Principals and Backgrounds
The AHA’s policies focus on two critical aspects of open science – increasing the availability of both scholarly research outputs and the raw data from which these outputs are derived. The former, typically referred to as “open access” or “public access,” focuses on the rapid online availability of peer-reviewed research results, permitting any users to read, download, copy, distribute, print, search or link to the full text of these articles, crawl them for indexing, pass them as data to software or use them for any other lawful purpose. The latter, typically referred to as “open data”, promotes the accessibility and reuse of the raw data generated during the scientific discovery phase. Open data typically applies to a range of non-textual materials, including datasets, statistics, transcripts, survey results, and the metadata associated with these objects. The data is, in essence, the factual information that is necessary to replicate and verify research results. Open data policies also usually encompass the notion that machine extraction, manipulation, and meta-analysis of data should be permissible. This extends beyond the human abstraction of facts..
Quite simply, public access and open data align with the American Heart Association’s strategic goals. The AHA invests heavily in research to accelerate the pace of scientific discovery, encourage innovation, enrich education, and improve the public good. We recognize that scientific investigation advances only through sharing of methods and results, and the value of an investment in research is only maximized through wide use of this information. Open science policies can facilitate increased discoverability and reusability. This reduces the gaps in the research cycle and makes it easier for interested parties to pursue promising investigative directions. It lessens the likelihood that multiple laboratories will be pursuing duplicative research in siloed environments. It decreases the potential for data miscalculation, misinterpretation, manipulation, and fraud by opening raw results up to the broader community. It also encourages the broadest possible audience to access and build upon research results.
From a practical standpoint, open science policies demonstrate a tangible return on investment. The AHA relies on private contributions to support our activities. Disseminating research outputs and data in a highly visible manner that promotes sharing, discussion, and follow-up science is a clear way to demonstrate the effective use of donations. It tangibly exhibits the American Heart Association’s commitment to the good stewardship of donors’ investments.
Refer to the award agreement. Awards are subject to the policies in place when the award agreement was signed. New award agreements are required during an active award in some situations (e.g. change of Investigator, change of Institution), which could result in policy changes.
Specified early-career awards are exempt from this policy. The programs that are currently exempt are AHA Predoctoral Fellowships, AHA Postdoctoral Fellowships, and Institutional Undergraduate Student Fellowship Programs. For other programs, if a data sharing plan is not included as part of the application process, the applicant should provide a rationale for why it is unnecessary or inappropriate. “Opt-out” requests will be evaluated according to established guidelines outlined in the policy document.
The AHA supports a wide range of research. As such, the nature of the data collected in conjunction with these projects varies greatly. Consistent with NIH guidelines, the AHA defines research data as recorded factual material commonly accepted in the scientific community as necessary to validate research findings. This does not include laboratory notebooks, partial datasets, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as gels or laboratory specimens. Like NIH, we leave it to the individual's discretion to determine the factual information that is necessary to replicate and verify research results.
Regardless of the type of research data to be shared, it must be accompanied by proper documentation. This documentation, sometimes referred to as metadata, is necessary to allow others to use the data properly and without confusion. Again, 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.”
The entire concept of open data is grounded in the notion that the market for the building blocks of science research outputs should not be artificially restricted. Who knows where the next innovation will come from, or what combination of datasets will produce a scientific breakthrough? Open data policies maximize the information the research community has at its disposal to pursue new leads, build upon the scientific record, and accelerate discovery.
No. Your data sharing plan must encompass all research data, consistent with the NIH definition offered immediately above, from funded research that can be shared without compromising individual subjects' rights, regardless of whether the data have been used in a publication. From a practical standpoint, if the AHA open data policy covered only data associated with published articles; this would slow down the availability of AHA data dramatically. The peer-review process, which often involves submission and rejection to multiple journals and long periods of review and revision, would unnecessarily and artificially delay the sharing of the underlying data. More fundamentally, the failure of a researcher to translate research into a published paper may not be due to the data’s inaccuracy or insignificance. The AHA policy aims to surface all the research data it funds so that the broadest possible scientific community can access, interpret, and build off of it.
Your data sharing plan must safeguard identifying information related to research subjects to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The HIPAA Privacy Rule establishes the conditions under which “protected health information” may be used or disclosed. In order to ensure demonstrable compliance, please follow the guidelines set forth in the AHA’s HIPAA Compliance Guidelines (PDF).
