Disclosure & Attestation Form - New York Eye and Ear Infirmary

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DISCLOSURE AND ATTESTATION FORM
FOR CME FACULTY, PLANNING COMMITTEE, REVIEWERS
Institute for Continuing Medical Education
ATTENTION COURSE DIRECTOR/COORDINATOR: Please fill in #s 3 & 4 below, prior to sending this form to course faculty, planners and/or reviewers.
CRITERIA FOR DISCLOSURE OF FINANCIAL RELATIONSHIPS: In accordance with ACCME and New York Eye and Ear Infirmary of Mount Sinai CME Guidelines, instructors, planners and reviewers who are in a position to effect
the content of an accredited CME activity are required to disclose relevant financial relationships they have with commercial interests over the past 12 months. A commercial interest is defined as “any entity producing,
marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.” Also, you must disclose relevant financial relationships your spouse or life partner has with applicable
manufacturers. Disclosure of spousal/ partner information should be included in your disclosure in the table below. This data will be used to ensure that your involvement in this activity is monitored for bias and/or lack of
content balance. In accordance with ACCME Standards for Commercial Support failure or refusal to provide the requested information in a timely manner will result in either your disqualification as a contributor to this
activity or the cancel-ation of accreditation for the activity. If you have additional questions about completing this form, please contact the New York Eye and Ear Infirmary of Mount Sinai CME office at 212-979-4383, or you
may review these guidelines at www.accme.org. For complete disclosure policy information please see pages 2 and 3 of this document.
1.
Your Name
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2.
I am a
☐Speaker/Author
3.
Name & Date of Educational Activity:
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4.
Commercial Interest(s)/Grantor(s) providing support for this
educational activity (if applicable):
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☐ Planner
☐ Manager
☐ I and/or my spouse/life partner DO NOT HAVE relevant financial relationships to report in the last 12 months with a commercial interest.
☐ YES, I and/or my spouse/life partner DO HAVE relevant financial relationships to report in the last 12 months with a commercial interest.
Affiliation/Financial Relationship
Name of Proprietary Entity(ies)
Me Partner/Spouse
☐ Salary
☐ Royalty
☐ Receipt of Intellectual rights / Patent Holder
☐ Consulting Fees (advisory boards)
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☐
☐
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☐ Contracted Research
☐ Honoraria from promotional, advertising or non-CME
services received directly from commercial interest or
their Agents (e.g. Speaker’s Bureaus)
☐ Ownership interest (Stocks options, or other
Holdings, excluding diversified mutual funds)
☐ Other Click here to enter text.
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☐
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☐ YES
☐ NO
Are any of these relationships relevant to the content you will be presenting?
☐ Reviewer
DISCUSSION OF OFF-LABEL USE
☐ Yes, I will be discussing off-label uses
for purposes other than that for which the
product use was approved by the Food &
Drug Administration. I will inform the
audience at the start of my presentation
that I will be discussing off-label usage, and
the nature of that discussion.
☐ I will not be discussing off-label uses.
☐ Not applicable to my role as a course
director, planner or session moderator.
If yes, list the product and the
manufacturer
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ATTESTATION - Resolution of Potential Conflicts of Interest
As noted in the Disclosure Policy information section on pages 2-3 of this document, New York Eye and Ear Infirmary of Mount Sinai is required to resolve any identified conflicts of interest prior to the
educational activity, as part of its required mandate from the ACCME, Therefore, in light of the relationships you have disclosed above, we ask that you attest that:
1. These relationships/affiliations will not bias or otherwise influence your involvement in the educational activity;
2. Practice recommendations given relevant to the companies with whom you have relationships will be supported by the best available evidence or, absent evidence, will be consistent with generally accepted medical practice;
3. All reasonable clinical alternatives will be discussed when making practice recommendations.
I have read and understood the above disclosure attestation.
Your Signature: Click here to enter text.
Date of Submission: Click here to enter text.
Mail, Fax or Email your completed form to Barbara Aubel ~ CME Coordinator ~ New York Eye and Ear Infirmary of Mount Sinai ~ 310 E. 14th St. ~ ICME ~ NY, NY 10003 Phone: 212-979-4383 ~ Fax: 212-353-5703 ~ E-mail:
baubel@nyee.edu
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Institute for Continuing Medical Education
Disclosure and Attestation Policy Information
for CME Faculty, Planning Committee, Reviewers
To:
All Faculty, Planning Committee Members & Reviewers Participating in
New York Eye and Ear Infirmary of Mount Sinai Continuing Medical Education Activities
From:
Kimberly A. Corbin, CCMEP
Director, Institute for Continuing Medical Education
Re:
Disclosure Policy Information – Updated 3-13-14
Please read the following disclosure policy information, complete and sign the attached Disclosure and Attestation for Faculty,
Planning Committee, Reviewers Form and return the completed form either by mail or fax to the address/fax listed on the form prior
to the date of the educational activity in which you will be participating.
