Disclosure / Objective form - University of South Alabama CME

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UNIVERSITY OF SOUTH ALABAMA
Office of Continuing Medical Education
Speaker/Author Disclosure, Objective Form 2016
FORM MUST BE TYPED, COMPLETED, AND SIGNED.
Name of Activity
Location
Title of Presentation
My Role
Date
Time
Name
Address
City, State, Zip
Employer
Alternate Contact
Alt contact phone
Co-authors
Email
Phone/Cell:
Department
Job Title/Credentials
Alt contact email
I am a member of Medical Performance Improvement
Committee.
Yes
No
STEP 1
EDUCATION
DEGREE
Institution Name, City, State
Major
Year
Awarded
ATTACHED CV (SKIP THIS SECTION)
Step 2
DISCLOSURE OF COMMERCIAL RELATIONSHIPS
ANYONE In a position to control content is required to disclose relationships* with commercial interests**.
This information is used in determining:
1) if a relevant relationship exists and
if and how
2) the conflict can be resolved.
Refusal to disclose prohibits participation of a contributing role in any CME activity. Review glossary of terms below.
I (my family/significant other) do not
have
OR
I (my family/significant other) have
a relevant financial relationship(s) with a
commercial interest(s).
Example: ABC Pharmaceuticals
Example: XYZ Pharmaceuticals
Step 3
Nature of Relevant Financial Relationship
Compensation –
What was received?
Relationship
Relevant / Irrelevant
(speaker, consultant)
(How, you believe, this relationship is relevant or not
relevant to your talk.)
Published Textbook
Principal Investigator
Relevant – Textbook and talk is on HIV.
Irrelevant – Grant for Plavix, talk is on HIV
(honorarium, grant, stock,
gift, salary, etc.)
Royalties
Research Grant
Resolution of Conflict of Interest
The following mechanisms have been identified to resolve some conflicts of interest. Additional information may be requested.
I will refrain from making recommendations regarding specific products. e.g., limit comments to pathophysiology, diagnosis, research findings
(Everyone)
I will support my presentation / clinical recommendations with the “best available evidence” from the medical literature.
(speaker/author)
I will submit my presentation in advance to allow for adequate peer review. (speaker/author)
I will make suggested changes as necessary to avoid bias. (speaker/author)
Step 4
Talk Specifics:
Current vs BEST PRACTICE
For information contact our office or visit our website www.usa-cme.com. USA Office of CME: 5795 USA Drive North, CSAB 251, Mobile, Alabama 36688
(251) 414-8080
(251) 414-8081 scranford@southalabama.edu or ymack@southalabama.edu
Revised: January 19, 2016
OBJECTIVES
What will prevent the participants
from implementing the changes
you have suggested?
I would like to provide ABIM
MOC credit for this talk. I will
provide questions/answers and
rationales in this section.
Step 5
Speaker Credit
I will not be claiming teaching credit for the learning that occurred during preparation for this original presentation.
I have not previously sought teaching credit for this presentation.
I gained / improved competence, performance, or implemented
the following changes as a result of what I learned while
preparing for this talk. (describe)
I reviewed the following materials for this presentation.
(list materials reviewed)
I understand and agree for this activity to be recorded and shared on the CME website.
I attest that the information provided on this form is true and accurate. I agree to not accept support, funding, or other
benefits from a commercial interest in relation to this talk.
Signature:
Date:
FORM MUST BE TYPED, COMPLETED, AND SIGNED.
For information contact our office or visit our website www.usa-cme.com. USA Office of CME: 5795 USA Drive North, CSAB 251, Mobile, Alabama 36688
(251) 414-8080
(251) 414-8081 scranford@southalabama.edu or ymack@southalabama.edu
Revised: January 19, 2016
GLOSSARY OF TERMS
What was received: Salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks,
stock options or other ownership interest, excluding diversified mutual funds), research grant, or other benefit.
Roles(s): Employment, management position, independent contractor (including contracted research), grantee, consulting,
speaking, and teaching, membership on advisory committees or review panels, board membership, and other activities.
CONFLICT OF INTEREST: The ACCME considers financial relationships to create conflicts of interest in CME when
individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME
about the products or services of that commercial interest. The potential for maintaining or increasing the value of the
financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive
to insert commercial bias. See also relevant financial relationships.
** COMMERCIAL INTEREST: A commercial interest, as defined by the ACCME, is any entity producing, marketing,
re-selling, or distributing healthcare goods or services consumed by, or used on, patients. The ACCME does not consider
providers of clinical service directly to patients to be commercial interests. A commercial interest is not eligible for
ACCME accreditation.
COMMERCIAL SUPPORTER INFLUENCE: Speakers/authors are not permitted to receive any direct remuneration or gifts from
the commercial supporter(s) of a CME activity nor should they receive direct input from a commercial entity regarding the
content or in the preparation of the presentation(s).
DISCLOSURE: Speakers/authors/planning committee members/content reviewers/USA CME staff and any other person who is
in a position to affect content must complete and submit the disclosure statement on the first page of this document prior to their
involvement in planning or presenting/authoring a CME activity. Speakers/authors/planning committee members/content
reviewers/USA CME staff is required to disclose all financial relationships that they have with all commercial interest.
GENERIC VS. TRADE NAMES: Speakers/authors should use scientific or generic names when referring to products in their
presentation. Should it be necessary to use a trade name, then the trade names of all similar products or those within a class
should be used.
*Relevant FINANCIAL RELATIONSHIPS: The ACCME requires anyone in control of CME content to disclose
relevant financial relationships to the accredited provider. Individuals must also include in their disclosure the
relevant financial relationships of a spouse or partner. The ACCME defines relevant financial relationships as
financial relationships in any amount that create a conflict of interest and that occurred in the twelve-month period
preceding the time that the individual was asked to assume a role controlling content of the CME activity. The
ACCME has not set a minimal dollar amount—any amount, regardless of how small, creates the incentive to maintain
or increase the value of the relationship. Financial relationships are those relationships in which the individual
benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’
bureau, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual
funds), or other financial benefit. Financial benefits are usually associated with roles such as employment,
management position, independent contractor (including contracted research), consulting, speaking and teaching,
membership on advisory committees or review panels, board membership, and other activities from which
remuneration is received, or expected. See also conflict of interest.
UNLABELED AND UNAPPROVED USES: Presentations that provide information in whole or in part related to non-FDA approved
uses of drugs and/or devices must clearly disclose the unlabeled indications or the investigational nature of their proposed uses
to the audience.
References:
ACCME Glossary April 2014
http://www.accme.org/sites/default/files/11_20140408_Glossary_of_Terms.pdf
For information contact our office or visit our website www.usa-cme.com. USA Office of CME: 5795 USA Drive North, CSAB 251, Mobile, Alabama 36688
(251) 414-8080
(251) 414-8081 scranford@southalabama.edu or ymack@southalabama.edu
Revised: January 19, 2016
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