An Introduction to Partners Policies
on
Interactions with Industry
Office for Interactions with Industry
Partners HealthCare
Updated October 31, 2014
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What do I need to know about interactions with
industry?
Partners entities have a long history of promoting fruitful
interactions with industry resulting in countless medical advances
But there are concerns about conflicts of interest
Policies on conflict of interest insure that relationships
with industry are conducted with integrity & transparency
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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Why is COI a concern?
• Decisions and judgments relating to our charitable activities should be
based on the best interests of our patient care, research and educational
missions.
• External financial interests create the concern that our decisions may be
biased, or be perceived as being biased, by those financial interests
o Clinical Care – are patients’ interests foremost?
o Research – is the design, conduct, and reporting of research
objective?
o Education – is the audience receiving unbiased information?
• Bias can be real, but even the perception of biased decision-making can
damage the individual’s and institution’s reputation, erode public trust and
undermine Partners hospitals’ charitable activities – and create legal
exposures.
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know?
Understanding Partners Policies
The remainder of this tutorial will tell you about Partners rules
and help you to manage your relationships with industry in a
positive way. Topics include:
• Outside Activities, including giving talks
• Gifts
• Industry Support of Educational Activities
• Research and Personal Financial Interests
!
The Office for Interactions with Industry (OII) and your
Compliance Officer are here to help you to navigate the
relevant Partners policies and procedures
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What is an Outside Activity?
Two Separate Paths can lead to an Outside Activity
Engagement in
an activity
beyond the
scope of what
you do at
Partners
Activity that
requires the
expertise you use in
your Partners
position
OUTSIDE
ACTIVITY
OR
Activity that
involves a company
that does or could
do business with
Partners, even a
non-medical one
OUTSIDE
ACTIVITY
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What is an Outside Activity?
Examples of Outside Activities
• Consulting, scientific advisory boards or Board of Director positions for:
o Pharmaceutical companies
o Medical device companies
o Financial services companies
o Any other vendor or likely vendor of Partners
• Giving talks or a training presentation paid for by a commercial company
• Online medical evaluations for non-Partners organizations
• Expert witness work
!
If you have any questions about existing or new
Outside Activities, please contact OII
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What requirements are there around
Outside Activities?
Partners encourages and supports engaging in outside activities.
Most are allowable. Only a few are prohibited.
Prohibited Activities
• Serving in an executive position of a for-profit company
engaged in commercial or research activities of a
biomedical nature (for full-time HMS faculty and
Institutional Officials only)
• Certain types of company-paid speaking engagements
(more on this later)
• Ghostwriting
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What requirements are there around
Outside Activities?
Outside Activities have limits regarding
• Compensation – Payment should not exceed fair market value for time spent
• Time – Medical staff who are full-time HMS faculty may spend up to 20% of working time on Outside
Activities, not to exceed one day a week, unless limited by your supervisor. Non full-time HMS faculty
must check with your supervisor about time permitted on Outside Activities.
• Institutional resources – For your Outside Activities, you cannot make substantial use of institutional
resources (space, materials, staff).
• Use of name/ Intellectual Property – Company may not use Partners & Partners hospitals’ names or claim
Partners IP.
• General – The activity must be conducted so that the time and creative energy does not, in the supervisor’s
judgment, compromise or interfere with individual’s responsibilities at Partners
Partners policies require a written agreement for most Outside Activities
• Written agreements are required when the outside activity is with an outside entity that is a
pharmaceutical, medical device or biotechnology company or a vendor or potential vendor of Partners.
Most agreements require review by OII., to ensure compliance with institutional policies
Many arrangements also need supervisor approval
Consult OII’s Consulting & Outside Activities web page for details about when agreements require review and
whether supervisor approval is required. http://pulse.partners.org/OII/ConsultingHome.html
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know about giving talks?
