, interventions, etc.
   • What, if any, individual student information will be provided to the school and if none, so state
   • Ability to withdraw participation or request an individual(s) measure be withdrawn. If school can not participate without inclusion of all measures, so state.
   • Contact information for the Principal Investigator and Office of Academic Research
2. Items to be ascertained from the schools:
   • Appropriate contact(s) for day to day issues
   • Authorized official for the school
   • Assessment of local context and related issues which the investigator must be sensitive to
   • Appropriateness of study measures for the local population
3. Information to be provided to parents/guardians and students:
   • Description of the study and clear statement that this is research
   • Confidentiality of responses:
     • What information will be shared with school
     • What information would be reported to other authorities
     • What information will be shared with parent and/or student
   • Ability to decline/withdraw:
     • Both parent and child can withdraw individually
     • Impact of study on students who decline to participate
   • Duration of study
   • Risks of participation
   • Benefits
   • Translation of certification and back translation documents are required for non-English speaking students and parents/guardians of students
   • Contact information for PI and IRB Office
4. Information to be provided to IRB, in addition to standard requirements:
   • Listing of all research personnel, their roles/responsibilities, and qualifications
   • Approval of the study by appropriate school official
   • Availability of appropriate level of funding for duration of project
   • Assurance that full scope of study is within PI’s area of expertise and if not, provide signed agreement from appropriately trained collaborator
   • Continuing review items
   • Reporting of all adverse events whether or not they were anticipated
   • Reporting of any complaints about the study
   • Reporting of any difficulties encountered by the investigator or participants:
     • Copies of any new measures/procedures
   • Justification for additional changes or measures to the study
   • Translation of certification form and back translation documents and forms are required for IRB review.
   • Any recruiting document(s) translated for those non-English speaking students and parents/guardians of students
   • Description of how change will impact the risks and benefits of the study
   • Description of how new measure will be administered
   • Approval of the school for additional measure:
     • Description of any changes in procedures from initial submission including revised measures with changes highlighted
     • Copies of all correspondence with school including relevant letters, reports, and e-mails