PHS Regulation Change: Financial Conflict of Interest How does it impact our unit?

PHS Regulation Outside Interest Disclosure – Who – When – Where System Information – M-Inform Unit Information Resources 2 Agenda

PHS Regulation Change To ensure objectivity in research, new PHS Financial Conflict of Interest regulations will be implemented on 08/24/12. PHS Requirements: 3 Key investigators must disclose ALL financial interests. Disclosures completed annually and within 30 days of a change. Significant financial interests reviewed in relation to ALL U-M responsibilities (not just research). U-M determines relatedness to proposed research. U-M manages significant financial interests before PHS funding awarded. U-M makes financial conflicts of interest (FCOI) and management plans available to the public. Objectivity in research = the design, conduct, and reporting of the research is not biased by conflicting financial interests

What I will do: As an investigator responsible for PHS funded research, I will disclose any outside interests in a timely manner. If a conflict of interest (COI) is identified, I will work with the COI Committee to manage my conflict. As a research administrator, I will help ensure required disclosures are submitted for PHS proposals. As a unit reviewer, I will ensure that unit-COI policies are followed. How U-M will help me: By providing a comprehensive disclosure system By enhancing management tools for COI committees: input, review, tracking, and archiving By including tracking for research personnel after award By establishing a means for public reporting By offering training 4 PHS Regulation Change How do I comply with the regulation?

Who discloses: When to disclose: – Annually – Within 30 days of a new interest, or a change to an existing one – When completing a PAF for new PHS opportunity Where to disclose: M-Inform – Log in: Wolverine Access > Faculty & Staff 5 Outside Interest Disclosure Sponsored by the Medical School U-M’s annual disclosure period begins July 1.

All disclosers answer three (3) General Questions – If the answer to each is “No,” your disclosure is complete – If the answer to one or more is “Yes”, complete the subsequent questions to provide details Examples and definition links provided for help 6 An outside interest, activity, or relationship that relies upon the same expertise as an individual’s ability to carry out his or her institutional responsibilities. Also, any interest, activity, or relationship that has the potential to influence the duties that the University considers part of the work it pays or otherwise engages an individual to do. Outside Interest Disclosure

Ten (10) questions that detail the relationship with an outside entity: – Who has the relationship – Which outside organization – Time & effort involved – Type of activity, interest, relationship – Financial value of the relationship Travel question – Limited scope: read the description for instructions & exceptions! 7 Outside Interest Disclosure What can I expect if I answer “Yes”?

8 Outside Interest Disclosure Points to remember Begin disclosing in M-Inform on July 1, 2012 Add a new disclosure for each outside entity with which you have a relationship The PHS regulation applies to new awards after 08/24/12 Have a pending PHS proposal? Disclose in July to save time! U-M can’t award a PHS project until all disclosures are completed, evaluated, and (if a conflict is identified) managed.

9 M-Inform Roles RoleDefinition School/College Administrator Manages user access for a unit, including assigning unit administrators, reviewers, and updating employee information. Unit Administrator High-level user for a Dept ID. Can assign reviewer and unit assistant roles in M-Inform for a discloser. Can send reminder s to disclosers. Unit Reviewer Provides the unit’s compliance check for discloser(s). Unit Assistant (Optional) Can enter disclosure data on behalf of a discloser. M-Inform has four (4) roles that support disclosers. For our department: – School/College Administrator: – Unit Administrator – Unit Reviewer – Disclosers work with their Unit Administrator to assign a Unit Assistant (optional).

Three (3) systems will work together to record, report, and manage COI. 10 System Integration Disclose in M-Inform Capture data on PAF in eRPM Manage in Conflict Admin PAF captures project personnel who need to disclose/have disclosed M-Inform & eRPM send disclosure & project data to the new COI Administration system. COI committees & staff facilitate the management and reporting of Financial Conflicts of Interest (FCOI): By individual By project By outside entity M-inform sends disclosure status to eResearch Proposal Management (eRPM) Who needs to disclose? Principal Investigators, Project Directors, Senior/Key personnel, and other investigators identified as responsible for the design, conduct, or reporting of the research (i.e., not simply working on, or engaged in, the project). E.g., Those who design the study protocol or methodology; analyze and interpret data or results.

11 Unit Information

You Tube video - PHS Financial Conflict of Interest: What U-M Researchers Need to Know OVPR web page - PHS Policy Change: Outside Interest Disclosure – See the Unit Resources section for links to: You Tube Video COI Newsletter – issue #1 Flyer - PHS Regulation Change FCOI: Top 5 Things a PHS Investigator Should Know 12 Resources Want more information?

QUESTIONS? 13 Ask our Unit COI Contact: