Notice of Clinical Trial Insurance Clarification on PAR-18-633, NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Notice Number: NOT-AI-20-011

Key Dates
Release Date: November 21, 2019

Related Announcements
PAR-18-633

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to clarify that Clinical Trial Insurance information should not be included in the application at the time of submission. Please direct any questions to the contact listed in this notice.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Scope

Currently reads:

The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of clinical trials that address high-priority research areas that are well matched with the mission and goals of NIAID. A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:

  • provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
  • administration of an unlicensed product; or
  • administration of a licensed product for an unapproved indication.

A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication.

Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial.

Activities and communications regarding all clinical laboratory testing for study participants must comply with US federal regulations [see 42 CFR part 493.2 and 493.3(b)(2)].

For the purposes of this FOA, implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:

  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial; and
  • preparation of the final study report; and other related post-trial activities;
  • Regulatory activities and site monitoring;
  • Clinical Trial Insurance costs.

Revised to read:

The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of clinical trials that address high-priority research areas that are well matched with the mission and goals of NIAID. A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:

  • provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
  • administration of an unlicensed product; or
  • administration of a licensed product for an unapproved indication.

A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication. Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial.

Activities and communications regarding all clinical laboratory testing for study participants must comply with US federal regulations [see 42 CFR part 493.2 and 493.3(b)(2)].

For the purposes of this FOA, implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:

  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial; and
  • preparation of the final study report; and other related post-trial activities;
  • Regulatory activities and site monitoring;


Section IV. Application and Submission Information

2. Content and Form of Application Submission

R&R or Modular Budget

Currently reads:

All instructions in the SF424 (R&R) Application Guide must be followed.

Because all applications must include detailed scientific and operational plans, funding needs for the entire trial and data analysis period must also be included. In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, regulatory submissions, quality management, safety oversight activities, Clinical Trial insurance and costs related to the conduct of clinical trials at non-domestic sites, as appropriate. Costs of study drug/product, labeling, distribution should also be delineated if applicable. Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution (see Letters of Support in the PHS 398 Research Plan below). These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding. NIAID reserves the right to independently procure drug for the study if that offers cost or other advantages to the clinical trial.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section VII. Agency Contacts.

Revised to read:

All instructions in the SF424 (R&R) Application Guide must be followed.

Because all applications must include detailed scientific and operational plans, funding needs for the entire trial and data analysis period must also be included. In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, regulatory submissions, quality management, safety oversight activities and costs related to the conduct of clinical trials at non-domestic sites, as appropriate. Costs of study drug/product, labeling, distribution should also be delineated if applicable. Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution (see Letters of Support in the PHS 398 Research Plan below). These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding. NIAID reserves the right to independently procure drug for the study if that offers cost or other advantages to the clinical trial.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section VII. Agency Contacts.

All other aspects of the FOA remain the same.

Inquiries

Please direct all inquiries to:

Regina Kitsoulis
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2946
Email: regina.kitsoulis@nih.gov