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 Institute on Aging (NIA)

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

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Cancer Institute (NCI)

Purpose

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data 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 focuses on data discoverability, and provides an opportunity for existing HEAL Initiative awardees to 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 only from existing awards funded or supplemented by the HEAL Initiative. 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. Centers are not eligible to apply. 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 be FAIR (see HEAL Data Sharing Policy), yet data management and stewardship efforts vary greatly across more than 500 HEAL awards. To coordinate efforts and provide infrastructure and support for HEAL data sharing, NIH awarded data resource teams, 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 providing guidance for HEAL data stewardship activities, and establishing a secure data access and computing platform. This aligns 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. Applicants must include in their proposals:

• description of current data management strategy and practices, including identification of potential areas for improvements and justification for why additional support is needed
• plan for conducting a self-assessment to identify gaps or deficiencies in “FAIR”-ness that are unique to their data
• description of how they would improve data FAIR-ness and plans for developing or enhancing a data management and sharing plan to be in line with the Final NIH Policy for Data Management and Sharing, HEAL public access and data sharing policy, and the plans for the HEAL Initiative data ecosystem
• defined steps toward implementing enhanced data management and sharing

Proposed activities should not exceed one year. Additionally, all applicants should outline an appropriate plan, including timeline, milestones, and staff with expertise to complete the proposed work within the timeframe. Applicants already working with central data coordinating groups and applicants who are serving data coordinating roles in the HEAL initiative will be considered low 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.”

Funded applicants are expected to:

• develop or enhance data management and sharing plans and practices to move data towards alignment with FAIR principles
• participate in a virtual kick-off meeting
• share outcomes of FAIR assessment
• 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
  • Please review HEAL-specific guidance in links above
• participate in a virtual meetings series 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

Application and Submission Information

Budget

To be eligible, the parent award must be able to receive funds in FY2022 (Oct. 2021 - Sept. 30, 2022) and not be in the final year or in a no-cost extension period at the time of award; the supplements should not extend beyond the project period of the parent award.

One-time supplement budget requests can be for up to 15% of the total budget of the current year of the parent award, and 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 requirement of the award will be given low priority and must provide additional justification for applying. Administrative supplement requests may be submitted for the following activity codes: R01, U01,R03, R00, R21, R33, R35, R37, R61, R41, R42, R43, R44, RM1, RF1, R15, U54, U18, U19, UG3/UH3.

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:

• 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?
• Does the applicant describe current data management strategy and practices, including identification of potential areas for improvements and justification for why additional support is needed ?
• Is a plan for conducting a self-assessment to identify gaps or deficiencies in “FAIR”-ness that are unique to their data included in the proposal?
• Are indications of how the applicant would improve data FAIR-ness included?
• Does the applicant outline plans for developing or enhancing a data management and sharing plan to be in line with the Final NIH Policy for Data Management and Sharing, HEAL public access and data sharing policy, and the plans for the HEAL Initiative data ecosystem?
• Does the proposal define steps toward implementing enhanced data management and sharing?
• Does the applicant propose engagement with the Data Ecosystem during the period of award?
• Will the proposed work be sustainable beyond the year of funding (e.g., will improved data management practices be maintained)?

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

• Application Due Date(s) –January 18, 2022 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include "NOT-OD-22-033" (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.
• Requests may be for one year of support only.
• 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.

Inquiries

Please direct all inquiries to:

Jessica Mazerik, Ph.D.
Helping to End Addiction Long-term Initiative
Immediate Office of the Director
Office of the Director
[email protected]