NOT-TR-24-027: Notice of Change for PAR-24-206 Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)

Notice of Change for PAR-24-206 Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)

Notice Number:

NOT-TR-24-027

Key Dates

Release Date:

July 18, 2024

Related Announcements

April 02, 2024 - Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional). See NOFO PAR-24-206.

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to correct Data Sharing Policy resource information for PAR-24-206 Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional).

The following sections of  PAR-24-206 are being corrected.

The revised sentences are indicated with bold, italicized font as follows:

Part 1. Overview

Key Dates

Currently Reads:

Application Due Date New and Renewal / Resubmission / Revision (as allowed) August 13, 2024

Expiration Date August 14, 2024

Modified to Read:

Application Due Date New and Renewal / Resubmission / Revision (as allowed) August 19, 2024

Expiration Date August 20, 2024

Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description

Currently Reads:
The RDCRCs will collaborate with the DMCC to establish and promulgate coordinated RDCRN data management and data sharing standards and policies within the RDCRC.

Revised to Read:
The RDCRCs will collaborate with the DMCC to establish and promulgate coordinated RDCRN data management and implement NIH data sharing standards and policies within the RDCRC.

Currently Reads:
The Administrative Core, in consultation with the DMCC, will establish data sharing and data use agreements within the RDCRC, for all clinical sites, and between the primary recipient institution and the DMCC.

Revised to Read:
The Administrative Core, in consultation with the DMCC, will establish RDCRN-specific data sharing and data use agreements within the RDCRC, for all clinical sites, and between the primary recipient institution and the DMCC.

Currently Reads:
They will also collaborate with the DMCC to establish and promulgate coordinated RDCRN data management and data sharing standards and policies within the RDCRC.

Revised to Read:
They will also collaborate with the DMCC to establish and promulgate coordinated RDCRN data management and NIH data sharing standards and policies within the RDCRC.

Currently Reads:
It is important that the RDCRC is prepared to identify a point of contact for communications with DMCC and share the following information with the DMCC:

Key contacts for individual research studies
Patient advocacy group contacts
Protocols and schedule of events
List of diseases/disorders studied
Consent
Documents and data use limitations
List of data elements and data modalities
List of sites and personnel

Revised to Read:
It is important that the RDCRC is prepared to identify a point of contact for communications with DMCC and share the following information with the DMCC:

Key contacts for individual research studies
Patient advocacy group contacts
Protocols and schedule of events
List of diseases/disorders studied
Consent documents and data use limitations
List of data elements and data modalities
List of sites and personnel

Currently Reads:
The Administrative Core will coordinate data sharing and biospecimen sharing, storage and tracking information across all clinical sites within the RDCRC and externally with appropriate agreements.

Revised to Read:
The Administrative Core will coordinate data sharing and biospecimen sharing, storage and tracking information across all clinical sites within the RDCRC and externally with agreements.

Section IV. Application and Submission Information
PHS 398 Research Plan (Overall)

Currently Reads:
This includes plans for continued relationships with patient and family groups, infrastructure support for critical components of the RDCRC, and data sharing (for current data and beyond).

Revised to Read:
This includes plans for continued relationships with patient and family groups, infrastructure support for critical components of the RDCRC, and future data sharing (for current data and beyond).

Other Plan(s):

Currently Reads:

The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Applicants should develop the DMS Plan taking the following into consideration:

NIH expects that datasets from the RDCRN will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information. Information such as study protocols, descriptions, bioinformatics tools, and publications are expected to be made available through an open access section of a database such as the RDCRN and other public web sites, and publication in the scientific literature.

Revised to Read:

The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Applicants should develop the DMS Plan taking the following into consideration:

It is expected that the investigator’s Data Management and Sharing Plan will specify the following elements: (1) description of what data will be collected including clinical data, diagnostic data, and physiological measurements such as MRI, (2) description of what biospecimens will be collected, (3) description of the data that will be derived from the biospecimens such as genotyping, sequence, metabolomic measures, proteomic measures, etc., (4) what data and/or biospecimens will be made available for deposit in databases or in a repository accessible to the research community, (5) a timetable for deposition of the data and/or biomaterials, and a specified time interval after which those data and materials can be released to the research community.

Section VI. Award Administration Information

Currently Reads:

A Data Sharing Policy between all participating sites of an RDCRC should be consistent with the RDCRN Template Document (linked above) and guidelines published by the RDCRN and the NIH. This policy should facilitate data sharing and outline the mechanisms of data sharing within the RDCRC and with external partners. The policy should clearly state the intention to transfer patient-level information, stripped of identifiers, to a federal data repository.
A Data Use Policy, consistent with the template and guidelines published by the RDCRN, that includes a publication policy outlining how data collected in RDCRC studies is to be used, disseminated, and attributed.

A Data Management and Sharing Plan, formulated in accordance with these RDCRN Data Sharing Terms and Conditions, must be included in the grant application. It is expected that the investigator’s data sharing plan will specify the following elements: (1) description of what data will be collected including clinical data, diagnostic data, and physiological measurements such as MRI, (2) description of what biospecimens will be collected, (3) description of the data that will be derived from the biospecimens such as genotyping, sequence, metabolomic measures, proteomic measures, etc., (4) what data and/or biospecimens will be made available for deposit in databases or in a repository accessible to the research community, (5) a timetable for deposition of the data and/or biomaterials, and a specified time interval after which those data and materials can be released to the research community.

Revised to Read:

NCATS provides here (https://ncats.nih.gov/sites/default/files/2024-07/RDCRN-data-sharing-policies-guidance-508.pdf) access to RDCRN-developed non-binding suggested approaches for new and existing award recipients to consider when establishing consortia-specific data sharing practices between participating sites of an RDCRC.

All other aspects of the NOFO remain the same.

Inquiries

Please direct all inquiries to:

Tiina K. Urv, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2746
Email: urvtiin@mail.nih.gov