Updates for PAR-16-098 "Cooperative Research Agreements Related to World Trade Center Health Program (U01)"

Notice Number: NOT-OH-18-009

Key Dates
Release Date:  July 3, 2018  

Related Announcements
PAR-16-098

Issued by
Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH)

Purpose

The updated requirements, guidance, instructions, and other information for PAR-16-098 are effective with the publication date of this notice.

Part 1. Overview Information

Applicants now have the option to use the NIH ASSIST system to prepare, submit, and track applications online.

Part 2. Section 1. Funding Opportunity Description

Length of the Award Project Period for "Intermediate-Term" and "Short-Term" Projects
Applicants are now limited to a maximum project period of two years. The total budget for a two-year project may not exceed $2M. The total budget for a one-year project may not exceed $750K.

Type of Project

Project Period

Total Cost per Year

Intermediate-term

Up to two years

Up to $1M

Short-term

Up to one year

Up to $750K

Part 2. Section IV. Application and Submission Information
PHS Human Subjects and Clinical Trials Information
Need help determining whether you are doing a clinical trial?

Note: The revised Common Rule defined clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Including behavioral health-related outcomes recognized that clinical trials may occur outside a biomedical context (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html).

On January 17, 2018, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies delayed the effective date and general compliance date of the revised Common Rule until July 19, 2018 (https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html).

On June 18, 2018, HHS and 16 other federal departments and agencies issued a Final Rule to further delay the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (the Common Rule) for an additional 6 months until January 21, 2019 (https://www.hhs.gov/ohrp/final-rule-delaying-general-compliance-revised-common-rule.html).

As implementation decisions are made and further information becomes available, CDC/NIOSH will provide guidance to applicants and awardees.

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

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

Part 2. Section V. Application Review Information


Significance
In addition, for applications proposing clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)
In addition, for applications proposing clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation
In addition, for applications proposing clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach
In addition, for applications proposing clinical trials:

Does the application adequately address the following, if applicable:

Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment
In addition, for applications proposing clinical trials:
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in using secure, accurate, and timely methods; and, (4) operate within the proposed organizational structure?

Inquiries

Please direct all inquiries to:

Scientific/Research Contact

Travis Kubale, PhD
CDC/NIOSH/OEP
Telephone: 513-841-4461
TKubale@cdc.gov

Peer Review Contact

Nina Turner, PhD
Scientific Review Officer, CDC/NIOSH/OEP
Telephone: 304-285-5976
Email: NTurner@cdc.gov