Key Dates

Related Announcements

PA-20-272?- Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

Office of The Director, National Institutes of Health (OD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Purpose

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data management, sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI provides an opportunity for existing HEAL Initiative recipientsto increase data FAIR -ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements from existing awards funded or supplemented by the HEAL Initiative or otherwise required to meet HEAL’s Public Access and Data Sharing Policy. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

Background

The NIH HEAL Initiative is an aggressive effort to speed scientific solutions to stem the national opioid public health crisis. All HEAL-generated data must align with FAIR principles (see?HEAL Public Access and Data Sharing Policy), yet data management and stewardship efforts vary greatly across HEAL awards. To coordinate efforts and provide infrastructure and support for HEAL data sharing, NIH awarded data resource teams at the University of Chicago (HEAL Platform Team) and the Renaissance Computing Institute at the University of North Carolina at Chapel Hill/RTI International (HEAL Data Stewardship Group), to lead a?HEAL Data Ecosystem. The primary roles of these teams include facilitating data sharing across HEAL through guidance for data management and stewardship, and establishing a secure data access and computing platform. These efforts align with broader trans-NIH efforts, including the?NIH Strategic Plan for Data Science, which describes actions aimed at modernizing the biomedical research data ecosystem, and the updated NIH data management and sharing requirements (NOT-OD-21-013), which will go into effect in 2023.

Research Objective

This Notice of Special Interest (NOSI) is meant to drive collaborative interactions and enable maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI provides an opportunity for existing HEAL Initiative awardees to increase data FAIR -ness and participate in HEAL Initiative activities to build a community and foster sustainability of HEAL Initiative-generated data.

Proposed activities must not exceed one year. Applicants already working with central data coordinating groups and applicants who are serving data coordinating roles in the HEAL initiative will be considered lower priority.

Additional HEAL-specific guidance can be found on the HEAL Data Ecosystem and Clinical Data Elements program websites, and at HEALdataFair. Overarching NIH guidance can be found at Elements of an NIH Data Sharing and Management Plan.

Recipientswill be expected to:

• enhance data management and sharing plans and practices to move data towards alignment with FAIR principles

• apply HEAL-relevant guidance including, but not limited to, selecting appropriate repositories and incorporating HEAL metadata model

• align with FAIR practices being applied in the HEAL Data Ecosystem, including selecting a repository and registering study-level metadata via the HEAL Data Ecosystem guidelines

• collaborate with the HEAL Data Stewardship Group and HEAL Platform team as appropriate, to ensure work following assessment will enable data discoverability as part of the HEAL Data Ecosystem

• participate in a virtual webinar(s) as required and an end-of-award workshop to report on the goals and milestones met, share lessons learned, and share recommendations with the HEAL Initiative community; contributions may result in a workshop report or a session at the HEAL Annual Investigators meeting

• share data and other work products including outcomes, tools, and best practices through the HEAL Data Ecosystem infrastructure

Description of circumstances for which administrative supplements are available.

Budget

To be eligible, the parent award must be active and may not be in the final year or in a no-cost extension period at the time of award; the supplements request must not extend beyond the project period of the parent award.

One-time supplement budget requests cannot exceed $100,000 in total costs. The number of awards is contingent on availability of funds and receipt of meritorious applications.

Eligibility

Only existing awards funded or supplemented by the HEAL Initiative are eligible for supplement under this NOSI. Applications from HEAL research teams that are serving as, or already working with, data coordinating centers as a requirement of the award will be given lower priority and must provide additional justification for applying.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

• Submitted applications must follow the guidelines of the IC that funds the parent grant. Administrative Supplements do not receive peer review. Responsive applications will be evaluated internally by NIH program staff and the most meritorious applications will be supported based upon availability of funds. The criteria described below will be considered in the administrative evaluation process:

  • How relevant is the descriptionof the current data management strategy and practices? To what extent are potential areas for improvements included? How well justified is the request for additional support??

  • How adequately will gaps?in FAIR -ness unique to their data be identified?

  • How adequate is the approach described to improve data FAIR-ness?

  • How appropriate is the plan to enhance data management and sharing practices and apply HEAL-relevant guidance (such as selecting appropriate repositories and incorporating the HEAL metadata model)?

  • How sufficientlydoes the applicant propose engagement with the Data Ecosystem during the period of award?

  • To what extent will the proposed work be sustainable beyond the year of funding (e.g., will improved data management practices be maintained)?

  • Is the applicant serving as a data coordinating group for HEAL initiative studies? Is the applicant a HEAL awardee who is getting data management support from a HEAL-supported coordinating center?

  All instructions in the?SF424 (R&R) Application Guide?and?PA-20-272?must be followed, with the following additions:

  • For funding consideration, applicants?must include "NOT-OD-22-110" (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B?will not be considered?for this initiative.

  • The Research Strategy section of the application is?limited to 2 pages. Research Strategy should include justification for additional data management needs, plan for FAIR evaluation and improvements, timelines for activities proposed, and staff expertise to complete the proposed work.

  • Electronic submissions are?required?for this funding opportunity. The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

  • For application guidance,?consultation with the Program Official for the qualifying HEAL award and point of contact listed under Inquiries below is recommended.

Applicants must include in their applications:

• description of data types being generated and current data management strategy and practices

• identification of potential areas for improvements and justification for why additional support is needed

• description of gaps or deficiencies?in FAIR -ness that are unique to their data

• description of how they plan to improve data FAIR-ness and enhance data management and sharing plans, following HEAL-relevant guidance, such as selecting appropriate repositories and incorporating the HEAL metadata model

• description of engagement with the Data Ecosystem during the period of award

• proposal for sustaining improvements in data management and sharing practices beyond the year of funding

• overview of a project plan, including timeline, milestones, and staff with expertise to complete the proposed work within the timeframe

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to:

Anthony Juehne
Helping to End Addiction Long-term Initiative
Immediate Office of the Director
Office of the Director

National Institutes of Health
Email: [email protected]