1. Purpose
This plan establishes procedures for the PIKO CTR-N to ensure full compliance with the National Institutes of Health (NIH) policy NOT-OD-26-026, governing disclosure and prior approval of collaborations with investigators at foreign sites and NIH-funded research involving foreign components.
This policy aligns with PIKO CTR-N’s commitment to ethical, transparent, and community-engaged research, particularly in advancing the health of Hawaii’s diverse populations.
2. Responsible Party and Scope
The Multiple Principal Investigators (MPI) of PIKO CTR-N are responsible for ensuring alignment with NIH priorities, compliance with the Notice of Grant Award, and adherence to all Notice of Funding Opportunity requirements, including the prohibition of foreign components.
This plan applies to:
- All PIKO CTR-N-supported research, including but not limited to pilot, developmental, and multi-site collaborative projects;
- All PIKO CTR-N faculty and staff across all cores;
- All investigators associated with the PIKO CTR-N, regardless of their academic, clinical, and/or community affiliations; and
- All other NIH-funded awards administered through PIKO CTR-N, such as supplemental funding.
3. IDeA Eligibility and Geographic Restrictions
The PIKO CTR-N is supported through the Institutional Development Award (IDeA) Program, administered by the National Institute of General Medical Sciences, of the National Institutes of Health.
3.1 IDeA Program Eligibility Requirements
IDeA funding is restricted only to IDeA-eligible jurisdictions, which are defined as U.S. states and territories that historically have received lower levels of NIH funding.
Eligible jurisdictions include:
- Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming
- The U.S. territory of Puerto Rico
3.2 Implications for Foreign Collaborations
Collaborations with investigators at foreign sites that are expected to result in co-authorship will not be funded without prior approval from NIGMS. The following additional constraints apply to PIKO CTR-N and other IDeA-funded programs:
- Primary programmatic activities and all funding must remain within IDeA-eligible jurisdictions
- Foreign collaborations must be:
- Clearly justified as necessary to achieve project aims
- Complementary, not central replacements for activities that could occur within IDeA-eligible jurisdictions
- IDeA funds may not be used to establish or support foreign sites as primary performance locations
4. Required Elements for NIH Prior Approval
All requests to NIH for prior approval of foreign components must include:
4.1 Identification of Foreign Component
- Full name of foreign investigator(s)
- Institutional affiliation(s) and country(ies)
- Description of the foreign site(s)
4.2 Nature of the Research Conducted at the Foreign Site(s)
Provide a detailed narrative including:
- Specific aims conducted outside the U.S.
- Study design, methods, and procedures
- Role of foreign personnel in data collection, analysis, or interpretation
- Community engagement (if applicable, especially in Pacific or Indigenous contexts)
4.3 Justification for Foreign Component Involvement
Provide a detailed narrative including:
- Why the foreign site(s) or foreign collaborator(s) is scientifically essential
- Unique populations (e.g., Pacific Islander communities), environments, or expertise
- Contribution to health equity and translational impact aligned with PIKO CTR-N goals
4.4 Data and Material Transfer
Provide a detailed narrative including:
- Whether data, biospecimens, or materials will be transferred
- Type of data (e.g., clinical, genomic, behavioral, environmental)
- Direction of transfer (U.S. ↔ foreign site)
- Safeguards:
- Data security protocols
- Compliance with U.S. and international regulations
- Indigenous data sovereignty considerations, if applicable
- Required documentation:
- Data Use Agreements
- Material Transfer Agreements
- Data Management and Sharing Plan alignment
If data involves Indigenous, Pacific Islander, or other vulnerable populations, provide a detailed narrative including:
- Community consultation, where appropriate
- Respect for cultural and local protocols
- Protection against misuse of data
5. PIKO CTR-N Internal Review Process
Before submitting the request to NIH for approval, an internal PIKO CTR-N review will be conducted.
5.1 Pre-Submission Consultation
Investigators must consult with:
- PIKO CTR-N Administrative Core to include MPI
- Institutional compliance and legal offices (as needed)
5.2 Required Documentation (uploaded onto PIKO CTR-N website’s online form)
- Foreign Component Disclosure Form
- Prior Approval Justification Narrative
- Draft Data Use Agreements/Material Transfer Agreements (if applicable)
- Updated Data Management and Sharing Plan
5.3 Review Criteria
The Administrative Core Director/contact MPI of the PIKO CTR-N will assess:
- Scientific necessity and justification
- Alignment with community priorities and ethical standards
- Risks related to:
- Data sharing
- Human subjects protections
- International regulatory compliance
5.4 Institutional Approval
Final approval required from:
- PIKO CTR-N MPI
- Authorized Organizational Representative (AOR) at John A. Burns School of Medicine, University of Hawaii at Manoa
6. Submission to NIH
After internal PIKO CTR-N and institutional approvals are obtained, submission to NIH can proceed. Facilitated through the PIKO CTR-N Administrative Core, the following procedure needs to be followed:
- Submit prior approval requests through NIH-approved channels (eRA Commons or via Grants Management Specialist)
- Ensure inclusion of all required elements:
- Foreign investigator/site identification
- Research description
- Scientific justification
- Data transfer disclosures
7. Post-Approval Oversight
7.1 Monitoring
- Track foreign collaboration activities through PIKO CTR-N Administrative Core
- Ensure adherence to approved scope and agreements
7.2 Reporting
- Include updates in:
- RPPR submissions
- PIKO CTR-N progress reports
- Immediately report:
- Changes in foreign component involvement
- New data-sharing activities
8. Risk Mitigation
The following steps will be taken to ensure that PIKO CTR-N will not fund or support research and/or publications involving foreign components:
- All subcontract agreements will include (or be amended to include) the requirement that publications with foreign co-authors are not permitted without prior NIGMS approval
- The PIKO CTR-N MPI will communicate this compliance requirement to all faculty, investigators and staff at the lead and partner institutions, and practice-based and community-based organizations
- A template of the appropriate grant acknowledgement for publications, as well as the restriction on using the PIKO CTR-N grant for foreign co-authored publications, will be posted on the PIKO CTR-N website
- The PIKO CTR-N foreign co-authors policy will be included in writing with all award letters or emails to those investigators receiving pilot, developmental, multi-site collaborative funds, or any other funds from the PIKO CTR-N
9. Roles and Responsibilities
| Role | Responsibility |
| Multiple Principal Investigators | Ensure full disclosure and compliance |
| PIKO CTR-N Administrative Core | Coordinate review and documentation |
| UH Office of Research Services | Institutional review and NIH submission |
| Compliance/Legal Offices | Assess regulatory and data-sharing risks |
| Community Advisors (if applicable) | Provide cultural and ethical guidance |
10. Continuous Quality Improvement
- Annual review of compliance procedures
- Incorporation of NIH policy updates
- Feedback from investigators and community partners