Revised November 2009
Open Data Access Overview
Each dataset has a protection period covering 9 months from the data release date, or publication, whichever comes first. The protected datasets include Metadata and Level 0-4 data. There will be one release date for Metadata and Level 0-4 data and that release date will be the date the Level 0 data is verified by the Epigenomics Data Analysis and Coordinating Center (EDACC) according to the procedures defined in the current Consortium Policies and Procedures Document (http://genboree.org/projects/EDACC/genb%5E%5EadditionalFiles/EDACC-Recommendations.doc, Word, 415KB). To facilitate compliance with the protection period rule, the EDACC will provide public web access to an up-to-date summary of release dates for all the data submitted by the Roadmap Epigenome Mapping Centers (REMCs) (http://www.genboree.org/java-bin/EpigenomeAtlas/index.jsp?isPublic=Yes). During this protected period, users may access and analyze the data, but may not submit any analyses or conclusions for publication or scientific meeting presentation until the protected period has ended.
By requesting and accepting any Epigenomics dataset, the user:
- Takes full responsibility for adhering to the protected period of use and is responsible for being aware of the publication status of the data they use,
- Agrees to comply with the policy.
Data that do not require human participant protections and controlled access are openly available to the scientific community. Investigators outside of the Roadmap Epigenomics Program are encouraged to use the data generated from this endeavor, and are asked to follow the guidelines elaborated in this document. NIH will monitor the adherence to this policy and take appropriate action in cases of non-adherence.
Use of unpublished data within the protected period:
Investigators accessing data generated by the Epigenomics Consortium (hereafter referred to as Òthe Consortium) and performing analyses on unpublished data are urged to proceed with submissions for publication only after the 9-month protected period has elapsed. If there is a compelling reason to publish during the protected period, data users are expected to use scientific etiquette and discuss their plans to use the publish data with the REMCs and EDACC and should obtain their consent prior to using the unpublished data in their individual publications or grant submissions.
The 9-month embargo period on publication will apply to submission of manuscripts for publication or submission of abstracts for scientific meetings by resource users. Resource users are expected to acknowledge the Consortium data producers, as well as relevant acknowledgements to the funding organization(s) that supported the work in all resulting oral or written presentations, disclosures, or publications of the analyses. The following website should be included in the acknowledgements: http://nihroadmap.nih.gov/epigenomics/. All investigators, through their roles as journal and grant reviewers, and journal editors, are asked to help maintain a high standard of respect for the scientific contribution of the Consortium.
Use of published or unpublished data for which the 9-month embargo has expired:
Following expiration of the projected publication period, any investigator may submit manuscripts without restriction, including integrated analyses using multiple unrestricted datasets. For unpublished and unrestricted datasets, users are expected to provide proper acknowledgement as suggested above.
Controlled Data Access Overview
Investigators seeking access to Epigenomics data in the dbGaP controlled-access database must complete a Data Access Request (DAR). The Requester and a Signing Official (SO) authorized to represent the Requester's organization must agree to the terms and conditions for data use as specified in the Data Use Certification (DUC). Submission of a completed DAR serves as acknowledgement of the DUC and binds the Requester and organization to the terms and conditions stated therein. Further, access to controlled-access Epigenomics data will be granted with the understanding that the data will be used in accordance with the conditions described in the DUC for appropriate research uses, including any limitations on such use, of a given dataset.
Although the guidelines for access to controlled data are similar for all Epigenomics related data and its affiliated programs, the specific process for some programs can differ and can require separate DARs. Processes to gain access to controlled data are detailed below.
Requesting Access to Roadmap Epigenomics Program Data
Requesters should access the data via the dbGaP home page (dbGaP - NCBI site). Although dbGaP was primarily created for genome-wide association study data (phenotype and genotype), it is readily adaptable to handling phenotype and sequence data as well.
Those requesting data via dbGaP will be asked to complete a Data Access Request (DAR), which will include a Data Use Certification (DUC) that the requester and institution, represented by an authorized Signing Official, will abide by any terms and restrictions associated with any data set. The Roadmap Epigenomics Program will attempt to enable access to all Roadmap Epigenomics Program datasets with a single DAR. However, some studies have use restrictions imposed by the original consent forms, and those may have to be requested individually. All DARs will be routed through the Joint Addiction, Aging, and Mental Health (JAAMH) Data Access Committee (DAC).
To complete the web-based DAR, the requesting investigator and the authorized institution Signing Official (SO) must have an active NIH electronic Research Administration (eRA) User ID and password. NIH intramural investigators may utilize their NIH directory User ID and password. Visit http://era.nih.gov/ for information on creating an NIH eRA account.
Within two weeks of receiving the completed DAR submitted by the SO, the DAC will either 1) Approve, 2) Disapprove, or 3) Postpone data access for the requesting investigator. Requesters approved and authorized by the DAC are designated Approved Users. Approved Users certify that they will abide by the terms and conditions specified in the DUC, including the provision not to distribute Roadmap Epigenomics Program controlled-access data in any form to any third parties other than those of their own research staff who have agreed to the terms of the DUC.
For collaborative projects, any independent collaborating investigator from a separate institution involved in the use of the Epigenomics data is required to submit a separate DAR. All Approved Users and their institutions will be required to acknowledge responsibility for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations, and with any relevant institutional policies. Investigators from the same institution may be listed under one DAR.
Approved Users will utilize their NIH eRA User ID and password to authenticate their identity and gain access to the controlled-access datasets. Access rights are granted for one year, subject to adherence to Roadmap Epigenomics Program policies. Annual renewal of approved access requires re-acknowledgement of the DUC and a modified Request Form that solicits the same information as a new request, plus information about research accomplishments from utilization of Roadmap Epigenomics Program data and information about any violations of the terms and conditions for data use. The JAAMH-DAC requests the latter information from Approved Users even in the absence of a renewal request.
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