Planning to Conduct Research in Schools: Working with the Schools and the VCU IRB

1. 1 Planning to Conduct Research in Schools:Working with the Schools and the VCU IRB A resource for investigators, research staff, students, and the IRB 8/07, rev. 1/09

2. 2 Developed by: The Office of Research Compliance and Education, Office of the Vice President for Research, Virginia Commonwealth University With important input from: Faculty from the VCU School of Education The VCU IRB Research directors and administrators from Richmond-area school divisions

3. 3 Types of research* conducted in schools*Human subjects research as defined by 45CFR46.102http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102 Education research � primarily done in Richmond-area schools by the VCU School of Education (SOE) faculty and/or students. Examples include: instructional and behavioral interventions, modifying teaching strategies, professional development, student achievement outcomes, etc. Examples of other kinds of research (social-behavioral or biomedical) involving schools, school children, and parents/guardians may also be conducted by non-SOE faculty: - surveys about lifestyles, attitudes, health (research exploring student sexuality, illegal or incriminating behavior, or critical appraisals of family members, etc. is usually not approvable by the division) - observations of student, classroom, or teacher behavior - interventions for health promotion and lifestyle change Hyperlink h.s. research to �Activities needing approval� on IRB websiteHyperlink h.s. research to �Activities needing approval� on IRB website

4. 4 How to plan research that will be conducted in schools Contact the research office in the school division of interest before the end of the school year preceding the academic year you wish to conduct the research. Most school districts have an office for research activities. For VCU SOE research, the SOE�s Research Office can provide information (if needed) about how and when to contact the school division�s research office. School divisions will approve research (including all documents) before investigators may contact individual school principals or teachers. Obtain school division approval and input before submitting to the VCU IRB. Do the divisions issue formal approval, i.e. letter? Is email/telephone OK in order to proceed to IRB? Do the divisions issue formal approval, i.e. letter? Is email/telephone OK in order to proceed to IRB?

5. 5 How to plan research that will be conducted in schools Be aware that school divisions are bound by Family Educational Rights and Privacy Act (FERPA) and No Child Left Behind (NCLB) regulations. Review FERPA guidelines and NCLB requirements in advance. Review the school division�s administrative policy manual regarding FERPA and research with students, generally found on the division�s Web site. See the Family Policy Compliance Office in the US Dept. of Education for more information [ http://www.ed.gov/policy/gen/guid/fpco/index.html ] Best resource for these?Best resource for these?

6. 6 Constraints within the schools for authorizing research projects Due to the many persons involved in approving research within the division, plan on at least 1 month for approval Research activities may not impinge on instructional time. Teachers� primary role is teaching, not research. Although teachers and other staff members may not be expected to do the work of the researcher, training of a very small number of teachers may be permitted. No research may ordinarily occur at or near the end of the school year due to student testing. Other times of research restriction may be subject area/grade level dependent. The number and scheduling of research projects is closely monitored by the school/ school division � windows for research may be few and far between.

7. 7 Constraints within the schools for authorizing research projects (cont�d) Many schools/school districts require an �opt in� process for parents and students. �Opt-in� means that the parent must give specific permission for the child�s participation. Other districts may approve an �opt out� process, wherein parental permission is presumed unless specifically refused. Students and parents come from diverse ethnic and educational backgrounds; research documents must be tailored accordingly. Surveys of children (those under 18 yrs. of age) require the child�s assent and parental permission, unless waiver of assent and/or parental permission is justified and approved. (Refer to the division�s administrative policies for clarification)

8. 8 Constraints within the schools for authorizing research projects (cont�d) The proposed research must be aligned with the school division�s goals and objectives and must be in the best interest of students and the schools (obtain this information from the divisions� website before planning a study). Manuscripts or presentations must use non-identifiable pseudonyms for students, staff, schools, and the school division. School division and school staff must be able to review research findings prior to publication or presentation outside of the school division.

9. 9 VCU IRB considerations for school-based research Type of IRB Review Much school-based research falls into the expedited review category (no greater than minimal risk) because student�s assent and/or parental permission must be considered or identifiers will be collected or codes maintained. Note that surveys of children (even if no identifiers are retained) are not subject to IRB exempt review. Research that is �greater than minimal risk� is subject to IRB Full Board review, which takes place on a monthly basis. See http://www.research.vcu.edu/irb/reviewtypes.htm for Review types. Parental Opt Out (if permitted by the school division) If a parental/guardian �opt out� is required by the school/division, the IRB must also approve waiver of parental permission. (Because many parents may likely never see the �opt out� information letter which their children are asked to bring home, parental permission or lack of permission cannot be presumed). Parental �Opt In� may be required Check division policies before designing your study RPS refers to parental �opt in� RPS refers to parental �opt in�

