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ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections
Source: International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)Date Published: 2/2020Format: TextAnnotation: This 22-page protocol is designed for any severe or potentially severe acute infection of public health interest, including COVID-19. It is a standardized protocol that enables data and biological samples to be collected rapidly in a globally-harmonized manner. It can be used for the rapid, coordinated clinical investigation of confirmed cases of COVID-19.
Population: All/Anyone
Administered by: Specialist/Doctor/Expert
Language(s): English...[See more] [See less]Type: Study Design/ProtocolAccess Notes: Direct link to Protocol: https://media.tghn.org/medialibrary/2020/03/ISARIC_CCP_v3.1.docx
COVID-19 Case Report Forms (CRFs) https://dr2.nlm.nih.gov/search/?q=20720
Freely/Publicly Available
Contact:: ncov@isaric.org
Citation: Jake W Dunning, Laura Merson, Gernot G U Rohde, Zhancheng Gao, Malcolm G Semple, Dat Tran, et al. Open source clinical science for emerging infections. Lancet Infect Dis. 2014;14(1):P8-9. https://www.sciencedirect.com/science/article/pii/S147330991370327X?via%3DihubIncludes Research Tools: Yes.ID: 21650. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Protocol for Assessment of Potential Risk Factors for 2019-Novel Coronavirus (2019-nCoV) Infection Among Health Care Workers in a Health Care Setting
Source: World Health Organization (WHO)Date Published: 1/25/2020Format: PDFAnnotation: This 32-page document is a case-ascertained prospective investigation of all identified health care contacts working in a health care facility in which a laboratory confirmed 2019-nCoV infected patient receives care. This study can be done in health care facilities at all three levels of a health system, not just in hospitals. It is intended to provide epidemiological and serologic information that will inform the identification of risk factors 2019-nCoV infection among health care workers.
Population: First Responders, Emergency Medical Services (EMS) Personnel, Police/Fire Departments, Healthcare workers
Length: 12 questions and a 21-day diary
Administered by: Self Administered/Self Report; Trained Lay Examiner/Interviewer
Special Considerations: Form 1: "Report Form for health care worker" is completed by worker. Form 2: "Report Form for health care worker" is completed by worker and study coordinator. Form 3: "Laboratory results" is completed by study coordinator. Form 4: "Symptom diary" is complted by worker. Form 5: "Health care facility infection prevention and control" is filled out by a health care facility administrator once for every
health care facility involved in the investigation.
Language(s): English...[See more] [See less]Type: Study Design/ProtocolAccess Notes: Direct link to document: https://www.who.int/docs/default-source/inaugural-who-partners-forum/20200131-2019-ncov-health-care-worker-protocol-v1.pdf?sfvrsn=a2b876f8_0&download=true
Permission/Request required
Contact Information: World Health Organization (WHO); godata@who.intIncludes Research Tools: Yes.ID: 20741. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
COVID-19: Documenting Challenges Faced by California Families with Children 0-5 Years Old on WIC Protocol
Source: University of California, DavisDate Published: 12/19/2019Format: TextAnnotation: This is the protocol for https://dr2.nlm.nih.gov/search/?q=23584. The purpose of the project is to: (1) identify barriers that WIC participants in Los Angeles County are experiencing in using WIC food benefits (e.g., access to WIC-eligible foods); (2) identify additional short-term unmet basic needs (e.g., food and housing insecurity, as well as access to unemployment benefits, healthcare, childcare, and social support while required to remain at home) of low-income families during the COVID-19 pandemic....[See more] [See less]Type: Study Design/ProtocolIncludes Research Tools: Yes.ID: 24226. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Oregon State University Chemical Exposure Disaster Study Protocol
Source: Oregon State UniversityDate Published: 9/2017Format: TextAnnotation: The Oregon State University Superfund Research Program and the Pacific Northwest Center for Translational Environmental Health are focused on chemical exposures before, during and after disasters. The Centers developed a broad Disaster Protocol, enabling rapid responses to disasters. In the case of Hurricane Harvey, using the pre-positioned protocol, researchers were able to obtain project-specific human subjects ethical approval and initiate data collection within three weeks of Harvey making landfall in Houston. The protocol pairs the passive sampling wristband with a short, self-report, online-based questionnaire administered via Qualtrics. The passive sampler can be stored at room temperature and mailed to participants with simple written instructions. Participants wear the wristband, typically for seven days. During that time, the wristband passively sequesters exposure to semi-volatile and volatile organic compounds. Participants return the wristband via mail with a pre-paid envelope. Currently, the wristband can be analyzed for over 1,530 chemical analytes. Training materials and recruitment materials are available online: https://superfund.oregonstate.edu/disaster-irb
