Policies and Standards Governing Research Awards

To foster a work environment free from harassment or discrimination, American Heart Association (Heart Association) Research is bolstering procedures, guidelines, requirements, and communications to make expectations clear. The Heart Association wants to ensure that individuals know their rights, where to report incidents of harassment, and the resources available to them.

The Heart Association strictly prohibits and does not tolerate unlawful harassment of employees or any other covered person, on the basis of age, race, color, creed, religion, sex, gender, ethnic or national origin, pregnancy leave, leave status, disability, uniformed service, veterans’ status, sexual orientation, gender identity or expression, genetic information, marital status or based on political or religious opinions or affiliations, membership or non-membership in employee organizations, or any other characteristic protected by applicable law., whether it is within the Heart Association organization, at research organizations that receive American Heart Association funding, or anywhere else American Heart Association-funded activities are conducted. The Heart Association believes that only in safe and respectful environments can individuals achieve their greatest potential and conduct the important work that supports the American Heart Association mission.

If for some reason you are unable to make a report to your institution(s)/employer(s), you may contact the Heart Association. Phone the American Heart Association ethics hotline at (866) 293-2427 to report your concerns. You may also log on to www.ethicspoint.com. (Please type American Heart Association when indicated in the prompts.)

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Public Access

The American Heart Association (Heart Association) requires that all journal articles resulting from Heart Association funding be made freely available in PubMed Central (PMC) and linked to an American Heart Association award within 12 months of publication. It is the responsibility of the awardee to ensure journal articles are deposited into PMC and that all necessary rights are retained in order to do so.

Open Data

The Heart Association requires certain applicants to include a data sharing plan with the application. Any factual data that is needed for independent verification of research results must be made freely and publicly available in an American Heart Association-approved repository as soon as possible, and no later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever comes first. Recipients of the following early-career awards are exempt from this policy: American Heart Association Predoctoral Fellowships, American Heart Association Postdoctoral Fellowships, and Institutional Undergraduate Student Fellowship Program.

Additional information regarding the Heart Association Open Science Policies is available at Open Science Policy Statements for American Heart Association Funded Research.

Effective Date: Oct. 28, 2021

The primary purpose of the American Heart Association, Inc. (“Heart Association”) in funding scientifically meritorious research is to advance its mission. The Heart Association recognizes that inventions having public health, scientific, business or commercial application or value may be made in the course of research supported by the Heart Association. The Heart Association desires that such inventions be administered in a manner that they are brought into public use at the earliest possible time. The Heart Association recognizes that this may be best accomplished through patenting, copyrighting, and/or licensing of such inventions. The Heart Association has implemented this Intellectual Property Policy for Research Funding (“Policy”) to be applicable to all American Heart Association research funding awards except as described herein.

For the purposes of this Policy, these definitions are provided:

1. DEFINITIONS
   

   These defined terms are used in this Policy:

   “Award” is the American Heart Association funding mechanism and accompanying financial support given to a specific institution to support the research of a specific investigator(s).

   “Award Agreement” means an agreement outlining the terms and conditions through which the American Heart Association disburses research funding for an Award.

   Income

   “Gross Income” means all revenue and other consideration (including distributions on equity) received related to commercialization of Intellectual Property resulting, in whole or in part, from an Award.

   “Net Income” means all Gross Income received related to commercialization of Intellectual Property resulting, in whole or in part, from an Award, less out-of-pocket expenses related directly to patent costs associated with the Intellectual Property. All other costs, including Unrecovered Indirect Costs and Internal Distributions, are not deductible when calculating Net Income.

   “Indirect Costs” means costs incurred by an Institution that are not directly attributed to Intellectual Property, including but not limited to overhead costs and general and administrative costs. Actual Indirect Costs may or may not exceed an Institution’s published or official “Indirect Cost Rate.”

   “Internal Distributions” means an Institution’s internal distributions to inventors, investigators, divisions, departments or others within the Institution.

   “Unrecovered Indirect Costs” means any Indirect Costs incurred by an Institution that exceed the Indirect Costs allowed under an Award.

   “Institution” is the entity (e.g., university, medical center, hospital, research institute) in which the research supported by an Award will be or was conducted as shown on an Award Agreement.

   “Inventor(s)” is the investigator, author or other person working under an Award who, according to applicable law, created Intellectual Property.

   “Intellectual Property” is any tangible or intangible discovery, composition of matter, method, idea, design, process, trade secret, concept, product, program, software, know-how, original work of authorship, or other intellectual property right, whether or not patented or patentable or copyrighted or copyrightable, that is conceived or reduced to practice in the performance or as a result of an Award and has an application of value such that its use, licensing, lease or sale can generate revenue or other consideration.

