The Focused Ultrasound Foundation’s top priority is accelerating the development and adoption of life-changing medical technology. Central to this mission is comprehensive, reliable research, and we believe that such research cannot be produced without scientific practices that cleave to the core scholarly norms of transparency and reproducibility. Research must be conducted transparently and held accountable to a high standard of scientific integrity. Furthermore, it is imperative that – once produced – such research is shared as widely and quickly as possible. This is not only so that significant developments are available to the public, but also to maximize the information and resources available to all researchers working to further our understanding of focused ultrasound technology and its potential applications. Data and materials must be shared freely between researchers and completed research must be published promptly and openly. Accordingly, the Foundation is committed to fostering values of openness and practices of transparency and accountability across the focused ultrasound research community.

Current Requirements

Open Publication
The Foundation requires that all research resulting from Foundation awards be made publicly and freely available – this means publishing in an open-access journal. The Foundation will reimburse awardees for the direct additional costs associated with selecting a journal’s open-access publication option.

Depositing Preprints
The Foundation requires all awardees deposit a copy of their final report in our preprint server for publication. Our server, FocUS Archive, is hosted by the Center for Open Science (COS) and publicly indexed by way of Crossref – the purpose of this server is to ensure that final reports of Foundation-funded research are available as quickly and broadly as possible.

Depositing Data in Public Repositories
The Foundation reserves the right to ask awardees to deposit their study data in public repositories – or to allow the Foundation to do so itself. We will discuss whether this requirement applies to a given project with the awardee during the contracting process; currently, we see this requirement most commonly in brain and oncology studies. In the specific case of immuno-oncology research, the Foundation asks awardees to deposit their data in the immuno-oncology repository we co-founded with COS.  

Clinical Trial Preregistration
Clinical trials must be prospectively registered in accordance with FDA regulations and field standards on clinicaltrials.gov.

Expectations and Future Requirements

Open Data, Code, and Materials

Transparency
The policy of the Foundation is to fund proposals in which the data, analytical methods (code), and materials used to conduct the research are clearly and precisely documented and maximally available to any researcher for purposes of reproducing the results or replicating the procedure. Completion of this requirement should be documented in the final progress report. Furthermore, awardees should include availability statements for data, code, and materials in their publication indicating whether these aspects of their research are publicly available and, if so, where.

  1. Awardees reusing data already available from public repositories should provide program code, scripts for statistical packages, and other documentation sufficient to allow an informed researcher to precisely reproduce all reported results.
  2. Awardees producing their own data are strongly encouraged to:
    1. Make the data available at a trusted digital repository (Note: if all data required to reproduce reported analyses appears in the article text, tables, and figures then it does not also need to be posted to a repository).
      1. As noted above: in certain instances, the Foundation will require awardees to deposit their data in certain data repositories.
      2. In all other instances, the Foundation reserves the right to ask awardees to deposit data in certain data repositories.
    2. Include all variables, treatment conditions, and observations described in the manuscript.
    3. Provide a full account of the procedures used to collect, preprocess, clean, or generate the data.
    4. Provide program code, scripts, codebooks, and other documentation sufficient to precisely reproduce all published results.
    5. Provide research materials and description of procedures necessary to conduct an independent replication of the research.
    6. Provide detailed descriptions of the treatment parameters for any focused ultrasound studies. See detailed reporting instructions; awardees are expected to observe all relevant requirements and recommendations noted therein.

Data Repositories
The Foundation encourages depositing research data in a public repository. Such a repository should feature:

  1. Gated access
    1. The repository has a governance structure for granting access to data wherein all requests for data are reviewed by a committee for relevance and legitimacy before being granted
  2. A robust archiving strategy that ensures long-term preservation and access
    1. Stable, persistent identifier for all submitted datasets
    2. User interface in which content is findable, accessible, interoperable, and reusable

Exceptions
In rare cases, despite awardees’ best efforts, some or all data or materials cannot be shared for legal or ethical reasons. In such cases, researchers should include an explanation and justification for the non-disclosure of any data or materials. Although the awardee may provide other rationale, most appeals fall into the following three categories:

  1. Human Subject Grounds: Human subject’s protection requires removing identifiers, which may be prohibitively expensive or render the data meaningless in research that relies heavily on personal 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.
  2. Superseding Regulations Grounds: Governing laws or institutional policies limit the release of certain data.
  3. Intellectual Property (IP) Grounds: Temporary suspension of data release until IP rights have been legally established.

