Research in the Schools: Working with the IRB Lisa M. Abrams, Ph.D. VCU IRB Panel B Assistant Professor, School of Education, Foundations Department Ann S. Allen, Ph.D. VCU IRB Panel B Coordinator, Research & Evaluation, Richmond City Public Schools Monika S. Markowitz, Ph.D. Director, Office of Education and Compliance Oversight Vice President’s Office for Research Virginia Commonwealth University
Belmont Principles (1978) are the ethical foundation of federal regulations for research • Respect for persons informed consent privacy & confidentiality • Beneficence benefit/risk or burden assessment • Justice distribution of risk and benefit inclusion/exclusion
Federal Regulations and Policy stemming from Belmont Principles 45 CFR 46 – DHHS Policy for Protection of Human Research Subjects- Subpart A Originally adopted January 13, 1981 Revised June 18, 1991 “The Common Rule” – adopted by 17 federal agencies, including FDA regulated research in 1991
Activities needing IRB approval • RESEARCH – A systematic investigation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) • HUMAN SUBJECT- A living individual about whom an investigator…conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information 45 CFR 46.102(f)
Start with ‘research’ ‘Systematic’: use of statistical analyses, scientific methods – can include ‘nonresearch’ AND What about ‘generalizable’ ? - Is the intent of this project to contribute to knowledge in the field or discipline? - Are there hypotheses or research questions? - Will analysis of data lead to generalizable claims, inform policy? - Is there an intent to publish or present the project as research? If ‘yes’ >>>>> the project is research
Generally NOT ‘generalizable’, i.e. Not defined as research needing IRB approval • Quality improvement projects – designed with goal of improving institutional/organizational practice • Quality assessment/ assurance projects • Case report or case series – if no systematic investigation, i.e. no statistical or data analysis; no outcome measures • Public health practice – surveillance, program evaluation • Education, in and of itself – intended to only provide a perspective or report on non-experimental methods • Survey/questionnaire development – no data retained for research purposes • Oral histories ~ controversial
What about ‘human subjects’? • More straightforward • Interventions or interactions with persons • Access to identifiable personal data • Secondary data sets without ANY identifiers or codes generally do not involve human subjects • Note difference between anonymous (absolutely no links) and de-identified (codes are retained) • Suggestion: Refrain from the word ‘research’ if project not to be considered human subjects research under IRB purview
See OHRP Decision Chart for guidance OHRP Guidance Chart 1: Is an Activity Research Involving Human Subjects Covered by 45CFR part 46? Find information at VCU IRB website at: Activities Needing IRB Approval http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm#c1 AND VCU WPP II-2 Determining what constitutes human research http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm#II-2.htm
Examples of social – behavioral - educational projects that will likely require IRB submission: • Interviews – quantitative or qualitative approaches • Focus groups • Pretest – intervention – posttest (eg., analysis of writing samples) • Surveys, including Internet-based surveys • Randomized intervention and control group • Data analysis of primary or secondary data that contain identifiers or codes (see IRB website) • School-based research
Practical Issues in School-Based Research: Negotiating School District and IRB Requirements
Considerations for Investigators: • Consent/assent issues • Public context of schooling • Coercion; undue influence • Potential for “educational harm” • Local school district regulations/requirements • Federal regulations: FERPA, PPRA
Considerations for Schools: • Educational benefit – student, school, district level • Focus of the research • Use of instructional and staff time • Parent notification; consent • Protections of student privacy
School District Internal Review Process: • School districts may have an internal approval process and requirements for the conduct of research. • Requirements may be consistent with the principles that underpin IRB regulations, but with different language. • Investigators may have to negotiate tensions between school district policies and IRB requirements (e.g. “opt out”; passive consent).
Example School District Research Proposal Requirements (#1): • Proposals should: • Explain the issues the research will address • Describe benefits that students or educational programs will experience as a result of the research; • Describe the procedures involved in the research, including: the identification and selection of subjects, type of data that will be collected, who will collect data, time frame and location of data collection; • Include all instrumentation that will be used; • Include assurances of: voluntary participation; no identifying information of students, staff, or district will be released; research will not detract from the educational program; • Provide for the submission of research findings to the school district.
Example School District Proposal Review Criteria (# 2): • IRB approval; • Sound research plan; • Adequacy of data collection instruments; • Potential for direct benefit for the study subjects and/or the district educational program; • Implementation of the research does not require a significant departure from the normal school routine and/or use of instructional or staff contract time; • Requests for participation and informed consent forms include statements about the purpose of the research; study procedures, right to review data collection documents and/or surveys; right to withdraw from the study at any time; • Research does not investigate the personal lives of students or staff; • Research is designed to protect the anonymity of subjects; • Assurance that the research findings will be reported to the school district.
Other Federal Requirements: • FERPA: The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records. • PPRA: The Protection of Pupil Rights Amendment (PPRA) is a federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature. Source: Family Policy Compliance Office (FPCO) http://www.ed.gov/policy/gen/guid/fpco/index.html
Rights under FERPA FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students."
FERPA - Exceptions Schools must have written permission from the parent or eligible student in order to release any information from a student's education record. However, FERPA allows schools to disclose those records, without consent, in nine (9) limited areas (34 CFR § 99.31): School officials with legitimate educational interest; Specified officials for audit or evaluation purposes; Organizations conducting certain studies for or on behalf of the school;
PPRA – Requirements The law requires that schools obtain written consent from parents before minor students are required to participate in any U.S. Department of Education funded survey, analysis, or evaluation that reveals information concerning the following areas:
PPRA – Requirements (continued) Political affiliations; Mental and psychological problems Sex behavior and attitudes; Illegal, anti-social, self-incriminating and demeaning behavior; Critical appraisals of family; Legally recognized privileged relationships (i.e.,lawyers, physicians, and ministers); Religious practices or beliefs; or Income.
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
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#VX-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.
Waiver/alteration of Elements of Informed Consent or Parental Permission Criteria (46.116): • The research involves no more than minimal risk to the subjects. • The waiver or alteration will not adversely affect the rights and welfare of the subjects. • The research could not be practically carried out without the waiver or alternative. • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
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. • Investigators should adopt methods that keep students’ decisions for participation in research activities private.
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 (FWA’s are in process for local school divisions). • 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.
Are school faculty/staff “Engaged” in research? YES, if employees or agents: intervene with living individuals by manipulating the environment for research purposes interact with living individuals for research purposes release individually identifiable private information, or permit investigators to obtain individually identifiable private information, without subjects' explicit written permission
Are school faculty/staff “Engaged” in research? NO, if employees or agents: inform prospective subjects about the availability of research; provide prospective subjects with written information about research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects' consent or act as authoritative representatives of the investigators; provide prospective subjects with information about contacting investigators for information or enrollment; obtain and appropriately document prospective subjects' permission for investigators to contact them.
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.
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.
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 BEFOREchanges are implemented, these include changes initiated by the school/district.
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 Education and Compliance Oversight, 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 instructions and provide thorough, well-organized information.