Materials for requesting controlled access data through FaceBase
Data use certification
Consent form language to describe sharing through FaceBase (and through NIH, such as dbGaP, when appropriate)
Sharing resources with the broad research community
Data-sharing timeline principles for FaceBase projects, to be discussed later today (see document below, p.4)
Make interim data available when possible and appropriate (e.g., summary statistics for anthropometric data that can be used as normative data)
Investigators make the data available to the scientific community through FaceBase after a short period of time for data cleaning and analysis (“data embargo”); no more than 6 months after receiving genotype data
No protected period of time for results dissemination by the FaceBase project team once data are released through FaceBase (no “publication embargo”)
Hosting and sharing data from non-FaceBase projects, to be discussed later today (see document below, pp.5-6)
Host links to data available through other sources, and host actual data based on FaceBase priorities
Priorities include projects with evidence of high-quality data (e.g., results published), within the scope of FaceBase (i.e., midface development), complementary to FaceBase, and difficult to access if not available through FaceBase
From the Human Research Working Group – May 25, 2010
FaceBase is a high-priority NIDCR initiative designed to further scientific understanding of craniofacial development and birth defects, and will provide a data resource for the scientific community.
A major measure of success of FaceBase will be the utility of the FaceBase database to the scientific community.
Sharing data quickly through FaceBase is essential, so that the community will have access to contemporary data in order to demonstrate utility.
Certain types of data lend themselves to being shared incrementally throughout the project.
At the same time, it is an important principle to allow the generators of the data to have the opportunity to analyze and publish their own data before others do. With that in mind, NIDCR prefers a “data embargo” period for FaceBase investigators to work with their data rather than a “publication embargo” for secondary users.
Approval from Institutional Official (Business Official or Signing Official) to submit data to FaceBase for sharing with the research community, verifying that the data submission is in accord with all applicable laws and regulations.
IRB/ethics board approval for sharing data through FaceBase:
Broad data-sharing not precluded by consent documents.
Assurance of an appropriate process for coding the data, so that FaceBase does not received study identifiers that are directly linked to personal identifiers.
Confirmation from the Principal Investigator and Institutional Official (Business Official or Signing Official) that FaceBase database staff will not have access to the personal identifiers of participants.
Statement of any data use limitations from Institutional Official (Business Official or Signing Official).
Data to be submitted are consistent with FaceBase data-sharing principles, e.g., HIPAA identifiers are removed, or consent given for sharing identifiable information such as facial images.
NIDCR, and others as appropriate such as the University of Pittsburgh as the database host organization, agree that sharing data through FaceBase is not precluded by consent documents.
For non-human data [need input from investigators working in non-human systems],
IACUC approval, when appropriate.
Approval needed from Institutional Official (Business Official or Signing Official) to submit data to FaceBase for sharing with the research community?
Priorities for accepting datasets
Scientifically strong projects as evidenced by successful peer review (i.e., datasets from published projects)
FaceBase will not be able to internally review quality of data
Highest priority datasets in areas of research consistent with current FaceBase focus on mid-face development and oral clefting
Data from studies of other craniofacial sites may be accepted depending on the difficulty the larger community might otherwise have in accessing these datasets
Datasets complementary to those created FaceBase studies in order to maximize the range of research than can be served by the hub’s informatics setup
Whether or not the donated datasets are actually located on the FaceBase servers or just linked to from the FaceBase site will depend on several factors including how difficult it will be for the community to access the data if they are stored remotely from FaceBase and how closely the dataset fits with the overall FaceBase focus on the midface.