IRB Training - Graduate Student Association

Report
Navigating the IRB Process for
School of Education Students & Faculty
A revision of previous PowerPoint Presentations for classes,
to serve as a supplement to information provided
by the Office of Human Research Ethics at UNC-Chapel Hill
Barbara Davis Goldman, PhD
Previously pre-IRB Review Consultant
UNC-Chapel Hill School of Education
Overview of Content

Overview of policies (federal and local), procedures, ethical
principles, and UNC IRB forms (slides 3-23)

Ethical principles of Belmont Report in practice (24-35)

Additional issues involved when conducting research in
schools (slides 36-46)
 FERPA
 PPRA
 Preliminary contact to determine feasibility and learn
local procedures (soft scopes)
 Dual roles: teacher & researcher (2-hat problem)
NOTE—this is supplementary material—consult
the online guidance of UNC’s Office of Human
Research Ethics for up-to-date information
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Protecting Research Subjects

Multiple sources of motivation for IRBs
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Negative examples from history (featured in CITI
training, and almost all introductory presentations)
Positive principles—embodied in the Belmont Report
Multiple sources of governance of IRBs
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Regulated by US law—45 CFR 46 (Code of Federal
Regulations: “the regs”)
Guided by interpretations from the federal Office for
Human Research Protections (OHRP)
Governed locally by the IRBs, with their own “standard
operating procedures” and traditions—at UNC-Chapel
Hill, that includes the Office of Human Research Ethics
or OHRE, as the overall administrative organization
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Code of Federal Regulations Title 45 Part 46
(45 CFR 46)
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Defines “research” and “human subjects”
Describes special procedures for “vulnerable
populations”
Describes
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what needs to be reviewed and approved
what can be exempted from review, OR reviewed and
exempted from further review
what does NOT need review
Describes requirements for obtaining informed
consent, and requirements for waiving consent or
its documentation
Mandates the existence of an IRB and specifies its
composition and structure
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IRB APPROVAL is only required if the activity
meets the definition of “human subjects research”


“Research” is defined by the federal guidelines as
“as systematic investigation, including development,
testing, and evaluation, designed to develop or
contribute to generalizable knowledge”
[45 CFR 46.102(d)]
A “human subject” is defined by the federal
regulations as a “living individual about whom an
investigator conducting research obtains

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(1) data through intervention or interaction with the
individual, or
(2) “identifiable private information” [45 CFR 46.102(f)]
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Belmont Report

The Belmont Report provides conceptual
guidance about ethics to:
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The 3 ethical principles of the Belmont Report:

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the IRB members who review research studies,
the researchers (and the STUDENT RESEARCHERS) who
propose them, and
the students interacting with persons in a research-like
manner doing class projects or practica
Respect for persons
Beneficience
Justice
How the principles play out in research is in the
second part of this PowerPoint (slides 24-35)
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Office for Human Research Protections (OHRP)
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Part of the federal Health and Human Services (HHS)—
governs IRBs
Responsible for ensuring the safety and welfare of the
people who participate in HHS-sponsored research
OHRP has formal agreements, or “assurances” with > 4000
institutions that they will conform to 45 CFR 46 and OHRP
guidance
Some institutions agree to apply “the regs” to ALL research,
not just federally funded work, but most do not—institutions
can also decide to apply the “Common Rule,” known as
Subpart A, but not the other 3 subparts (B, C, D)

