Policies Governing All Research Awards

Updated:Oct 24,2014

Open Science Policies for AHA-funded research

Open Data
The AHA requires grant applicants to include a data sharing plan as part of the application process. 
Any research data that is needed for independent verification of research results must be made freely and publicly available within 12 months of the end of the funding period (and any no-cost extension).

Public Access
The AHA requires that all journal articles resulting from AHA funding (“outbound” research) should be made freely available in PubMed Central within 12 months of publication. 
It will be the responsibility of the author to ensure this occurs.

For additional information refer to Open Science Policy Statements for AHA Funded Research page.

For non-exempt Programs, all applications due starting in July 2014 and awards beginning in January 2015 must comply with these policies. Additionally, active grant holders are encouraged (though not required) to adhere to the policy. 
                        
                                                                                                                                                                                                                                                                                                                                                                                                                            Patent, Intellectual Property and Technology Licensing Policy
of the American Heart Association, Inc.
Effective Date: Oct. 27, 2011 

Though the primary purpose of the AMERICAN HEART ASSOCIATION INC. (hereinafter designated AHA) in funding scientifically meritorious research is to advance its mission, the AHA recognizes that inventions having public health, scientific, business or commercial application or value may be made in the course of research supported by the AHA.  It is the desire of the AHA that such inventions be administered in a manner that they are brought into public use at the earliest possible time.  The AHA recognizes that this may be best accomplished through patenting, copyrighting, and/or licensing of such inventions.

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

"Invention" is any discovery, composition of matter, method, process, product, program, software or know-how, whether or not patented or patentable or copyrighted or copyrightable, that is conceived or reduced to practice in the performance of an AHA award and has an application of value such that its use, licensing, lease or sale can generate revenue.
“Award” is the American Heart Association funding mechanism and accompanying financial support given to a specific institution to support the work and/or training of a specific Investigator and any Co-Investigators.
“Institution” is the entity (university, medical center, hospital, research institute or any other organization) in which the work and/or training supported by AHA funding will be conducted.
“Principal Investigator” (and “Co-Investigator(s)” if applicable) is the individual(s) receiving the award and responsible for the conduct of the research supported by an AHA Award.
“Collaborating Investigator” is an individual who contributes in a substantive way to the scientific development or execution of the project. 

“Inventor(s)” is the Investigator, Co-Investigator(s) and/or Collaborating Investigator(s) (if applicable) who made an Invention.

  1. Inventions are subject to AHA’s Patent, Intellectual Property, and Technology Licensing Policy as set forth below:

     
  2. All Inventions shall be reported in writing to the AHA within 60 days of the date when the Invention is disclosed to the Institution where the work was done, and prior to any public disclosure. The report to AHA should be the initial copy of the Institution’s Invention disclosure form and any subsequent versions that have substantive changes or additional information.

  3. If the Institution receiving or disbursing the AHA funds that support the Invention has an established and applicable patent, intellectual property or technology transfer policy and procedure for administering Inventions, the AHA will defer to that policy with the following exceptions and requirements which shall control in the event of a conflict:

    a.     Title to any Invention shall reside in the Institution; and title may be permitted to reside in the Inventor(s) or any other person or institution with the prior written approval of the AHA, upon advice of the AHA's Legal Counsel and science advisors, except that no AHA approval is required for title to reside in the United States Government.

    b.     Institution and Investigator(s), if appropriate, shall promptly determine whether they desire to seek patent or other statutory protection for an Invention and shall notify the AHA in writing within 60 days of the decision to seek (or not seek) such protection. The AHA also will be notified in writing within 60 days of a patent application being filed, and any patent subsequently being issued, and/or of a license, lease, sale or revenue generating agreement concerning the Invention prior to their execution.  No patent or patent application shall be abandoned without prior notification by the Institution or Inventor(s) to the AHA and offering to assign to AHA all right, title and interest to the Invention to the extent permitted by law.

    c.     Notwithstanding any other provision of this policy, the AHA shall participate in the income derived from the Invention.  The AHA's participation shall be determined, within one year or a reasonable period of time after reporting of the Invention to the AHA, by mutual agreement between the Institution or other titleholder and the AHA, with the AHA’s rights hereunder not being affected if such determination is not made within said time period.  The amount of the AHA's participation shall be guided by the principle that the AHA's sharing of income shall be in proportion to the AHA's portion of support for the work or research giving rise to the Invention.  The AHA waives receipt of income until the cumulative net income (i.e., net of any direct out-of-pocket patenting costs) from an Invention conceived or reduced to practice from the performance of an AHA Award exceeds $500,000.

