Human Research Working Group Report



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FaceBase Steering Committee Meeting

Human Research Working Group Report

May 27, 2010
Members:

  • PIs and co-investigators from the three research projects that involve human subjects, and from a technology project

  • Hub PIs and project staff

  • NIDCR Program staff

Scope of considerations by the Human Research Working Group:



  • Sharing resources with collaborators within and outside of FaceBase

  • Sharing resources with the broad research community

  • Human participant issues, such as returning individual-level results in the case of clinically important incidental findings or research results

  • Topics for scientific collaborations

Meeting schedule:



  • Meet regularly by conference call, twice a month

Focus so far:



  • Sharing resources with collaborators within and outside of FaceBase

    • FaceBase data-sharing guidelines (see Figure 1 for overview), approved by the Steering Committee via e-mail

      • Two levels of data: 1) open access; 2) restricted access

      • Open access - registration on FaceBase requested but not required

        • Project descriptions

        • Summary data, such as normative data on anthropometric measurements

      • Restricted access – request reviewed by the FaceBase Data Access Committee

        • Summary genotype data, individual-level data

        • Process for gaining access to restricted access data includes sign-off by the investigator requesting data access and her/his institution

        • Same request process for non-FaceBase investigators and FaceBase investigators requesting data from other projects

        • Access to facial image data will require local IRB approval as non-exempt human subjects research, based on the interpretation of these data as identifiable by at least one FaceBase project IRB

        • A limited set of anthropometric measurements are considered deidentified

    • Implementation materials, approved by the Steering Committee via e-mail

      • Terms of Use for using unrestricted (open access) FaceBase data

      • Materials for requesting controlled access data through FaceBase

        • Request form

        • Data use certification

        • Renewal form

        • Final report

    • 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)

      • Recommendations:

        • 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)

      • Recommendations:

        • 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

Future issues:



  • Implementation materials for submitting and accepting data from non-FaceBase projects

  • Biorepository

    • Obtained IRB approval from the University of Iowa

    • Obtained a Certificate of Confidentiality

    • Awaiting review by NIDCR’s Clinical Study Oversight Committee

  • Topics for scientific collaborations

Figure 1.


DRAFT

Timeline for Data-sharing for FaceBase Projects: General Principles

From the Human Research Working Group – May 25, 2010

Principles

  • 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.

Timeline overview

Data available to the project



Data submitted to FaceBase Hub

(“data embargo”)





Data released by FaceBase Hub



Dissemination of results by secondary users permitted (“publication embargo”)

Phenotype (facial image projects)




In batches, when critical mass available*










Immediately

Phenotype (oral clefts project**)




With genetic data










Immediately

Genotyping




No more than 6 months after available to the project










Immediately

Copy Number Variants (CNVs)




No more than 6 months after available to the project










Immediately

Sequencing




TBD***










Immediately

* Details to be determined in discussions with NIDCR staff

** Oral clefts genome-wide association data already available through dbGaP

*** Pending discussion with Terri Beaty, Alan Scott, and NIDCR staff


DRAFT

Sharing data from non-FaceBase projects through FaceBase

From the Human Research Working Group – May 25, 2010

Technical requirements for FaceBase receiving/hosting data from non-FaceBase projects

For all data,



  1. Written approval from the study PI to submit data to FaceBase

  2. Documentation of study and data

    1. Description of study design and methods

    2. Data quality standards

    3. Data dictionary

For human data,

  1. 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.

  2. IRB/ethics board approval for sharing data through FaceBase:

    1. Broad data-sharing not precluded by consent documents.

    2. Assurance of an appropriate process for coding the data, so that FaceBase does not received study identifiers that are directly linked to personal identifiers.

  3. 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.

  4. Statement of any data use limitations from Institutional Official (Business Official or Signing Official).

  5. 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.

  6. 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],

  1. IACUC approval, when appropriate.

  2. 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

  1. Scientifically strong projects as evidenced by successful peer review (i.e., datasets from published projects)

    1. FaceBase will not be able to internally review quality of data

    2. Datasets pages will contain the same disclaimer about accuracy of the data that will be applied to FaceBase datasets

  2. Highest priority datasets in areas of research consistent with current FaceBase focus on mid-face development and oral clefting

    1. Data from studies of other craniofacial sites may be accepted depending on the difficulty the larger community might otherwise have in accessing these datasets

  3. 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

    1. 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.

  4. Good beta-test for hub processes



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