Citation
The Foundation expects that all data, program code, and other methods will be appropriately cited. Such materials are recognized as original intellectual contributions and afforded recognition through citation.

  1. All data sets and program code used in a report or publication generated by this funding should be cited in the text and listed in the reference section.
  2. References for data sets and program code should include a persistent identifier, such as a Digital Object Identifier (DOI). Persistent identifiers are assigned to data sets by digital archives, such as institutional repositories, and ensure future access to unique published digital objects.
  3. When citing any research product, awardees should include the DOI and Object type (preprints, datasets, program codes) in the citation. Awardees should also list any information about the document version (e.g. date of last modification) as well as the date the product was cited if relevant. Included below are examples of preferred citation formats for preprints and datasets provided by the National Institutes of Health (NIH). More information available at this address regarding acceptable variations of these citation formats and examples of other citation formats).
    1. Preprint ex: Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS. Biotinylation by antibody recognition- A novel method for proximity labeling. BioRxiv 069187 [Preprint]. August 11, 2016 [cited 2017 Jan 12]. Available from: https://doi.org/10.1101/069187
    2. Dataset ex: Kraemer MUG, Sinka ME, Duda KA, Mylne A, Shearer FM, Brady OJ, Messina JP, Barker CM, Moore CG, Carvalho RG, Coelho GE, Van Bortel W, Hendrickx G, Schaffner F, Wint GRW, Elyazar IRF, Teng H, Hay SI. The global compendium of Aedes aegypti and Ae. albopictus occurrence [dataset]. 2015 Jun 30 [cited 2015 Oct 23]. Dryad Digital Repository. Available from: https://datadryad.org/resource/doi:10.5061/dryad.47v3c Referenced in doi: 10.7554/eLife.08347

Design and Analysis Transparency 

The Foundation expects that all research it funds will conform to high standards of design and analysis transparency. Awardees should review the standards available here and use those that are relevant for their reported research applications. Awardees should note which standards they plan to conform to in their proposal and demonstrate conformity in the manuscript.

Encouraged Actions 

Registered Reports

The Foundation accepts and encourages applications to conduct research in the Registered Report format. Registered Reports differ from traditional publishing formats in that the research question and proposed methodology undergo peer review before data collection ever takes place. Furthermore, the results of all data collection and analysis that do take place are published regardless of content – this means that researchers are guaranteed publication of well-conducted research and are thus free to accurately report serendipitous findings or data that does not support their initial hypothesis. Research proposals that include a plan for submitting work as a Registered Report will receive favor.

Regarding the altered publication process and timeline of a Registered Report:

  • For original research, Registered Reports are often submitted when preliminary findings or pilot studies provide justification for confirmation, which may be partway through the proposed grant period.
  • Awardees are expected to allow time up front for the journal review process to occur prior to commencing that confirmatory research. Please allow 2 to 4 months for this reviewed process to occur in your grant timeline and be aware that changes to the proposed research design are an expected outcome of this review process. If this changes the scope or cost of the grant, awardees are required to notify the Foundation immediately.

Preregistration – Preclinical/Technical Studies 

The Foundation strongly encourages researchers to preregister both their study and analysis plans. Authors of funded proposals should indicate whether the proposed research will be preregistered in an independent, institutional registry such as clinicaltrials.gov or Open Science Framework

  • Preregistration of studies involves registering the study design, variables, and treatment conditions prior to conducting research.
  • Including an analysis plan involves specification of sequence analyses or the statistical model that will be reported.
  • For all proposals and progress reports of preregistered research a link to each preregistration in an institutional registry must be made available. The funder, or an entity acting on its behalf, may verify that preregistration adheres to the specifications for preregistration and then provide certificate of preregistration.

Replication 

The Foundation encourages submission of replication studies through our general funding mechanism. On initial submission authors of replication studies should:

  1. Denote in the cover letter that the study is a replication study submission.
  2. Include a full description of the introduction justifying the importance of the replication and methods with a complete analysis plan.

Contacts

Emily White, MD
Director of Operations
Managing Director of FUS Partners

Charlie Manning
Open Science Manager

 

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