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Research Planning, Protocols & Funding

Funding Announcements
Protocols
Institutional Review Boards (IRB)
Paperwork Reduction Act (PRA) Clearance Requirements

 

Funding Announcements

Selected federal funding announcements for disaster-related medical and public health research are listed here until funds are no longer available. Please send suggested funding announcements for this list to dr2@niehs.nih.gov

  • New $10M Grant Opportunity to Enhance Resilience in the Gulf of Mexico Region.

    The Gulf Research Program of the National Academies of Sciences, Engineering, and Medicine and the Robert Wood Johnson Foundation are committing $10 million to enhancing coastal community resilience. We need researchers and community members working across the boundaries of science and practice and of society and the environment to advance our understanding of what makes and keeps Gulf communities resilient, healthy, and thriving. We’re funding projects that explore the human dynamics of resilience. Apply for a grant today or register for our August 11th webinar to learn more.
  • Mechanism for Time-Sensitive Research Opportunities in Environmental Health Sciences (R21 Exploratory/Developmental Research Grant Award)

    This funding opportunity announcement (FOA) is intended to support environmental health research in which an unpredictable event provides a limited window of opportunity to collect human biological samples or environmental exposure data. The primary motivation of the FOA is to understand the consequences of natural and man-made disasters or emerging environmental public health threats in the U.S. and abroad. A distinguishing feature of an appropriate study is the need for rapid review and funding (substantially shorter than the typical NIH grant review/award cycle) in order for the research question to be addressed and swiftly implemented. http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-16-005.html

    The shortened timeframe will be achieved by more frequent application due dates and expediting peer review, council concurrence and award issuance. The entire cycle, from submission to award, is expected to be within 3-4 months.
  • Centers for Disease Control and Prevention (CDC) Public Health Emergency Preparedness & Response Applied Research (PHEPRAR) Funding Opportunity (Broad Agency Announcement)

    The CDC Office of Public Health Preparedness and Response (OPHPR) has posted a Broad Agency Announcement (BAA) open for concept paper submission March 25 until April 25, 2016.

    The aim of this funding is to support innovative research to improve the ability of CDC and its partners, including state and local health departments, emergency management organizations, and health care entities, to effectively prepare for and respond to public health emergencies and disasters. Research topics were identified and prioritized based on the needs of OPHPR and also informed by State and local Public Health Emergency Preparedness (PHEP) officials. Several research topics have been identified within each of the following broad domains: 1) Information Management and Risk Communications, 2) Surge Management, 3) Biosurveillance, 4) Countermeasures and Mitigation, 5) Incident Management and 6) Community/Systems Resilience and Cross Cutting Issues.

    Eligible organizations include accredited U.S. universities; private or public research institutes and centers based in the U.S.; for-profit and non-profit scientific, consulting, and advisory organizations; and state or local government agencies. Research contracts can range up to $1.5 Million and can have a period of performance of up to 3 years (36 months). Awards are expected to be made in July or August 2016. For detailed information and instructions for this research funding opportunity, see: https://www.fbo.gov/index?s=opportunity&mode=form&id=09aff2aaf497929d97d932e22cd6acb1&tab=core&_cview=0
  • Research to Action: Assessing and Addressing Community Exposures to Environmental Contaminants (R01 Research Project Grant)

    This funding opportunity announcement encourages applications using community-engaged research methods to investigate the potential health risks of environmental exposures of concern to the community and to implement an environmental public health action plan based on research findings. The overall goal is to support changes to prevent or reduce exposure to harmful environmental exposures and improve the health of a community. http://grants.nih.gov/grants/guide/pa-files/PA-16-083.html
  • Zika Virus Health Information Resource Guide. Section on Research, Development and Funding

    The National Library of Medicine is maintaining a list of funding opportunities on their Zika Guide.

 

Protocols

 

RAPIDD Study

RAPIDD logo

While disaster research protocols are usually developed post-disaster, there is increasing interest in the development of pre-positioned disaster research protocols in order to minimize the time to begin collecting human health data. The Rapid Acquisition of Pre- and Post-Incident Disaster Data  (RAPIDD) study was designed by the National Institute of Environmental Health Sciences (NIEHS) for just this purpose. NIEHS provides the approved study protocol as a helpful blueprint for investigators.

The primary objective of the RAPIDD study is to create a research registry of disaster response workers who are rostered before or immediately after deployment to a disaster area.   Disaster response workers are at great risk for adverse outcomes due to direct exposure to hazardous environmental contaminants during the emergency response.  The RAPIDD protocol is designed for a range of disaster situations. The RAPIDD protocol has a flexible and scalable approach to fit varying conditions on the ground. Since some elements of a disaster cannot be specified in advance, RAPIDD has built in a customizable set of materials that can be readily reviewed and approved at the time of a disaster.   An example of a disaster scenario, under which RAPIDD may be implemented, can be found here.

The NIEHS Institutional Review Board (IRB) reviewed and approved the RAPIDD protocol on May 7, 2015 for a one-year period with the following conditions: 1) it may only be used for a single disaster activity; 2) it must undergo an IRB review of an amendment to cover its use in a disaster; and 3) study investigators must report back to the IRB regarding any study activities that impact the safety of research subjects within 60 days of study implementation.  These conditions assure that the RAPIDD study complies with all regulations for the protection of human subjects.The RAPIDD Study is included in Disaster Lit.

Goals of the RAPIDD Study:

  • Provide standardized methodology with instruments previously used in disasters
  • Provide pre-positioned study documents, questionnaires, surveys, supply lists and staff requirements
  • Gather socio-demographic, health, exposure, and lifestyle information immediately before or after deployment to a disaster area
  • Collect biological samples immediately before or after deployment to a disaster area
  • Establish a well-characterized disaster response worker cohort that will allow future analysis

RAPIDD Study documents:

 

University of Iowa Protocols

 

University of Texas Medical Branch Protocols

 

Institutional Review Boards (IRB) and Protection of Human Subjects

NIEHS Institutional Review Board
The NIEHS IRB, Human Research Protection Program and the Office of Human Research Compliance have considerable experience with minimal risk disaster-related research. NIEHS is sponsoring the Best Practices Working Group for the Development of Special Considerations for Institutional Review Board (IRB) Review of Disaster and Emergency Related Public Health Research on July 27-29, 2016 in Research Triangle Park, NC. See the News for details on this event.

Public Health Emergency Research Review Board (PHERRB)
The PHERRB is a specialized Institutional Review Board (IRB) established under the auspices of the National Institutes of Health (NIH) network of IRBs. The PHERRB is designed to provide centralized, rigorous and expeditious human subject protections review of research studies addressing public health emergencies (PHEs). This review includes other agencies and sponsors with an IRB Authorization Agreement (reliance agreement) between the NIH and the institution conducting the research. PHERRB-reviewed protocols are conducted, supported, or regulated by HHS and subject to 45 CFR 46 and/or 21 CFR 50 and 56. Request more info at: PHERRB@mail.nih.gov

Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

Conducting research in the context of global health emergencies: identifying key ethical and governance issues
This report provides an overview of key ethical and governance challenges associated with conducting research and innovation in the context of global health emergencies. In addition to identifying key pre-existing contributions, it identifies gaps and areas of potential further interest. It discusses how establishing and maintaining the proper distinctions and priorities between response and research raise particularly challenging questions

Paperwork Reduction Act (PRA) and Office of Management and Budget (OMB) requirements

Information coming soon.