Human Subjects Approval
All research involving human subjects must be approved by the Institutional Review Board (IRB) before any interaction with participants (including recruitment!) can take place. To determine whether or not your research is considered human subjects research according to federal guidelines, see Decision Chart #1 established by the U.S. Department of Health and Human Services.

Some Definitions
Protocol: A protocol is the set of materials and procedures related to a specific research project that is approved by the IRB. The IRB assigns a unique number to each protocol once it has been approved ("OSU protocol number"). The research protocol submitted with an application for IRB approval describes the materials and procedures that will be used in the proposed project. Any changes to the protocol must be approved by the IRB before they are implemented.

Umbrella Protocol: An umbrella protocol (or program protocol) is the set of materials and procedures related to a group of research projects conducted in a single lab, program, or department. The research protocol submitted with an umbrella IRB application describes the general types of materials and procedures that will be used in the lab, program, or department. Specific materials and procedures must be added individually to the umbrella protocol before they are implemented.

Amendment: An amendment is the means for obtaining approval for all changes and additions to regular and umbrella protocols. An amendment must be approved by the IRB before the changes or additions are implemented.

Principal Investigator: The Principal Investigator (PI) is the person responsible for overseeing the research project and ensuring compliance with all Federal and OSU regulations governing human subjects research. At Ohio State, only faculty members are eligible to be the PI on IRB protocols.

Exemption: Some human subjects research qualifies for an exemption from IRB review. However, potentially exempt research projects must be evaluated by a member of the IRB staff and an official exemption must be obtained prior to beginning the project. To determine if your project might be eligible for an exemption, see the decision charts (#2 through #7) at the U.S. Department of Health and Human Services. Application forms for IRB Exemption are available from the IRB Website: http://orrp.osu.edu/irb/exempt/index.cfm.

Useful Links
Human subjects research decision charts at the U.S. Department of Health and Human Services.
Ohio State University IRB Website: http://orrp.osu.edu/irb/
Schedule of help sessions for students completing IRB applications and exemptions: http://orrp.osu.edu/irb/workshops/studentassist.cfm.

Human Subjects Training Requirements
Everyone who conducts human subjects research must be trained in the protection of human subjects. At OSU, training is conducted through an online course by the Collaborative IRB Training Initiative (CITI) program. You must successfully complete the Basic Course in Social and Behavioral Science with a score of at least 80% to meet the OSU training requirement. Your CITI training is valid for three years and you must complete the refresher course every three years to continue conducting human subjects research. CITI training information is available online at: http://orrp.osu.edu/irb/training/.

Everyone who conducts human subjects research must also have a current Conflict of Interest Disclosure on file with the Office of Research. New Conflict of Interest Disclosures must be completed every academic year. The Conflict of Interest Disclosure form is available online at: https://rf.osu.edu/secure/e-coi. You should login using your OSU userid and password. If you get a message saying that you don't have access to the form, you will need to email the Office of Research Helpdesk (orhelpdesk@osu.edu) to request access to the COI Disclosure.

The Department Protocol
The Department of Linguistics has an approved umbrella protocol (Comprehensive Research Program in Linguistics, IRB Protocol 2004B0112) that covers most of the kinds of research conducted in the Department of Linguistics (eye movement monitoring and ultrasound research are not covered). Therefore, depending on your research project, you may not need to file an application for approval of a new protocol. Instead, you may be able to file an amendment to the department protocol to add your specific research project.

Kathryn Campbell-Kibler is the Principal Investigator for the department protocol and will need to sign your application before it can be submitted to the Office of Responsible Research Practices. You should give her all of the materials that you are planning to submit so that she can look them over. After she signs the amendment form, you should make one hard copy of the entire amendment (including the signature) for yourself, one copy for Kathryn, and submit the original to the IRB.

All student research projects added to the department protocol must be approved by a faculty advisor for the project and a signed Student Research Project Agreement form must be submitted to the PI with the first amendment for each project. This agreement lays out the responsibilities of the student and the faculty advisor for research projects conducted under the department protocol and ensures that all researchers involved in such projects are familiar with the policies and regulations governing human subjects research.

Under OSU and Federal regulations, non-compliance with IRB policies governing human subjects research by any individual associated with the department protocol may result in the suspension of all research conducted under the department protocol.

