Transcript Slide 1

The Linguistics Department
Institutional Review Board
Committee
Silvina Montrul, chair
Fred Davidson
Irene Koshik
Ryan Shosted
September 22, 2008
What is the Institutional Review
Board?
• The IRB’s purpose is to protect human subjects who
participate in research experiments. This includes:
– Making sure that subjects are not harmed physically or
psychologically as a result of the experiment
– Protecting the data collected so that subjects cannot be
identified without their consent
– Ensuring that subjects understand what they will be asked to do
in the experiment, and what their data will be used for
– Ensuring that subjects understand the benefits of the research
relative to the risks
– Ensuring that subjects are not coerced into participating
• http://www.irb.uiuc.edu/
What is Human Subjects
Research?
• Basically anything that involves collecting data
from people, whether it be biological or
behavioral data.
• Examples:
– Grammaticality judgments
– Elicited productions or comprehension responses in
phonetic experiments
– Speech data that is in the public domain
– Human subjects data that was already cleared by
another IRB
Does all Human Subjects Research
Receive the Same Level of Scrutiny?
• No!
– Some kinds of research can be classified as
exempt according to Title 45, Part 46,
Paragraph 101(b) of the Office for Human
Research Protections (OHRP), part of the US
Department of Health and Human Services
– http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101
Title 45, Part 46, Paragraph 101(b)
• (b) Unless otherwise required by department or
agency heads, research activities in which the
only involvement of human subjects will be in
one or more of the following categories are
exempt from this policy:
– (1) Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as (i) research on regular
and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison
among instructional techniques, curricula, or
classroom management methods.
Title 45, Part 46, Paragraph 101(b)
– 2) Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of
public behavior, unless:
(i) information obtained is recorded in such a manner
that human subjects can be identified, directly or
through identifiers linked to the subjects; and (ii) 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.
UIUC IRB has agreed to include (non-invasive) production
and perception studies under this rubric
Title 45, Part 46, Paragraph 101(b)
– (3) Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of
public behavior that is not exempt under paragraph
(b)(2) of this section, if:
(i) the human subjects are elected or appointed public
officials or candidates for public office; or (ii) federal
statute(s) require(s) without exception that the
confidentiality of the personally identifiable
information will be maintained throughout the
research and thereafter.
Title 45, Part 46, Paragraph 101(b)
– (4) Research involving the collection or study
of existing data, documents, records,
pathological specimens, or diagnostic
specimens, if these sources are publicly
available or if the information is recorded by
the investigator in such a manner that
subjects cannot be identified, directly or
through identifiers linked to the subjects.
Title 45, Part 46, Paragraph 101(b)
– (5) Research and demonstration projects which are
conducted by or subject to the approval of department
or agency heads, and which are designed to study,
evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures
for obtaining benefits or services under those
programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible
changes in methods or levels of payment for benefits
or services under those programs.
Title 45, Part 46, Paragraph 101(b)
– (6) Taste and food quality evaluation and consumer
acceptance studies, (i) if wholesome foods without
additives are consumed or (ii) if a food is consumed
that contains a food ingredient at or below the level
and for a use found to be safe, or agricultural
chemical or environmental contaminant at or below
the level found to be safe, by the Food and Drug
Administration or approved by the Environmental
Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.
Linguistics Department IRB
• The IRB committee of the Linguistics Department can
review proposed research projects and grant an
exemption if
– The project is reasonably believed by the researcher and the
committee to be exempt under 45.46.101(b)
– The project is not funded by an outside agency
– The project does not involve “vulnerable” populations “such as
children, prisoners, pregnant women, mentally disabled persons,
or economically or educationally disadvantaged persons”
• Note that “children” includes anyone under 18, so watch out if you
plan to use undergraduates. Also be careful about using your own
children.
• If any of these conditions are not met then the project
must be reviewed by the UIUC IRB.
Linguistics Department IRB
• Review submissions by PI’s conducting human subjects’ research
• Classify said submissions into one or another of the six exemption
categories of Title 45, Part 46, paragraph 101(b).
– If a proposal clearly does not fall under one of the exemption categories,
the proposal will be returned to the PI, who will be told that they have to
submit it for full IRB approval
– Similarly, if the committee is unsure of the proposal’s status with respect
to exemptions, the committee will refer the proposal to the IRB office.
• File a copy of the proposal, the protocol and any consent forms
associated with the proposal in the Department’s IRB Files
• Publish and maintain a set of guidelines for human subjects’
research. These guidelines will be available via the Linguistics
Department web page.
What you will need to submit
• A copy of the research proposal
• An application form that includes a description of the
protocol that highlights how the human subjects’
research will be conducted, and why the proposed
research should qualify for an exemption.
• If the research involves recruited human subjects (i.e.,
does not involve human subjects’ data already in
existence), copies of subject recruitment and consent
forms.
• A copy of both the IRB certificate of completion and the
CITI completion report, certifying that you have
completed the two training modules required by the
university’s IRB