Obtaining IRB Approval for Research at the Pod

Overview:

All researchers working at the Language Pod are required to have current IRB approval for their research. Faculty will be asked at the beginning of each semester (fall, spring, and summer) to provide documentation confirming that they have current IRB approval for their research.

The umbrella IRB protocol for research at the Pod that has been in place since 2012 (Protocol Number 2012B0213) has been phased out. Beginning May 1, 2018, all data collection at the Pod must be covered by an approved IRB protocol with an individual faculty member PI. Thus, all individual faculty researchers must obtain their own IRB approval for all of their studies at the Pod, including studies previously approved on the umbrella protocol.

Required Elements:

Although researchers must obtain their own IRB approval, research protocols for research at the Pod must comply with Pod-specific requirements. Faculty researchers will be required to provide documentation confirming that their materials are in compliance with these requirements.

Key personnel:

Anyone who is involved in any aspect of a research project at the Pod must be approved as key personnel on the appropriate IRB protocol(s). Involvement with research includes, but is not limited to: recruitment, obtaining informed consent, data collection, and data analysis. Approval as key personnel requires completion of the CITI training course in Human Subjects Research once every three years (http://orrp.osu.edu/irb/training-requirements/citi/), the CITI training course in Responsible Research Practices once (https://orrp.osu.edu/irb/training-requirements/rcr/), and the Conflict of Interest Disclosure annually (http://orc.osu.edu/regulations-policies/coi/ecoi/). Faculty researchers are responsible for ensuring that all of their RAs have current CITI training and COI disclosures and are listed as key personnel on the appropriate protocol(s).

Location of research:

In the Buck-IRB application for all protocols covering research at the Pod, COSI must be listed as a Location of Research under Domestic Research Sites.

A letter of support from COSI must also be included in this section of Buck-IRB. Each faculty researcher is required to obtain a single letter of support for use with all of their protocols for research at the Pod. That is, the same letter can accompany all protocol submissions from the same researcher and a different letter is not required for each protocol. Faculty researchers who do not have a letter of support can obtain one directly from COSI (http://orrp.osu.edu/irb/osuirbpolicies/cosi/).

Recruitment requirements:

The Pod has established a recruitment protocol (Protocol Number 2017B0408) that allows students in the EDUTL/LING/PSYCH 5700 “COSI course” to participate in recruitment activities for any study at the Pod which references the recruitment protocol as part of its IRB-approved recruitment procedures. Faculty researchers are therefore required to:

  1. include the following text in the Procedures section of their approved research protocol and in the appropriate sections of Buck-IRB: “Recruitment will be conducted by key personnel on this protocol, as well as by key personnel on the Recruitment Protocol for the Language Pod at COSI (2017B0408, PI: Cynthia Clopper) using the attached recruitment script.”
  2. include a recruitment script following the approved recruitment script template (pod-recruit-template.docx) as part of their approved recruitment materials

Individual faculty researchers are responsible for ensuring that every 5700 student who participates in recruitment for their studies receives training every shift they participate in recruitment. Faculty researchers are therefore responsible for ensuring that their own RAs can provide this training as required. This recurring training must include:

  1. a review of the study-specific recruitment script and any other study-specific recruitment procedures, as approved as part of the recruitment procedures for the relevant IRB protocol
  2. confirmation that the 5700 student can answer the following questions about the study:
    • WHAT is the study about?
    • WHO is the study for? (adults? English speakers? people from Ohio?)
    • HOW LONG does the study last? (10 minutes? 45 minutes?)
    • WHAT will happen in the study?

The involvement of 5700 students in research is limited to recruitment. They are not permitted to participate in any other research activities, including, but not limited to: obtaining informed consent, collecting data, and analyzing data.

Demographic information requirements:

Faculty researchers are required to request the following demographic information about their participants:

  1. Age (years)
  2. Gender: male, female, both/neither/something else
  3. Race/ethnicity: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, White, more than one
  4. Zipcode

Researchers may request this information electronically as part of an experiment (e.g., in E-Prime) or on a hard copy questionnaire. The methods for collecting this information must be described in the Procedures section of their approved research protocol and in the appropriate sections of Buck-IRB. Questionnaires must be approved by the IRB.

Faculty researchers will be asked to provide summary information about the demographics of their participants to the Pod at the beginning of each semester (fall, spring, and summer). The Pod may share this information with the COSI administration upon request. Participants must therefore be given the opportunity to decline to provide any or all of the requested information.

Consent requirements:

All participants must consent to have their demographic information shared with the Pod and the COSI adminstration. This consent may be obtained in one of two ways:

1. All consent materials, including parental permission materials, can include the following language in the Future Research section: “Your de-identified information may be used or shared with other researchers without your additional informed consent.”

2. All consent materials, including parental permission materials, can include the following language in the Confidentiality section: “The demographic data collected in this study may be shared with the Language Sciences Research Lab and/or COSI. This data will only be shared in aggregate form with the data from other participants in a completely anonymous format with no personal identification marks.”

To avoid potential IRB concerns about requiring a repository for the demographic data, researchers may want to explain the limited purpose and extent of the demographic data sharing on the Data Confidentiality page in Buck-IRB. Suggested language is as follows: “Demographic data will not be shared with the lab or COSI for research purposes. De-identified, aggregated demographic data (e.g., subject counts by age, gender, race/ethnicity) will be shared so that the lab can track the total number of participants across protocols, as requested by COSI. This data sharing is similar to providing subject demographic counts to funding agencies, such as NIH.”

Debriefing requirements:

Unless your study involves deception, debriefing materials are not required by the IRB. However, debriefing outreach materials are required for all studies conducted in the Pod. These materials must be approved by Kathryn Campbell-Kibler (campbell-kibler.1@osu.edu) prior to beginning a study. These materials should not be submitted for IRB approval because any subsequent changes would require IRB approval by amendment.

Data confidentiality requirements:

The Pod is not responsible for the secure storage of data (electronic or hard copy). Faculty researchers are responsible for establishing secure backup protocols for all electronic data collected at the Pod and for ensuring the secure long-term storage of hard copy data, including signed consent materials.

Suggested Elements:

Recruitment suggestions:

In addition to the required recruitment script (conforming to this template: pod-recruit-template.docx), faculty researchers are encouraged to obtain IRB approval for recruitment slides to be displayed on PodTV. Recruitment slides must conform to this template: pod-slides-template-2017.pptx. PodTV slides may only be used if they conform to this template and are approved by the IRB.

Any recruitment methods other than those involving a verbal script or PodTV slides must be approved by Cynthia Clopper (clopper.1@osu.edu) prior to implementation at the Pod.

Consent suggestions:

Faculty researchers are encouraged to consider the pros and cons of different methods for obtaining consent, assent, and parental permission at the Pod. The three methods that are currently in use at the Pod are:

  1. verbal consent/assent/parental permission using an IRB-approved script and requiring a waiver of consent documentation
  2. electronic signature on an iPad using an IRB-approved consent/assent/parental permission form and requiring a waiver of consent documentation
  3. hard copy signature on an IRB-approved consent/assent/parental permission form