Principles and Background Information
- What is open science?
- What is AHA's approach to open science?
- What is the AHA's public access policy as it relates to the research it funds?
- What is the AHA's public access policy as it relates to research it publishes?
- What is the AHA's open data policy specifically?
- Why is the AHA implementing these policies?
- Are there examples of acceptable data plans?
- Does the AHA's open data policy apply to all grant recipients?
- What types of research data must be shared in accordance with AHA's policy?
- My data will have limited or no value to others. Why must I share it?
- Does the AHA policy apply only to data associated with published articles?
- My research involves human subjects. What steps must I take to safeguard their privacy?
- What is the process for submitting my data sharing plan?
- Where should I deposit my research data?
- What are some examples of acceptable data repositories?
- Can I opt out of data sharing?
- When must I make my research data available?
- What if there is an issue with making all the relevant research data available within 12 months of the end of funding period?
- What if I am not able to publish a paper using my research data within 12 months of my grant's expiration? Why can't I hold my data privately until I get my article published?
- Why can't I make the research data available as a supplementary file on a publisher's website?
- Why doesn't making my paper freely available via PubMed Central satisfy AHA's open data requirement?
- Why can't interested parties just contact me directly to get a copy of the research data?
- Data derived from this research may be eligible for intellectual property protection. Should that be indicated in my data plan as a limit to data sharing? Is this justification for seeking opt-out approval?
- What if no appropriate repository exists to house my research data?
- How much will it cost to deposit my research data? Who pays for it?
- Once I share my research data, who owns it?
- What about the possibility of scientific misuse or unsophisticated analysis of the research data?
- Will source code be required to be included in the data sharing plan?
- Some of the AHA pre-approved data repositories restrict the use of the data and are not always “freely and publicly available” as required by the AHA open data policy. Will this result in my data plan being rejected?
- What if my research builds on restricted data and/or leverages cohorts that include consented human data?
- I have selected an approved repository for my data, but what if over the course of the award I want to modify the data plan. Is it possible to change repositories or add repositories to my data plan?
- What happens if I fail to comply with the AHA's open data policy?
- To whom does the AHA's public access policy apply?
- My paper is based on research only partially funded by AHA. Is the paper still bound by the AHA's public access policy?
- What is PubMed Central?
- What are the benefits of posting peer-reviewed papers to PubMed Central?
- How do I deposit my papers in PubMed Central?
- Do I need to do anything to retain rights with the publisher so that I can make the article available in PubMed Central within 12 months of publication?
- Does it matter what version of my article I make available in PubMed Central?
- Does the AHA public access policy apply to new grants only or to existing grants as well?
Principles and Background Information
Open science is the idea that scientific knowledge of all kinds should be freely and openly shared as early as is practical in the discovery process. Open science is characterized by the notion that some or all aspects of the research and discovery lifecycle should be made available with little or no restrictions to the scientific community.
What is AHA's approach to open science?
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.
What is the AHA's public access policy as it relates to the research it funds?
The AHA requires that all journal articles resulting from AHA funding should be made freely available in PubMed Central within 12 months of publication. It is the responsibility of the author to ensure this occurs.
To be clear, the AHA’s policy advocates the rapid, but not the immediate, free dissemination of journal articles. The plan is therefore more accurately characterized as a public access policy rather than an open access policy. Public access, unlike open access, does not demand the immediate availability of peer-reviewed articles. Rather, it recognizes that the realities of the current publishing system allow for publishers to embargo access for some period of time.
What is AHA's public access policy as it relates to the research it publishes?
All research articles in AHA journals are made freely available on that AHA journals website after six months. All other articles in AHA journals are freely available on the AHA journal web site one year after publication. Statements and clinical practice guidelines are always freely available upon publication.
Unique among AHA publications, the Journal of the American Heart Association (JAHA) is an open access journal. Because it is open access using an author pays model, the author’s paper is accepted the author pays for publication costs. The author also keeps copyright and the AHA has a license to publish the article. Articles are deposited in PubMed Central upon publication.
What is the AHA's open data policy specifically?
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). Specific early career awards are currently exempt from this requirement.
Why is the AHA implementing these policies?
Quite simply, public access and open data align with the American Heart Association’s strategic goals. The AHA invests heavily in research in order to accelerate the pace of scientific discovery, encourage innovation, enrich education, and to 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. At present, the building blocks of science research outputs and the raw data supporting these outputs are not made available rapidly to the broadest community of potential users. Internet technologies provide an increasingly cost-effective opportunity to bring these components to a wider audience, and to use these materials in new, innovative ways. 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.
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Yes. View the sample data plans.
Does the AHA's open data policy apply to all grant recipients?
Specified early-career awards are exempt from this policy. The programs that are currently exempt include Undergraduate fellowships, Medical Student Research fellowships, Predoctoral Fellowships, Postdoctoral Fellowships, Mentor/AHA Mentee Awards and Mentored Clinical & Population Research Awards. 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.
What types of research data must be shared in accordance with the AHA's policy?
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.”
My data will have limited or no value to others. Why must I share it?
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.
Does the AHA policy apply only to data associated with published articles?
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.
My research involves human subjects. What steps must I take to safeguard their privacy?
Your data sharing plan must safeguard identifying information related to research subjects in order 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).
What is the process for submitting my data sharing plan?
Grant applicants should complete the Data Sharing Plan section of the online application.
Where should I deposit my research data?
