Policies Governing All Research Awards

 

Overhead (Indirect Cost) Policy

This is to certify that the Emerald Gate Charitable Trust has a board policy of limiting indirect costs to no more than 5% of the total direct costs for a proposal.   Direct costs include costs directly incurred in conducting the proposed work.  Indirect costs relate to overhead, allocations, accounting or other costs not directly incurred in conducting the proposed work.

 

The Emerald Gate Charitable Trust is a non-profit, private foundation.  We would be happy to answer any further questions on this matter.

 

Open Science Policy

Public Access

The Emerald Gate Charitable Trust requires that all journal articles resulting from EGCT funding be made freely available and linked to an EGCT award in The Center for Open Science OSF system https://www.cos.io/products/osf within 12 months of publication (for pre-clinical sciences).  Journal articles may also be deposited in the PubMed Central system at the investigators discretion (for clinical trials of health-related interventions).  It is the responsibility of awardees to ensure journal articles are deposited into one or the other repository and that all necessary rights are retained in order to do so.

 

Open Data

The Emerald Gate Charitable Trust (EGCT) requires certain applicants to include a data sharing plan with their proposal.  Any factual data that is needed for independent verification of research results must be made freely and publicly available in an EGCT-approved repository within 12 months of the end of the funding period (and any no-cost extension).

The Emerald Gate Charitable Trust is committed to following the FAIR guiding principles for scientific data management and stewardship- Findable, Accessible, Interoperable, and Reusable.  Two examples of EGCT-approved repositories:

  • Open Science Framework (general)
    Open Science Framework is a repository hosted by the Center for Open Science, which is a non-profit technology company providing free and open services to increase inclusivity and transparency of research.
  • ClinicalTrials.gov
    ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
Compliance Threshold

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.

Opt-Out Conditions

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.
Data Types

Because the EGCT 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.”

Embargo Period

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).

Acceptable Repositories

Because of the wide range of projects funded by the EGCT, no single repository is universally preferable. Therefore, the EGCT grants awardees flexibility to select the repository most compatible with their data. Any repository approved by the EGCT 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 EGCT Data: The repository must be willing to accept data submitted by EGCT-funded researchers.

 

Preregistration

EGCT 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.

Preprints

Sharing manuscripts before (or alongside) the formal peer review process is highly encouraged for EGCT 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).

Open Science Research Lifecycle