• If talk is part of CME event hosted by ACCME accredited provider (or equivalent)
• If presentation is hosted by, and pay is from, a professional society or academic
institution
• If presentation is hosted or directly paid for by a company, provided that the
speaker has FULL control of content and the talk is not otherwise prohibited
OK
Not OK
• If
•
•
•
•
talk is hosted or directly paid for by a company, it is not OK if
It is called a “Speakers Bureau”
The company has control over content
The speaker has agreed to be on a company-held list of available speakers
The speaker is engaged in promotional activity for the company (See guidelines for
determining whether an activity is promotional on OII’s web site.)
Not sure?
Call OII
More than 6 talks or presentations/year/company is not
allowed without approval from the Committee on
Outside Activities (formerly called the Committee on Conflicts of Interest).
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What kind of gifts are acceptable?
No gifts may be accepted from vendors or potential vendors.
Includes all vendors, not just drug & device companies.
NO Gifts
• Entertainment: tickets, rounds of golf
• Trinkets: pens, mugs, tote bags
• Conference giveaways
• Food/Meals *
*Are there times when a meal is not a gift?
See FAQs, scenarios on OII’s web page.
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know about Purchasing?
If you or a family member have a financial interest
in (or Outside Activity with) a company proposing
a transaction with Partners/ Partners Affiliate
• You may not:
• Participate in discussions or recommendations regarding the
transaction unless asked by the decision-maker
• If you are asked and do participate in
discussions:
• You need to disclose your relationship with the company
• You may not participate in final decision-making
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know about Industry Support of
Partners Educational Activities?
Program Requirements
• Funding for a specific program must come from more than one company
• Conferences must meet the standards of the ACCME or comparable
standards, even if not for CME credit
Examples of Partners Educational Activities
• Training programs, including residency and clinical fellowship programs
• Educational events, such as Grand Rounds, lectures and conferences
• Newsletters and websites designed to deliver educational content
!
All industry support of Partners educational activities
must be processed through OII
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know about Research?
Special concerns about conflicts of interest in research
• Objectivity of data, conclusions impacted
• Misuse of human subjects or patients; injury or worse
• Misuse/ exploitation of students, trainees, junior faculty
who are involved in research enterprise of conflicted
supervising researcher
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What do I need to know about Research?
Many research collaborations with industry are allowed and encouraged.
However, just a few arrangements are not okay:
Doing clinical research (regardless of funding source) on the technology of a company in
which you/your family has financial interests (includes stock, other forms of equity, cash
income), except if the only financial interest is cash income that does not exceed $10k/year.
Receiving research support either from a publicly traded company in which you/your family
owns equity (stock, stock options, other ownership interests) with value greater than
$30,000 or any equity in a privately held company.
Receiving research support from a company, or doing research on a technology of a
company for which you serve on the Board of Directors
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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What’s Ahead: Conflicts in Clinical Care
• The Partners Commission for Interactions with Industry
recommended implementing a policy and process for
managing conflicts in clinical care.
• In 2013, the Partners Committee on Outside Activities
(formerly called the Committee on Conflicts of Interest)
established a physician task force to study the issue in-depth.
Recommendations from the Task Force are under
consideration by Partners Leadership. Stay tuned!
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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Where can I learn more?
Partners Policy
The Partners Policy for Interactions with Industry is posted at :
http://www.partners.org/About/Ethics/Interactions-With-Industry/Policy.aspx
The key sections of the Policy are:
• Section 1: Researchers’ Financial Interests and Outside Activities Related to
Research and Financial Conflicts of Interest
• Section 2: Clinical Care and Interactions with Industry
• Section 3: Industry Support Related to Education
• Section 4: Consulting and Other Outside Activities
• Section 5: Institutional Conflicts of Interest
OII web site
Guidelines, FAQs, Resources and Forms related to Consulting Agreements,
Industry Support for Educational Activities, Partners Disclosure Forms, Speaking
Engagements, NIH Regulations affecting Sponsored Research
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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Where can I get more help?
Your Compliance Officer and OII are here to help!
•
If you have questions, your Compliance Officer is knowledgeable
about these issues and can help you work through them.
•
If you are entering into a new consulting or other outside activity,
contact OII or visit OII’s web page.
Office for Interactions with Industry
Partners HealthCare
617-643-7752
PHSOII@partners.org
Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org
http://pulse.partners.org/OII/index.html
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