JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE



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 |

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|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: |5th 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 |      |

|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 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.

________________________________________________________ _______________

Typed or Electronic Signature: Name and Credentials (Required) Date

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