Informed Consent
Informed consent must be obtained from each participant prior to their participation in an experiment. For the department protocol, informed consent may be obtained in writing, but signed consent may also be waived and consent obtained verbally. If you obtain verbal consent, you must keep a log of all of the participants from whom you obtain verbal consent. Current approved consent materials (verbal scripts and written forms in a number of languages) are available on the department internal page: https://www.ling.ohio-state.edu/ling201/consent_forms.html (login required).

If you are making audio recordings of your participants, you must obtain a signed taping release waiver from each participant to use the recordings as stimulus materials or in future presentations. Current approved taping release forms for the departmental protocol are also available on the department internal page: https://www.ling.ohio-state.edu/ling201/consent_forms.html (login required).

Filing an Amendment
ALWAYS download the most current IRB forms directly from the OSU IRB Forms Page. If you use outdated forms, your materials will be returned without review.

Once you have submitted your amendment materials to the IRB, you can check the status of your amendment online using the IRB's Protocol Lookup. Approval of amendments generally takes about two weeks.

Amendment/Changes to Research
1. Project Title: Comprehensive Research Program in Linguistics
Protocol Number: 2004B0112
To help the PI keep track of paperwork, indicate an Amendment Number in parentheses following the project title. The Amendment Number should be 8 digits: 2 letters indicating your initials followed by 6 digits indicating the date (MMDDYY). For example, if Cynthia Clopper were to file an amendment on January 3, 2010, in the Project Title box, she would enter: Comprehensive Research Program in Linguistics (Amendment CC010310)

2. Principal Investigator
The Principal Investigator for the department protocol is Kathryn Campbell-Kibler.
Name: Campbell-Kibler, Kathryn
Email: kbck@ling.ohio-state.edu

3. Additional Contact
Please complete this section with your contact information. If the IRB has a question about your amendment, they will contact both you and the PI.

4. Proposed Changes
a. Change in study personnel: Everyone involved in research under the department protocol must be listed as Key Personnel. Involvement in research includes recruiting participants, collecting data from participants, and analyzing data. If you are not already listed as key personnel on the protocol, you must complete Appendix O to add yourself as Key Personnel. Any undergraduate research assistants or interns working on your project must also be added as Key Personnel.
b. Change in the number of participants: You must complete Appendix Q to add the number of participants that you are planning to include in your study to the protocol. Once you have collected data from the number of participants you've requested, you must not collect any further data without first obtaining approval from the IRB to add additional participants to your study.
c. All other research changes: You must complete Appendix T to request approval for the addition of your study and study-related materials to the department protocol.
d. Attachments will include recruitment emails, flyers, and experiment descriptions for the LOC subject pool; study information, instruction, and debriefing sheets; language or other background questionnaires, interview scripts, and sample stimulus materials.
e. You will not be making changes to the research protocol and should not need to change the consent forms. However, if you are planning to obtain consent in a language other than English, you may need to submit an amendment to add a translation of the standard form to a new language if a translation has not already been approved. Current approved consent materials are available on the department internal page: https://www.ling.ohio-state.edu/ling201/consent_forms.html (login required). Any materials in a language other than English must be accompanied by a statement describing the translator's qualifications. Note that translation certification by a third party is no longer required.
f. You will also need to submit additional appendices if you will be conducting research with children (Appendix I), with non-English speakers (Appendix J), or outside of the United States (Appendix U), or if you plan to make your data available as a data repository (Appendix C).

5. Principal Investigator's Assurance
The Principal Investigator for the departmental protocol is Kathryn Campbell-Kibler and she will need to sign your application before it can be submitted to the Office of Responsible Research Practices.

Appendix O
Add yourself and any undergraduate research assistants or interns as Key Personnel in Section 2 and enclose a copy of the CITI training completion certificate for all new Key Personnel. All Key Personnel must also have a current Conflict of Interest Disclosure on file with the Office of Research.

Appendix Q
For item 1, write "Not applicable for department protocol"

For items 2 and 3, indicate the total number of participants you plan to include in your study. Remember that you may not be able to use all of the data that you collect and you can only collect data from the number of participants that you request in your application, so be sure to round up! If you collect data from the total number of requested participants and still need additional data, you must file another amendment to increase the number of participants in your study and have the amendment approved by the IRB before collecting data from additional participants.

