NIEHS RAPIDD Study

 

The Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) study is a pre-positioned protocol intended to minimize the time needed to begin collecting health data and biological samples from disaster response workers who may be exposed to environmental contaminants. RAPIDD includes all the documents and procedures needed to create a registry of workers.

The NIEHS Institutional Review Board (IRB) approved the RAPIDD protocol for one year 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
3.  Study investigators must report back to the IRB regarding any study activities that impact the safety of research subjects. 

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:

• The RAPIDD Study [Description]
  • Appendix B: Protocol Amendment Checklist
  • Appendix D: Example of Protocol Implementation During a Disaster Scenario
  • RAPIDD Informed Consent Form
  • RAPIDD Answers to Your Questions

• Core-level data collection:
  • Core Registry Form
    • 27 questions, approximately 5 minutes to complete
    • Registry and contact information
  • RAPIDD Core Specimen Collection Questionnaire

• Basic-level data collection:
  • Basic Health Registry Form
    • 81 questions, approximately 10 minutes to complete
    • Registry and contact information
    • Demographics, sociological factors, general and mental health status
    • Deployment information and exposures
  • RAPIDD Basic Anthropometric and Specimen Collection Questionnaire

• Enhanced-level data collection:
  • Enhanced Health Registry Form
    • 148 questions, approximately 20 minutes to complete
    • Registry and contact information
    • Demographics, sociological factors, general and mental health status
    • Deployment information and exposures
  • RAPIDD Enhanced Anthropometric and Specimen Collection Questionnaire

University of Iowa Protocols

The University of Iowa developed an IRB application, questionnaires, and consent documents for collecting health data and biological samples after an environmental disaster.

• IRB Protocol: Disaster Response Research
• Informed Consent Document
• Minor Assent Document
• Protocol Amendment Checklist
• Disaster Response Research Recruitment Phone Script
• Disaster Response Home Inspection Checklist
• Disaster Response Research Project Questionnaire Part I
• Disaster Response Research Project Questionnaire Part II

University of Texas Medical Branch (UTMB) Protocols

UTMB adapted RAPIDD for use in Texas and obtained one-year approval of the protocol from its IRB.

• UTMB Rapid Acquisition of Pre- and Post-Incident Disaster Data Protocol (UT-RAPIDD)
• UT-RAPIDD Informed Consent Form
• UTMB Initial Study Approval

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 sponsored 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

 

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

Use of a single IRB may expedite approval for multi-site research following a disaster.