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An IRB working group in Texas created a new Common Rule to-do list through collaboration between the University of Texas at Arlington IRB and other area IRBs. The working group has shared this example of items on its action list:
• Potential burden-reducing provision: expansion of exclusion and exempt categories
- Address feasibility of broad consent and system for tracking refusals/declines for new exempt categories seven and eight. Note: If institution moves forward with broad consent option, develop informed consent document template;
- Update application forms with new exempt categories.
- Update eIRB system with new exempt categories.
- Train staff and IRB on new exempt categories. Note: Consider documentation requirements such as an eIRB system, approval letters, etc., with new categories.
- Update written procedures/SOPs with new exempt categories.
- Update any existing guidance (documents, training modules, presentations, etc.) regarding human subject research (HSR) versus non-HSR and new exempt categories. Note: example: clarify oral history, journalism, etc., and include new exempt categories.
- Update approval letter templates for new exempt category options.
• Potential burden-reducing provision: elimination of continuing review (CR) for some expedited
- Develop process for determining when CR is required, and how to document the determination.
- Address how lack of CR may affect your annual checks/processes for conflict of interest (COI) and training. Note: if IRB process is used as an action/touch point, how will it be managed now (for example, if training or COI is checked at some time of CR but CR will no longer exist for expedited)?
- Consider alternative process for studies with no CR. Note: informal/automated annual check-ins?
- Update written procedures/SOPs with new CR requirements/processes developed from items above.
- Update eIRB system. Note: allow flexibility to select CR-required or no-CR required; address requirement to document when CR is required; build in features for annual follow-ups in lieu of formal CR.
- Train staff and IRB on new CR requirements and how to document when CR is required for a study. Note: Will your IRB want certain studies to require CR (certain populations, procedures, etc.)? How to document justification or criteria for CR (review checklists, indication or comment in the eIRB system, in the approval letter, etc.)?
- Address/update approval letter templates to identify when CR is/isn’t required plus expiration date only if applicable.
- Update any existing guidance (documents, training modules, presentations, etc.) regarding CRs. Note: How to explain/notify principal investigators that CR is no longer required.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.