The associated Questionnaire can be found: https://dr2.nlm.nih.gov/search/?q=24239
Language(s): English...[See more] [See less]Type: Study Design/ProtocolAccess Notes: Free/Publicly Available
Citation(s):
Rohlman, D., Bethel, J., Hoffman, P., Tidwell, LG and Anderson, KA. Oregon State University Chemical Exposure Disaster Study Protocol. Superfund Research Program, Pacific Northwest Center for Translational Environmental Health Research, Oregon State University, Corvallis, OR.
Available Formats: Text
Contact Information: Diana Rohlman, PhD. Oregon State University. diana.rohlman@oregonstate.eduIncludes Research Tools: Yes.ID: 24238. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
University of Iowa Protocols: Disaster Response Research Project
Source: University of Iowa (UI)Date Published: 4/21/2016Format: TextAnnotation: The University of Iowa's IRB protocol's intent is to establish an umbrella IRB approval for rapid response research in the event of disasters, including floods, fires, earthquakes or chemical spills. The IRB application is created in such a way as to be easily modifiable to fit the needs of the specific organization or disaster that it is being used in response to. This protocol has been successfully used in the field in response to the Iowa Flood of 2008, the Iowa City Landfill fire of 2013, and for a train derailment that occurred in 2014.
The University of Iowa's Protocols propose that when a disaster occurs, health and home survey information, as well as biological samples, will be collected from all consenting individuals in the vicinity of the disaster area. The University of Iowa has developed an IRB application, questionnaires, and consent documents to facilitate this data collection.
Disaster Response Research Project Questionnaire Part I https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Health_Questionnaire_Part1(1).docx
Disaster Response Research Project Questionnaire Part II https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Health_Questionnaire_Part2.docx
IRB Protocol: Disaster Response Research https://disasterinfo.nlm.nih.gov/content/files/IRB_Protocol_Disaster_Response_508-compliant(1).pdf
Informed Consent Document https://disasterinfo.nlm.nih.gov/content/files/Informed_consent_Disaster_Response-2-1(1).docx
Minor Assent Document https://disasterinfo.nlm.nih.gov/content/files/Child_assent_document_Disaster_Response(1).docx
Protocol Amendment Checklist https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Protocol_Amendment_Checklist.docx
Disaster Response Research Recruitment Phone Script https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_phone_script.docx
Disaster Response Home Inspection Checklist https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Home_Inspection.docx
Questions Adapted From:
Questions on questionnaires obtained from ECRHS http://www.ecrhs.org/Quests/ECRHSIImainquestionnaire.pdf
1-5, 7-9, 11-12, 14-20, 21-38, 41, 43, 45-49, 52, 54, 56-63, 64-65 68, 71-83; Questions modified from ECRHS
10, 13; Questions from LEIP
6, 39, 40, 42, 44, 50, 51, 55, 64-67, 69-70; Questions modified from SF-36
84-97
Language(s): English...[See more] [See less]URL: https://disasterinfo.nlm.nih.gov/content/files/IRB_Protocol_Disaster_Response_508-compliant(1).pdfType: Study Design/ProtocolAccess Notes: Free/Publicly Available
Available Formats: TextIncludes Research Tools: Yes.ID: 24219. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
UTMB Rapid Acquisition of Pre- and Post-Incident Disaster Data Protocol (UT-RAPIDD)
Source: University of Texas Medical Branch (UTMB)Date Published: 4/8/2016Format: TextAnnotation: Similar to the NIEHS Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) protocol, the UTMB RAPIDD (UT-RAPIDD) protocols main goal is to establish a human subject's research protocol for future research response before or following a natural or manmade disaster including floods, earthquakes, or chemical spills. A research registry of community members and/or first responders who live in close proximity to the disaster area will be created based on their exposure to the disaster. The protocol then provides the steps for collecting sociodemographic, health status, occupational exposure and lifestyle information from that cohort before or immediately following exposure to a disaster area. Additionally, the protocol outlines the collection, processing, and storage of biological samples that will be collected before or immediately after exposure to a disaster area. The UT-RAPIDDs primary goal is to have all steps of a research study completed prior to a disaster so that rapid implementation and data collection can occur.
