An Introduction to Partners Policies on
Description: An Introduction to Partners Policies on Interactions with Industry Office for Interactions with Industry Partners HealthCare Updated October 31, 2014 What do I need to know about interactions with industry? Decisions and judgments relating
Related Topics
Download Presentation
"An Introduction to Partners Policies on" is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Presentation Transcript
slide1. An Introduction to Partners Policies on Interactions with Industry Office for Interactions with Industry Partners HealthCare
Updated October 31, 2014<br>
slide2. What do I need to know about interactions with industry?<br>
slide3. 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
Clinical Care – are patients’ interests foremost?
Research – is the design, conduct, and reporting of research objective?
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?<br>
slide4. 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<br>
slide5. 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<br>
slide6. 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:
Pharmaceutical companies
Medical device companies
Financial services companies
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<br>
slide7. 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.<br>
slide8. 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 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. http://pulse.partners.org/OII/ConsultingHome.html Partners policies require a written agreement for most Outside Activities What requirements are there around Outside Activities?<br>
slide9. What do I need to know about giving talks? 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).<br>
slide10. 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<br>
slide11. What do I need to know about Purchasing?<br>
slide12. 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<br>
slide13. 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<br>
slide14. What do I need to know about Research?<br>
slide15. 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<br>
slide16. Where can I learn more? 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:Â Clinical Care and Interactions with Industry
Section 3:Â Industry Support Related to Education
Section 4:Â Consulting and Other Outside Activities
Section 5:Â 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<br>
slide17. 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
617-643-7752
PHSOII@partners.org Your Compliance Officer and OII are here to help!<br>
slide18. 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<br>
Updated October 31, 2014<br>
slide2. What do I need to know about interactions with industry?<br>
slide3. 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
Clinical Care – are patients’ interests foremost?
Research – is the design, conduct, and reporting of research objective?
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?<br>
slide4. 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<br>
slide5. 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<br>
slide6. 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:
Pharmaceutical companies
Medical device companies
Financial services companies
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<br>
slide7. 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.<br>
slide8. 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 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. http://pulse.partners.org/OII/ConsultingHome.html Partners policies require a written agreement for most Outside Activities What requirements are there around Outside Activities?<br>
slide9. What do I need to know about giving talks? 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).<br>
slide10. 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<br>
slide11. What do I need to know about Purchasing?<br>
slide12. 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<br>
slide13. 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<br>
slide14. What do I need to know about Research?<br>
slide15. 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<br>
slide16. Where can I learn more? 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:Â Clinical Care and Interactions with Industry
Section 3:Â Industry Support Related to Education
Section 4:Â Consulting and Other Outside Activities
Section 5:Â 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<br>
slide17. 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
617-643-7752
PHSOII@partners.org Your Compliance Officer and OII are here to help!<br>
slide18. 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<br>