For item 4, explain that you are requesting approval for the addition of a study on your proposed project and that the requested subjects are for that study. You might also explain that you have Y conditions, that you want W subjects in each condition, and that Y x W = the number of requested participants.

Appendix T
In item 2, explain that you are requesting approval for the addition of a study on your proposed project and briefly explain the purpose or goal of the study. Since you will be adding a project to the departmental protocol, you should indicate that you are requesting the approval of new project materials (rather than changes to existing materials), but that the pre-approved protocol consent materials will be used.

Attachments
You will need to attach copies of anything that the participants will see, from recruitment through the end of the experiment. Examples of such attachments follow.

Recruitment Materials
If you are using the Linguistics Outside the Classroom (LOC) subject pool, you will need to obtain approval for a title and one-sentence description of your experiment that the participants will see on the online experiment signup page.

If you are planning to recruit participants from somewhere other than the LOC pool, you will need to obtain approval for your flyers, email solicitations, oral scripts, and any other recruitment materials you plan to use. The recruitment materials should include at least the following information:
1. a statement that the research is being conducted in the Department of Linguistics at OSU
2. a brief description of the project, participation requirements, experiment duration, and payment or other incentive
3. your contact information
4. a statement that participation is voluntary, that participants may withdraw before the experiment is over, and how early withdrawal from the experiment will affect the payment or incentive

Scripts or Information Sheets
You must provide your participants with written or verbal information about the experiment, as well as instructions. You must therefore obtain approval for either verbal scripts with this information or printed sheets with this information that participants will read. The information sheets should include at least the following information:
1. an explanation of the purpose of the study
2. the expected duration of the experiment
3. a summary of the foreseeable risks or discomforts to the participants
4. a summary of the benefits to the participants
5. a description of the incentives to the participants
6. a statement about how participant confidentiality will be maintained
7. a statement about the voluntary nature of their participation
8. your contact information
9. the PI's contact information: Kathryn Campbell-Kibler, 200A Oxley Hall, 614-247-5321, kbck@ling.ohio-state.edu
10. experiment instructions

At the end of the experiment, you must provide the participants with additional information about the study, called debriefing.

Instruments
If you plan to collect any background information from your participants, you will need to obtain approval for your background questionnaire. You may also use the language background questionnaires that have already been approved for this protocol and are available on the department internal page: https://www.ling.ohio-state.edu/ling201/consent_forms.html (login required).

If you are planning to interview your participants, you will need to obtain approval for an interview script that provides a list of the kinds of questions that you will be asking your participants. You should explicitly state that the script provides an indication of the kinds of questions that you will ask and is not an exhaustive list.

If you will be presenting your participants with any visual or spoken stimulus materials to read or respond to, you will need to obtain approval for those materials. You can include an exhaustive list (which, once approved, cannot be changed without further approval) or a list of representative sample materials (10-15 items).

Additional Notes
If you are planning to record stimulus materials for a perception experiment, you will need to obtain approval for both the stimulus recording and the perception experiment. If you use a friend or classmate as a talker for your stimulus materials, you must treat them as a subject and obtain informed consent and a taping release. The only case in which you can treat a talker as an experimenter (and not obtain consent and a taping release) is if the talker is acting as a trained linguist in some manner (e.g., producing specific features, segments, or intonation contours). So, if you choose your talker because they are a phonetician, they are an experimenter. If you choose your talker because they are a native speaker of the language you are studying, they are a subject.

If you will be analyzing previously recorded materials, you may need to obtain either approval or exemption for those analyses, depending on how the data were coded.

If you plan to pay participants, you will need to talk to Claudia Morettini IN ADVANCE. The policies for paying participants are complicated and differ for OSU employees and non-employees. If you simply pay participants out-of-pocket, you may not be able to be reimbursed. You may also compensate participants with cookies, candy, or other food, instead of money, if you obtain IRB approval to do so.

Sample IRB Amendment Application
Please note that not all forms in this sample amendment application are current
Amendment Form
Appendix O
Appendix Q
Appendix T
Recruitment
Instructions
Debriefing

Other Examples
Sample Instructions 1 Sample Instructions 2
Sample Debriefing 1 Sample Debriefing 2