NOTE: 45 CRF 46, Subpart A (the Common Rule) limits what
research can be considered “exempt” from the regulations when the
research involves children
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IRB Overview at UNC-Chapel Hill
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The purpose of the Institutional Review Board (IRB) is to
review RESEARCH protocols that involve human subjects to
HELP RESEARCHERS ensure ethical treatment
There are now only 2 IRBs on UNC-Chapel Hill campus—the
Biomed IRB (4 separate boards) and the NON-Biomed IRB
(a recent combination of the previous Behavioral IRB and
Public Health-Nursing IRB). All are under the larger umbrella
of the UNC-CH Office of Human Research Ethics (OHRE)
Who's on the IRB? Faculty, students, community member,
prisoner advocate, non-scientist (a non-scientist and
quorum must be present at a full board meeting).
However, almost all SoE studies are eligible for “expedited
review” rather than “full board review” so they are
generally reviewed by an IRB coordinator and an IRB Chair
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IRB Overview at UNC-Chapel Hill
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NOTE: some UNC Institutes (e.g., FPG), Departments (e.g.,
Psychology) and Schools (e.g., Social Work, Education)
that feed into the NON-Biomedical IRB offer “pre-IRB local,
departmental review” to help researchers navigate the IRB
process as well as providing the required departmental
review
The level of assistance provided is entirely up to the local
department
IRB approval is required before any contact is made with
RESEARCH subjects, whether contact is for recruitment or
data collection
IRB approval is required before secondary analyses that are
considered to be “human subjects research” are begun,
BUT not all secondary analyses need IRB approval in
advance—it depends on their purpose, who is conducting
them, and the identifiability of the data
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START HERE
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See the OHRE website at http://ohre.unc.edu :
Provides news and updates—currently information
about requirements for naming all attachments
including consent documents
GO TO
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For Researchers
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Submission Instructions READ this section
FAQ—very big; REVIEW the 1st section, DETERMINE
WHETHER IRB REVIEW IS REQUIRED, including “What
about student research and class projects”
Ethics Training (for access to the CITI online training
and UNC ethics training database)--CONSULT
Dates & Deadlines (generally NOT an issue)
How do I apply

NOTE—”loading” can often take a fair amount of
time in-between actions
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Types of student activities & IRB involvement
There are 3 major types of activities that students could
carry out that are, or resemble, research:

Working on a RESEARCH project as a research assistant that is
headed by a faculty member or other principal investigator
l
l
Generally, a student RA needs only CITI online ethics training; PI
asks the IRB to add the student to the study’s roster
Conducting a CLASS PROJECT or fulfilling a PRACTICUM
assignment for educational purposes
l
l
Generally, NO interaction with the IRB needed, except in certain
circumstances
Carrying out student RESEARCH activities such as masters
theses or projects, or doctoral dissertations, as part of a
degree program
l
l
Need to submit an application—depending on responses to early
screening questions, your work may be considered to be “Not
Human Subjects Research” (NHSR) OR as HSR but eligible for
exemption from extensive review
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Student Research & Class Projects/Practica
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
Students are special—OHRE provided explicit NEW
guidance for students in the spring of 2006, which
was revised slightly in the spring of 2007 and
revised slightly twice in 2008—most current
“official” version is dated 2-16-2012.
Guidance focuses on the differentiation between
work that may “look like” research, but is done for
practica or class projects, and “real” student
research, for undergraduate honors theses,
masters papers & theses, and dissertations, as well
as additional research intended for publication
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Class projects and practica

Most class projects and practica are
conducted for educational purposes, not as
“research,” and will NOT need IRB approval,
with some exceptions:

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If you plan to use secondary data that includes
Protected Health Information (PHI)
If your work involves direct interaction AND is
intended to be both an educational experience
AND you intend to present this activity AS
RESEARCH or as “generalizable knowledge” TO
OTHERS (which doesn’t mean when it is
presented as a class project to others, which is
the more common situation)
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Even if your interaction is not “research”
because it is a class project,
ethical guidelines still apply

The Belmont Report provides conceptual guidance to
researchers, and to those interacting with persons in a
research-like manner doing class projects or practica

Faculty member will provide specific guidance

The 3 ethical principles of the Belmont Report:

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Respect for persons
Beneficience
Justice
You will need to consider this in more detail if and when
you choose to do class projects that involve direct
interaction---SEE slides 24-35
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Student Research Guidance Overview
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Student RESEARCH includes undergraduate honors theses;
masters papers, theses and projects; dissertations; and
comparable activities
Application for IRB APPROVAL is generally required if there
is direct interaction with human subjects
Application for IRB APPROVAL is generally required for
secondary analyses if the researchers have access to
identifiers or PHI, or in other special circumstances
Student RESEARCH involving ONLY secondary analysis of
publicly available, de-identified, or “coded” data where the
student will not have access to identifiers does NOT require
approval, but an application MAY need to be submitted to
document its status as “not human subjects research.”
Most likely you will primarily be responding to screening
questions and some description that will formally document
the status as “NHSR” which does not need IRB approval
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Student Research cont.

