SMART IRB requests your input as they strive to harmonize the implementation of single IRB review across the nation – your voice is vital to this process.
As SMART IRB develops resources to support users of the platform, they realize that an important goal is enabling a process that could lead to harmonizing the diverse approaches that may be used by institutions as they implement single IRB review. Therefor, they have convened the Harmonization Steering Committee, whose membership reflects institutions, organizations, and agencies, and whose charge is to advance the alignment of policies and processes, the adoption of common forms, and the identification of common practices and workflows.
The documents outlined below were developed through a robust process of drafting and review by the dozens of leaders and topic experts who comprise the SMART IRB Harmonization Steering Committee and its working groups.
Take part in the process.
Your feedback will help SMART IRB ensure these documents are consistent with the policies and practices of research institutions across the nation.
SMART IRB invites you to review and comment on these documents by filling out the surveys on our website and to read more about our work in harmonization.
Documents open for comment through January 31, 2018:
Fees and Costing Models under NIH sIRB Policy
Charging for single IRB review
Structuring and justifying fees
Federal regulations and guidance on direct/indirect costs
Institution v. IRB Responsibilities Guidance
Regulatory purview of a Reviewing IRB
Role and responsibilities for Relying Institutions
Accomplishing the goal of harmonization across institutions requires all of us to participate in this collaborative effort. Thank you in advance for your contributions; we look forward to hearing from you.
The Harmonization Steering Committee is currently working to address the following topic areas: fees & charging models, institution v. IRB responsibilities, local requirements, reportable events, and standard templates. Please email us at email@example.com to suggest additional topics or learn more about this process.