    d.  The Institution or other titleholder, when it licenses an Invention to another party for commercialization, shall include provisions in the license obligating the licensee to commercialize the Invention in a diligent manner and meet appropriate diligence requirements and concrete development milestones to avoid the license terminating, and the Institution or other titleholder shall 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 invention to practical or commercial application in a reasonable time period (based on type of Invention) 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 Invention for a further period of time, then, if no other parties have superior legal rights, the Institution or other titleholder and the AHA shall determine a course of action including but not limited to (i) the Institution or other titleholder’s renegotiation of milestones with the current licensee or termination of the current license and licensing of the Invention to another licensee; (ii) a non-exclusive right to the Institution or other titleholder to practice the Invention for any non-commercial purpose; (iii) a global, exclusive or non-exclusive, non-revertible, royalty-free license to the AHA; (iv) the provision to the AHA 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 AHA’s assistance; or (v) any other action appropriate in the circumstances.
     
  4. If the Institution has no established and applicable patent, intellectual property or technology transfer policy or procedure for administering Inventions, title to any invention shall reside in the Institution or Inventor(s) as agreed by them and the Institution and Inventor(s) shall comply with all requirements in Sections 3b and 3d and the AHA shall have all rights set out in Sections 3c and 3d.
     
  5. Situations with multiple funders in addition to the AHA. The right of the AHA to participate in revenue derived from an Invention pursuant to section 3.c is not waived in these situations.

    a.  Multiple funders. If any Invention is conceived or reduced to practice from the performance of research funded by the AHA and by independent funding from another health agency or funding organization, not an agency or department of the United States Government, the Inventors and the Institution will work with the AHA to negotiate with the other agency/organization in good faith for a mutually satisfactory determination of rights to administer the Invention and determination of the fair share of the royalty or other income to be paid to the Institution, Inventor(s), AHA and other parties who independently funded such research.

    b.  Federal funders. Notwithstanding any other provisions of this policy, if an Invention is conceived or reduced to practice from the performance of research funded by the joint support of the AHA and an agency or department of the United States Government, the AHA may defer to the patent, intellectual property or technology transfer policy of the United States Government.
Standards on Falsification of Scientific Data, Plagiarism and Scientific Misconduct
  1. Statement of Principle and Purpose
    The American Heart Association requires highly ethical scientific behavior in all of its programs and activities. The American 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 arise of falsification of scientific data, plagiarism, or other scientific misconduct in AHA scientific publishing, scientific sessions and conferences, or research funded by the AHA or Affiliates.

     
  2. Submitted Articles and Abstracts

    1. Allegation or Indication of Scientific Misconduct
      When a credible allegation is made of falsification of scientific data, plagiarism, 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 AHA and requesting a written response. In the absence of a timely response or in the event of a response that is deemed by the AHA as insufficient in providing a reasonable explanation for the AHA's concern, the AHA shall reject the submitted journal article or abstract. The AHA, 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 AHA 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 AHA scientific sessions and conferences. The AHA President shall be advised as deemed appropriate by the responsible parties.

       
  3. Published Refereed Articles and Abstracts

    1. Requests to Retract 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 AHA 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.
      1. When a request to retract a refereed article or abstract that has been published by the AHA is from all authors, the AHA shall retract.
         
      2. When a request to retract a refereed article or abstract that has been published by the AHA 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 AHA shall retract upon a showing of "high probability" of the specifically cited violation having occurred.
         
    2. Format of Retraction
      A request for retraction shall be published in the appropriate AHA 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 AHA 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. 
  1. AHA-Funded Scientist Suspected of Violation

    1. AHA Level
      1. When a credible allegation or reasonable indication of scientific misconduct by an AHA-funded scientist, or applicant for AHA funding, arises and when a determination is made by the AHA that the institution has an acceptable procedure to investigate and resolve the allegation, the AHA ordinarily will allow the institution to investigate and resolve the allegation. However, the AHA 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 AHA 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. Affiliate Level
      The AHA shall offer assistance to an Affiliate as appropriate and consistent with these Standards.
       