Given the wide range of projects funded by the AHA, no single deposit location is universally applicable. Instead, the AHA provides its grant recipients with a degree of latitude in selecting the most appropriate repository to house their research data. In order for a repository to be approved by the AHA, it must be deemed appropriate across each of the following dimensions:
- Security. The repository must describe how datasets are stored, as well as how any confidential information is protected.
- Stability. The repository must have a clearly articulated funding mechanism or business plan to provide reasonable assurances that the data will be available for the indefinite future. It should also have a continuity plan addressing what will happen to the data in the event the repository is discontinued.
- Fee Structure. What is the cost, if any, to deposit data in the repository? Is the payment one-time or recurring? Does the size of the dataset impact the cost? The repository must define its rates and explain how these fees ensure financial stability.
- Subject Focus. There are hundreds of topic-specific repositories in operation at this writing. The grant recipient should endeavor to deposit his/her data in a repository that is appropriate for the subject matter in question. Further, if a repository has emerged within a specific research community as the default resource in that field (e.g., GenBank for DNA sequences), grant recipients should, as a general rule, utilize that repository. This optimizes the ability of others to discover and build upon the data.
- Metadata. The repository must require a depositor to provide sufficient metadata provided to enable the dataset to be used by others. These metadata should be searchable so that repository visitors can easily discovery appropriate datasets.
- File Formats. The repository should be able to accommodate all aspects of the grant recipients’ dataset, regardless of file type.
- Machine Extraction. The data stored in the repository should ideally be available in a machine-readable and machine-interpretable format.
- Willingness to Accept AHA Data. Finally, the repository must be willing to accept data submitted by AHA-funded researchers.
What are some examples of acceptable data repositories?
As previously mentioned, the AHA funds a wide range of projects with a broad array of data outputs. Therefore, it is difficult to identify a comprehensive list of “pre-approved” repositories that can accommodate all the possible datasets covered by this policy. There are, however, a number of examples that can be cited as meeting the criteria outlined in the section immediately prior.
We currently have a list of vetted, free repositories that are recommended by NIH and the Wellcome Trust. If you would like to recommend a specific repository for AHA evaluation, please contact us at email@example.com.
View the list of AHA Acceptable Data Repositories.
Can I opt out of data sharing?
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 four 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.
- Financial Grounds. Data sharing should not cause an undue financial burden for the grant recipient.
If the opt-out request is not approved and the application receives funding, the awardee will be required to submit a data plan.
When must I make my research data available?
Any 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). The AHA’s open data policy is designed to provide you with prolonged – but not indefinite - first use of the data.
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What if there is an issue with making all the relevant research data available within 12 months of the end of funding period?
The AHA open data policy requires any data needed for independent verification of research results to be made freely and publicly available within 12 months of the end of the funding period (and any no-cost extension). 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 firstname.lastname@example.org.
What if I am not able to publish a paper using my research data within 12 months of my grant's expiration. Why can't I hold my data privately until I get my article published?
The AHA recognizes the unique interest grant recipients have in extracting value from their original data. However, this must be balanced against the interest that the AHA, the research community, and the general public share in accelerating the pace of scientific discovery. Some research projects never generate publishable articles. Others take many years to do so. A policy that gave grant recipients an unlimited exclusive window to produce published articles off of their data would, on the whole, create unnecessary delays in the sharing of data. Grant recipients who feel they have a compelling reason to delay their data’s release should contact email@example.com.
Why can’t I make the research data available as a supplementary file on a publisher's website?
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.
Why doesn't making my paper freely available via PubMed Central satisfy AHA's open data requirement?
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.
Why can’t interested parties just contact me directly to get a copy of the research data?
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 parties repositories that have an established track record of fulfilling this role are a more suitable vehicle for making your data available.
Data derived from this research may be eligible for intellectual property protection. Should that be indicated in my data plan as a limit to data sharing? Is this justification for seeking opt-out approval?
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.
What if no appropriate repository exists to house my research data?
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."
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.
Once I share my research data, who owns it?
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.
What about the possibility of scientific misuse or unsophisticated analysis of the research data?
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.
Will source code be required to be included in the data sharing plan?
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 AHA pre-approved data repositories restrict the use of the data and are not always “freely and publicly available” as required by the AHA open data policy. Will this result in my data plan being rejected?
Some of the repositories such as dbGaP provide two levels of access - open and controlled - in order to allow 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.
What if my research builds on restricted data and/or leverages cohorts that include consented human data?
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.
I have selected an approved repository for my data, but what if over the course of the award I want to modify the data plan. Is it possible to change repositories or add repositories to my data plan?
It is possible to make changes to your data plan through Grants@Heart as needed going forward, so it would not be an issue to change the selected open repository 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.
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.
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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.
My paper is based on research only partially funded by AHA. Is the paper still bound by the AHA’s public access policy?
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.
What are the benefits of posting peer-reviewed papers to PubMed Central?
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.
How do I deposit my papers in PubMed Central?
The AHA will be adopting the deposit procedures put in place by the Health Research Alliance (HRA). We anticipate that this will be available for AHA researchers beginning in 2015. 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.
Do I need to do anything to retain rights with the publisher so that I can make the article available in Pub Med Central within 12 months of publication?
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 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.
Does it matter what version of my article I make available in PubMed Central?
The AHA encourages authors to deposit the final, published version of an article as it appears on the journal's web site 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.
Does the AHA public access policy apply to new grants only or to existing grants as well?
All new grants awarded after July 1, 2014, 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
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