NOTE: ACCME UPDATED STANDARDS FOR COMMERCIAL SUPPORT MANDATE THAT FAILURE TO COMPLY WITH THIS REQUEST WILL
DISQUALIFY YOU FROM PARTICIPATING IN ACCME ACCREDITED EDUCATIONAL ACTIVITIES SPONSORED OR JOINTLY SPONSORED BY
NEW YORK EYE AND EAR INFIRMARY OF MOUNT SINAI.
New York Eye and Ear Infirmary of Mount Sinai Institute for Continuing Medical Education (ICME) Disclosure Policy
As required by the Accreditation Council for Continuing Medical Education (ACCME), New York Eye and Ear Infirmary of Mount
Sinai has established an institutional policy on disclosure to ensure balance, independence, objectivity, and scientific rigor in all of its
directly or jointly sponsored educational activities. To achieve our objective to create Continuing Medical Education activities that
remain free from undue commercial influence, New York Eye and Ear Infirmary of Mount Sinai ICME requires that commercial
relationships with anyone in a position to control educational content, including faculty, speakers, authors, co-authors, planning
committee members or peer-reviewers, be identified and resolved at the beginning of the planning process. In addition, we require that
these commercial relationships, as well as the presentation of investigational products or products not labeled for use be disclosed to
the learner prior to each educational activity.
Conflicts of Interest
Conflicts of interest develop when an individual has an opportunity to affect the content of a CME activity with regard to the products
or services of a commercial interest with which he/she has a financial relationship. It is required that we document and disclose all
financial or other relationships faculty members and planners may have with relevant commercial interests defined as “any entity
producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients,” with the
exemption of non-profit or government organizations and non-health care related companies. The intent of this policy is to openly
identify any such relationships so that the New York Eye and Ear Infirmary of Mount Sinai ICME can:
1) identify any conflict of interest which may have been uncovered at the beginning or at any time during the planning process,
2) act to resolve those conflicts and
3) disclose commercial relationships to the learners so that they may form their own opinions as to whether the speaker's/
contributor’s presentation/contribution displays possible bias in either exposition or conclusion.
Financial Disclosure
It is recognized that those involved with the development or delivery of educational content, at times, enter into financial or other
materially beneficial relationships with profit-making (commercial) corporations. However, as the frequency of opportunities and the
complexity of financial relationships have increased, the potential for biased or non-objective judgments and instances of marketing
occurring under the guise of education have increased. Therefore, as an ACCME accredited provider we require that faculty, course
planners and those involved with the development or delivery of educational content participating in any New York Eye and Ear
Infirmary of Mount Sinai CME activity disclose any financial relationships between themselves and relevant commercial interests that
would potentially affect the objectivity of the educational material presentation at an accredited CME activity. These relationships
include, but are not limited to, receipt of honoraria or support for research, acting as a paid consultant on a Board or on an Advisory
Committee for a commercial company, or having significant investments in a commercial company that might benefit from
information that a presenter discusses during his/her presentation.
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As a faculty or planning committee member, peer-reviewer or other person in a position to control activity content, you are required to
provide complete disclosure of your relevant commercial financial relationships (within the past 12 months) well in advance of the
course activity in which you are participating so potential conflicts of interest can be identified and resolved and the learner can
receive full disclosure of any potential conflict-of-interest, real or perceived, which is related to your contribution to this CME
activity. The disclosed information in no way presumes to assess your qualifications or suitability to participate in this CME
activity, however, your failure to provide the requested information will disqualify you from participating as a faculty or
planning committee member in this educational activity. The information you provide will be released to the audience/participants
in this CME activity either by means of a spoken announcement made prior to the commencement of the activity or by a printed
statement in the course program or course material distributed to the learner(s) prior to the start of the CME activity.
Disclosure of Investigational Products or Products Not Labeled for Use
It is also the policy of New York Eye and Ear Infirmary of Mount Sinai to notify all faculty participating in CME accredited activities
that when an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an
educational activity, the presenter or author is required to disclose that the product is not labeled for the use under discussion and/or
that the product is still investigational.
Please call me if you have any questions regarding this disclosure policy, and thank you for your cooperation.
Sincerely,
Kimberly A. Corbin, CCMEP
Director, Institute for Continuing Medical Education
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