2. APPLICABILITY
   

   This Policy applies to any Award Agreement through which the American Heart Association disburses funding for research, EXCEPT:

   • Subawards of entirely federal research grant funds when such subawards contain conflicting provisions on intellectual property rights such as those imposed by federal law or the primary award terms;
   • Contracts for research and development services to the Heart Association on behalf of other entities;
   • Agreements to create predefined “works for hire” deliverables under a contract with the Heart Association;
   • Unique research awards with substantial or complex funding arrangements or designed by the Heart Association for significant impact on a particular topic, in each case when other intellectual property rights terms are described in the notice of funding availability or equivalent invitation; and
   • Any other Award specifically excluded from this Policy at American Heart Association’s sole discretion.

   Acceptance of any Award constitutes express agreement to the terms of this Policy. Except as otherwise noted herein, the terms of this Policy control in the event of a conflict between this Policy and an Institution’s or Inventor’s policy. The American Heart Association is unable to negotiate the terms of this Policy or any Award Agreement with any individual Institution or Inventor.

3. GENERAL POLICY
   
   A.  If an Institution receiving or disbursing American Heart Association research funds has an established and applicable patent, intellectual property or technology transfer policy and procedure for administering intellectual property, the Heart Association will defer to that policy for title to intellectual property. 
    
   B.  If an Institution has no established and applicable patent, intellectual property or technology transfer policy or procedure for administering intellectual property, title to any Intellectual Property shall reside in the Institution or Inventor(s) as agreed by them.  Title to any copyrightable work shall reside in the author unless and except to the extent the author has transferred ownership rights to the Institution prior to creation of the copyrightable work as allowed by applicable law.
   
   C.  If Intellectual Property is conceived or reduced to practice from the performance of research funded by the joint support of the Heart Association and an agency or department of the United States Government, the Heart Association will defer to the patent, intellectual property or technology transfer policy of the United States Government.
   
   D.  An Institution shall license, lease or sell Intellectual Property in accordance with its own patent and intellectual property policies.
   
   
4. NOTICES AND OTHER OBLIGATIONS
   
   A.  All Intellectual Property shall be reported in writing to the Heart Association within 60 days of the date when the Intellectual Property is disclosed to the Institution where the work was performed, and prior to any public disclosure. The report to the Heart Association should include the Institution’s initial invention disclosure form related to the Intellectual Property and any subsequent versions that have substantive changes or additional information.  
   
   B.  Institution and Inventor(s) shall promptly determine whether they desire to seek patent or other statutory protection for Intellectual Property and shall notify the Heart Association in writing within 60 days after the decision to seek (or not seek) such protection. Institution and Inventor(s) shall also notify the Heart Association in writing (i) within 60 days after a patent application being filed and any patent subsequently being issued, and/or (ii) prior to the execution of a license, lease, sale or revenue generating agreement concerning Intellectual Property. No patent or patent application shall be abandoned without prior notification by the Institution or Inventor(s) to the Heart Association and offering to assign to the Heart Association all right, title and interest to the Intellectual Property to the extent permitted by law. 
   
   C.  When an Institution or other titleholder licenses Intellectual Property to another party for commercialization, it shall (i) include provisions in the license agreement obligating the licensee to commercialize the Intellectual Property in a diligent manner and meet appropriate diligence requirements and concrete development milestones to avoid the license terminating, and (ii) monitor performance of the licensee relative to these requirements and milestones. The Institution or other titleholder, or its designee, or licensee shall take commercially reasonable steps to bring the Intellectual Property to practical or commercial application in a reasonable time period (based on type of Intellectual Property) after issuance of a patent or other clear determination of commercial value. If the Institution or other titleholder, or its designee, or licensee, has not taken commercially reasonable steps and cannot show reasonable cause why it should retain title to and all rights in the administration of the Intellectual Property for a further period of time, then, if no other parties have superior legal rights, the Institution or other titleholder and the Heart Association shall determine a course of action including but not limited to:

• the Institution or other titleholder’s renegotiation of milestones with the current licensee or termination of the current license and licensing of the Intellectual Property to another licensee;
• a non-exclusive right to the Institution or other titleholder to practice the Intellectual Property for any non-commercial purpose;
• a global, exclusive or non-exclusive, non-revertible, royalty-free license to the American Heart Association;
• the provision to the Heart Association of any additional materials necessary for regulatory filing and the technology’s enablement that might be in the possession or control of the Institution or other titleholder, except for intellectual property that was not generated as a result of the American Heart Association’s Award; or
• any other action appropriate in the circumstances.
  
