Transcript COI for VA - AMSA Scorecard

For VA Facilities-Identifying
and Managing Institutional
Conflict of Interest
Peter A. St. Arnold
Administrative Officer and Director of Operations
For Research and Development
Human Subjects Protection Administrator
Memphis VA Medical Center
Types of Conflicts of Interest
• Individual – AAHRPP Elements: I.1.D, I.3.G, I.3.G, I.5.A, II.1.C, III.1.A
AAHRPP Tip sheet at: http://www.aahrpp.org/www.aspx?PageID=105$9
(VHA Handbook 1200.13 due out soon)
For Conflict of Interest see the ORD Pride website:
http://www.research.va.gov/programs/pride/conferences/accountability.cfm
Office of the General Counsel:
http://vaww.gc.va.gov/law/employment/ethics/coi.htm
• Oversight Committee (IRB and R&D) -
AAHRPP Elements:
I.1.D, II.1.C, II.3.C
AAHRPP Tip sheet at: http://www.aahrpp.org/www.aspx?PageID=105$9
VHA Handbooks 1200.1 R&D Committee, and 1200.5 Requirements for the Protection
of Human Research Subjects in Research.
• Institutional – AAHRPP Elements: I.3.H
– suggestions and guidance only, not in the regulations
Identifying and Managing
Institutional Conflict of Interest
• AAHRPP Element I.3.H.
The organization is developing
written policies and procedures for
recognizing and managing
institutional conflicts of interest.
Institutional Conflict of Interest
(ICOI) – not a new concept
New Engl J Med. 1995 Jan 26;332(4):262-7.
Institutional conflict of interest.
Emanuel EJ, Steiner D.
Dana-Farber Cancer Institute, Boston, MA
AAU Report –
October 2001
The Task Force concluded that a university’s
institutional financial conflict of interest
processes – for both financial holdingrelated conflicts and those involving
senior officers – should follow a three-fold
approach:
1) disclose always;
2) manage the conflict in most cases;
3) prohibit the activity when necessary to
protect the public interest or the interest
of the university.
A key goal is to segregate the decision
making about the financial activities and
the research activities, so that they are
separately and independently managed.
GAO Report –
November 2001
• Develop and communicate
information on best practices
for institutions to consider for
identifying and managing
investigator and institutional
financial conflicts of interest
in biomedical research.
• Develop specific guidance or
regulations concerning
institutional financial conflicts
of interest.
AAMC Report –
October 2002
Accreditation.
The effectiveness of an
institution's ICOI policies and a
formal assessment of the
institution's compliance with
these policies should be
examined as an element of
any accreditation process for
the institution's human
subjects protection program.
OHRP Guidance
– July 2004
Establishing criteria to
determine what constitutes
an institutional conflict of
interest, including identifying
leadership positions for
which the individual's
financial interests are such
that they may need to be
treated as institutional
financial interests.
ICOI Regulation – not much
• VHA Handbook 1200.5
7 A (9) Conflict of Interest. The IRB must
ensure that steps to manage, reduce or
eliminate potential or real conflicts of interest
(financial, role (investigator/patient
relationships), and/or institutional) have been
taken. All VA investigators must comply with
VHA policies and procedures regarding conflict
of interest.
Institutional Conflict of Interest
“An institution may have a conflict of interest in
human subjects research whenever the financial
interests of the institution, or of an institutional
official acting within his or her authority on behalf
of the institution, might affect –- or reasonably
appear to affect --institutional processes for the
conduct, review, or oversight of human subjects
research.”
AAMC, Task Force on Financial Conflicts of Interest in
Clinical Research, October 2002
Identify ICOI
Financial – patents and royalties.
Example:
The royalty money sent to the Memphis VAMC (151) is as follows
I.
Director
$2,705
ACOS for Research
$6,770
Individual Research labs
Investigator 1
$1,145
Investigator 2
$1,233
Investigator 3
$1,233
Investigator 4
$1,233
Investigator 5
$8,689
Total to be sent to Memphis (151)
$23,008
II
Technology Transfer admin fee
$4,061
•
•
From the Technology Transfer Handbook:
"Facilities may use royalty funds received for scientific research and development consistent with
the VA research mission and objectives; to further scientific exchange among VA laboratories; for
education and training of employees consistent with the VA research mission and objectives; to
reward scientific, engineering, technical, and other employees of the laboratory with incentive
awards; and other activities that increase the potential for enhancement of research within the VA.
[15 USCS §3710c(a)(B)(i) – (v)] "
Identify ICOI
Organizational / personal relationships
Example:
GTx, Inc. (http://www.gtxinc.com/) – Memphis Biotech Company started
1997 by a Department Chairman – many in the department were
involved financially, personally, and by organizational structure.
Began in two laboratories at the Memphis VA Medical Center on a
Space Sharing Agreement (lease) and two employees, now with
over a hundred employees and publicly traded on NASDAQ.
RxBio, Inc. (http://www.rxbio.com/) – New start-up Biotech Company
with three employees in two leased laboratories at the Memphis
VAMC. Company founded in 2002 by University Vice-Chancellor of
Research and two Senior Faculty.
Identify ICOI
National multi-center clinical trial sponsored
by National Institutes of Health (NIH) in
which the Memphis VA holds the
Interagency Agreement (IAA) for $3
million/year for ten years (including 18%
indirect) to conduct this trial at 10 centers.
Identify ICOI
OTHERS?
Identifying and Managing
Institutional Conflict of Interest
• AAHRPP Element I.3.H.
The organization is developing
written policies and procedures for
recognizing and managing
institutional conflicts of interest.
Manage ICOI
Remember the AAU report?
1) disclose always;
2) manage the conflict in most cases;
3) prohibit the activity when necessary to
protect the public interest or the
interest of the university.
Manage ICOI
Disclosure by all parties
involved
- Investigators
- Oversight Officials
- Disclosure to subjects
- Disclosure to the
institution
- Monitor
“Keep it in the sunshine”
Manage ICOI
Management Strategy
- start a plan
1. Get info – call Office of
Research
Development (ORD)
Program for Research
Integrity Development
and Education
(PRIDE) or AAHRPP
2. Draft and formulate
policy
3. Outside review if
needed
4. Finalize
ICOI Template
Courtesy of PRIDE and Columbia, MO
ICOI Template
Courtesy of PRIDE and Columbia, MO
At what point does an ICOI
become too great to manage?
- Define criteria
-Designate responsible individuals/
committees – Conflict of Interest
Officer / Research and Development
Committee
-Set parameters
- Alternatives?
-Perhaps have another IRB review it!
“…St. Arnold, a former Air Force medic, said
that he takes special pride in what
accreditation means for VA research
and the program’s volunteers: “We
want to advance science and medical
care, but at the same time protect our
veterans to the fullest degree.”
Peter A. St. Arnold
VA Research Currents,
Vol. 3, No. 11/Nov. 2003