    3. Responsible Parties
      The Officers of the AHA are the responsible party in consultation with the chairperson of the Research Committee.
  1. Procedure
     
  2. In each of the above situations the responsible parties, in consultation with AHA'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 AHA takes final action in the matter. Though the intent of this Standard is to protect the reputation of the AHA 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).
Policy on Collection and Use of Personal Information

The American Heart Association (AHA) values and respects an individual's right to keep certain Personal Information private. Likewise, the AHA values the need to collect and use Personal Information which will enable the AHA to effectively deliver products and services leading to a reduction in disability and death from heart diseases and stroke. "Personal Information" is "Demographic Information" and/or "Medical Information" which identifies a specific individual with a minimal degree of effort. Demographic Information includes name, address, city and other similar information. Medical Information includes diseases, treatments, lifestyle behaviors, family history, genotype, phenotype and other similar information. Transactional Information is data collected on an individual based on the individuals' interactions with the AHA. Aggregate Information is information in summary form which does not contain data that would permit the identification of a specific individual.
  1. AHA Collection of Personal Information
    The AHA will collect Personal Information on an individual only if the individual provides the information to the AHA. Notwithstanding, the AHA does collect Demographic Information for fund-raising purposes from various sources, such as renting Demographic Information from third parties. Also, the AHA collects Aggregate Information for research purposes. 
     
  2. AHA Use of Personal Information
    1. When an individual provides Personal Information to the AHA, the AHA may use the Personal Information for its programs, research and fund raising.
    2. From time to time, there is a benefit in allowing a third party to use collected Personal Information on individuals. However, unless an individual gives permission, the AHA will not allow any third party to use Personal Information collected by the AHA.
    3. The AHA uses and allows third parties to use Aggregate Information for research purposes for the development or implementation of its programs, products and services.
    4. The AHA uses Transactional Information for research purposes for the development or implementation of its programs, products and services. The presumption is that since Transactional Information is highly proprietary, it will not be disclosed to third parties.
    5. The AHA will disclose all information as required by law.
    6. The AHA will suppress the use of an individual's Personal Information if requested by that individual.

       
  3. Specific Requirements
    1. Administrative Requirements
      1. All Personal Information collected on individuals will be kept confidential and in a secure environment.
      2. Access to Personal Information will be restricted to only those personnel with a legitimate business purpose.
      3. The AHA owns all Personal Information provided to it by individuals. When an individual provides Medical Information to the AHA, the AHA will ensure that the individual acknowledges their assignment of the right to use the data to the AHA.
         
    2. Scientific Research Requirements
      Any research funded by the AHA that involves human subjects (e.g., information collected on individuals) must be endorsed by the sponsoring institution's committee on clinical investigation or other appropriate body, and conform ethically to the guidelines prescribed by the National Institutes of Health, which include obtaining informed consent from each individual. 
       
    3. Third Party Disclosure Requirements
      Permission is required before the AHA discloses Personal Information to a third party. No permission is necessary for Aggregate Information, since Aggregate Information does not identify a specific individual.

      1. For disclosure of Demographic Information (e.g., rental or exchange of donor lists with other organizations), the AHA as a minimum will use the "Opt-Out" approach. An "opt-out" is obtained when the AHA, through some correspondence, gives an individual an opportunity to decline or "opt-out" of disclosures to third parties. If the individual does not opt out, permission is deemed granted. Depending upon the nature of an activity or project, a higher standard than "opt-out" may be used, such as "opt-in" whereby an individual must affirmatively give consent before information is disclosed.
         
      2. For research awardees, permission is deemed granted upon submission of an application for a grant to the AHA. Therefore, the AHA may disclose Personal Information, including funding and project summary information, on research program awardees to third parties. The purposes of such disclosure include publicizing AHA awards, assessing AHA research programs/awardees relative to subsequent success in obtaining funding from other agencies, and determining contribution of awardees to print and online research grants and databases.
         
      3. For disclosure of Medical Information, Informed Consent is required before the AHA discloses Medical Information to a third party. Informed Consent occurs when an individual has sufficient facts about the disclosure, comprehends those facts, and voluntarily consents to the disclosure. Where a third party such as the employer or health care provider of an individual requires the individual to participate in an AHA program which collects Medical Information, the AHA will require the employer or health care provider to procure Informed Consent before the AHA will release Medical Information to that employer or health care provider.
Approved by the Board of Directors
2/18/2000
American Heart Association Policy on Support of Stem Cell Research

Human Embryonic or Fetal Stem Cell Research
  1. 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
  1. The American Heart Association funds human adult stem cell research. Human adult stem cell research is governed by the standards described in "Ethical Aspects of Research With Human Subjects and Animals." (See Below.) These standards shall be applied by the AHA in funding any research involving human adult stem cells.
Cloning Research
  1. The American Heart Association funds cloning research including human DNA sequences, cell lines and animals subject to ethical principles and restrictions to prevent abuse.
Acceptable Research
  1. Acceptable research involves cloning to generate animal models (such as transgenic animals) which express human disease for research use:
  2. to develop specific treatments for persons suffering from diseases, and
  3. to produce tissue or organs for transplantation to replace or augment damaged or diseased tissues or organs in humans.
     
