*COMMENTS/MODIFICATIONS: SUMMARY: Study purpose: Funding source (funded/unfunded/sponsor name): Study intervention and duration of study: Planned enrollment number: Special populations (if any): Informed consent process Monitoring process Incentives [describe any additional findings] COMMENTS: [Reviewer describes any necessary modifications or concerns] EXAMPLE: SUMMARY: The purpose of this unfunded study is to create a repository of speech and language samples from individuals in Appalachian communities. Subjects will be interviewed and recordings made for future investigation. Data collected will be used only by Ohio State investigators and will not be shared externally. Future data requests from the repository will be reviewed and considered with appropriate IRB approval, as necessary. The investigators seek 100 adult participants for the repository. Recruitment flyers will be used. A waiver of consent documentation is requested as some participants will be contacting the investigators over the phone. A small incentive will be provided to subjects, such as a pencil or lotion and a thank you card. COMMENTS: Buck-IRB: The data repository section does not include a clear answer to what happens to the data collected if the PI leaves the university. Informed consent: Page 2 does not fully describe that data and recordings are stored indefinitely for future, unspecified research. Page 2: The survey is not included as a requirement of study completion. Page 3 includes a statement that payments are considered taxable income, however, are no subject payments in this research. Jane Doe 7/1/2016 IRB Reviewer Date
*COMMENTS/MODIFICATIONS: SUMMARY: Study purpose: Funding source (funded/unfunded/sponsor name): Study intervention and duration of study: Planned enrollment number: Special populations (if any): Informed consent process Monitoring process Incentives [describe any additional findings] COMMENTS: [Reviewer describes any necessary modifications or concerns] EXAMPLE: SUMMARY: The purpose of this unfunded study is to create a repository of speech and language samples from individuals in Appalachian communities. Subjects will be interviewed and recordings made for future investigation. Data collected will be used only by Ohio State investigators and will not be shared externally. Future data requests from the repository will be reviewed and considered with appropriate IRB approval, as necessary. The investigators seek 100 adult participants for the repository. Recruitment flyers will be used. A waiver of consent documentation is requested as some participants will be contacting the investigators over the phone. A small incentive will be provided to subjects, such as a pencil or lotion and a thank you card. COMMENTS: Buck-IRB: The data repository section does not include a clear answer to what happens to the data collected if the PI leaves the university. Informed consent: Page 2 does not fully describe that data and recordings are stored indefinitely for future, unspecified research. Page 2: The survey is not included as a requirement of study completion. Page 3 includes a statement that payments are considered taxable income, however, are no subject payments in this research. Jane Doe 7/1/2016 IRB Reviewer Date
Convened-INITIAL-Rev-Sheet-Behavioral.docx