Introduction to the UIUC Institutional
Review Board – Library Summer
Workshop
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June 20, 2013
Ron Banks- Human Subjects
Coordinator
rbanks@illinois.edu; 244-3939
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OVERVIEW: Human Subjects Protections
at UIUC
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The Belmont Report and regulations
What is human subjects research
Levels of review – NHSR (not human subjects
research), exempt, expedited, full board) w/GSLIS
or UIUC Library research examples
Overview of IRB procedures/pathways to
approval/tips/required training
Amendments
Informed Consent
UIUC IRB application approval criteria
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History leading to IRB
system
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PHS Syphilis Study (Tuskegee)
Willowbrook
Milgram
Beecher article in 1966
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National Research Act
1974
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The National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research is
established, and Congress passes the
National Research Act.
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Belmont Report - 1979
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Respect for Persons
Beneficence
Justice
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Respect for Persons
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People to be treated as autonomous
agents with freedom of choice
Protect those with diminished
autonomy
People must provide informed consent
Privacy must be respected
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Beneficence
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Obligation to do no harm
Obligation to do good
Risk Benefit ratio
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Justice
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Fairness in recruiting
Distributed justice. Burdens and
Benefits shared equally
Vulnerable populations
Choice to participate or not
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Federal Regulations
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45 CFR 46 – Common Rule - Regulations for the
Protection of Human Subjects of Biomedical and
Behavioral Research
– Basic regulations established in 1974
– Adopted by 16 federal agencies as the Common
Rule in 1991
– Proposed changes in the regulations being
reviewed
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What is a Human Subject?
A living individual about whom an
investigator obtains data through
intervention or interaction with
the individual
OR
…about whom an investigator
obtains individually identifiable,
private information
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What is Research?
A systematic investigation
designed to lead to generalizable
knowledge
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What this means for UIUC
Researchers…
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All research involving humans, human
tissues or fluids, or records
Funded or not
Regardless of where the research is
conducted
Regardless of level of risk
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What this means for UIUC
Students
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If you are conducting research with
humans including senior theses or
dissertation…
– Complete an IRB application
– Complete the required training
– Get IRB approval before starting!
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Levels of Review
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NHSR (Not human subjects research)
Exempt Research
Expedited Review
Full Board
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Not Human Subjects
Research Overview
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Some research involving human
subjects or analysis of data doesn’t
require IRB review/approval (doesn’t
fit federal definition)
Contact the IRB office first BEFORE
filing application if you are not sure
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Examples of Not Human
Subjects Research
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Survey done for internal purpose only (e.g., program
improvement)
Survey/interview requesting factual information only (no
opinions/attitudes/perceptions/beliefs)
Course projects policy – student research done solely to learn
how to be an effective researcher
Certain kinds of oral history
Analyzing data other researchers collected that GSLIS
researchers can’t link back to identity of the participants.
Only analyzing data that is publicly available (on a public
message board)
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Example of application approved as
NHSR (not human subjects
research)
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Gender and Salary in the Illinois Public
Libraries, 1993-94 and 2006-07
– Data being analyzed from the Illinois
Public Library Annual Report was library
specific but not linkable to individual
employees by the researchers (library ID
was removed)
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Review Levels - “Exempt”
Studies
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Exempt research: Exempt means exempt from the
federal regulations and formal board member review.
However UIUC essentially adheres to these regulations for
all studies, but with more flexibility and a shorter
application available.
All exempt studies must be designated no more than
minimal risk and fit one of the allowable exemption
categories as per the federal regulations.
Timelines - approximately one to two weeks from
submission to approval, improved turnaround time since
an Exempt Specialist was hired at the campus IRB
Exempt Category #1
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Category 1: Title 45, Code of Federal Regulations
§46.101(b)(1) exempts research conducted in
established or commonly accepted educational
settings, involving normal educational practices,
such as
– research on regular and special education
instructional strategies, or
– research on the effectiveness of or the
comparison among instructional techniques,
curricula, or classroom management methods.
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GSLIS Example of study approved under
exempt category #1
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Data Curation Education in Research
Centers (DCERC)
– Evaluating the impact of a data curation
educational program
– Actitivies – online surveys, data from
online forums, interviews, reflections…
– Approved under exempt category 1
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Pre-review issues for exempt
category #1 study
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Section 12 – lines 9-12 state: “As part of the case study, one researcher from each
DCERC institution (UIUC and Univ. of TN at Knoxville) will serve as a participant
observer and record observations of telling moments during the course program. Only
moments from those signing permission forms will be recorded with personally
identifying information removed.”
Please clarify the consent process for the observations in section
20D and if participants will sign and return a consent form for this
part of the study, please supply a copy of that consent form with
any revisions.
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Consent letter - please note that the dissemination statement in the consent
forms should more closely match what is in section 19F of the IRB-1 form.
Issue: consent letter didn’t relate all of the various possibilities
mentioned in the application.
