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A commitment to provide consulting, advising, or other services to any for-profit outside entity must be governed by a written agreement that is established in advance, includes a detailed outline of the services to be provided, and specifies the associated compensation.
When a faculty member intends to initiate an outside activity and/or financial interest in a for-profit the arrangement should generally be administered under a private agreement between the faculty member and the entity. JHU and JHHS are not parties to and therefore do not review or sign private agreements.
All outside activities and/or financial interests administered under private agreements must adhere to the SOM Policy on Disclosure and Professional Commitment and other relevant JHU, SOM, and JHM policies. Included below are guidelines that highlight the main aspects of these policies.
Faculty are personally responsible for ensuring that private agreements and outside activities comply with JHU, SOM, and JHM policies. You may wish to consider appending this Rider to your agreement. The Rider, if entered into without modification or edit by you or the entity to which you plan to provide the outside service, will cause your private agreement to be in compliance with applicable policies. Prior to signing any private agreement and/or providing outside services, you must disclose the proposed arrangement for review in the JHU online system, eDisclose. This disclosure requirement is applicable regardless of whether you use the Rider.
To protect your personal interests, it is recommended that you consult your own attorney or other professional advisor before signing private agreements.
Consulting/Scientific Advisory Board/ Medical Advisory Board
You may consult with or advise an outside entity. However, when it is anticipated that your services for the entity will result in qualification as an author in accordance with International Committee of Medical Journal Editors (ICMJE) standards, it is expected that you will provide the services under an institutional research agreement.
- On occasion, the consulting or advising services you provide under a private agreement may ultimately qualify you for authorship of resulting research publications according to ICMJE standards. When this occurs you must ensure the publication includes a disclaimer and the following language is suggested: "[Name] is a [Professor/Associate Professor/Assistant Professor] in the Department of [Department Name] at the Johns Hopkins University School of Medicine. [Name] engaged in this research as a private consultant or advisor and not in [his/her] capacity as a Johns Hopkins faculty member. [Name] was compensated for the consulting or advising service in [income/stock/equity/other form of compensation]." Should you qualify for authorship in this manner, you are expected to follow all ethical standards of the research community. Further, you should also update the relevant disclosure in eDisclose to include the authorship role.
- Should you propose to participate in an Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) protocol outside of JHU under a private agreement, the arrangement must be reviewed by the School of Medicine (SOM) Office of Human Subjects Research or JHU Animal Care and Use Committee, respectively, to determine whether it is permissible. This review is required regardless of whether you anticipate authorship.
- See the section below regarding Engagement in Research for additional information.
Under the JHM Policy on Interaction with Industry, faculty and staff must retain full control and authority over professional material they present. Activities with any of the following characteristics may not be undertaken at any location, whether on-site or off-site: a company has the contractual right to dictate what the faculty member says; a company (not the faculty member) creates the slide set (or other presentation materials) and has the final approval of all content and edits; the faculty member receives compensation from the company and acts as the company’s employee or spokesperson for the purposes of dissemination of company-generated presentation materials or promotion of company products; and/or a company controls the publicity related to the event. Further, faculty and staff may not train others to participate in activity that would violate this policy. For additional information please refer to the Policy on Interaction with Industry.
Medical-Legal (Expert Witness)
If your medical legal activity involves legal services being rendered by your consulting client (e.g., law firm) to a pharmaceutical, medical device, or medical services entity, you must indicate in your disclosure if you are conducting or proposing to conduct research that is either sponsored by the entity or involves the entity’s products or services.
You should be aware of the Internal Revenue Service's insider trading rules. Providing information that is not publicly available may put an individual at risk for insider trading liability, regardless of whether the individual benefits financially. The safest course of action is to restrict any comments to information that can be verified with information that is publicly available.
- Recent articles in the national media have highlighted the risks associated with consulting for expert network firms, matchmaker firms, and professional investors such as venture capital firms, brokerage houses, investment advisors, market analysts, hedge fund managers, particularly with respect to investigational drugs and devices. Access to non-public or proprietary information is extremely valuable to investors. However, you should be aware that there are institutional policies and agreements that require you to maintain the confidentiality of non-public information (for example, research data) and there may be legal consequences for sharing non-public information with individuals who trade on the information.
