Human Research Ethics Software and Implementation Services

The Vendor is required to provide to replace the existing research administration system with a software system specific to human research ethics to support research administration within the office for protocol and submission processing and board review management.
- Research ethics initial application (protocol)
•    The initial application is submitted to the office for REB review when a researcher applies for ethics approval to conduct research with human participants at um. 
•    The form will include all research team members and their certifications (core, phia and privacy training, oath of confidentiality, CVS). 
•    All context sensitive questions will be completed, and all supporting documents (consent form, study materials etc.) Will be uploaded prior to submission. 
•    The application must be electronically signed by all signature authority users identified on the application (pi, co-pi, and advisor). 
•    Initial applications cannot be submitted through the system when any member of the research team has incomplete or outstanding requirements related to any project, such as a principal investigator with a terminated protocol that still needs to be formally closed.
- Application management
•    Applications will consist of smart forms with dynamic dependency questions (hidden until parent question is answered). 
•    This will include the ability to attach supporting documents (e.g., consent forms, recruitment materials). 
•    All forms must allow for electronic sign-off of multiple users. 
•    All forms will allow the research team to collaborate by either having multiple users work on a form at one time or the ability to pass the form between team members. 
•    Ability to add external user’s on-the-fly. 
•    These users are added to a protocol at time of submission but do not have access to the system. 
•    Their profiles are reconciled by system administrators. 
•    Data validation - all required fields completed prior to submission. 
•    Basic input validation on date fields and numeric fields is also required. 
•    Ability to print or save as pdf any application and form in progress along with corresponding comments and board feedback. 
•    Ability to print or save as pdf the currently approved protocol. 
•    Ability to link consultation forms, protocols and projects (grants and contracts) within the system. 
•    All file attachments uploaded within any application and form will retain its original filename when downloaded at any time. 
•    Ability to have multiple file attachments open at the same time within the browser.