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SEE OHRE Student Guidance Handout and BDG’s
HANDOUT “Gloss” to explain in more detail the OPTIONS
now available for IRB APPROVAL of student research
NOTE:
 Student researcher and faculty advisor MUST have
current ethics training to submit an application for IRB
approval—CITI online training (Basic, Group 2 Social
Behavioral)
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Everyone else on the research team with access to
identifiable information or in contact with participants
needs to be ethics-trained too BUT not all need to be
listed now in the online form (change from the past)
Ethics training should NOT be required by the IRB if
your work is considered “Not Human Subjects Research”
which simply receives a “determination” from the IRB,
not approval, but CITI research ethics training may be
required by the faculty advisor
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Secondary data issues continued
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Some activities that ARE research, but are NOW
not considered to be “human subjects research” do
NOT need approval by the IRB
This 2006 policy brought UNC-CH more in line with
federal (OHRP) policy (August 10, 2004; updated
October 16,2008) about the handling of secondary
analyses of de-identified or of CODED data or
specimens, AND to deal with other “not human
subjects research” scenarios—this was a BIG
change
STUDENTS--Be aware that the process for
determining that work is “NHSR” online may be
unfamiliar to some faculty advisors
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Secondary data issues cont.

Your secondary data analyses for research
purposes may be determined to be NHSR,
and not need formal approval IF:
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the identifying information is NOT available to
the researcher, because the data/records or
specimens are de-identified, or there never
were identifiers, OR
the data have a CODED identifier, and the
researcher will not have access to the code,
by formal agreement, OR
the data are publicly available
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Secondary data issues
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EXCEPTION—cannot consider the research to NOT
involve human subjects if the data are protected by
HIPAA (if the data come DIRECTLY from a health plan,
health care clearinghouse, or health care provider)
 If the data are protected by HIPAA, the researcher
needs to submit an IRB application to get a WAIVER
of HIPAA authorization
EXCEPTION—if the data belong to the student’s faculty
advisor/mentor who has access to the identifiers, or
someone who will be listed as an author of a publication
from this work has a list linking identity to ID codes,
then that work is considered to be HSR, and requires the
complete application and approval, focusing on the
data, and requesting a waiver of consent, EVEN IF the
student does not have access to identifiers
.
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Miscellaneous Approval Matters
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IRB approval is for one year (and occasionally less) and in
general must be renewed for continued research activity,
including analysis of identifiable data and publication, for as
long as you are a student at the university
Any changes, anticipated or unanticipated, to the protocol
must be approved as “modifications” prior to
implementation
MODIFICATIONS also allow the researcher to apply
for approval as the research develops — you don’t
have to know absolutely everything in advance, but say so
if something you mention in the application will be
submitted later, so the IRB doesn’t think it’s “missing”
All documents and procedures used with subjects must be
approved—so researchers MUST submit MODIFICATIONS
for those changes and obtain approval before they are
instituted
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Applying for IRB Approval for Research Involving
Direct Interaction or Identifiable Data
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Application in “Online Submission” at http://ohre.unc.edu
Informed consent/parent permission/assent/fact sheets will
be constructed within the program. Specific forms will be
required based on how you responded to various questions.
You can edit them as needed—will be uploaded as
attachments in “Consents”
 Justification in IRB application for waivers of signature if
necessary
 Justification in IRB application for consent waiver if
secondary analysis
All other documents that will be used with subjects (e.g.,
recruitment letter, flyers, questionnaires, focus group guide,
and other instruments, even if draft, will also be uploaded as
attachments in “Attachments”
Copy of research proposal (ONLY IF FUNDED RESEARCH)
I strongly recommend NOT submitting student proposals if
there is no grant supporting them
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My personal advice
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Lay out a detailed study plan on paper FIRST, for a clear
picture of what you want to do, when, with whom, and how
you will recruit, obtain consent, and collect data, or what
datasets you will analyze—the form can be confusing.
THEN do a mock-up of the application—you can put in as
much or as little “good” info in textboxes as you like, but
you must answer questions with “radio buttons” so you see
all the questions that will need answers--later questions
depend on answers to earlier ones. READ CAREFULLY!!
Add to your paper plan where needed, and then start filling
in the application with more complete, “good” text.
Consult with your advisor—that’s who the IRB folks
consider “responsible” for the study—get advice, advisor
can edit your drafts online, you can send pdfs, etc. Chances
are it will take several drafts—this takes time and thought.
You may also ask the IRB coordinators for help (6-3113).
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The IRB application for APPROVAL must be presented with
enough information for the reviewers to evaluate risks and
benefits, adequacy of consent procedures, and protection of
confidentiality
The IRB IS REQUIRED to determine whether there is a
favorable risk-to-benefit ratio for studies with direct
interaction, and for secondary analyses with identifiable
data, and only approve a study if that ratio is “favorable,”
which means MORE BENEFIT (generalizable knowledge)
than risk to participants
The online application will also provide guidance at the end
about maintaining the security (confidentiality) of your data,
based on your responses to the questions. You will be told
what protections are recommended for your study, in terms
of whether it needs Level I, Level II, or Level III security
measures. You may need to consult with departmental IT
people for assistance.
End of OVERVIEW
23
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Using the 3 principles from the
Belmont Report when collecting data
from individuals as part of
“human subjects research”
OR as part of class projects
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Using the 3 principles from the Belmont
Report when collecting data from individuals
as part of “human subjects research”
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Belmont principle #1, Respect for persons,
is seen in the recognition of the personal dignity
and autonomy of individuals, with special
protections for those with diminished autonomy
Applications:
Protecting privacy and confidentiality (almost always,
unless agreed otherwise)
 Informed consent
 Voluntariness—no coercion or subtle pressure

