2014-010-XXX_Ebola_Guinea

File Name: [GenIC#]_[problem]_[requesting entity]

Request for Approval Under the Generic Clearance for

Emergency Epidemic Investigation Data Collections
(0920-1011)

Instruction: This form should be completed by the primary contact person from the CDC CIO that will be sponsoring the investigation.

Determine if your investigation is appropriate for this Generic mechanism: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the EEI Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria in Column A, the EEI Generic IR mechanism can be used. If you select “yes” to any criterion in Column B, the EEI Generic ICR mechanism cannot be used.

Column A	Column B
CDC epidemiological assistance is requested by one or more external partners (e.g., local, state, tribal, military, port, other federal agency, or international health authority or other partner organization). Yes No	The Investigation is initiated by CDC, without request from an external partner. Yes No
The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce injury, disease, or death). Yes No	The investigation is not urgent in nature. Yes No
The investigation is characterized by undetermined agent, undetermined source, undetermined mode of transmission, or undetermined risk factors. Yes No	The investigation is conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research to contribute to generalizable knowledge. Yes No
One or more CDC staff (including trainees and fellows) will be deployed to the field. Yes No	CDC staff (including trainees or fellows) are not deployed to the field. Yes No
Data collection will be completed in 90 days or less. Yes No	Data collection expected to require greater than 90 days. Yes No

Did you select “Yes” to all criteria in Column A?

If yes, the EEI Generic ICR may be appropriate for your investigation. → You may proceed with this form.

Did you select “Yes” to any criterion in Column B?

If yes, the EEI Generic ICR is not appropriate for your investigation. → Stop completing this form now.

GenIC #

     

-

     

Date

06/27/2014

Title of Investigation: Instruction: Provide the title of the investigation in the following format: [Undetermined agent, undetermined source, undetermined mode of transmission, undetermined risk factor] for [disease/problem] among [subpopulation]—[State], [Year]

Undetermined Sources and Risk Factors for an Ebola Hemorrhagic Fever Outbreak—Guinea, 2014

Location of Investigation: Instruction: Indicate location where investigation will occur. If multiple locations, specify each one.

State:	Multiple districts
City/County (if applicable)	     
Country	Guinea, West Africa

Requesting Agency: Instruction: Indicate name of agency requesting epidemiological assistance and the name and position title of the requestor

Agency:	World Health Organization, Global Outbreak & Alert Network
Name and Position Title:	Patrick Drury, Director, WHO Global Outbreak & Alert Network

Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the outbreak or event; 2) steps already taken toward prevention and control, if any; 3) request for CDC assistance, including objectives of the investigation; and 4) how data will be used to inform prevention and control measures. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.

Description of Investigation

1. Problem to be Investigated: Instruction: Provide a summary of the outbreak or event. The summary should include all the information you know at this time about the outbreak or event and the investigation that is planned. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event, including a justification of the need for an investigation and why this issue requires an urgent response; 2) the objectives of the investigation, including how the information collected will be used to inform prevention and control measures; and 3) a brief overview of the investigation planned, including study design, respondents, mode of data collection. In the description, indicate whether a data collection instrument is attached with the GenIC request (refer to as Appendix 1, etc) and what instruments will be developed in the field. (suggested length: 250-500 words).

On March 21, 2014, the World Health Organization and the Ministry of Health (MoH) of Guinea reported an outbreak of Ebola viral disease (EVD) in three southeastern districts and in the capital district of Conakry. By March 30, cases had been reported in Liberia, and in May, the first cases identified in Sierra Leone were reported. As of June 18, the outbreak was the largest EVD outbreak ever documented, with a combined total of 528 cases and 337 deaths (case-fatality rate = 64%) reported in the three countries. Guinea had reported 398 cases with 264 deaths (case-fatality rate = 66%) across nine districts.

In late April, it appeared that the outbreak was slowing. Since then, however, the EVD outbreak has resurged. Major challenges faced by all partners in the efforts to control the outbreak include its wide geographic spread, weak health-care infrastructures, and community mistrust and resistance.