  

D.  Institution, Inventor, and the Heart Association shall promptly notify the other of any suspected infringement, misappropriation, misuse, theft or breach of confidence regarding any intellectual property rights related to any Intellectual Property when detected and shall cooperate in good faith to determine the appropriate action needed.

   
   V.  ECONOMIC RIGHTS AND APPORTIONMENT

A.  Notwithstanding any other provision of this Policy, the Heart Association shall participate in the income derived from Intellectual Property as set forth below. 

B.  The Institution’s technology transfer officer (or equivalent) shall provide the Heart Association with an annual report for each Award, including Intellectual Property. The annual report is due by January 31 of each calendar year after an Award has been accepted by the Institution.  The annual reports shall continue for three (3) years after the expiration and/or termination of the Award. The annual report shall include a listing or description of the following information about Intellectual Property for each Award: 

• All issued patents and pending patent applications;
• All licenses, leases, sales or other revenue generating agreements;
• All Gross Income and Net Income for each preceding calendar year;
• The filing, publication and issuance or grant of any application for a patent or other statutory right for Intellectual Property; and
• The latest stage of development of any product arising from Intellectual Property.

C.  Institution shall pay all costs and expenses incidental to all applications for patents or other statutory rights and all patents and other statutory rights that issue thereon.

D.  Institution shall pay the Heart Association annually a percentage of the Net Income derived from Intellectual Property conceived or reduced to practice in the performance or as a result of an Award, regardless of the amount of Net Income actually received, equal to the Heart Association’s portion of support (expressed as a percentage) for the work or research giving rise to the Intellectual Property.  In no event shall the application of the foregoing result in either American Heart Assocition or Institution receiving less than 10% of Net Income. 

E.  Payments under Section V.D. shall be made on an annual basis by January 31 of the year after the calendar year that Net Income was derived. If the Institution is unable to make payment by January 31 for any calendar year in which Net Income was derived, Institution shall inform the Heart Association at least seven (7) days prior to missing a payment. If such prior notification is made timely, Institution shall have a grace period of 90 days to make the missed payment. Failure to make payment after the 90-day grace period will be deemed a breach of the applicable Award Agreement. The American Heart Association shall have the right to audit, at the Heart Association’s expense, the Institution's books and records related to any Award annually upon reasonable advance notice. 

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1. Statement of Principle and Purpose
   The American Heart Association requires highly ethical scientific behavior in all of its programs and activities. The Heart Association endorses the principles of the Association of American Medical Colleges (AAMC) report "The Maintenance of High Ethical Standards in the Conduct of Research. This statement serves as a guideline when allegations are made or indications of falsification of scientific data, use of someone else’s work or idea, or other scientific misconduct in the Heart Association scientific publishing, scientific sessions and conferences, or research funded by the Heart Association arises.
   
   
2. Submitted Articles and Abstracts
   
   
   1. Allegation or Indication of Scientific Misconduct
      When a credible allegation is made of falsification of scientific data, use of someone else’s work or idea, or other scientific fraud or misconduct, or reasonable indications thereof arise in the review of an article or abstract submitted for publication or presentation, a written statement shall be provided to the submitting author(s)/scientist(s) specifying the particular concern(s) of the Heart Association and requesting a written response. In the absence of a timely response or in the event of a response that is deemed by the Heart Association as insufficient in providing a reasonable explanation for the Heart Association's concern, the Heart Association shall reject the submitted journal article or abstract. The American Heart Association, as it deems appropriate, may advise or seek assistance from the institution(s) of the author(s)/scientist(s).
      
      
   2. Responsible Party
      The editor and the chairperson of the Scientific Publishing Committee are the responsible parties in the case of manuscripts submitted for publication in the Heart Association scientific publications. The chairperson of the Scientific Sessions Program Committee and, when such is the case, the chairperson of the conference are the responsible parties in the case of abstracts submitted for publication or presentation at the Heart Association scientific sessions and conferences. The American Heart Association President shall be advised as deemed appropriate by the responsible parties.
      
      
3. Published Refereed Articles and Abstracts
   
   
   1. Requests To Retract
      
      1. When a request to retract a refereed article or abstract that has been published by the Heart Association is from all authors, the Heart Association shall retract.
         
         
      2. When a request to retract a refereed article or abstract that has been published by the Heart Association is from less than all authors and the non-requesting author is suspected of a violation or the request to retract is from non-authors, the Heart Association shall retract upon a showing of "high probability" of the specifically cited violation having occurred.
         