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Respecting Privacy and Protecting Confidentiality

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Recruitment of subjects—maintain privacy (usually)
In general, names should not be given to researchers, as in “snowball
recruitment” without first asking permission of the individual whose name
is given—other ways to handle this

BUT names can be obtained from organizations when membership is not
sensitive—but be sure to tell participants how you got their name

Data collection procedures should respect privacy

Confidentiality: protection of data, especially if sensitive

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What is sensitive can depend on the context
Usually or always sensitive: illegal behavior, immigration status, sexual
behavior, health status (e.g., specific disease status) IF IDENTIFIABLE
Potentially sensitive depending on cultural context: income, membership in
specific organizations, workplace competency (often not considered)

Minimization of risk of deductive disclosure by “insiders” who have
knowledge of the participant pool

Separation of data from identifying information
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Informed Consent

Consent is a PROCESS...

Researcher tells all the important
information, emphasizing voluntariness in
multiple ways

Participant has chance to ask questions

Researcher answers questions

Participant (usually) signs a consent form
agreeing to participate, but information can
be shared orally, and consent can be oral
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Informed Consent for RESEARCH
The “spiel” or the form, includes:
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Purpose of the research
What the person will be asked to do, and how long it takes
Description of risks and benefits, if any
Costs; incentive payments for participation
Confidentiality statement and procedures description
Subject rights: Right to not participate, participate in part,
discontinue participation
IRB contact information for concerns about rights
Researcher contact information for questions about study
The online template will “pre-populate” some of the
information at the top of the 1st page, but you will need to
write/edit the information on the rest of the form. You may
instead craft and upload a different format or process that is
more appropriate for your specific study and your
participants. If you do this, do explain why you are doing so
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Informed Consent for CLASS PROJECTS or PRACTICA
that do not need IRB approval


More flexible but generally similar to “research” information on the
“standard IRB consent” or “Fact sheet” but definitely have many options
for formatting, sequencing, etc.
However, the same ethical principles apply, and similar information needs
to be provided

