UFIRST, myIRB and eDisclose
eDisclose utilizes two-way integrations with UFIRST and myIRB to reduce researcher burden and increase transparency. Basic study data (award or protocol number, project title, sponsor, key personnel and study team members) of awards, agreements and myIRB protocols are visible in eDisclose, and the system will create and maintain a research portfolio for each researcher. For investigators with management plans, awards and protocols are associated with each Management Plan so it is clear which studies are under management.Investigators’ Disclosure Profile certification dates and the status of Research COI reviews will be displayed in UFIRST and myIRB
UFIRST
PROPOSALS
For Key Personnel, the Disclosure Profile certification date will display in UFIRST. If the certification is within the past 365 days, the proposal will be submitted. If the certification is expired (more than one year since certification), DSP will not submit the proposal until the Disclosure Profile certification is current.
SFI Tab Statuses:
| Discloser Profile | Explanation |
|---|---|
| Action Required | If Disclosure Profile certification date is more than 365 days ago, the Investigator must log into eDisclose and certify Disclosure Profile. If less than 365 days ago, no impact to proposal submission (action is required for a myIRB or UFIRST submission). |
| No Action Required | No action required before proposal submission. |
| Email uf-coi@ufl.edu to be added to eDisclose | Investigator does not yet have a Disclosure Profile in eDisclose and must be manually added by COI Program. |
| This person is no longer active in UFIRST | Investigator does not have an active HR record, and is not a UF employee |
AWARDS AND AGREEMENTS
The research COI review will happen in two phases:
- For new agreements and awards, eDisclose will verify whether an employee certified their Disclosure Profile within the past 30 days. If necessary, eDisclose will notify them via email that they must log in and certify their disclosure to ensure the COI Program reviews current information.
- If a Disclosure Profile includes a Significant Financial Interest (SFI, as defined by the UF COI and COC Policy), eDisclose will prompt a COI Program review in the background (“Research Certification”) to determine whether the SFI creates a Financial Conflict of Interest with the new research study that must be managed. If a plan is required, UFIRST will display the status of that review in a column labeled “Management Plan Status.” The table below explains the different status messages and their meanings.
SFI Tab Statuses:
| Certification | Explanation |
|---|---|
| Overnight sync with eDisclose pending | Research certification must be created during overnight process |
| Awaiting Profile Update | Investigator must log into eDisclose and certify Disclosure Profile |
| Administrative Review | Certification being reviewed by COI Program |
| Clarifications Requested | COI Program requested information from discloser |
| Review Complete | COI Program completed its administrative review |
| No Review Required | Research COI review not required for the certification |
| Committee Review | Assigned to the Research COI Committee for review |
| Clarifications Requested by Committee | Research COI Committee requires additional information |
| Withdrawn | Certification was withdrawn by COI Program |
| Management Plan | Explanation |
|---|---|
| Blank | Determination pending or if review is complete, no management plan is required. |
| Drafting | COI Program is drafting plan and routing for review and approval |
| Clarifications Requested | COI Program requires a response from Investigator |
| Pending Discloser Agreement | Management plan is approved and pending acceptance by the Investigator |
| Active | Management plan is in place and applicable to the study |
| Satisfied | There was an approved management plan for this research that has been satisfied and is no longer applicable (e.g. an investigator no longer holds the relevant SFI). |
MYIRB
The research COI review will happen in two phases:
- When an employee is listed on a myIRB application that is submitted, eDisclose will verify whether they certified their Disclosure Profile within the past 30 days. If necessary, eDisclose will notify the discloser via email that they must log in and certify their disclosure to ensure the COI Program reviews current information.
- If a Disclosure Profile includes a Significant Financial Interest (SFI, as defined by the UF COI and COC Policy), eDisclose will prompt a COI Program review in the background (“Research Certification”) to determine whether the SFI creates a Financial Conflict of Interest with the human subjects research study that must be managed. If a management plan is required, myIRB will display the status of that review in a column labeled “Management Plan Status.” The table below explains the different status messages and their meanings.
eDisclose Tab Pre Submission:
If the “Disclosure Profile Last Submitted Date” is more than 30 days from date of submission, the study team member will receive an eDisclose notice via email that they have been added to a new research project and to certify their Disclosure Profile. They must then log into eDisclose and certify concurrent with IRB review.
eDisclose Tab Statuses Post Submission:
| Certification | Explanation |
|---|---|
| Overnight sync with eDisclose pending | Research certification must be created during overnight process |
| Awaiting Profile Update | Investigator must log into eDisclose and certify Disclosure Profile |
| Administrative Review | Certification being reviewed by COI Program |
| Clarifications Requested | COI Program requested information from discloser |
| Review Complete | COI Program completed its administrative review |
| No Review Required | Research COI review not required for the certification |
| Committee Review | Assigned to the Research COI Committee for review |
| Clarifications Requested by Committee | Research COI Committee requires additional information |
| Withdrawn | Certification was withdrawn by COI Program |
| Management Plan | Explanation |
|---|---|
| Blank | Determination pending or if review is complete, no management plan is required. |
| Drafting | COI Program is drafting plan and routing for review and approval |
| Clarifications Requested | COI Program requires a response from Investigator |
| Pending Discloser Agreement | Management plan is approved and pending acceptance by the Investigator |
| Active | Management plan is in place and applicable to the study |
| Satisfied | There was an approved management plan for this research that has been satisfied and is no longer applicable (e.g. an investigator no longer holds the relevant SFI). |