1 The OII is here to help you! or An Introduction to Partners Policies on Interactions with Industry Office for Interactions with Industry Partners HealthCare Updated October 31, 2014 Click PLAY or FORWARD to move through the slides.

2 Office for Interactions with Industry | | 2 What do I need to know about interactions with industry? Policies on conflict of interest insure that relationships with industry are conducted with integrity & transparency But there are concerns about conflicts of interest Partners entities have a long history of promoting fruitful interactions with industry resulting in countless medical advances

3 Office for Interactions with Industry | | 3 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. Why is COI a concern?

4 Office for Interactions with Industry | | 4 What do I need to know? 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 ! Understanding Partners Policies

5 Office for Interactions with Industry | | 5 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 Activity that involves a company that does or could do business with Partners, even a non-medical one OR OUTSIDE ACTIVITY OUTSIDE ACTIVITY OUTSIDE ACTIVITY OUTSIDE ACTIVITY

6 Office for Interactions with Industry | | 6 What is an Outside Activity? If you have any questions about existing or new Outside Activities, please contact OII ! 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 Examples of Outside Activities

7 Office for Interactions with Industry | | 7 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 Prohibited Activities What requirements are there around Outside Activities? Partners encourages and supports engaging in outside activities. Most are allowable. Only a few are prohibited.

8 Office for Interactions with Industry | | 8 Compensation – Payment should not exceed fair market value for time spent Time – M edical 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 Outside Activities have limits regarding 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. Partners policies require a written agreement for most Outside Activities What requirements are there around Outside Activities?

9 Office for Interactions with Industry | | 9 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 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 OK 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).

10 Office for Interactions with Industry | | 10 What kind of gifts are acceptable? No gifts may be accepted from vendors or potential vendors. Includes all vendors, not just drug & device companies. *Are there times when a meal is not a gift? See FAQs, scenarios on OII’s web page. Entertainment: tickets, rounds of golf Trinkets: pens, mugs, tote bags Conference giveaways Food/Meals * NO Gifts

11 Office for Interactions with Industry | | 11 What do I need to know about Purchasing? 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 If you or a family member have a financial interest in (or Outside Activity with) a company proposing a transaction with Partners/ Partners Affiliate

12 Office for Interactions with Industry | | 12 What do I need to know about Industry Support of Partners Educational Activities? All industry support of Partners educational activities must be processed through OII ! 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 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 Program Requirements Examples of Partners Educational Activities

13 Office for Interactions with Industry | | 13 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

14 Office for Interactions with Industry | | 14 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: 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

15 Office for Interactions with Industry | | 15 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! What’s Ahead: Conflicts in Clinical Care

16 Office for Interactions with Industry | | 16 Where can I learn more? The Partners Policy for Interactions with Industry is posted at : 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 Partners Policy Guidelines, FAQs, Resources and Forms related to Consulting Agreements, Industry Support for Educational Activities, Partners Disclosure Forms, Speaking Engagements, NIH Regulations affecting Sponsored Research OII web site

17 Office for Interactions with Industry | | 17 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. Where can I get more help? Office for Interactions with Industry Partners HealthCare Your Compliance Officer and OII are here to help!

18 Office for Interactions with Industry | | 18 To receive HealthStream credit, close this window, return to instructions window, and click Exit Lesson. To track CE/CME credit for any HealthStream course, update your information under the My Profile tab > Manage Discipline and License Information