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PHS Regulation Change: Financial Conflict of Interest. How does it impact our unit? <Date>. Agenda. PHS Regulation Outside Interest Disclosure Who When Where System Information M-Inform Unit Information Resources. PHS Regulation Change.

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Presentation Transcript
slide2

Agenda

  • PHS Regulation
  • Outside Interest Disclosure
    • Who
    • When
    • Where
  • System Information
    • M-Inform
  • Unit Information
  • Resources
phs regulation change
PHS Regulation Change

To ensure objectivity in research, new PHS Financial Conflict of Interest regulations will be implemented on 08/24/12.

PHS Requirements:

Objectivity in research = the

design, conduct, and reporting of the research is not biased by conflicting financial interests

  • 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 beforePHS funding awarded.
  • U-M makes financial conflicts of interest (FCOI) and management plans available to the public.
slide4

PHS Regulation Change

How do I comply with the regulation?

What I will do:

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

  • 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.
slide5

Outside Interest Disclosure

  • Who discloses: <Enter disclosure population (e.g., Faculty with/applying for PHS funding)>
  • 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

U-M’s annual disclosure period begins July 1.

Sponsored by the Medical School

slide6

Outside Interest Disclosure

  • 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

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.

slide7

Outside Interest Disclosure

What can I expect if I answer “Yes”?

  • 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!
slide8

Outside Interest Disclosure

Points to remember

U-M can’t award a PHS project until all disclosures are completed, evaluated, and (if a conflict is identified) managed.

  • 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!
slide9

M-Inform Roles

  • M-Inform has four (4) roles that support disclosers.
  • For our department:
    • School/College Administrator: <Enter name>
    • Unit Administrator <Enter name & Dept ID(s)>
    • Unit Reviewer <Enter name(s) & Dept ID(s)>
    • Disclosers work with their Unit Administrator to assign a Unit Assistant (optional).
slide10

System Integration

Three (3) systems will work together to record, report, and manage COI.

Capture data on PAF in eRPM

Manage in Conflict Admin

Disclose in M-Inform

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.

slide11

Unit Information

  • <enter unit information here>
slide12

Resources

Want more information?

  • You Tube video - PHS Financial Conflict of Interest: What U-M Researchers Need to Know

http://www.youtube.com/watch?v=w0in5z3o8Io

  • OVPR web page- PHS Policy Change: Outside Interest Disclosure

http://research.umich.edu/conflict-of-interest/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
  • <Unit web site:> <name of page>

<url>

slide13
Questions?

Ask our Unit COI Contact:

<insert name & contact info here>

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