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

The Millennium Cohort Family Study is a DoD-sponsored research study conducted at the Naval Health Research Center (NHRC). The study is led by a multidisciplinary team of investigators at NHRC, Abt Associates, Duke University, and New York University.

Formal guidelines for Collaborative Research within the Family Study are available upon request. Briefly, research proposals are reviewed and approved by an oversight committee to ensure alignment with the study’s objectives. The overall objective of the Family Study is to determine the impact of military experiences, including deployments, on health and well-being of military families, and to provide strategic evidence-based policy recommendations that inform leadership and guide interventions that positively impact the lives of military families.

Requests for collaboration by researchers must be made in writing, in the form of a pre-proposal (see pre-proposal application requirements below), to the Family 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, and 3) novel. Further, reasons for proposing the use of the Family Study data, rather than another data source, must be clearly outlined, and the proposed study cannot be currently in progress using the Family Study data. Of note, studies that involve information beyond that currently available within the Family 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. The applicant will be requested to submit a full proposal (see full-proposal application requirements below) if pre-proposal is approved by the committee.
3. A decision regarding the use of the Family Study data for the proposed research will be provided to the requesting investigator. If the full proposal is approved, applicants will be asked to complete forms required for IRB approval, data use sharing agreements and funding (e.g., Data Use Agreement, Business Associate Agreement, 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 Family Study investigators and PI, who will serve as members of the study team. Because of the complexity of the dataset and Family Study 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.

For further questions, investigators are invited to contact [email protected].

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

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