The Linguistics DepartmentInstitutional Review Board

Committee

Silvina Montrul, chairFred DavidsonIrene 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) productionand 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