Sponsored projects and protocols (BAs and research coordinators)

An interactive version of this guide is available using the link below.

Open the interactive training

RIA is used to submit disclosures for all sponsored projects and all IRB protocols. Every investigator submits an initial financial disclosure, even with no significant financial interests (SFIs). Investigators who have SFIs or intellectual property (IP) interests also complete a Research Relatedness Assessment (RRA) for each new project.

RIA doesn't keep its own personnel lists. It reads them from PennERA (sponsored projects) and eIRB (protocols) every night. A BA is responsible for keeping those lists accurate, making sure disclosures start, and confirming the green light before the award is set up.

CHOP-based Penn faculty: when CHOP is institutionally involved in the research, they disclose in CHOP's systems and CHOP does the FCOI review. On a Penn-only study, where CHOP has no institutional involvement, they complete RIA like any other investigator. Questions go to the Research Integrity Office at coi@pobox.upenn.edu.

Step 1: The PI tells you funding is likely

The PI lets the BA or research coordinator know when funding is likely to be received.

Step 2: Update the personnel list

Proposals (PennERA). The BA updates the Personnel List in PennERA Proposal Tracking (PT):

• when funding is likely (for example, Just In Time or the RPPR)
• when a new or renewal Notice of Award arrives, or during sponsored research agreement negotiation
• any time people are added or removed during the project

Confirm with the PI who will work on the project and whether each person is responsible for the design, conduct, or reporting of the research. Responsible people are typically the PI, Co-PI, Co-Investigators, Other Investigators and Key Personnel. Mark them Responsible on the PennERA Personnel screen, and keep the list current for the life of the project.

PennERA uses a stage-gate process that affects funding, so don't delay updating the list or initiating disclosures. PennERA data reaches RIA every night, but updates can take up to 24 hours to show.

Protocols (eIRB). List the PI and everyone else, regardless of title, who is responsible for the design, conduct, or reporting of the research. That usually includes Co-Investigators, Other Investigators, Protocol and Scientific Advisors, and an individual Regulatory Sponsor. Mark them "COI required" in eIRB. List Regulatory Sponsors and Scientific and Protocol Advisors as Key Personnel. If someone is both an investigator and a study contact, list them as both.

A Study Contact is needed for anyone who will edit the eIRB application and submit it to the IRB. Study Contacts aren't required to disclose in RIA.

If the protocol is NIH-funded, the BA helps the PI collect and enter the required information in eRA Commons, and the Authorized Organization Representative (AOR) reviews and submits it.

Step 3: Initiate disclosures

Initiating a sponsored project or non-competing renewal

1. Log in at https://apps.research.upenn.edu/ with your PennKey.
2. Click the Research, Interests, and Activities (RIA) tab, scroll down and select Sponsored Projects.
3. On the Filter Search page, enter the ORS number, award ID or project title (also called the Institution Number or PennERA number) and/or the PI. Access depends on your organizational roles in PennERA.
4. Select the project and click the green Search button. To see every project you can access, leave the fields blank and click Search.
5. Find the project and select + to show everyone on it. COI-responsible key personnel have the checkbox checked. People who aren't COI responsible are highlighted in red and don't disclose in RIA.
6. If the list is wrong, fix it in PennERA. Changes can take up to 24 hours to appear in RIA.
7. If everything looks right, open the three-dot menu at the project level and select Initiate Disclosures, then confirm. COI Status changes to Assigned on that date and the project moves to Active.

Investigators then get an email titled "Research Relatedness Assessment Required" and a task in RIA.

Checking a protocol in eIRB

1. Go to the eIRB tab and select Search IRB Protocols.
2. Search by protocol number, title or PI and click the green Search button, or scroll to the list of protocols you can access.
3. Open the protocol and choose Research Team from the Panel Shortcuts menu.
4. Check the Allowed to Work on Protocol and COI columns. COI shows Incomplete, Complete Not Required, or Complete for each person. The protocol isn't approved until everyone is Complete or Complete Not Required.

No COI requirement is created for protocols that are archived or inactive, in an excluded status, or of an excluded review type:

• Excluded statuses: Grant Review Complete, Disapproved, Suspended, Administratively Closed, Withdrawn, Completed, Expired
• Excluded review types: Not Human Research, Quality Improvement, Not Engaged, Single Patient Treatment Use Not Engaged, Grant Review, Not Human Subject Research

Step 4: Confirm FCOI clearance in the Green Light Report

1. Go to the Research, Interests, and Activities tab, hover over Reports and select Green Light Report.
2. Search by ORS number, award ID or project title, select the project, and click the green Search button.
3. Click + to open the report. It shows the same people as the project page, with the same red shading for people who don't need to disclose.

Hover over any blue text for details (for example, the last FCOI training date). How to read each row:

• Investigator requirements: COI Required, FCOI Training, Annual Disclosure within the past 12 months, and Research Relatedness Assessment. Incomplete in any of these means the investigator still has something to do.
• Review requirements: Financial Interest Status, Management Plan Status, Management Plan Certification, FCOI Reports to Sponsor, and HRAC Review (protocols only). If these say Incomplete while the investigator requirements are Complete, the school FCOI officer or the Research Integrity Office is still reviewing.
• Next Action Required By shows who has an open task: usually the discloser, the school FCOI officer, or the Research Integrity Office.
• FCOI Clearance shows Yes when that person has finished.

When everyone's FCOI Clearance is Yes (or N/A), the project or protocol gets a green light and is cleared for funding.

Clearance is also removed when someone's FCOI training or annual disclosure lapses, an IP task has been open for 30 days or more, or a relatedness assessment is pending.

External (non-Penn) investigators don't appear on the report. If one isn't covered by their home institution's COI policy, contact the Research Integrity Office at coi@pobox.upenn.edu.

Step 5: Notice of Award

The Notice of Award goes to the PI and the Office of Research Services (ORS).

Step 6: Tell ORS the project is cleared

ORS Operations reviews the award and sets it to "FCOI Pending" in PennERA if the Green Light Report shows FCOI incomplete, or "FCOI Cleared" once it shows FCOI clearance.

Once the project or protocol has a green light, open a ticket in the ORS Support Portal under the AIS Prob Area of Service, category "RIA Status Green Light: Yes." That ticket tells ORS Operations to finish setting up the account in PennERA, and an Account Information Sheet (AIS) is issued for the project.

Terms

• SFI (significant financial interest): an activity, equity or IP interest that is worth more than $5,000, is equity in a private company, or is a fiduciary role.
• IP (intellectual property interest): a person's financial, legal or ownership rights in patents, copyrights or other innovations.
• RRA (Research Relatedness Assessment): the project-specific disclosure that connects a discloser to a project.
• FCOI (financial conflict of interest): a related SFI that could directly and significantly affect the design, conduct or reporting of the research.