In June 2014, the World Health Organization, via the Global Outbreak Alert and Response Network, requested additional support from CDC and other partners, necessitating the deployment of additional staff members to Guinea and Sierra Leone to further coordinate efforts aimed at halting and preventing virus transmission. Persistence of the outbreak necessitates high-level, regional and international coordination to bolster response efforts among involved and neighboring nations and other response partners in order to expeditiously end this outbreak.

WHO requested CDC assistance with the investigation to identify sources and risk factors for Ebola infection in order to implement prevention and control measures. The epidemiological objectives are to maintain a centralized database for data collected from all outbreak villages, and to assist in contact tracing, case report collection, and patient or family interviews. These actions will be necessary to interrupt transmission of disease from person to person.

The investigation will follow a case series study design, where case report forms (see Appendix 1) will be collected for every patient meeting the suspect case definition criteria (see Item 4 below). Forms are collected through interview of patients or family members if patients have died or are infants, in either French or the local language. Relevant clinical data, including the patient’s date of onset, date of death, hospitalization and funeral information, and contacts that the patient had prior to developing illness all are collected, in an effort to determine the risk factors that led to this patient’s infection. If diagnostic testing confirms that this patient has EVD, a separate contact tracing form (see Appendix 2) is completed to collect information of people who had direct unprotected contact with the patient while they were ill and prior to treatment in a facility with barrier nursing. These contacts are then followed daily for onset of fever and other EVD symptoms, and will be investigated as cases and treated under barrier nursing precautions if they develop illness.

In addition to these 2 instruments described here, there are not any other known data collection instruments that are anticipated to be used.

2. Characteristics of Outbreak or Event (Check all that Apply):

Undetermined agent

Undetermined source

Undetermined mode of transmission

Undetermined risk factor

3. Respondents: Instruction: Select all that apply. For each respondent type selected, provide a brief description. Be sure to include a description of control respondents, if applicable. Use as much space as necessary for each description.

General public (describe):

Persons who exhibit symptoms consistent with the case definitions of EVD (See Item 4 below)

Healthcare staff (describe):

Healthcare staff who exhibit symptoms consistent with the case definitions of EVD (See Item 4 below)

Laboratory staff (describe):

Laboratory staff who exhibit symptoms consistent with the case definitions of EVD (See Item 4 below)

Patients (describe):

Healthcare staff who exhibit symptoms consistent with the case definitions of EVD (See Item 4 below)

Restaurant staff (describe):

     

Other (describe):

     

4. Selection of Respondents: Instruction: Provide a brief description of how respondents will be identified and selected. Use as much space as necessary for the description.

Respondents are selected on the basis of meeting case definition criteria. Cases are categorized into one of three case definitions: suspected (alive or dead person with fever and at least three additional symptoms, or fever and a history of contact with a person with hemorrhagic fever or a dead or sick animal, or unexplained bleeding); probable (meets the suspected case definition and has an epidemiologic link to a confirmed or probable case); confirmed (suspected or probable case that also has laboratory confirmation).

5. Study Design: Instruction: Select all that apply. For each study design planned, provide a brief description. Use as much space as necessary for the description.

Epidemiologic Study (indicate which type(s) below)

Descriptive Study (describe):

The investigation will follow a case series study design, where case report forms (see Appendix 1) will be collected for every patient meeting the suspect case definition criteria (see Item 4).

Cross-sectional Study (describe):

     

Cohort Study (describe):

     

Case-Control Study (describe):

     

Other (describe):

     

Environmental Assessment (describe):

     

Laboratory Testing (describe):

When possible, diagnostic testing will be used to confirm Ebola virus infection or rule out infection. Laboratory testing will not be performed by CDC personnel, but laboratory results will be recorded.

Other (describe):

     

6. Data Collection Mode: Instruction: Select all that apply. For each data collection mode planned, provide a brief description. Use as much space as necessary for the description.