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Rationale for exemption
(Category #1)
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Category 1 applies because the study involves surveys, observational
case study analysis, interviews, and an end of program debriefing
essay by students and principle parties. The goal is to evaluate the
impact of the Data Curation Education in Research Centers (DCERC)
program on students, the faculty, and institutions involved (therefore
the study is occurring in a commonly accepted setting for education
and is attempting to determine the effectiveness of an instructional
curricula)
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Exempt category #2
Category 2: Title 45, Code of Federal Regulations §46.101(b)(2)
exempts research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior, unless
– information obtained is recorded in such a manner that
human subjects can be identified, directly or through
identifiers linked to the subjects; and
– any disclosure of the human subjects' responses outside
the research could reasonably place the subjects at risk
of criminal or civil liability or be damaging to the
subjects' financial standing, employability, or reputation.
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Library Exempt example category #2
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Integration of makerspace
technologies in a public computer lab
– Interviews with 3 librarians from the
Cleveland Public Library about integrating
makerspace technology in library
computer lab
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Pre-review issues
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Section 6: Please describe the measures you will take to assure
confidentiality of the subjects’ responses. For example, will you use
pseudonyms? Will the data be stripped of any identifiers to both person and
place of employment before disseminated? The consent states that they will
be unidentifiable, but the application needs to show me your process.
Section 7: Please describe the measures you will take to secure the handwritten notes and audio recordings. For instance, will the notes be kept in a
locked office? Will the recordings be kept on a password-protected
computer?
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Rationale for Exemption (GSLIS example
exempt category #2)
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The study involves interview procedures,
the data is identifiable (coded and audio
recordings exist) but any disclosure of
responses would not reasonably place the
participants at risk of criminal/civil liability
nor would it be damaging to their financial
status, employability or reputation.
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Review Levels - “Expedited” Review
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research must be ‘no more than minimal risk’
There are nine categories of expedited research including research
on individual or group characteristics or behavior (including, but not
limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral history, focus
group, program evaluation, human factors evaluation, or quality
assurance methodologies. (NOTE: Some research in this category
may also qualify as exempt)
experimental manipulation of some kind, blood draws, MRI,
deception, etc.
TIMELINE - approximately one month from submission to approval. one board member reviews.
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Library Expedited Review:
Example #1
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Library Collections Visualized: A User
Study of Prototype Collection Analysis
Tools
Procedures:
– User testing of tool to analyze
use/content of library collections
– Morae/Silverback software captures
screen, video of interaction, etc.
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Pre-review issues expedited review study
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Section 18b/18c/18e – clarify whether the NetID login remains with the data or whether this is replaced
by any kind of participant number. If there is such a system is an identity key created that links the
number (or pseudonym) back to the real name of the participant. If there is an identity key explain
how its stored securely in 18c and for how long its retained in 18e.
Section 18b – are the audio recordings of interviews and video collected through the Morae Software
for transcription/research analysis only (not dissemination)?
WAIVER of DOCUMENTATION:
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Please add details as to <why> the study represents no more than minimal risk of harm <and> why there are no
procedures for which signed consent would be necessary outside of the research context (such as if the results were
being used for internal evaluation only to see if the system assists library research rather than broader research
purposes signed consent wouldn’t be required?)
CONSENT LETTER - suggest adding a sentence or two being more specific about what the user testing
session entails, what they are asked to do, find, etc.
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GSLIS expedited review
(example #2)
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Data Sites: Collaborative Practices and
Data Repositories
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To investigate data practices, data sharing, and interfaces with data repositories in
the natural environment
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Activities – document analysis, interviews, and observations of work environments
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Rationale for expedited review:
Expedited under 45 CFR 46, categories 6 and 7. Category 6 applies since
observations of meetings and interviews may be audio recorded with
permission and participants and workplaces may be photographed.
Category 7 applies since the study involves individuals at specific
scientific sites being observed, participating in interviews, and providing
work related documents in order to investigate data practices, data
sharing, and interfaces with data repositories in the natural sciences. It
was felt the category 2 exemption would not apply since observations are
not public.
Board member issues prior to approval Expedited review GSLIS example #2
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Section 20a- since the research occurs in the participants work environment please add some specific
discussion about any possible risks related to employment (such as if they had different opinions about
the organizations approach than that advocated by administration) and if there might be any how these
risks are minimized.
Section 18b- seems from the interview consent that participants could choose to allow their response
to be connected to their identities, is that true of the observational data as well? Explain this in the data
collection section, and if there is to be such an option add a discussion in section 18b to make it clear
that participants can choose confidential participation or to allow identities to be linked to their research
contributions in research dissemination efforts. NOTE: if there is not such an option just delete that
information from paragraph 2 on the interview consent.
Section 19d- so for the various observations would the researchers always need to have obtained
consent from everybody in the meeting or work area prior to conducting observations? If even one
person has not consented do no observations occur in other words for that given meeting, in that work
space, etc.?
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Review Levels - “Full Board”
Review
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IRB applications that require full board review are thought to
involve potentially higher levels of risk to subjects. Research
involving the study of illegal activity, some drug and alcohol
studies, X ray studies, prisoners, or that involves maximal
exercise require full board review. Small percentage of IRB
applications require IRB review.
