Open Science Policy Statements for AHA Funded Research

Updated:Oct 24,2014




 

Public Access


"Outbound" 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. 

Mechanism

The AHA has adopted the procedures put in place by the Health Research Alliance (HRA). The HRA has arranged for its member organizations (including AHA) to establish a mechanism by which grant recipients can deposit papers directly into PubMed Central. More information is available on the HRA website

Timeline

For non-exempt programs, all awards beginning January 2015 must comply with the outbound Public Access policy. Active grant holders are encouraged (though not required) to adhere to the policy for any articles published after July 1, 2014.

"Inbound" Public Access

All original research articles in the 11 subscription-model HA journals are made freely available on that AHA journal 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.

If an author identifies in the manuscript, per the instructions to authors, that the manuscript is funded by a funder that requires deposit of the manuscript in PubMed Central, such as the NIH or the AHA, the publisher will deposit the manuscript in PMC on behalf of the author. It remains the legal responsibility of the author(s) to confirm with the funder the provenance of their manuscript for purposes of deposit.

The Journal of the American Heart Association (JAHA) is an Open Access journal published by AHA. Because it is Open Access using an author pays model, if 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. 

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 in an AHA approved repository within 12 months of the end of the funding period (and any no-cost extension). Specified early-career awards will be 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 and 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 below.

Compliance Threshold

The AHA’s approach as to what constitutes an acceptable data sharing plan is consistent with other leading research funders such as the National Institutes of Health and the Wellcome Trust.  All AHA data sharing plans must address these key questions as clearly and concisely as possible:
  1. What data outputs will the research generate and what data will have value to other researchers?
  2. When will the data be shared?
  3. Where will the data be made available?
  4. How will other researchers be able to access the data?
  5. Are any limits to data sharing required – for example, to either safeguard research participants (e.g., HIPAA) or to gain appropriate intellectual property protection?
  6. How will the grant recipient ensure that key datasets are preserved to ensure their long-term value?

Data sharing plans must provide clear solutions to address each component of the above list as part of their application in order to expedite grant application approval. 

Grant applicants should account for any time and expenses required to properly prepare data for sharing as part of their standard budgeting and reporting. Any proposed costs associated with requests for non-standard repository deposits will be reviewed by an Open Science standing subgroup of the AHA Research and Scientific Publishing Committees.

Policy Start Date

For non-exempt Programs, all applications due starting in July, 2014 must comply with this policy. Additionally, active grant holders are encouraged (though not required) to adhere to the policy. 

Opt-Out Conditions

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 appropriate section of the application to indicate the grounds on which they are lodging these requests. 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 IP rights.
  • Financial Grounds. Data sharing should not cause an undue financial burden for the grant recipient.

Data Types

The AHA supports a wide range of research. As such, the nature of the data collected in conjunction with these projects varies greatly. In general, any 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.

Regardless of the type of 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. 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.”

Embargo Period

Grant applicants should endeavor to make their data publicly available as quickly as possible. All relevant data must be made freely and publicly available within 12 months of the end of funding period (and any no-cost extension).

Acceptable Repositories

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:

 

  • Re-Use. The repository must allow any interested party to freely access the data without restriction on research reuse. This should be codified in the repository’s terms of use.
  • 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 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.

Examples of Acceptable 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 pre-approved, free repositories that are recommended by NIH and the Wellcome Trust. If you would like to recommend a specific repository for AHA pre-approval, please contact us apply@heart.org.

View the list of AHA Acceptable Data Repositories.

Please note that it is not acceptable to simply post datasets as supplementary files on a journal publisher’s website. Such a solution does not adequately address the re-use, security, stability, metadata, and machine extraction criteria outlined above.