Research Collaborations

The Millennium Cohort Study is a DoD research project that was created in 2001 in response to growing public concern about the potential health effects of deployments following the Vietnam and Gulf War conflicts. Although the original designers of the Millennium Cohort Study could not foresee the post-2001 military conflicts, the project is perfectly positioned to address health outcomes related to these operations.

Formal guidelines for Collaborative Research within the Millennium Cohort are available upon request. Briefly, research proposals are reviewed and approved by an oversight committee to ensure alignment with the study's objective. The overall objective of the Millennium Cohort Study is to characterize the military service experiences and health outcomes of a large cohort of military and Veteran personnel and contribute to the understanding of factors that influence military health. Ultimately, the goal is to impact DoD policy and prevent illnesses and injuries among military and Veteran populations.

Requests for collaboration by researchers must be made in writing, in the form of a pre-proposal, (see guidelines below) to the Millennium Cohort Study principal investigator (PI) who will serve as the point of contact for all collaborative research. Proposed projects must be 1) feasible, 2) of substantial scientific and military interest and merit, 3) novel and not currently under consideration by another investigator. Further, reasons for proposing the use of the Millennium Cohort Study data, rather than another data source, must be clearly outlined. Of note, studies that involve information beyond that currently available within the Millennium Cohort Study database are rarely considered as it is vital for the full Cohort to be protected from the introduction of bias by secondary research investigations. Additionally, the source of funding of the proposed work should be included within the pre-proposal.

Once the pre-proposal application is received:

  1. The pre-proposal will be formally reviewed by the Study's oversight committee.
  2. If pre-proposal receives approval, the applicant will be requested to submit a full proposal (see guidelines below)
  3. A decision regarding the use of the Millennium Cohort data for the proposed research as outlined in the full proposal will be sent back to the submitting investigator. Applicants will be asked to complete forms required for IRB approval and data use sharing agreements (e.g., Data Use Agreement, Business Associate Agreement, or Memorandum of Understanding)

Additional requirements:

Before research commences, a full proposal must be formally approved and all IRB approvals, data use sharing agreements, and funding must be in place. External collaborators will work with at least one of the Millennium Cohort investigators and the Study PI, who will serve as members of the study team. Because of the complexity of the dataset and Millennium Cohort investigators' knowledge of the strengths and limitations of these data, input from the NHRC study team is compulsory to ensure both the validity and maximal use of the data. All research findings, including in the form of presentations and publications, require review and approval by NHRC and the Department of the Navy prior to release.

Investigators interested in obtaining further information on collaborative research within the Millennium Cohort are invited to contact [email protected].

Pre-Proposal Guidelines

The Pre-proposal is an approximate three to five page synopsis of the proposed study and will include the following elements:

  1. General Information
    1. Initiating investigator(s), analyst(s), collaborator(s) involved (including CV/biosketch)
    2. Project title
    3. Brief background/introduction and rationale (include statement on the use of Millennium Cohort data versus another dataset)
    4. Brief description of methods and study population
    5. Objectives
    6. Outcomes
    7. Independent variables of interest
    8. Military relevance
    9. Source of funding
  2. References

Full Proposal Guidelines

The full proposal is a longer, more descriptive document (10-15 pages) of the proposed study and will include the following elements:

  1. General Information
    1. Initiating investigator(s), collaborator(s), and site(s) involved
    2. Project title
    3. Planned start and end dates; timeline with milestones
    4. Human subjects protection issues
  2. Design and Methods
    1. Brief background and rationale
    2. Military relevance
    3. Research question(s) or hypotheses
    4. Specific aims
    5. Specific methods
    6. Specific outcomes and variables of interest
    7. Sample size and statistical power matrix (if needed)
    8. Participant burden (including time and/or discomfort)
    9. Potential impact on the full Millennium Cohort Study and NHRC team
    10. Mechanisms for data security, confidentiality, and informed consent
  3. References
  4. Source(s) of Funding and Budget