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Your Environment. Your Health.

Policies and Process PEGS: Personalized Environment and Genes Study

PEGS encourages collaborative research and welcomes proposals for studies seeking to leverage PEGS data. All projects using PEGS data are conducted as collaborations with PEGS investigators. The PEGS Executive Leadership Committee (ELC) established the PEGS Scientific Collaboration Guidelines (106KB) to ensure that collaborations meet applicable NIH requirements for data sharing and that the privacy and confidentiality of human subjects are protected. It provides detailed information on the PEGS collaboration process, policies, and guidelines for completing the research concept proposal.

Collaboration Workflow

PEGS Collaboration Workflow

Scientific Collaboration Process

  1. Contact PEGS ELC Member
    The first step for researchers interested in initiating a collaborative investigation with PEGS is to contact a member of the PEGS ELC and provide a brief description of the proposed project. The PEGS ELC member forwards this initial request to the PEGS ELC to ascertain whether it represents a novel area of research that differs sufficiently from already approved studies. At least one PEGS investigator must serve as a co-investigator for all collaborative research, and the ELC members determine the appropriate PEGS investigator involvement at the time.
  2. Submission of Research Concept Proposal
    Next, submit a research concept proposal using the PEGS research proposal form. The proposal will summarize the research hypothesis, the planned study design and the data and/or specimens requests.The proposal will identify the institutions and affiliations of the researcher and all potential collaborators. The PEGS Scientific Collaboration Guidelines (106KB) provide detailed guidelines for completing the research concept proposal.
  3. Review of Research Concept Proposal
    The PEGS ELC reviews and provides comments on the submitted research concept proposal and notifies the submitter/researcher within 90 days of submission. The PEGS ELC issues one of the following decisions for each reviewed research proposal and data/specimen request: approve, approve pending minor revisions, defer approval until revised, or reject.
  4. Revisions of Research Concept Proposal
    If revisions are requested by the PEGS ELC, the submitter may revise and resubmit their proposal using the proposal form, within 30 days of receiving the review decision from the PEGS ELC.
  5. Approval of Research Concept Proposal
    The PEGS ELC reviews the submitted research concept proposals and notifies the submitter/researcher within 90 days of application. The ELC evaluates applications using several criteria that include potential overlap with already approved studies, the soundness of the proposed methodology, the scientific validity and importance of the proposed research, the researcher’s access to funding necessary to conduct the work, and the relevance of the proposed research to the PEGS cohort.
  6. Signing of Data Agreements
    After approval of the Research Concept Proposal, researchers must agree to the Data User Code of Conduct, the Data Use Agreement, the Data Confidentiality Agreement, and the No Publication Agreement.
  7. Authorization to Access Data
    Upon completion of the Data User Code of Conduct and Data Use Agreements, researchers are authorized to access the requested PEGS data.
  8. Data Use and Access Period
    Collaborators can access PEGS data for a specified period and only for the purpose(s) outlined in the approved research concept proposal. As specified in the PEGS study protocol, the rights and privacy of cohort participants must be respected. Researchers should carefully review the Data Access and Propriety rules outlined in the PEGS Scientific Collaboration Guidelines (106KB).
  9. Submission of Progress Reports
    Researchers will submit annual progress reports on their research to the PEGS ELC. The report should describe the current status of the research, milestones completed, risks or impediments to completing the project, mitigation plans for any risks/impediments, and any substantial modifications or expansions to the original submitted proposal (e.g., the research concept, hypotheses, etc.). Any abstracts and manuscripts submitted for presentation or publication should be included with the report.
  10. Publication Guidelines
    Before submission for publication, a copy of all abstracts and manuscripts describing research conducted using PEGS data must be submitted for review to the PEGS ELC. Researchers will be notified of the outcome of the review within 30 days. It is the responsibility of the senior PEGS investigator serving as co-author to assist the researcher(s)/lead author(s) in meeting the requirements for conducting studies and publishing results using PEGS data.
  11. Post-publication Process
    Upon completion of the proposed research and manuscript publication, collaborators will return newly created and/or additional collected data along with appropriate documentation to NIEHS. Collaborators will destroy all local copies of PEGS data in their possession after NIEHS/PEGS acknowledges receipt of their files.
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