10. 10 VCU IRB considerations for school-based research (continued) Parental permission, waiver, documentation of permission The IRB may grant a request for waiver of parental permission if adequately justified by the investigator (See VCU IRB WPP #XV-2 Assent and Parental/Guardian Permission Considerations, (http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm#XV-2.htm). Be aware that the school division and IRB may utilize different vocabulary. While the division may not approve a study with a waiver of consent, it may approve �opt out.� If a waiver of parental permission is approved by the IRB, the investigator is usually required to provide an informational letter about the research to parents. For school divisions which allow it, this letter affords an �opt out� opportunity for parents. A tear off section on the bottom of the letter may be returned to the school if parents/guardian wish for their child to �opt out� of the research. The researcher must explain how �opt outs� will be tracked. If the nature of the research calls for documentation of parental permission (often described as an �opt in� process by the school divisions), describe how parental permission/non-permission will be tracked and how corresponding students will be identified. Hyperlink above WPPHyperlink above WPP

11. 11 VCU IRB considerations for school-based research (continued) Child�s Assent Participation in research must be voluntary, without coercion or manipulation. Alternatives to participation in the research should be comparable in time, effort, and �appeal.� Be sensitive to the amount and type of attention directed toward children participating in research in comparison to those who are not participating. Consider: research/non-research setting, presence of adults, the emotional effect on children of participation or non-participation. Any credit/compensation offered for research participation should be comparable to that offered for completing the non-research alternative.

12. 12 VCU IRB considerations for school-based research (continued) Engagement of non-VCU institutions The VCU IRB is interested in who will be involved or �engaged� in the research. If the research is non-exempt and VCU is the direct recipient of federal funds, the school/ district must have a Federal-Wide Assurance (FWA) if the involvement rises to the level of �engagement.� See VCU IRB WPP #XVII-6 Involving Non-VCU Institutions in VCU Human Subjects Research at http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm#XVII-6.htm (All Richmond-area local public school divisions now have FWAs). In your research synopsis: - Indicate whether the school/division is �engaged� in the research. Describe the role of the school/school district and its personnel. (It may be possible to �disengage� school personnel). - If �engaged� and Federally-funded, provide the OHRP FWA number. Hyperlink WPP referenceHyperlink WPP reference

13. 13 VCU IRB considerations for school-based research (continued) Engagement of non-VCU institutions and training In your research synopsis/proposal: Provide the IRB with info about the qualifications of personnel who will be involved or engaged. Describe the �who� and �what� for training about the protocol. Although the CITI course is ordinarily required for �key personnel� conducting VCU research, completing the CITI may pose an obstacle to collaboration in some cases. As an alternative, the investigator may provide a plan for training �engaged� school personnel about human subjects protection. The alternative plan for training must be approved by the IRB. HyperlinkHyperlink

14. 14 Working with the schools on the research project Readability of parental information Information supplied to parents � parental permission form, opt out letter, info about the research � should be readable (6th grade reading level preferred). Letters should be no more than 1 page long, including the opt-out �tear off� at the bottom of the page. Endorsement of the research by the school district The school/district may choose to �expand� on the research project proposed by the VCU faculty or student if it addresses educational or research objectives of broad interest. If the school requires that information supplied to parents be printed on school system letterhead, the VCU investigator should submit the informational letter to the IRB on the letterhead. The VCU investigator(s)�s name and contact info should appear on the letter together with the name of the school/division�s collaborator.

15. 15 Working with the IRB on school-based research Describe school-imposed constraints and requirements Provide a cover letter with the IRB submission explaining any and all time constraints in the initiation and completion of the research in the schools. The VCU IRB recognizes that the schools may impose certain requirements on your research project. Describe these requirements in your IRB submission. Be aware of IRB constraints and requirements Remember to follow IRB submission instructions, especially those related to �engagement.� Factor in time for the IRB review. The IRB submission should be thorough and include all materials, such as surveys, letters, ads, and assent/permission forms. Any changes to a research project must be approved by the IRB BEFORE changes are implemented, these include changes initiated by the school/district. Any changes to the IRB-approved recruitment plan MUST be approved by the IRB before the changes are initiated.

16. 16 Questions? Contact the Office of Research Protections at ORSP@vcu.edu or 828-0868 for information about �engagement� of schools in research and the IRB submission process. Contact an IRB member and/or the Office of Research Compliance and Education, 827-2157, for information about design, content, and ethical considerations. Remember: The IRB review is highly dependent on the quality of the submission. Carefully address IRB instructions and provide thorough, well-organized information.