TIMELINE - submit by deadline date (typically first Friday of
month) for meeting that occurs in the 2nd week of the
following month (e.g. submit by May 4 for June 12th meeting)
Board can approve, defer approval to the next month’s
meeting, or vote to reject the study
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GSLIS full board example
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Community Informatics Across the Curriculum
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Procedures:
– Done in part at the Champaign County Juvenile Detention
Center (subpart C applies)
– Focus on the incarcerated youth’s perceptions of the
library collection and services (informal conversations and
collections analysis
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Full Board Concerns
(prior to approval)
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If an incarcerated youth doesn’t agree to be part of the study they are still
given access to the library when it is not staffed, but is that equivalent
access? The youth who do not assent should still be able to enter the room
when the librarians are there, so there needs to be a system in place that
keeps track of who opts out of participation. An alternative plan could also be
developed such as observing for research purposes only in one-half of the
staffed time so that youth who don’t participate in the research could still
access the library when librarian assistance is available. In other words a
reasonable plan should be developed that assures that any incarcerated youth
who chooses not to participate will have the same equal access to the library
that they have always had.
Section 10a, 12 and 19b- Be more specific than stating that “data will involve
conversations with youth” by clarifying what the limits would be for these
conversations in terms of topics that are eligible for research data collection.
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UIUC IRB Procedure
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Submit an IRB-1 application OR
Application for Exemption along with:
– Consent documents
– Measures
– Recruitment flyers
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Pre-review procedure
Board member review if study is not
exempt
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IRB Application Tips
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Be consistent throughout your application
Have patience with process, planning in advance
will lead to less stress,
IRB is service oriented, you can meet with us, call
with questions, etc.
Try to be as detailed as possible on first
submission. Fill in all boxes/sections, go through
form carefully.
Read and respond to questions that appear on the
form.
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IRB Application Tips
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Use online help available on the IRB web site.
Use lay language in section 7 and throughout
(especially on consent), when academic jargon is
necessary define what it means.
Respond to each request for revision from the prereview or board member review, helpful to have a
response letter. On pre-review when requested
changes aren’t made clarify why!
99+% of studies get approved, but great range in
terms of how stressful the process is prior to
approval!
IRB Web Site
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Pathway to Approval
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Submit application and complete the required training
Respond to IRB Office comments quickly (pre-review from
office staff reviewer)
Review level determination will be made at the IRB Office exempt, expedited, full board
– if exempt approval after pre-review complete
– If not exempt, sent to one board member or full board
Respond to board member modifications letter
Approval is good for three years for exempt, one year for
expedited or full board (sometimes just 6 months)
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Required online training – CITI
Program
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Belmont Report and CITI Course Introduction
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History and Ethical Principles - SBR
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Defining Research with Human Subjects - SBR
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Assessing Risk in Social Behavioral Sciences - SBR
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Informed Consent - SBR
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Privacy and Confidentiality - SBR
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Research Amendments
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AFTER initial approval if anything changes in procedures,
participants, consent letters, etc.
– If approved via expedited or full board review: Submit a Research
Amendment form
– If approved as exempt just summarize changes in an email
– Supply ‘markup’ versions of anything is changed – no need to supply
materials that are not changing
– Supply final versions and anything new
– Minor modifications approved in office, major changes approved via
board member after pre-review.
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Elements of Informed
Consent
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Purpose
Procedures
Risks and Benefits
Voluntariness
Confidentiality
Contact Information
Signature Statement
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Informed Consent Overview
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Signed (written) Informed Consent
Waiver of Informed Consent
Alteration of Informed Consent
Waiver of Documentation
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Informed Consent
Overview Cont’d
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Informed consent is an ongoing process rather than
just given/obtained at a moment of time.
no exculpatory language, 8th grade reading level,
correct grammar/typos
Give participants opportunities to ask questions
Ensure participants understand what they have
consented to do
Ensure participants understand that they can
discontinue at any time
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Purpose and Composition
of UIUC IRB
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To facilitate safe and ethical research with human
subjects conducted by UIUC faculty, staff and
students.
Two boards – Social/Behavioral/Educational and
Biomedical
Approximately 15 faculty, community members,
physicians on each board
IRB office - 8 person staff
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Seven Criteria for
Approval
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Risks to subjects are minimized.
Risks to subjects are reasonable in
relation to anticipated benefits and the
importance of the knowledge that may
reasonably be expected to result.
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Seven Criteria for Approval
cont’d
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Selection of subjects is equitable.
Informed consent will be sought from
each prospective subject.
Informed consent will be
appropriately documented.
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Seven Criteria for Approval
cont’d
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The research plan makes adequate
provision for monitoring the data
collected.
Adequate provisions to protect the
privacy of subjects and to maintain the
confidentiality of data.
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Connection Belmont to
Review Criteria
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Respect for Persons
– Informed consent, assent,
privacy/confidentiality, vulnerable populations
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Beneficence
– Risk/benefit analysis, data safety, experimental
design, qualifications of PI
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Justice
– Subject selection, inclusion/exclusion,
recruitment
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Assistance Available
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Tip sheets online with examples
Phone: 333-2670
Email: irb@illinois.edu
Schedule appointments with IRB staff
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