Form 1 Key Informant Interview Questions

OMB Control #: 0925-0668

Expiration Date: 1/31/2016

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CEIRS Network Pandemic Influenza Research Response Planning

Key Informant Interview Questions

Johns Hopkins University CEIRS (JHCEIRS)

OVERVIEW

The purpose of this interview is to inform pandemic and pre-pandemic planning for the National Institutes of Allergy and Infectious Diseases (NIAID) Centers of Excellence for Influenza Research and Surveillance (CEIRS) network. The scope of this planning effort is intended to cover a range of different pandemic or pre-pandemic influenza scenarios—from a catastrophic pandemic (such as the 1918 pandemic) to a less severe pandemic (such as the 2009 pandemic) to the emergence of a novel strain with pandemic potential (such as vH3N2 or H7N9). On behalf of the National Institutes of Health, a Federal agency, the University of Minnesota/Center for Infectious Disease Research and Policy (CIDRAP) is conducting key informant interviews to provide critical information needed to develop a pandemic influenza research response plan for the National Institutes of Allergy and Infectious Diseases (NIAID) Centers of Excellence for Influenza Research and Surveillance (CEIRS) network. A summary of findings from these key informant interviews will be submitted to NIAID.

This interview will be divided into two sections. Most of the questions are intended to be open-ended and may generate brief discussion.

• The first section reviews the technical capabilities and expertise of your CEIRS center—particularly in relation to pandemic response (25 minutes).

• The second outlines your perspectives on priorities for CEIRS research during the emergence of an influenza pandemic or other influenza public health emergency (25 minutes).

SECTION 1: SUMMARY OF TECHNICAL CAPABILITIES AND EXPERTISE OF YOUR CENTER THAT MAY AID IN A PANDEMIC OR PRE-PANDEMIC RESEARCH RESPONSE

1. What do you consider to be your center’s top 5 capabilities that may be of value for pandemic research response and why?

2. What do you consider to be your center’s top 5 areas of expertise that may be of value for pandemic research response and why?

3. Would these capabilities or areas of expertise be any different for pre-pandemic situations, such as the emergence of H7N9?

4. Does your center have a continuity of operations plan (or does your institution) in case of an influenza pandemic or other public health emergency?

SECTION 2: PRIORITIES FOR CEIRS RESEARCH DURING A PANDEMIC OR FOLLOWING EMERGENCE OF A NOVEL INFLUENZA STRAIN

5. With regard to pandemic response, what do you think should be the primary overarching roles of the CEIRS centers?

6. Would you envision these roles to be any different in a pre-pandemic phase (i.e., following the emergence of a novel strain with pandemic potential such as H7N9) than during the onset of a pandemic? (For example, could there be opportunities for the CEIRS network to engage in activities to prevent the development of a full-blown pandemic?)

7. Please comment on the level of priority the following research efforts or support functions should be for the CEIRS network during a pandemic (scale of 1 [low] to 5 [high]):

1. Conduct animal studies related to transmissibility.

2. Conduct animal studies related to pathogenicity.

3. Conduct animal studies related to virulence.

4. Conduct other viral characterization studies (animal or human subjects; please elaborate).

5. Characterize the human host response to infection.

6. Characterize the animal host response to infection.

7. Determine preclinical efficacy of vaccines and antivirals.

8. Evaluate vaccine response and efficacy (assuming a vaccine is available).

9. Develop reagents (i.e., generating rescue plasmids of the emerging strains)

10. Serve as subject matter experts to public health authorities or NIAID (elaborate).

11. Provide laboratory surge support for clinical testing of isolates.

12. Provide drug resistance testing of clinical isolates.

13. Other (please elaborate).

8. At the onset of a pandemic, or in a pre-pandemic phase, do you think that the CEIRS network should have a coordinated strategic approach to: identify research questions, determine knowledge gaps, and develop a research agenda that could be rapidly implemented across the network?

1. If yes, what do you think the process or the structure for that might look like (i.e., how could this be operationalized)?

2. What are the challenges or barriers to such an approach and how can they be addressed?

3. What advanced planning would be of value and what might that look like (for example development of research agendas, development of generic study protocols, IRB review for generic protocols, etc.)?

4. What do you think the role of NIAID should be in pre-pandemic strategic planning?

9. How do you think your particular CEIRS center could support CEIRS network pandemic response efforts?

10. Does your center have any research plans or protocols in place for pandemic response? (If so, may we obtain copies?)

11. Can center resources (staffing surge, supplies, etc.) be shifted during an emergency to support and sustain key projects as defined by NIAID?

CLOSING

12. Do you have any other thoughts or comments regarding pandemic research planning for the CEIRS network that you would like to share?

Thank you for your time.

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