of Commercial Interest - Johns Hopkins Medicine

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The Institute for Johns Hopkins Nursing
600 N. Wolfe Street
Baltimore, Maryland 21287
IJHN@jhmi.edu
Instructions: Complete the items on p.1-2. An electronic signature will suffice on p.2. Do not complete the
sections highlighted in red. These will be completed by the planning committee.
Conflict of Interest and Disclosure Statement
The Institute for Johns Hopkins Nursing must ensure balance, independence, objectivity, and
scientific rigor in its educational activities. The potential for conflicts of interest exists when an
individual has the ability to control or influence the content of an educational activity and has a
financial relationship with a commercial interest, the products or services of which are pertinent to
the content of the educational activity. The Nurse Planner is responsible for evaluating the presence
or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest
during the planning and implementation phases of an educational activity. If the Nurse Planner has
an actual or potential conflict of interest, he or she should recuse himself or herself from the role as
Nurse Planner for the educational activity.
The Nurse Planner is responsible for ensuring that all individuals who have the ability to control
or influence the content of an educational activity disclose all relationships with any commercial
interest, including but not limited to members of the Planning Committee, speakers, presenters,
authors, and/or content reviewers. Relevant relationships must be disclosed to the learners
during the time when the relationship is in effect and for 12 months afterward. All information
disclosed must be shared with the participants/learners prior to the start of the educational
activity.
Planning committee members and faculty must disclose financial relationships with “commercial
interest.” Commercial interest is defined as an entity producing, marketing, re-selling or
distributing health care goods or services consumed by or used on patients, with the exception of
non-profit or government entities. Commercial interests do NOT include providers of clinical service
directly to patients. Examples of commercial interest include pharmaceutical companies, medical
device manufacturers, and companies providing health information technology.
Relevant Financial relationships are relationships with financial benefits. Examples include
receiving a salary/employee or consultant, receiving direct grants or research support employee,
consultant, direct stockholder, or member of speaker’s bureau. Such relationships must be
disclosed for you and your immediate family members if they are current or have existed within the
past 12 months. IJHN reviews disclosures for potential conflicts of interest, and has policies and
procedures in place for resolution.
Faculty must disclose their intent to discuss off-label, experimental, or investigational use of drugs or
devices.
This form must be completed and submitted to The IJHN as soon as possible, but
no later than one month prior to the educational activity.
Title of Program/Activity:
6th Annual Johns Hopkins Medicine Patient Safety Summit
Name:
I (and my immediate family members) have NO financial relationships with any commercial
interests now or in the past 12 months.
I (or an immediate family member) have the following financial relationships with
commercial interests now or in the past 12 months:
Name(s) of Commercial Interest
Type of Financial Relationship
Grants/Research Support
Consultant
Version effective 11.01.09 rev 4.2013, 9.2013
The Institute for Johns Hopkins Nursing
600 N. Wolfe Street
Baltimore, Maryland 21287
IJHN@jhmi.edu
Member of Speakers Bureau
Stock Shareholder (directly
purchased) or other ownership
Salary, royalty, or direct
honorarium
Other Financial or Material
Support
I agree to the Terms and Conditions included in this form and attest to the accuracy of the
information given above.
I intend to reference unlabeled/unapproved/investigational uses of drugs or products
in my presentation (specify product by name)
If yes, you must disclose this information during your presentation. How will you do this?
Check all that apply:
Information provided on handouts
Information provided in audiovisuals
Other (describe):
State Statement of Understanding
Signature of the individual completing this form attests to the accuracy of the information
given.
________________________________________________________
______________________
Type Typed or Electronic Signature: Name and Credentials (Required)
Date
TERMS AND CONDITIONS
REGARDING CONFLICT OF INTEREST/COMMERCIAL SUPPORT
Disclosure: All planning committee members and educational activity faculty must complete and
submit the Disclosure Statement and ensure that the Disclosure Statement is complete and truthful
to the best of the individual’s knowledge. As the accredited provider, The IJHN and NP are
responsible for ensuring that learners are aware of any relevant financial relationships. The IJHN
and NP discloses the name of the individual, the name of the commercial interest, and the nature of
the relationship to the audience.