- Researchers who are involved in clinical trials or serve on data safety monitoring committees are bound by strict contractual obligations to maintain the confidentiality of study information. This means that researchers and those with knowledge of confidential research information should only discuss what is publicly known about the drug, device or technology. In this case, "publicly known" implies a presentation at an open national meeting (not a meeting of other investigators involved with the same study) or a publication. If the data or information is not publicly known, individuals with access to the information must refrain from offering an opinion about the drug, device or technology being studied or "previewing" the results of unpublished research.
Data Safety Monitoring Board/Data Safety Monitoring Committee (DSMB/DSMC)
As a DSMB/DSMC member, you should not be an investigator in the relevant study. This situation, while unlikely, would create an unmanageable COI.
Teaching at Institutions of Higher Education Other than JHU
If the teaching is provided to a U.S. institution of higher education then the activity does not need to be disclosed. If the activity is provided to a foreign institution of higher education, the activity must comply with the speaking conditions above, in accordance with the Policy on Interaction with Industry.
Publishing, Editing, and/or Authoring
This activity should be disclosed only if remuneration has been received or is anticipated.
Practice of Medicine
You may not practice medicine under a private agreement, which includes the prospective review of individual patient information and/or indirect provision of patient care. This does not apply to part-time faculty.
Using JHU Facilities/Resources
In providing services for an outside entity under a private agreement, you may not use facilities, equipment, materials, funds, or resources owned or administered by JHU and/or JHHS. Minimal and discretionary use of your office and office equipment such as computer, telephone, fax machine, etc. is permitted. Should the provision of services require the use of JHU and/or JHHS funds or resources the work must be conducted under an institutional agreement administered by ORA and/or other appropriate institutional offices.
Engaging JHU Students and/or Employees
You may not engage or employ students, trainees, post-doctoral fellows or other employees of JHU or JHHS to provide services to the outside entity. Any JHU student, trainee, post-doctoral fellow, or employee who proposes to consult for an outside entity must enter into his/her own private agreement with the entity.
No Disclosure of JHU or JHHS Proprietary Information
In the course of providing services to an outside entity, you may not disclose any invention, unpublished data, patient information or other information that is proprietary to JHU.
Nothing in your private agreement may restrict or interfere with your ability to conduct or publish research and other academic activities conducted at or on behalf of JHU.
Compensation for Services
Any compensation associated with services provided to an outside entity under your private agreement must be provided directly from the entity to you. Such compensation may not be directly deposited from the entity into any JHU or JHHS account.
Use of Name
Other than citing your JHU or JHHS title and affiliation, an outside entity may not use the names or logos of Johns Hopkins in any of its documents or marketing materials, whether in print, electronic, or any other media. The entity may not quote you in its documents or materials in the areas of your professional expertise. Exceptions may be made only in rare instances and with the written permission of an authorized JHM official. To seek permission or if you have questions, visit the JHM Branding & Use of Name Toolkit.
You may not participate in any activity that could imply or constitute endorsement or promotion of any product, technology, service, or company.
An outside entity shall have no rights to any intellectual property other than intellectual property developed as a sole and direct result of your private service and without JHU-administered funds, space, material, equipment, or other resources. Intellectual property developed with University support is subject to the JHU Intellectual Property Policy and should be reported to the Office of Johns Hopkins Technology Ventures (JHTV). JHU support is defined as financial or other support, regardless of origin, that is used in the discovery or development of intellectual property and is provided through University channels. JHU defines Intellectual Property as any new and useful process, machine, composition of matter, life form, article of manufacture, software, copyrighted work, or tangible property. Intellectual property developed under an institutional research agreement between JHU and the entity is governed by the terms of the institutional agreement. For additional information please refer to the Johns Hopkins University Intellectual Property Policy.
Click here to access a private agreement template that you may use as a reference, and/or forward to a company along with the request that the company incorporate the document into your agreement.
Engagement in Research under Private Agreements
As referenced above, when it is anticipated that your services for an outside entity will result in qualification as an author in accordance with ICMJE standards, it is expected that you will provide the services under an institutional research agreement administered by ORA. The ICMJE recommends that authorship be based on the following 4 criteria:
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
- Drafting the work or revising it critically for important intellectual content; AND
- Final approval of the version to be published; AND
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Click here to review a flow chart that will help determine whether the services you intend to provide to an outside entity are appropriate to be administered under a private agreement or an institutional research agreement.
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