There may be certain instances in which grant applicants seek to be exempted from the data sharing policy. Grant applicants seeking waivers should complete the out-out-request portion within their application to indicate the grounds on which they are lodging these requests. The opt-out request information will be provided with the application in lieu of the data plan fields. Broadly speaking, waiver requests will be expected to fall into one of three predetermined categories, although the applicant can provide additional rationales as appropriate:
- Human Subject Grounds. As the NSF spells out in its exemption guidelines, “[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 cannot violate privacy regulations (e.g., HIPAA) or in any way fail to safeguard the rights of research participants.
- Superseding Regulations Grounds. Governing laws or institutional policies may limit the release of certain data elements.
- Intellectual Property Grounds. Under certain circumstances, data sharing may violate existing IP rights. Opt-out requests would not be approved for potential or anticipated IP rights. Once IP rights are established, awardees can still seek opt-out approval up until the deadline for depositing their data.
If the opt-out request is not approved and the application receives funding, the awardee will be required to submit a data plan.
The AHA open data policy requires that 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 comes first. It is the AHA’s intention to require compliance in all but the most exceptional circumstances. If you believe you have a justifiable reason for delaying the release of your data, please contact us at [email protected].
Publishers, be they not-for-profit or commercial, are unlikely to satisfy all of the conditions enumerated in the AHA’s acceptable repository description. Of particular concern are issues of re-use restrictions, long-term preservation, and machine extraction. It is critical for your data to be made widely available, in the near term and the long term, to any interested party. Publishers’ websites are unlikely to meet these criteria.
PubMed Central is an archive of publicly accessible journal articles. While it is an extremely valuable resource, it is not a data repository. In addition, the AHA's policy extends beyond data associated with published articles.
As above, it is essential for your data to be made widely available, in the near term and the long term, to any interested party. Third-party repositories that have an established track record of fulfilling this role are a more suitable vehicle for making your data available.
Potential or anticipated IP protection is not justification for opting out of our open data policy requirements or even limiting your data sharing. If IP rights are obtained for some or all of the data before the deadline for depositing it in the approved repository, the data plan can then be modified, or an opt-out request submitted.
No one will be expected to develop a de novo database. The list of AHA-approved data repositories is growing and we anticipate that it will grow to cover a wide spectrum of research areas. If you do not see a repository on this list that is an appropriate home for your data, we recommend the following next steps:
- Go to the Registry of Research Data Repositories and look for a subject-appropriate match. NOTE: Not all of the repositories listed in this database will meet AHA standards. If you identify a subject-appropriate repository, please check its policies against the AHA's criteria for acceptable data repositories. If you feel that the identified repository fits the AHA's guidelines, you can submit the repository as “other” in the data plan portion of your application and AHA will review it.
- If you cannot identify an appropriate subject-focused repository, consider depositing your data in your institutional repository (IR). Many universities have developed IRs to house works created by their affiliated researchers. The OpenDOAR Directory provides a searchable database of institutional repositories – you can query it to see if your university has an IR. As with the Registry of Research Data Repositories, not all of the repositories listed in this database will meet AHA standards. Please check your IR’s policies against the AHA's criteria for acceptable data repositories. If you feel that the IR fits the AHA's guidelines, you can submit the repository as “other” in the data plan portion of your application and AHA will review it.
- Currently, there are a few AHA-approved data repositories that are considered "general" vs. "subject-focused". These include Zenodo, figshare, and Dataverse. All of these will accept image sets. "Subject-focused repositories, when available, are preferred over general repositories."
Our open data policy is new and we are not able to make recommendations to applicants for repositories other than the AHA-approved list above. We will vet additional repositories that are recommended by our applicants and add new ones to the list as they are approved.
All of the data repositories in the vetted list above are free of charge to both deposit and access data. Although we anticipate that most deposits will occur in free repositories, the AHA recognizes that there is an effort associated with data preparation. The Open Science Committee would need to approve any request to deposit data in a repository that is not on our approved list (including any that charge for deposit). Any costs associated with preparing the data for sharing should be covered in your award and tracked for reporting. Given the strong likelihood that researchers are already performing fundamental tasks to organize their data for internal consumption and the plethora of free data archiving repositories, it is expected that, in most circumstances, no additional grant funds shall be required to fulfill the data sharing plan.
It is generally held that factual data cannot be copyrighted. Anyone can access the data from the repository in which you deposit it, use the data, and build upon it, provided they provide appropriate attribution.
Data sharing can actually decrease the potential for data miscalculation, misinterpretation, manipulation, and fraud by opening raw results up to the broader community. Any conclusions that a scientist draws from the data can be checked, questioned, and countered by the broader community.
All unprocessed 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. GitHub is currently the default location for open source code and is on our list of pre-approved repositories.