    Areas Ineligible for AHA Funding
     
  1. Cloning of humans as asexual reproduction or cloning of humans intended as sources of tissue or organs to harvest are not acceptable. However, the 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.
Updated by the Board of Directors
6/23/2002

Ethical Aspects of Research With Human Subjects and Animals

  1. 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.  
  2. The American Heart Association does not fund scientific research that involves the use of human fetal tissue. 
  3. With respect to human and animal experimentation, the awardee, sponsor and department head at the sponsoring institution must affirm:
  4. that the investigations involving human subjects proposed and subsequently carried out in the application have been endorsed by the committee on clinical investigation, Institutional Review Board or other clearly designated appropriate body, of the sponsoring institution; and
  5. that any research involving human subjects will conform ethically with the guidelines prescribed by the National Institutes of Health (NIH) including the provision of suitable explanation to human subjects or their guardians concerning the experimental design and all significant hazards, so that they may be in a position to provide appropriate informed consent prior to the investigation; and
  6. that research involving animals will conform  to the following:
    1. Animals shall be used in biomedical research only when no other means of obtaining scientifically sound, valid and useful results are available.
    2. The minimum number of appropriate animals required to obtain and validate results shall be used.
    3. The acquisition, care and use of animals must be in accordance with all applicable federal, state and local laws and regulations.
    4. Institutional assurance must be provided from research facilities prior to being funded for a research grant that the facility(ies), its researchers and employees adhere to Animal Welfare Act, “Guide for the Care and Use of Laboratory Animals” (National Health Council publication, National Academy Press) and any appropriate U.S. Department of Agriculture or National Institutes of Health regulations and standards.
    5. Institutions receiving AHA awards must have unqualified accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) or hold a current Public Health Service (PHS) Animal Welfare Assurance.
    6. Funded research projects have been approved by the Institutional Animal Care and Use Committee; and
    7. In cases requiring the death of an animal, only the most appropriate and humane form of euthanasia shall be used consistent with the purpose of the research.
  7. that wherever applicable, the research protocol will be reviewed and approved by the institution's biohazards committee, as well as conforming to NIH guidelines.
  8. The American Heart Association will reserve the right to final ethical approval even if the research has been approved by the institution.
Family, Medical and Military Leave for Awardees
  1. For occasions such as family and medical leave or authorized military leave, the principal investigator of an AHA award may request that grant funds be temporarily held in an "escrow" account. These circumstances include the same reasons an employee (i.e., investigator) might take a period of family or medical leave from an employer (i.e., institution). Examples are maternity or adoption leave, leave of absence to care for an immediate family member who is seriously ill or disabled, medical leave due to personal illness or disability, or authorized military leave. These periods for holding grant funds in "escrow" are limited to 12 months.
  2. All requests for placing grant funds in escrow must be submitted to the American Heart Association in writing by the principal investigator, and the request must be authorized by both the Department Head and the appropriate institutional grants officer. A copy of the Family and Medical Leave request and approval from the institution must be submitted to the AHA, if applicable. All requests are subject to review by AHA staff and/or the Research Committee of the appropriate AHA funding component. The outcome of the request will be communicated to the awardee. If the request is approved, all payments for the award will be suspended until the escrow period is terminated and the principal investigator resumes active research on the project.
Investigator Financial Disclosure Policy/Objectivity in Research
  1. Investigators and institutions are required by the American Heart Association to comply with the PHS regulations, Final Rule, 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research.  The intent is to ensure that the design, conduct, or reporting of research funded by the Association will not be biased by any conflicting financial interest of those investigators responsible for the research.
  2. The signature of the official signing for the applicant institution on the Signature Page of the Association application indicates compliance with the requirement that an institutional administrative process be in effect to identify and resolve conflicting financial interests of the type described in Subpart 50.605(a) with respect to all research projects for which funding is sought from the Association.

 


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