The following forms and checklists may be needed when submitting applications, amendments, or reports to the Homewood Institutional Review Board (HIRB). Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations (e.g., children), research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. Exempt Applications
Studies involving certain types of minimal risk research may qualify as exempt from full HIRB review. The application packet for exemption includes a checklist to help you determine whether your study qualifies for exempt status as well as an application. Studies that may qualify for exempt status may not be undertaken until HIRB verifies the exemption. Click for the Application for Exemption. Expedited and Full Board Applications
Some studies involving human research participants may qualify for expedited review. The application form for expedited and full board review is the same, but studies qualifying for expedited status may be reviewed by only one or two HIRB members rather than by the full board. Click for the Application for Expedited/Full Board Review. Consent Forms Continuing Review
Federal regulations require that all non-exempt studies approved by institutional review boards undergo continuing review at least once a year. Applications for continuing review must be submitted 6 weeks prior to the expiration of a study’s approval date to allow adequate time for review. Please note that failure to submit a continuing review application by the deadline requires the complete stoppage of a study until a new application can be reviewed and approved by HIRB. Click for the Application for Continuing Review. Additional Forms - Research Team Member: With the Application for Expedited/Full Board Review, A Research Team Member form should be included for each research team member in addition to the PI and the student investigator or coinvestigator who are listed in the application. To add a team member after initial approval of the study, a Research Team Member form must be sent to HIRB with an Application for Amendments and Changes.
- Assent Checklist: When children are included in the participant population, investigators must include this checklist, in which child assent options are listed, with their Application for Expedited/Full Board Review.
- Child Checklist: When children are included in the participant population, investigators must include this checklist, in which the study’s risks and benefits to children are categorized, with their Application for Expedited/Full Board Review.
- Application for Amendments and Changes: Investigators should use this application to request HIRB review and approval of changes to their research team, research protocol, recruitment materials, measures, or consent documents. According to Federal regulations, investigators may not implement changes without prior HIRB review and approval, unless necessary to eliminate immediate to participants.
- Unanticipated Problems and Adverse Events: Investigators must submit this report to HIRB when an unanticipated problem or adverse event occurs that poses risk to participants or others and is reasonably related to the conduct of the study.
- Certificate of Translation: When some or all of the targeted population is not fluent in English, informed consent documents must be translated, typically after HIRB has approved the English version, and the translation must be certified as accurate by a noninvestigator using this form.
- Study Closure: The PI should submit this document to HIRB once data analysis is complete and no further contact with participants is expected. Closing a study eliminates the need for HIRB approval and continuing review.
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