UT-RAPIDD Informed Consent form https://disasterinfo.nlm.nih.gov/content/files/RAPIDD_Informed_Consent_UTMB_5-23-16(1).docx
UTMB Initial Study Approval https://disasterinfo.nlm.nih.gov/content/files/Initial%20FB%20Approval.pdf
Questions Adapted From: Modified from RAPIDD Protocol
Language(s): English...[See more] [See less]Type: Study Design/ProtocolAccess Notes: Free/Publicly Available
Available Formats: Text
Contact Information: Sharon Croisant, MS, PhD
Principal Investigator
Department of Preventive Medicine and Community Health
Director, Community-Based Research Facility, UTMB Center in Environmental Toxicology
spetrone@utmb.eduIncludes Research Tools: Yes.ID: 24220. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) Study Protocol
Source: National Institute of Environmental Health Sciences [National Institutes of Health] (NIEHS)Date Published: 7/16/2015Format: PDFAnnotation: This 62-page document provides a pre-planned research study protocol to be used for rapidly implementing a new study at the time of a disaster. The protocol provides the information and documents for creating a research registry of disaster response workers who are rostered before or immediately after deployment to a disaster area. The protocol provides the steps for gathering sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area. The protocol includes documents needed to conduct the research such as an informed consent form, enrollment information and questionnaires. The goal is to have all documents and steps developed before a disaster for rapid deployment at the time of a disaster. Researchers may also use this protocol as a model for developing additional ready-to-use protocols for other disaster research efforts....[See more] [See less]Type: Study Design/ProtocolAccess Notes: Documents included in the Study Protocol:
RAPIDD Core Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Core_Registry_Form_V3_0_20150421_CLEAN-508.pdf
RAPIDD Core Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Core_Specimen_v1_0_20150304.pdf
RAPIDD Basic Health Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Basic_Registry_v4_0_20150421_CLEAN-508_a.pdf
RAPIDD Basic Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Basic_Specimen_v1_0_20150304.pdf
RAPIDD Enhanced Health Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Enhanced_Registry_v4_0_20150421_CLEAN-508.pdf
RAPIDD Enhanced Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Enhanced_Specimen_v2_0_20150421.pdf
RAPIDD Informed Consent Form: https://www.nlm.nih.gov/dimrc/RAPIDD_ICF_v4.0_20150421_508_OPS.pdf
RAPIDD Answers to Your Questions: https://www.nlm.nih.gov/dimrc/RAPIDD_FAQs_V4.0_20150421_508.pdf
Appendix B: Protocol Amendment Checklist: https://www.nlm.nih.gov/dimrc/RAPIDD_Appendix_B_508.pdf
Appendix D: Example of Protocol Implementation During a Disaster Scenario: https://www.nlm.nih.gov/dimrc/RAPIDD_Appendix_D_508-1.pdfIncludes Research Tools: Yes.ID: 12463. From: Disaster Lit®a database of the U.S. National Library of Medicine.
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