Some of the repositories such as dbGaP provide two levels of access - open and controlled - in order to allow the broad release of non-sensitive data, while providing oversight and investigator accountability for sensitive data sets involving personal health information. The assumption is that AHA funded data would fall under the open category unless there are exceptional circumstances.
It is sometimes required that the research data generated be redeposited in a repository that is not publicly available, such as BioLINCC or the controlled section of dbGaP. These data would still be available for use in other approved studies, but would not be publicly available as required by our open data policy. In these situations we expect the PI to address in their data plan whether ANY data COULD BE deposited in one of our approved open repositories. If ALL the resulting data is restricted, then an opt-out request should be submitted.
It is possible to make changes to your data plan during the award term, so it is not an issue to change the selected open repositor(ies) if you find a better fit or want to add additional repository selections sometime before the data needs to be deposited. New or modified data plans or even opt-out requests can be submitted prior to the deadline for depositing the data. Step by step instructions on how to modify an open science data plan can be found here.
Just the data supporting the publication is due at that time. The rest of the data needed to replicate the research would be due no later than the end of the award period (and any no-cost extension).
What happens if I fail to comply with the AHA’s open data policy?
In situations where the AHA or members of the research community feel that AHA-funded researchers are not sharing data in a manner consistent with our policy, you may be asked by the AHA to demonstrate your compliance. If you cannot do so, this may affect future funding.
The AHA requires that all journal articles resulting from AHA funding must adhere to the public access policy. This means that any researcher receiving AHA funds must comply with the policy.
Yes, the public access policy applies to any journal article manuscript that arises from any amount of direct funding from the AHA.
PubMed Central is a free digital archive of full-text biomedical and life science literature in biomedical and life sciences. PubMed Central was developed and is maintained by the U.S. National Library of Medicine (NLM), a division of the National Institutes of Health.
PubMed Central is a highly visible database that has emerged as a research destination for scientists, clinicians, patients, educators, and students interested in accessing full-text articles on a wide range of biomedical subjects. The inclusion of AHA papers in PubMed Central provides a prominent discovery path for the research we support.
The AHA will be adopting the deposit procedures put in place by the Health Research Alliance (HRA). The HRA has arranged for its member organizations (including the AHA) to establish a mechanism by which grant recipients can deposit papers directly into PubMed Central. View more information about depositing papers in PubMed Central
Grant recipients should endeavor to make publishers aware of the access conditions associated with their funded research at the earliest possible juncture. A template letter may be adapted and included during the manuscript submission process for these purposes. This notification should not influence the acceptance of your article by any reputable journal. After your manuscript has been accepted by a journal, you should ensure that the publication agreement you sign is consistent with the AHA’s public access policy. The terms of such agreements vary widely from publisher to publisher. If the agreement does not provide for your right to make the article publicly available in PubMed Central no later than 12 months after the official date of publication, you will need to adapt it. Simply add the following language to the agreement before returning it to the publisher:
As an author whose research is funded in part or in whole by the American Heart Association, I am obligated as a condition of my grant to reserve certain rights. The Journal, therefore, acknowledges that Author retains the right to provide a copy of the authors’ final manuscript, including all modifications from the publishing and peer review process, to PubMed Central at the NIH upon acceptance for Journal publication for public archiving as soon as possible but no later than 12 months after publication by Journal. ________________ [Publisher Name] accepts these terms and agrees that the terms of this agreement are paramount and supersede any provisions to the contrary any publication agreement for this article, already signed or to be signed at a later date that may conflict.
In the unlikely event the publisher balks at accepting a modification of their standard agreement, you should reiterate the conditions of your funding and remind them that the requirement is similar to that of the National Institutes of Health, Howard Hughes Medical Institute, and other funders. There is no evidence of financial or other material harm to publishers as a result of embargoed free public access to research articles. If the publisher still balks, please contact your funder for assistance.
The AHA encourages authors to deposit the final, published version of an article as it appears on the journal's website into PubMed Central. However, some publishers require deposits to PubMed Central to be made in the form of an author's final, peer-reviewed manuscript of an article. Check your publishing agreement with the publishers for details. We prefer the version of record to be deposited, but we will accept the penultimate version as a Plan B if that is all a publisher allows.
All new grants awarded after January 1, 2015, must comply with the outbound public access policy. However, active grant holders are strongly encouraged (though not required) to adhere to the policy. Doing so will demonstrate a commitment to the acceleration of the pace of scientific discovery.
Sharing 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. ASAPbio (Accelerating Science and Publication in biology) maintains a directory of preprint servers that awardees may find helpful when determining where to deposit manuscripts.
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.
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
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 similar to 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 forM which more protection is desired, the Uniform Biological Material Transfer Agreement (UBMTA) can be used.