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
Purpose
What the person will be asked to do, and how long it will take
Whether information will be confidential
Risks and benefits, if any
Can choose not to participate, can skip over parts, can quit at any time (entirely
voluntary)
But DO NOT use the standard IRB template form, if using written
consent—use one developed specifically for the project, practicum, or
evaluation, and in that form, be sure to follow the guidance below

DO NOT use the word “research” since by definition, a class project,
practicum, or “in-house” evaluation, is NOT research

DO NOT refer PROJECT participants to the IRB for concerns

They contact the student and faculty advisor with any questions or concerns (IRB NOT
involved)
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Other Consent Matters
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Parent permission required for participation by minors,
although waivers may be possible
Children “assent” instead of “consent”-- may be signed, depending on
age, or only oral--IRB may prefer written assent if the minors are older
and if the activity is “RESEARCH” but what is appropriate depends on
the nature of the study
Fact sheet: Same information as a consent form, but without a
signature—often accompanies oral explanation and oral consent, or is
sent along with surveys and questionnaires
Fact sheet for class projects and practica also can take advantage of
increased flexibility—key is content appropriate for the
project/practicum
For “RESEARCH” the IRB may grant a waiver of signed (“written”)
consent, or of omission of consent elements, or of consent or parent
permisison entirely, as specified in the Code of Federal Regulations
(CFR)
For class projects/practica, student and faculty member decide together
what is appropriate for particular activities
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

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
Belmont principle #2 , beneficience, is seen in
protecting participants from harm (minimizing
risks), and determining that there are sufficient
benefits (to individual participants and to society, in
the form of knowledge) to balance the risks to
participants
IRB has to decide there is a favorable risk:benefit
ratio (more benefit than risk) to approve
Benefit can be to participants AND to society, in the
form of scientific knowledge, but risks are only to
participants
If there is no risk, then it’s ok if the participants
don’t benefit, and the scientific merit may be
minimal too.
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Types of Risk the IRB (and YOU) Need to Consider

MOST risk in studies that do NOT involve treatment stem
from problems that could ensue if there were accidental
disclosures, or breaches of confidentiality



about illegal behaviors such as underage alcohol use, underage sexual
behavior, illegal drug use,
about “sensitive” information such as diagnoses, workplace
competence, and so forth
Risk can be:

Physical (e.g. pain, drug side effects, or injury) in some studies

Psychological (e.g. emotional distress)

Social (e.g. stigmatization)

Economic (e.g. loss of job—related breach of confidentiality that
relates to stigma, or workplace competency issues)

Legal (requirements to report some illegal activities, whether they are
the focus of the study, or reports emerge without prompting)
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

Belmont principle #3, justice, is seen in the selection of
subjects and protections for vulnerable populations
Selection of subjects needs to be FAIR:




If there is a possibility of benefit from the research (not true for many
studies)
If there is the chance of risk, but no real chance of benefit to
participants—need to avoid burdening participants unfairly
If no appreciable benefit and no real burden, then less of an issue
Researchers must provide additional protections for
vulnerable populations
 Children (Subpart D)
 Pregnant women (if recruited intentionally for a study that
impacts them or their fetuses) (Subpart B)
 Prisoners (Subpart C)
 Individuals who are “decisionally impaired” or who have
diminished capacity (no separate subpart, just provisions)
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
Belmont principle #3, justice, vulnerable populations
continued


More than one Subpart of 45 CFR 46 may apply
Subparts D+C, for children and prisoners, would apply for
youth who are being detained in a juvenile facility
 Consent process needs to deal with issues of feeling
coerced, of understanding their rights in a context of
limited rights, how researchers can contact parents,
whether the facility would allow a waiver of parental
permission, etc.
 Be sure to obtain guidance from the facility about the
multiple steps involved in conducting research in these
kinds of facilities—this may include going through
additional review with officials responsible for research
in prison facilities
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
Belmont principle #3, justice, vulnerable populations, cont.
 Subpart D+ provisions (not yet a subpart) for individuals who
are both minors AND could be considered to be “decisionally
impaired” or to have “diminished capacity” to decide about
research participation
 This could be true for studies that involve children and
adolescents with intellectual disabilities or delays, conditions
such as autism or considerable learning disabilities, and so forth
 Consider carefully the appropriate ways to obtain parental
permission and meaningful child assent for these children
 NOTE: you do NOT need to check “decisionally impaired” in the
online application’s list of vulnerable populations—the parent
permission for a minor will be handling the legal aspect of the
requirement for informed consent, but you should describe
what you will be doing that might be different than it would be
for a typical child of the same age, such as just obtaining oral
assent, in order to be appropriate for your participants
END of Part 2, Belmont Principles in Practice
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Part 3: Issues Specific to Research with Children
in Elementary and Secondary Schools


