Appendix s – Involvement of Students in Human Subjects REsearch

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Office for the Protection of Research Subjects
Institutional Review Board
FORM: Appendix S - Involvement of
Students in Human Subject Research
203 AOB (MC 672)
1737 West Polk Street
Chicago, IL 60612-7227
Phone: 312 996-1711 Fax: 312 413-2929
www.research.uic.edu/protocolreview/irb
Version: 2.1
Date: 11/21/2012
I. Introduction
Additional regulatory considerations are required for human research that is funded by the U.S.
Department of Education (ED) and/or is conducted in public elementary and secondary schools,
school districts, post-secondary institutions, and any public or private agency that receives fund
from ED.
The Family Educational Rights and Privacy Act (FERPA) (20 USC 1232g; 34 CFR 99) is
intended to protect all student and parent information maintained in an Education Record.
The Protection of Pupil Rights Amendment (PPRA) (20 USC 1232h; 34 CFR 98) is intended to
protect the rights of parents and students as regards their personal information, and includes
special provisions for information collected via surveys, questionnaires, and evaluations.
FERPA stipulates that an educational institution has the final authority to determine what
information may be accessed from an Educational Record and may deny access even if the IRB
has approved access for research purposes. The determination of the educational institution to
deny access cannot be appealed to or overruled by the IRB.
Investigators are responsible for meeting both FERPA and PPRS requirements when
conducting research (please refer to: UIC OPRS Document 636: Guidance and IRB Review:
Research Involving Students or Performed in Educational Settings).
II. Research Site
A. Does the research involve students, or obtaining information about students and/or their parents,
from the following:
elementary/primary school (including charter schools)
secondary school (including charter schools)
post-secondary institution (including community colleges and technical schools)
other program or site funded by the Department of Education (ED)
Please remember that all non-UIC sites must be listed on Appendix K.
Note: The UIC IRB will specify whether approval or a written waiver must be obtained from school
principals, department heads, classroom instructors/professors, and/or school district/postsecondary IRBs before research activities may begin at each site.
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B. Classroom Sites
1. Does the research include activities that will take place in the classroom during regular
instructional periods?
No. Go to Section III
Yes
2. Describe procedures that will be put into place to minimize the loss of classroom time
(remember, students are not in a class in order to be a research subject):
3. Describe in detail the classroom activity(ies) planned for non-participants including, but not
limited to, a description of supervisory provisions and how non-participants will be excluded
from video and/or audio recordings:
4. If participation requires removal of students from the classroom, please explain in detail how
this will be conducted including, but not limited to, how the privacy of the student will be
protected and possible stigmatization of the student will be avoided:
III. Limited Evaluation Activities
A. Student Directory Information
1. Is the research limited to the collection of student directory information?
No
Yes - For UIC: request appropriate waivers of consent (for eligible student, i.e., 18
years or older or postsecondary student) and/or assent and permission (for child
subjects and their parents) for use of directory information
Yes - For non-UIC sites: submit a copy of FERPA policies regarding student directory
information for the non-UIC institution to the UIC IRB, as well as requesting
appropriate waivers of consent and/or assent and permission for the use of directory
information
B. Limited Activities Using Educational Records
1. Is the research limited to the use of educational records for the following:
• the development, validation, or administration of predictive tests OR
• the administration of student aid programs OR
• the improvement of instruction
No. Go to C
Yes
2. Has a written agreement containing the following information been obtained?
• purpose, scope, and duration of the research;
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• information to be disclosed;
• that information from education records may only be used to meet the purposes of the
research as stated in the agreement;
• that the research will be conducted in a manner that does not permit personal identification
of parents and students by anyone other than the named representatives of the institution
with which the agreement has been made;
• that the investigator and/or the investigator’s institution is required to destroy or return all
personally identifiable information when no longer needed for the research;
• the date on which the investigator or the investigator’s institution will either destroy or return
the information.
No
Yes – may request appropriate waivers of consent (for eligible students ) and/or
assent and permission (for child subjects and their parents)
C. Use of Permanently De-identified and/or De-linked Information
Will the information be permanently stripped of all personally identifiable information (both direct
and indirect) and/or all codes linking the information with identifiers will be destroyed before it is
accessed, released, or transferred to the investigator (please refer to: UIC OPRS Document 636:
Guidance and IRB Review: Research Involving Students or Performed in Educational Settings for
the Department of Education criteria for de-identification data)?
No
Yes: may request appropriate waivers of consent (for eligible students ) and/or assent and
permission (for child subjects and their parents)
NOTE: Consent or waiver of consent for qualified eligible students refers only to the access of
educational records. If a postsecondary school student is less than 18 years of age, parental
permission or a waiver of parental permission is required for participation in research.
IV. Research Activities
A. Right to Review Research Materials
1. Please outline how the parents of minor students will be informed of their right to review
surveys, interview guides, focus group guides, questionnaires, and other data collection
instruments that will be used in the research (e.g., PPRA mandated annual notification of
parents, consent form, information sheet):
2. Please outline how the parents of minor students will be provided with the opportunity to
review data collection instruments that will be used in this research:
B. Research Involving Sensitive Topics
1. Will the research involve surveying, interviewing, analyzing, or evaluating information from
and/or about student subjects that would disclose any of the following:
• political affiliations or beliefs of the student or the student’s parent;
• mental or psychological problems of the student or student’s family;
• sexual behavior or attitudes;
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• illegal, anti-social, self-incriminating, or demeaning behavior;
• critical appraisals of others with whom the child student subject has a close family
relationship;
• religious practices, affiliations, or beliefs of the student or student’s parents;
• family income, other than as required by law to determine the student’s and/or family’s
educational grant, loan, scholarship or other education-related program eligibility;
• information protected by other legally-recognized privileged relationships, such as with
doctors, lawyers, or religious leaders.
No
Yes. If research is funded by ED, parental permission MUST be obtained. If research
is not funded by ED, the school’s local PPRA policy should be followed.
Please attach a copy of the local school’s PPRA policy.
2. Please outline what students and/or parents will be told about the steps that will be taken to
protect the student’s and/or family’s privacy if research regarding the eight topic areas listed
above is conducted (this information must be included in the consent and/or assent and
permission documents):
C. Research Involving New or Experimental Instructional Design, Curriculum, or Instructional
Materials
Will the research involve the use of a new or experimental instructional design or materials
including, but not limited to, a new/experimental curriculum and/or new/experimental teachers’
manuals, films, tapes, computer programs, or other supplementary instructional materials?
No
Yes. Submit all new/experimental materials to the UIC IRB for review
D. Research Involving the Physical Examination or Screening of Students
1. Will the research involve the physical examination or physical screening of students?
No
Yes. Complete #2 and #3
2. Please outline what students and/or parents will be told about the steps that will be taken to
protect the student’s and/or family’s privacy if information regarding the physical examination
or screening of students is collected (this information must be included in the assent and
permission documents):
3. Will physical examination or screening information will be inserted into the student’s medical
record?
No
Yes. Include HIPAA language in the permission documents
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