Research, Interests, and Activities (RIA) System
The Research, Interests, and Activities (RIA) System was successfully launched in July of 2023 for the disclosure of outside interests and activities, as well as financial conflict of interest (FCOI) review of PHS and PCORI sponsored projects, thereby replacing PHS-FITS.
On March 18, 2024, the RIA system will expand to include all sponsored projects, regardless of funding, and all IRB protocols (replacing FIDES).
Historically (for non-PHS/PCORI projects), only the Principal Investigator was required to indicate, through screening questions in HS-ERA and on behalf of the other Investigators, whether any Significant Financial Interests (SFIs) needed to be reported in FIDES.
Effective March 18, all Investigators will be required to submit a disclosure and, if they have any SFIs, complete a “Research Relatedness Assessment” for each project in RIA (i.e., indicate whether any of their SFIs are “related” to a given project).
“Investigators” in this context are defined as those who (regardless of title) are deemed to be “responsible for the design, conduct, or reporting of the research.” These Investigators will need to submit a disclosure form in RIA and be cleared of any FCOIs before the study gets a “green light” in the RIA system to move forward.
If faculty have a large research portfolio and need assistance with entering their information, please contact support@research.upenn.edu.
The recent Town Halls presented an overview of the upcoming policy and procedure changes. If you were unable to attend, please view the slide deck and recording here. Please visit the RIA website at https://portal.research.upenn.edu/conflict-of-interest for complete training and support resources as well as a link to the RIA system.
How does this impact IRB review?
Beginning March 18th, the IRB office staff will begin checking the RIA system green light report for all initial and continuing review submissions to make sure all Investigators (as defined above) are cleared (have a green light).
The IRB will schedule a submission for convened review and screen expedited/exempt submissions, if there are pending green lights. Investigators will not be permitted to be engaged in research on the study while green lights are pending. Initial approval will be withheld and continuing reviews will be conditionally reapproved due to lack of green light clearance. During the first two weeks of system role out, the IRB will extend a grace period on conditional re-approval of continuing reviews.
One primary impact this change will have is that the maintenance of personnel lists in HS-ERA will be essential. This includes the removal of personnel who have left the institution or study prior to (preferred) or at the time of the continuing review submission.
The principal investigator, other investigator, and key personnel listed in HSERA will be automatically prompted to disclose in RIA. The personnel list in HSERA will feed directly to the RIA system, for submissions that have an active status in HSERA (logged, pending, approved, approved no CR, exempted, etc.).
Commonly Asked Questions
What if someone is listed as key personnel but does not meet the definition of an Investigator? How is this designated?
Everyone listed as key personnel will be required to disclose in the system. There is no way for the study team to identify someone as not responsible. However, study contacts are excluded from disclosing under the assumption that they are not “responsible for the design, conduct, or reporting of the research.” If a study contact is responsible, they should also be listed as key personnel.
The study team can provide written/email communication to the IRB that an individual is not “responsible for the design, conduct, or reporting of the research.”
How will disclosures be handled for paper studies that are not in HSERA?
IRB protocols that do not exist in HSERA because they are paper-based will be subject to the new COI disclosure process when the new IRB submission system is implemented in 2025.
Will regulatory coordinators / managers have access to view which study team personnel have incomplete disclosures?
Study contacts will be able to view the green light report for the protocols on which they are listed as study contacts on the personnel page. If wider access is necessary, please contact support@research.upenn.edu.