45 CFR 46, Subpart D has included special rules for the
protection of children in general that also apply to students in
schools
Additional federal laws protect information in students’
educational records:
 The Family Education Rights and Privacy Act
(FERPA) or the Buckley Amendment, gives parents
certain rights over the content of their children’s
educational records
 The Protection of Pupil Rights Amendment (PPRA),
amended by a rider on the “No Child Left Behind Act” in
2001, was intended to provide (require) parental
permission (consent) over the CONTENT of surveys,
instructional materials, analyses, and evaluations of
students, with the level of control depending upon the
source of funding for the research
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Issues Specific to Research with Children
in Elementary and Secondary Schools, continued

The Family Education Rights and Privacy Act (FERPA)
 Gives parents certain rights over the sharing of the
content of their children’s educational records



Those rights transfer to the students when they turn 18
Generally, schools MUST have written permission from the
parent (or student at 18+) before releasing any
IDENTIFIABLE information from a student’s record,
including information about grades, test scores,
attendance, disciplinary actions, gender, ethnicity,
citizenship, and religious affiliation
FERPA does allow schools to disclose IDENTIFIABLE
records WITHOUT PARENTAL PERMISSION OR STUDENT
CONSENT to certain parties, including organizations
conducting research, when the school, school district, or
state department of instruction initiates the research
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Issues Specific to Research with Children
in Elementary and Secondary Schools, continued

The Family Education Rights and Privacy Act (FERPA),
continued



Schools can also disclose without consent “directory”
information but must tell parents and eligible students (18+)
that the directory information is not protected, and allow them
to request that the school not disclose such information about
them
Directory information: name, address, telephone number, date
of birth (so age can be determined) and place of birth
(citizenship), dates of attendance, honors and awards
Researchers themselves can request school records that are
NOT identifiable for secondary analysis – FERPA not an issue
when records are not identifiable, but the IRB may be
concerned about “deductive disclosure of identity” if
combinations of rare characteristics allow for the researcher to
deduce the identity of a student (e.g., the only 11-year-old
Latina in 8th grade algebra in a specific school)
BDG for SoE 10-6-2012
38
Issues Specific to Research with Children
in Elementary and Secondary Schools, continued

The Protection of Pupil Rights Amendment (PPRA),
provides (requires) parental permission for their child’s
participation in or exposure to third-party (not the school’s
own) survey research or curricula that include any of 8
sensitive topics:








Political affiliations or beliefs of the student or the student’s parent
Mental and psychological problems of the student or the student’s
family members
Sexual behavior and attitudes
Illegal, anti-social, self-incriminating, or demeaning behavior
Critical appraisals of family members
Legally recognized privileged or analogous relationships, such as with
lawyers, physicians, or ministers
Religious practices, affiliations, or beliefs of the student or parents
Income other than that required by law to determine eligibility
BDG for SoE 10-6-2012
39

Issues Specific to Research with Children
in Elementary and Secondary Schools, continued
Protection of Pupil Rights Amendment (PPRA), cont.
 If the research asks students to provide information about
any of the 8 topics, AND the research is funded in whole
or in part by ANY program administered by the US Dept of
Education, the requirement for parental permission
CANNOT be waived by the IRB


PPRA does NOT require written parental permission for
the use of surveys and related instructional materials
when the research is NOT funded by the Department of
Education, so the IRB can waive the requirement if there
is sufficient reason to do so (criteria built into application)
PPRA DOES require that every public school system that
ACCEPTS ANY MONEY from the Department of Education
(which means ALL public elementary and secondary
schools) have a policy that informs parents about their
rights to inspect third-party surveys and instructional
materials and ask that their children not participate
BDG for SoE 10-6-2012
40
Other issues related to research with children in schools,
continued





