Notice Number: NOT-TR-17-012
Key Dates
Release Date: March 2, 2017
PAR-15-304
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
This Notice announces the NCATS policy designed to provide CTSA hubs with greater flexibility in managing the Participant and Clinical Interactions (PCI) program to meet local clinical research needs within the existing hub funding levels; this arrangement has previously been referred to as a voucher program.
Applicability
This policy applies to awards funded under Request for Applications RFA-14-009 and Program Announcement PAR-15-304 and to new applications submitted to PAR-15-304, starting with applications submitted on or after May 25, 2017.
Background
Implementation of the 2013 Institute of Medicine (IOM) recommendation to evolve the CTSA Program into a national collaborative network that helps bring more discoveries to the level of health benefit has required changes at both the local hubs and national level. At the local level, RFA-TR-14-009 and PAR-15-304 each called for changes to the structure of the hub that included the addition of a new Network Resources and Optional Modules (NRO) component or Network Capacity Core, respectively, that would enable hub interaction with newly established central network resources. Additionally, the funding opportunity announcements (FOA) called for a restructuring of the CTSA Hub Research such that space or beds could no longer be included as direct costs, and study participant evaluation (e.g. laboratory testing or imaging) had to be budgeted for as part of a specific research proposal. Therefore, the recommended budget for the Participant and Clinical Interactions (PCI) core was reduced, with the option to justify a larger budget in response to local needs and opportunities.
While it is NCATS expectation that clinical research infrastructure and personnel receive support from the academic medical institutions where CTSA Program hubs are located or from other sources, NCATS recognizes that in compelling cases there may be a justifiable need to provide support for clinical research activities including staff and patient-level evaluations. Such cases may include early stage clinical trials, deep-phenotyping studies, or research carried out by scholars or new investigators.
Policy
In order to provide local flexibility in meeting the need to provide support for clinical research activities, NCATS will allow new CTSA hub applicants as well as currently funded CTSA hubs to establish a new or modify an existing PCI Management program to make funds available to support the clinical research activities listed below:
- a limited number of clinical research professionals, such as research nurses or coordinators who can facilitate access to resources, provide training, quality control, and/or assist with study-specific tasks as needed and
- patient-level evaluations such as laboratory testing or imaging necessary for the conduct of a clinical research study.
Implementation
The PCI Management program replaces the previous voucher program as defined in RFA-TR-14-009 and PAR-15-304.
PCI Program Budgets: The budget levels and ranges suggested in the FOA for the former voucher program are no longer applicable. The budget for a PCI Management program should not exceed the total suggested budget (in direct costs)* for the PCI (PAR-15-304) or Research Implementation and Participation (RFA-TR-14-009) component*.
Currently funded CTSA hubs that lack a PCI Management program and wish to implement one are required to submit a prior approval request to NCATS via their Authorized Organization Representative (AOR) for review and approval.
CTSA Program hubs submitting a new (Type 1) application or other organizations applying to PAR-15-304 may propose a PCI Management program consistent with these budgetary suggestions as part of their overall application.
PCI Program Management Guidelines: Specific decisions made under the PCI Management program do not require prior approval by NCATS once the overall program has been approved and implemented. For all PCI management programs, formal guidelines:
- should address solicitation, review, funding level and justification, prioritization, business and cost management, progress tracking, and program evaluation;
- must ensure that institutional review is rigorous and includes a meeting of a multi-disciplinary committee patterned after an NIH study section during which reviewers interact as a group in real-time to discuss the requests; and must include appropriate policies to ensure compliance with all federal regulations and NIH policies including, but not limited to, human research protections, genetic material or stem cells.
*The recommended annual budget amounts in $1000s are $400K for small, $750K for medium, and $1 million for large awards (direct costs) for both RFA-TR-14-009 and PAR-15-304
Inquiries
Please direct all inquiries to:
Mary Purucker, M.D., Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0741
Email: puruckerm@mail.nih.gov
and Human Services (HHS)