Survey Mode (indicate which mode(s) below):

Face-to-face Interview (describe):

     

Telephone Interview (describe):

     

Self-administered Paper-and-Pencil Questionnaire (describe):

     

Self-administered Internet Questionnaire (describe):

     

Other (describe):

     

Medical Record Abstraction (describe):

Hospital records may be used to collect relevant clinical information in the case report form

Biological Specimen Sample

Blood or oral swab specimens will be collected from patients to confirm or rule out Ebola virus infection. Laboratory testing will not be performed by CDC personnel, but laboratory results will be recorded.

Environmental Sample:

     

Other (describe):

     

7. Type of Information to be Collected: Instruction: Select all that apply. For each type of information to be collected, provide a brief description. Use as much space as necessary for the description.

Behaviors (describe):

Risk factors prior to becoming ill such as caring for other sick individuals, attending & participating in funerals, traveling, recent hospital visits, consulting spiritual or traditional healer, and zoonotic contacts are all assessed.

Clinical information/symptoms (describe):

Date of symptom onset and the presence/absence of several symptoms of disease, hospitalization information, and disease outcome (fatal/survival).

Contact information (describe):

The phone number of the patient or their family member, head of household is collected.

Demographic information (describe):

Occupation is collected, sex, age, and residential information.

Environmental factors (describe):

     

Exposures (describe):

Risk factors prior to becoming ill such as caring for other sick individuals, attending & participating in funerals, traveling, recent hospital visits, consulting spiritual or traditional healer, and zoonotic contacts are all assessed.

Medical history (describe):

     

Risk factors (describe):

Risk factors prior to becoming ill such as caring for other sick individuals, attending & participating in funerals, traveling, recent hospital visits, consulting spiritual or traditional healer, and zoonotic contacts are all assessed.

Specimen/lab information (describe):

Diagnostic laboratory testing results for viral hemorrhagic fever infections are collected.

Travel history (describe):

Both travel prior to illness and travel during illness is collected.

Other (describe):

     

8. Duration of Data Collection (number of weeks):

Unknown, but the investigation will continue for at least 2-3 months.

Research Determination: Instruction: Indicate the research determination decision. If the decision is research, provide the research determination letter and IRB approval, if required.

Research

Not Research

CDC Investigation Lead: Instruction: Indicate the name, title, and affiliation of the person who will serve as the CDC lead for this investigation.

Name:	Pierre Rollin, MD
Title:	Deputy Branch Chief
Affiliation:	Viral Special Pathogens Branch, Division of High-Consequence Pathogens & Pathology

CDC Sponsoring Program and Primary Contact Person: Instruction: Indicate the sponsoring CIO/Division/Branch for this investigation. Indicate the name, title, and contact information of the CDC Primary Contact Person for this investigation. Indicate the preferred method of contact during the OMB approval process. Note, contact person or a designee must be available during the OMB approval process in case questions arise.

CIO/Division/Branch:	NCEZID/DHCPP/Viral Special Pathogens Branch
Name:	Barbara Knust
Title:	Epidemiologist

Contact Information: [email protected], 404-639-1104 email preferred

Certification: Please read the certification carefully. Type your name to validate that you are providing certification. Note: If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved. Certification should be signed by the CDC Primary Contact Person for this Investigation.

I, [insert name of CDC sponsoring program contact], certify the following to be true:

1. The collection is voluntary.

2. Respondents will not be personally identified in any published reports of the study.

3. Information gathered will be primarily used to inform effective prevention and control measures.

CDC Sponsoring Program Primary Contact Name:	Barbara Knust
Date of Certification:	     

Requested Approval Date (mm/dd/yyyy): Instruction: Indicate the date by which approval is needed.

     

E-mail the completed form to the Information Collection Request Liaison (ICRL) or EIS program ICRL designee.

EEI Information Collection Request Liaison:

Danice Eaton, PhD, MPH

EIS Program Staff Epidemiologist

EWB/DSEPD/CDC

2400 Century Center, MS E-92

Office: 404.498.6389
[email protected]

For internal use. Do not complete.

Date/Time initial GenIC received by ICRL		     
Date/Time final GenIC received by ICRL		     
Date/Time submitted to OMB		     
Date/Time approved		     

Date Form Revised: GenIC 6.16.14 5