1. September 16, 2011  12:00-1:00 pm Eastern Presenters:
HHS Issues Final Rule on Conflicts of Interest This roundtable discussion is brought to you by the Conflicts of Interest and Transparency Affinity Group (COIT AG) of the Teaching Hospitals and Academic Medical Centers Practice Group 
  September 16, 2011  12:00-1:00 pm Eastern Presenters:
Sally J. Rockey, PhD National Institutes of Health, Bethesda, MD
Ann N. James, PhD, JD Stanford University, Stanford, CA 1

2. Sally J. Rockey, PhD National Institutes of Health, Bethesda, MD rockeysa@od.nih.gov2

3. Assuring Objectivity in Research: Financial Conflict of Interest
September, 2011
Sally J. Rockey, PhD
Deputy Director for Extramural Research
National Institutes of Health

4. FCOI Regulations - Final Rule
Revising the regulations on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
Federal Register published August 25, 2011
(this link points to a non-HHS website which may not be accessible to all visitors)
Implementation no later than 365 days after publication of the final rule in the Federal Register, i.e. August 24, In the interim:
Institutions comply with 1995 regulations
Institutions revise policies, establish procedures for compliance, and train Investigators
NIH provides training materials for extramural community and NIH staff, expands FCOI reports database
Basic framework remains the same

5. FCOI Regulations Framework
COGR
FCOI Regulations Framework
Disclosure of SFI
Compliance with Institutional Policy
Investigator
Compliance with Regulations
Reporting to NIH
Institutional Policy
Implementation
Evaluation of SFI
Identification of FCOI
Management
Institution
NIH
Oversight
PHS regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94

6. Major Areas Addressed in the Revised Regulations
Definition of Significant Financial Interest (SFI)
Extent of Investigator Disclosure
Information Reported to PHS Awarding Component (e.g. NIH)
Information made accessible to the public
Investigator Training

7. Major Changes to the Regulations I
Significant Financial Interest (SFI)
Minimum threshold of $5,000 generally applies to payments and/or equity interests
Includes any equity interest in non-publicly traded entities
Exclusions include income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education.
Excludes income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
Investigator Disclosure
All SFIs related to Investigators’ institutional responsibilities
Institutions responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI)

8. Major Changes to the Regulations II
Reporting to PHS Awarding Component (NIH)
Previous requirements, (grant/contract number, name of PD/PI, name of Investigator with FCOI) plus:
Name of the entity with which the Investigator has a FCOI
Value of the financial interest
Nature of FCOI, e.g. equity, consulting fees, honoraria, and description of how FCOI relate to PHS-funded research
A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
Key elements of the Institution’s management plan
Public Notice
Before spending funds for PHS-supported research, an Institution shall ensure public accessibility of information on certain SFIs that the Institution has determined are related to the PHS-funded research and are FCOI, via a publicly accessible Web site or by a written response to any requestor.
Investigator Training
FCOI training required for Investigators before engaging in PHS-funded research, every four years thereafter, and immediately under designated circumstances.

9. Resources Mailbox for inquiries OER FCOI Web Site
COGR
Resources
Mailbox for inquiries
OER FCOI Web Site
New FAQs and tutorial coming soon

10. Ann N. James, PhD, JD Stanford University, Stanford, CA anjames@stanford.edu10

11. Planning for August, 2012
Review revised regulations in comparison with present policy
Determine what policy changes will be needed
Consider form and documentation for
Training for all PHS-funded investigators
Initial reports on FCOI and annual reports
Management of FCOI
Requirements for sub recipients 11

12. New Terms to Consider
All SFI related to investigator's “institutional responsibilities”—a new and important term
Income from outside sources but not from a specified list of excluded sources
Disclosure of travel reimbursement “related to” institutional responsibilities
FCOI training “prior to engaging in research" funded by PHS 12

13. Prepare for Disclosures
Process to provide information on FCOIs
Web site?
Written response to any requestor within 5 business days of a request
Process to update such information
Develop plan to track faculty/employee data on industry web sites 13

14. The world according to Wikipedia
"There is not a crime, there is not a dodge, there is not a trick, there is not a swindle, there is not a vice which does not live by secrecy." — Joseph Pulitzer
Sunlight is the best disinfectant." — William O Douglas 14

15. HHS Issues Final Rule on Conflicts of Interest © 2011 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America.
Any views or advice offered in this publication are those of its authors and should not be construed as the position of the American Health Lawyers Association.
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