PARENT PERMISSION: Even when parents have provided
permission for their children to participate in research, children
must still be allowed to provide assent (or decline) in a manner that
is appropriate for their age and maturity
Children should not be made to feel pressured to participate—if
they feel even subtle coercion, then their participation is not truly
voluntary
They should be told explicitly that even though their parents have
given permission, they can decide whether they want to be in the
study, that they can stop at any time, and that they can skip over
questions or parts of the study they don’t want to answer or do
Children, especially younger children, may need to be reassured
explicitly that neither their parents, nor their teacher, nor the
researcher will be mad at them, or disappointed, if they choose not
to participate in the study or to stop early
Children, especially older children, may be concerned about what
their classmates are doing, and could feel some peer pressure to
participate, or not to participate—they need privacy to make their
decisions
41
BDG for SoE 10-6-2012
Other issues related to research with children in schools,
continued

Protection from research-related harms


Participation should not subject children to
stigma or ridicule by their peers—so studies that
focus on problematic behaviors need to be
carefully designed to prevent such harms
Parents and older children need to be informed
that promised protections of confidentiality may
be restricted by requirements to report child
abuse and neglect
Not necessary to include such information for every
study—need to consider the topic of the research, and
the sample, to determine if it makes sense
 Should indicate explicitly that there are, or are not
questions that relate to this if it is mentioned at all

BDG for SoE 10-6-2012
42
Other issues related to research with children in schools, cont.

Feasibility/scouting or “soft scoping”




Researchers will frequently need to make preliminary contacts
with school and/or district personnel to determine the
feasibility of their studies (e.g., enough students of various
ages, enrollment of certain kinds of students or existence of
certain programs, times of the year when research is allowed)
Researchers will also need to inquire about local procedures
and preferences—how can children be recruited, can
information be sent home via the PTA newsletter, etc.
“Soft Scope” the situation BEFORE submitting the IRB
application so you can provide reasonable information about
recruitment, parental permission, and how and when and
where the study will be conducted
This is NOT recruitment, and that needs to be clear to
all concerned—school personnel CANNOT agree
formally to allow you to conduct a study before you get
IRB approval
43
BDG for SoE 10-6-2012
Other issues related to research with children in
schools, continued

Dual roles: teacher & researcher (2-hat problem)



Researchers who are already employed by schools and
have returned to graduate school part-time, or students
doing internships or practice teaching, need to be VERY
careful about the conflicts in their two roles
Teachers do NOT have legitimate access AS
RESEARCHERS to the information they have access to as
teachers without additional processes
Teachers need to be VERY wary about conducting
research on the children they teach—parents do NOT
expect random assignment to groups, for example—they
expect teachers to do what is in the best interests of the
child, not of a study
BDG for SoE 10-6-2012
44
Other issues related to research with children in
schools, continued

Dual roles: teacher & researcher (2-hat problem)
continued



Parents cannot readily feel that giving permission for
their child to participate, or giving consent for their own
participation, is voluntary when the person asking is the
child’s own teacher
Older students can feel “used” when they discover that
their teacher has used their assignments for his/her own
research purposes—they may wonder if the assignment
was really to help them learn, or just to help the
teacher/grad student complete a course or a thesis
Doing pedagogical research in one’s own class is not
always forbidden, but it is VERY complicated, and
requires consultation/negotiation with the IRB
BDG for SoE 10-6-2012
45




For ANY and all questions, students should talk
with their advisor(s) FIRST, and faculty may want
to talk to other faculty who have done similar kinds
of work.
If there is still any doubt about the appropriate
course of action, contact the IRB—there are IRB
coordinators & IRB chairs who can help
IRB phone 6-3113 -- general number, so you
should ask for the behavioral coordinators and/or
the behavioral chairs (though they are only
occasionally in the office
IRB website http://ohre.unc.edu
BDG for SoE 10-6-2012
46

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