myGRANT Conflicts of Interest (COI) Module Renee Harada ORS Compliance Specialist reneeh@hawaii.edu

Investigator (reporter) instructions

COI Background UH Executive Policy and Administrative Procedures Annual Disclosure form collection for disclosure of: Significant Financial Interests (SFI) Outside Activities Employment of Students and/or Staff Other Financial Transactions Supervisor Review and Approval

myCOI Module Applies only to Investigators applying for or receiving extramural funding Disclosures of Significant Financial Interests (SFI) and other Conflicts of Interest (COI) Create/Update annually on ‘rolling’ expiration date Valid for one year from submission date, or until the disclosure is updated Examples: submitted on Dec. 1, 2016 (no changes/updates) expires on Dec. 1, 2017. submitted on Dec. 1, 2016, then updated on Mar. 31, 2017, expires on Mar. 31, 2018.

Disclosures WHAT must be disclosed? SFI - anything of monetary value or potential monetary value, to Investigators and members of their immediate family, which is, or appears to be, reasonably related to an Investigator’s institutional responsibilities and received from non-UH entities in the past 12 months. Other FCOI

Significant Financial Interests (SFI) Includes: Remuneration value in excess of $5,000, aggregated per entity; Equity interests (e.g., stock, stock options) For publicly traded entities: value in excess of $5,000, aggregated per entity, For non-publicly traded entities: ANY value Intellectual Property: royalties/income from intellectual property (e.g., patents, copyrights or trademarks) not partially licensed to and/or owned by UH Sponsored travel: PHS-funded Investigators ONLY Reimbursement or sponsorship paid by a non-UH entity; and Total travel costs in excess of $5,000, aggregated per entity

Disclosures WHO is required to submit a disclosure? All Investigators applying for or receiving extramural funding All Investigators conducting, or proposing to conduct non-exempt research involving human subjects Investigators include, but are not limited to: Principal Investigators and Project Directors, Co-Investigators, Co-Directors, Clinical Investigators, Key Personnel, Others responsible for the design, conduct, or reporting of extramurally-funded activities.

Disclosures WHEN do Investigators submit disclosures? Prior to, or at the time of proposal submission; Within 30 days of any change to SFI or FCOI; Newly added to existing extramurally-funded activity; At least annually based on prior submission

myCOI Module Access to COI Module - https://mygrant.ors.hawaii.edu/mygrant Use my COI Dashboard shortcut

COI Dashboard Navigation from your dashboard To start your disclosure click on “Update Financial Interest Disclosure” and begin the questionnaire Return to myGRANT menu

Questionnaire “Screening Questions” READ THE INSTRUCTIONS “Yes” answer to question #1 generates 2 secondary questions Displays by default, click to close

Questionnaire After questionnaire completion, a summary is displayed and answers can be edited.

Certify & Submit If you answered “No” to all questions (you have no SFI and no financial entities to disclose) – you will be taken directly to the certification page to submit your disclosure.

SFI & Financial Entity If you have SFI and you answered “Yes” to at least one of the questions in the questionnaire, you MUST enter Financial Entity information and relationship details. Click on “New Financial Entity” to enter details

Financial Entity Information Add Entity name Add Entity information – all fields required Add optional attachment (example) (example)

Relationship Details Clicking Next on Entity page will take you to Relationship Details page where relationship details are entered All fields are required (example)

Relationship Details To add another relationship (e.g., you also hold a position in that entity, or your spouse has a relationship), “Add Additional Relationship” and enter details accordingly. (example)

Relationship Summary Summary view (example)

Project Declarations Users who have SFI (entity information entered) are prompted to take “Action” when listed on a new proposal or award (i.e., new project). Proposal and award records saved in myGRANT automatically populates Projects in the COI module for Investigators with SFI.

Project Declarations Select the relationship you believe exists for each SFI. It is recommended that you provide an explanation or rationale for your selection in the optional comments field.

Certify & Submit After providing SFI and relationship information the last step is to submit your disclosure Any attachments (optional) may be added to the record by uploading or drag-and-drop

COI Dashboard After submitting your disclosure it will route for review and approval You will be taken back to your COI Dashboard where you can view your disclosure

COI Dashboard Reviewed and approved disclosure Expiration date displayed View disclosure archive Update disclosure at anytime

COI Dashboard Users who have SFI and already have an “Up to date” disclosure will receive a notification to update their disclosure when listed on a new proposal or award (i.e., new project). The new project triggers a disclosure status change from “Up to date” to “Update needed” and a user-selected relationship is required.

Email Notifications Investigator notifications Action Required: Submit SFI Disclosure, Update SFI Disclosure or Revise SFI Disclosure

Email Notifications Investigator notifications

Email Notifications Investigator notifications Disclosure Approval