I. Overview

Language Studies in the Labs in Life Pod at the Center of Science and Industry (COSI), IRB Protocol 2012B0213 ("Pod Protocol"), is an umbrella IRB protocol that covers all of the research conducted in the Language Sciences Lab ("Language Pod") at the COSI Labs in Life exhibit. IRB approval for individual research projects must be obtained by amending the Pod Protocol to add the specific project.

All research projects added to the Pod Protocol must be submitted to Cynthia Clopper by an OSU faculty member who agrees to be responsible for oversight of the project ("supervising faculty researcher").

The research conducted under the Pod Protocol can involve a wide range of behavioral methods that are commonly used in cognitive and developmental psychology, linguistics, and speech and hearing sciences. The research projects covered under the Pod Protocol can investigate a range of different aspects of language, including its production, perception, comprehension, on-line processing, acquisition, and people's attitudes towards it and thoughts about it. Research has been approved for children as young as 2 years old and adults as old as 105 years old.

II. Key Personnel

Anyone who interacts with human participants or their data must be listed as key personnel on the protocol.

Key personnel can be added at any time by emailing Cynthia Clopper with the name and OSU name.# of each person to be added. Key personnel must have current CITI training and a Conflict of Interest disclosure on file to be added to the protocol. The supervising faculty researcher should use the Study Team Lookup tool in Buck-IRB to verify that CITI training and COI disclosures are complete for all new key personnel before emailing Cynthia Clopper to request personnel changes to the protocol. Note that it can take up to 24 hours for the Buck-IRB system to update following completion of CITI training.

III. Adding New Studies

Each individual research project must be added to the protocol by amendment. The materials approved under the Pod Protocol umbrella include:
1. signed consent (for adults), assent (for children), and parental permission form templates
2. electronic consent (for adults), assent (for children), and parental permission form templates to be signed on an iPad
3. verbal consent (for adults), assent (for children), and parental permission script templates
4. a signed audio/video taping release
5. an electronic audio/video taping release to be signed on an iPad
6. a signed parent audio/video taping release
7. an electronic parent audio/video taping release to be signed on a iPad
8. a recruitment script template
9. recruitment slides template
10. a debriefing template
11. a demographic questionnaire for adult participants
12. a demographic questionnaire for parents

Note that these materials, with the exception of the audio/video taping releases and demographic questionnaires, are templates only and cannot be used with potential participants until they have been completed with project-specific information and approved by the IRB.

Each amendment must include the following project-specific documents:
1. A project summary including:
      • a project title
      • a summary of the project background and rationale (150-200 words)
      • a description of the target participant population
      • an explicit statement of the duration of the study
      • a description of how consent, assent, and/or parental permission will be obtained
      • a description of the experimental procedures to be used, including sample stimulus materials

To use an approved taping release, you must indicate in the consent section of your project summary that you will use a previously-approved taping release for adults and/or parents, as appropriate, and how you will obtain a signature (hard-copy or iPad).

To use an approved demographic questionnaire, you must indicate in the procedure section of your project summary that you will use a previously-approved demographic questionnaire for adults and/or parents, as appropriate. You may also obtain the same demographic information as part of a study-specific questionnaire or demographic screening. All study-specific demographic questionnaires must be approved by the IRB and described in the procedure section of your project summary.

The project summary must be contained in a single document with the naming convention: ShortStudyName-studyinfo.docx (for Word documents) or ShortStudyName-studyinfo.pdf (for PDF documents).

Please see this example project summary for additional guidance.

2. Study-specific materials (based on the approved templates):
      • study-specific recruitment script and slides
      • a study-specific debriefing brochure
      • study-specific consent, assent, and/or parental permission forms/scripts

To facilitate review by Cynthia Clopper and by the IRB staff and reviewers, these materials must be submitted as separate documents with the following naming conventions:
Recruitment script: ShortStudyName-recruit.doc
Recruitment slides: ShortStudyName-slides.doc
Debriefing brochure: ShortStudyName-debrief.doc
Consent form/script: ShortStudyName-consent.doc
Assent form/script: ShortStudyName-assent.doc
Parental permission form/script: ShortStudyName-parent.doc

All amendment materials should be emailed to Cynthia Clopper for approval and submission to Buck-IRB. In the body of the email, please briefly describe the nature the requested additions/changes to the protocol.

Each amendment for a new study must also be accompanied by a completed and signed Pod Protocol Human Subjects Research Agreement. The Research Agreement is a Pod-internal document and will not be submitted to the IRB.

IV. Amending Previously Approved Studies

Previously approved studies can be revised through the amendment process. The IRB requires two copies of all revised documents: one version with the changes tracked (using track changes in Word) and one version with the changes incorporated (clean).

Both sets of materials should be emailed to Cynthia Clopper for approval and submission to Buck-IRB. In the body of the email, please briefly describe the nature the requested additions/changes to the existing study.