         Non-requesting authors -- whether or not they are the individuals suspected of a violation -- will be advised by certified mail of the request to retract and will be asked to consent or comment within a specified time limit. No reply received within the time limit will be construed as consent to retract. Should the reply be a statement of defense or argument against retraction, the decision to retract will be made upon a showing of "high probability" of the specifically cited violation having occurred.
         
         "High probability" is a satisfactory showing to the Heart Association of a thorough investigation with fair and impartial procedures and investigators, with an adequate opportunity provided for the suspected scientist to explain his or her conduct, and yielding a deliberative reasonable decision based on credible evidence.
         
         
   2. Format of Retraction
      A request for retraction shall be published in the appropriate Heart Association publication followed by a brief statement of endorsement or acceptance by that publication's editor.
      
      
   3. Responsible Parties
      The editor of the publication is the responsible party in consultation with the chairperson of the Scientific Publishing Committee and the American Heart Association President. In the case of abstracts, the chairperson of the Scientific Sessions Program Committee and, when such is the case, the chairperson of the conference are responsible parties.
      
      
4. American Heart Association-Funded Scientist Suspected of Violation
   
   
   1. American Heart Association Level
      1. When a credible allegation or reasonable indication of scientific misconduct by a Heart Association funded scientist, or applicant for the Heart Association funding, arises and when a determination is made by the Heart Association that the institution has an acceptable procedure to investigate and resolve the allegation, the Heart Association ordinarily will allow the institution to investigate and resolve the allegation. However, the American Heart Association reserves the right to itself conduct or call for an independent investigation resulting in findings or suggestions.
         
         
      2. When the institutional procedure is found not to be acceptable or there is no institutional procedure, the Heart Association shall determine an appropriate course of action including, but not limited to, conducting an independent investigation, or requesting an independent investigation by a third party, making findings or recommendations, seeking restitution from the scientist or institution, notifying other funding or appropriate agencies, or requesting retractions of published articles or studies.
         
         
   2. Responsible Parties
      The Officers of the American Heart Association are the responsible party in consultation with the chairperson of the Research Committee.
      
      
5. Procedure
   In each of the above situations the responsible parties, in consultation with the American Heart Association's Corporate Legal Counsel, shall determine a specific course of action based upon the particular facts and circumstances of the matter. The author(s) or scientist(s) against whom an allegation or indication of scientific misconduct arises shall be permitted a reasonable opportunity to respond or explain before the Heart Association takes final action in the matter. Though the intent of this Standard is to protect the reputation of the American Heart Association and the integrity of its scientific publishing, scientific sessions, and funded research programs and activities, due regard also will be given to the protection of the reputation of the involved author(s) or scientist(s).

The ethics of experimentation with human subjects and animals has a number of implications.  Above all, there is a basic obligation to the experimental subject. In addition, it is important to ensure that any tissues or cells derived from experimental subjects be handled respectfully.  Circumspection in ethical areas is also important for the investigator and for the scientific community as a whole. Research applications involving the creation of human embryos or the derivation or use of human stem cells from in vitro fertilization (IVF) treatment embryos or fetal sources will not be accepted. Human adult stem cell research is governed by these standards and procedures that are created to implement them as with any other research.

American Heart Association research procedures will be implemented to ensure, among other things, that:

1. The Heart Association does not fund scientific research that involves use of human fetal tissue.
2. Any research involving human subjects is approved by an appropriate Institutional Review Board or an equivalent body and conforms to applicable U.S. National Institutes of Health guidelines.
3. Any research involving animals is approved by an appropriate animal care and use committee or equivalent and adheres to the U.S. Animal Welfare Act, and any applicable regulations and guidelines by the National Health Council, U.S. Department of Agriculture, or National Institutes of Health.

Cloning Research

The American Heart Association funds cloning research including human DNA sequences, cell lines and animals subject to ethical principles and restrictions to prevent abuse.

1.  Acceptable research

Acceptable research involves cloning to generate animal models (such as transgenic animals) that express human disease for research use:

a)  to develop specific treatments for persons suffering from diseases, and 
b)  to produce tissue or organs for transplantation to replace or augment damaged or diseased tissues or organs in humans.

2.  Areas ineligible for American Heart Association funding

Cloning of humans as asexual reproduction or cloning of humans intended as sources of tissue or organs to harvest are not acceptable. However, the Heart Association will fund research using human cell lines and DNA sequences for purposes of producing tissue or organs for transplantation to replace or augment damaged or diseased tissues or organs in humans.