Robust feasibility assessment promotes early identification of recruitment barriers, highlights logistical challenges, and uncovers aspects of research that may require detailed planning. The goal of this vetting process is to ensure that research is well designed, likely to achieve participant accrual goals, and that costs are adequately covered. Furthermore, evaluating the presence of suitable facilities, resources, and personnel is essential to the protection of human subjects.
The purpose of this policy is to define the minimum expectations for feasibility assessment and documentation of non-exempt human-subjects research conducted by School of Medicine and Public Health (SMPH) faculty and staff.
This policy applies to most non-exempt human-subjects research conducted by UW faculty with an SMPH primary appointment, regardless of funding source or initiating entity. In the case of research studies that will be reviewed by a UW Health Sciences Institutional Review Board (IRB), this policy does not apply to applications limited to grant submissions, statistical data analysis or reading centers, emergency/one-time uses, compassionate uses of test articles, and humanitarian use devices.
Feasibility reviews will be required for any non-exempt research ceded to an external IRB. This policy is not intended to supersede existing systematic processes for assessing feasibility by a department, but rather to set a minimum standard.
|Fiscal||Acceptable Clinical Practice|
|Space and Facilities||Data Security and Electronic Health Record Considerations|
|Equipment and Test Articles||Multi-Site Investigator-Initiated Research|