Preventing Bias in Continuing Education: The content and format of a CNE activity must promote
quality in health care and not a specific proprietary business interest of an entity with a commercial
interest. Faculty and presenters are required to prepare fair and balanced presentations that are
objective and scientifically rigorous. Use scientific or generic names when referring to products. If it
is necessary to use a trade name, then the trade names of all similar products or those within a
class should be used.
Conflict of Interest: A conflict of interest arises when an individual has an opportunity to affect
CNE content with products or services from a commercial interest with which he/she has a financial
relationship. The IJHN and NP are responsible for identifying and resolving conflicts of interest.
Examples of methods use to resolve conflicts of interest include peer review, modification of the
scope and objectives of a presentation, and in some cases removing the individual from the activity.
Unlabeled and Unapproved Uses: Presentations that provide information in whole or in part
Version effective 11.01.09 rev 4.2013, 9.2013
The Institute for Johns Hopkins Nursing
600 N. Wolfe Street
Baltimore, Maryland 21287
IJHN@jhmi.edu
related to non-FDA approved uses for drug products and/or devices must clearly acknowledge the
unlabeled indications or the investigational nature of their proposed uses to the audience.
Speakers/authors who plan to discuss non-FDA approved uses for commercial products and/or
devices must advise The IJHN and NP of their intent.
For educational activities supported by commercial interests:
Planning committee members and faculty are not permitted to receive any direct remuneration or
gifts from the commercial interest supporting this activity as it relates to this specific activity. The
commercial interest must not advise or give direct input regarding the choice of faculty, or any
educational matter including the content of presentations. Please report any concerns about
commercial interest influence to The IJHN and NP immediately.
Conflict Evaluation (to be completed by Nurse Planner)
No relevant relationship with a commercial interest exists. No resolution required.
Relevant relationship with a commercial interest exists. The relevant relationship with the
commercial interest is evaluated by the Nurse Planner and determined not to be pertinent to the content
of the educational activity. No resolution required. (Documentation should reflect rationale for content not
pertinent).
Relevant relationship with a commercial interest exists. The relevant relationship with the
commercial interest is evaluated by the Nurse Planner and determined to be pertinent to the content of
the educational activity. Resolution is required.
Conflict Resolution (to be completed by Nurse Planner): Procedures used to resolve conflict of
interest or potential bias if applicable for this activity:
Not applicable since no conflict of interest.
Removed individual, with conflict of interest, from participating in all parts of the educational activity.
Revised the role of the individual with conflict of interest so that the relationship is no longer
relevant to the educational activity.
Not awarding contact hours for a portion or all of the educational activity.
Undertaking review of the educational activity by a content reviewer to evaluate for
potential bias, balance in presentation, evidence-based content or other indicators of
integrity, and absence of bias, AND monitoring the educational activity to evaluate for
commercial bias in the presentation. (Content reviewer must submit Biographical data,
Conflict of interest and reviewer forms.)
Undertaking review of the educational activity by a content reviewer to evaluate for potential
bias, balance in presentation, evidence-based content or other indicators of integrity, and
absence of bias, AND reviewing participant feedback to evaluate for commercial bias in the
activity. (Content reviewer must submit Biographical data, Conflict of interest and reviewer
forms.)
Other – Describe:
Nurse Planner Signature (*If form is for the activity Nurse Planner, an individual other than
the Nurse Planner must review and sign).
Completion of the line below serves as the electronic signature of the Nurse Planner reviewing the
content of this Biographical/Conflict of Interest Form.
________________________________________________________
_______________
Version effective 11.01.09 rev 4.2013, 9.2013
The Institute for Johns Hopkins Nursing
600 N. Wolfe Street
Baltimore, Maryland 21287
IJHN@jhmi.edu
Typed or Electronic Signature: Name and Credentials (Required)
Version effective 11.01.09 rev 4.2013, 9.2013
Date
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