The American Heart Association (AHA) requires that all journal articles resulting from AHA funding be made freely available in PubMed Central (PMC) and linked to an AHA 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.
The AHA has adopted the procedures established by the Health Research Alliance (HRA) which enable awardees to deposit publications directly into PMC.
The AHA 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 AHA-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 come first. Recipients of the following early-career awards are exempt from this policy: AHA Predoctoral Fellowships, AHA Postdoctoral Fellowships, and Institutional Undergraduate Student Fellowship Program.
The AHA is deeply committed to following the FAIR guiding principles for scientific data management and stewardship – Findable, Accessible, Interoperable and Reusable.
Applicants will be prompted to answer each of the following questions when completing a data plan in the application:
- What data outputs will the research generate?
- When will the data be shared?
- Where will the data be made available?
- Are any limits to data sharing required?
Any costs associated with preparing data for sharing may be covered by award funds and must be tracked in the project budget and financial reports. In most circumstances, additional grant funds will not be required to comply with the Open Data Policy.
Certain applicants may seek exemption from the Open Data policy. These applicants must submit an opt-out request with the application to explain why the Open Data policy should be waived. Although the applicant may provide other rationale, most opt-out requests fall into one of the following four categories:
- Human Subject Grounds: As the National Science Foundation explains, “[H]uman subject’s protection requires removing identifiers, which may be prohibitively expensive or render the data meaningless in research that relies heavily on extensive in-depth interviews.” Data sharing may not violate privacy regulations stipulated by HIPAA or fail in any way to safeguard the rights of research participants. It is the responsibility of the applicant to make a case for why the use of the HIPAA Safe Harbor de-identification method would not be feasible for their data.
- Superseding Regulations Grounds: Governing laws or institutional policies may limit the release of certain data.
- Intellectual Property (IP) Grounds: Although data sharing may not protect IP, opt-out requests citing protection for potential or anticipated IP will not be approved until after IP rights are established.
- Financial Grounds: Data sharing should not cause an undue financial burden for the awardee.
Because the AHA supports a wide range of research, the nature of the data collected varies greatly. Any factual data that is needed for independent verification of research results must be included in the data sharing plan. This may in some instances include source code if special programs have been developed to analyze or manipulate data associated with the research.
All data must be properly documented. This documentation, sometimes referred to as metadata, is necessary for others to properly use and interpret the data. Consistent with NIH guidelines, the metadata must provide “information about the methodology and procedures used to collect the data, details about codes, definitions of variables, variable field locations, frequencies, and the like. The precise content of documentation will vary by scientific area, study design, the type of data collected, and characteristics of the dataset.”
Awardees should make their data publicly available as soon as possible. All pertinent data must be made freely and publicly available within 12 months of the end of the funding period (and any no-cost extension).
Because of the wide range of projects funded by the AHA, no single repository is universally preferable. Therefore, the AHA grants awardees flexibility to select the repository most compatible with their data. Any repository approved by the AHA must meet the following criteria:
- Re-Use: The repository must guarantee to any interested party free access to the data without restriction on research reuse.
- Security: The repository must describe how datasets are stored and confidential information is protected.
- Stability: The repository must assure that the data will be available for the indefinite future, regardless of whether the repository is dismantled.
- Subject Focus: The repository should be compatible with the subject matter. If a repository emerges as the standard resource in a field (e.g., GenBank for DNA sequences), the awardee is encouraged to use that repository to better disseminate the research results to like-minded investigators interested in building upon the research.
- Metadata: The repository must require the awardee to provide sufficient metadata to explain the data to others. These metadata must be searchable so that repository visitors can easily locate desired datasets.
- File Formats: The repository should accommodate all file types generated by the awardee.
- Machine Extraction: Preferably, the repository will feature machine-readable and machine-interpretable functionality to enable third-party users to more easily locate the data.
- Reception to AHA Data: The repository must be willing to accept data submitted by AHA-funded researchers.
If a desired repository is not currently approved by the AHA, the applicant may request in the application that the AHA consider the repository for approval. If the repository is approved, it will be added to the list of AHA Acceptable Data Repositories.
Recipients of non-exempt awards beginning January 1, 2015, and after must comply with both the Public Access policy and the Open Data policy.
AHA requires preregistration for funded clinical trials and encourages preregistration for any studies that make an inferential claim from a sampled group or population, as well as studies that are reporting and testing hypotheses. After a project is completed, protocols and preregistration analysis plans can be used in conjunction with the final study and analysis by researchers seeking to replicate, reproduce, and build upon findings.
Preregistration of studies involves registering the study design, variables, and treatment conditions prior to conducting the research. Preregistration should address the study protocol (how a study or experiment will be conducted), as well as the analysis plan (how the collected data will be organized and evaluated).
There are a limited number of established public repositories. For clinical trials of health-related interventions, NIH’s ClinicalTrials.gov is the default system. Within the pre-clinical sciences, the Open Science Framework is becoming a default registry. Some public repositories tend to be disciplinarily focused. The Center for Open Science provides multiple resources on how to preregister studies and analytic plans, including templates.
PreprintsSharing manuscripts before (or alongside) the formal peer review process is highly encouraged for AHA awardees. It allows for rapid communication of new findings and can benefit the research community and the public by accelerating the pace of discovery. There are many benefits to using preprint servers including allowing researchers to establish precedence, opening manuscripts to wider feedback than just the peer-review process, and increasing visibility for work (especially since services like Google Scholar are indexing preprint servers).
ASAPbio (Accelerating Science and Publication in biology) maintains a directory of preprint servers that awardees may find helpful when determining where to deposit manuscripts. In addition, our grants management system allows preprints to be entered any place publication information is requested.
Material Transfer Agreements
For the transfer of tangible research materials (for example, reagents, cell lines, mouse models, chemical compounds, etc.), the AHA is now recommending the use of Material Transfer Agreements. We are using guidance like the NIH, in that, for simple transfers not involving intellectual property, we recommend using a Simple Letter Agreement. For materials that may be patented or for which more protection is desired, the Uniform Biological Material Transfer Agreement (UBMTA) can be used.
Templates for MTAs are available from the NIH’s Office of Technology Transfer.