Supporting Statement A

Harvard_Supporting Statement A_instrument_1.docx

CDC/ATSDR Formative Research and Tool Development

Supporting Statement A

OMB: 0920-1154

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Generic Clearance for CDC/ATSDR

"Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness", 0920-1154











April 14, 2017









Contact Information:



Tracy N. Thomas, MSc, MPH

Senior Health Scientist

Office of Public Health Preparedness and Response (OPHPR)

Centers for Disease Control and Prevention

1600 Clifton Rd NE MS K72

Atlanta, GA 30333

Tel: 770-488-1570

BB: 404-772-1447

Email: tct5@cdc.gov

Telework: Tuesdays and Fridays









Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness


Principal Investigator:

Elena Savoia, MD, MPH,

Senior Scientist, Department of Biostatistics

Deputy Director, Emergency Preparedness, Research, Evaluation & Practice Program (EPREP)

Division of Policy Translation & Leadership Development

Harvard T.H. Chan School of Public Health,

677 Huntington Avenue, Boston, 02115 MA

Phone number +1 617-735-5273

Email: esavoia@hsph.harvard.edu



Administrative Contacts:

1. Lauren Masella

Financial Administrator

Department: Division of Policy Translation & Leadership Development

Office Phone: +1 617 432 0097

Office Fax: +1 617 432 1852

Address: Harvard T. H. Chan School of Public Health

Kresge building, Room 350

677 Huntington Ave, Boston MA 02115

Email: lmasella@hsph.harvard.edu

2. Arisleyda Veras Nunez, MSM

Associate Director of Administration & Finance

Department: Division of Policy Translation & Leadership Development

Office Phone: +1 617 432 4373

Office Fax: +1 617 432 3699

Address: Harvard T. H. Chan School of Public Health

Kresge building, Room 350

677 Huntington Ave, Boston MA 02115

Email: Averas@hsph.harvard.edu

Project Officer:

Tracy N. Thomas, MSc, MPH

Senior Health Scientist

Office of Public Health Preparedness and Response (OPHPR)

Centers for Disease Control and Prevention

1600 Clifton Rd NE MS D75

Atlanta, GA 30333

Tel: 770-488-1570

BB: 404-772-1447

Email: tct5@cdc.gov



Table of Contents

Section

A. Justification

  1. Circumstances Making the Collection of Information Necessary

  2. Purpose and Use of the Information Collection

  3. Use of Improved Information Technology and Burden Reduction

  4. Efforts to Identify Duplication and Use of Similar Information

  5. Impact on Small Businesses or Other Small Entities

  6. Consequences of Collecting the Information Less Frequently

  7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

  8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

  9. Explanation of Any Payment or Gift to Respondents

  10. Protection of the Privacy and Confidentiality of Information Provided to Respondents

  11. Institutional Review Board (IRB) and Justification for Sensitive Questions

  12. Estimates of Annualized Burden Hours and Costs

  13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

  14. Annualized Cost to the Federal Government

  15. Explanation for Program Changes or Adjustments

  16. Plans for Tabulation and Publication and Project Time Schedule

  17. Reason(s) Display of OMB Expiration Date is Inappropriate

  18. Exceptions to Certification for Paperwork Reduction Act Submissions


Attachments


Att 1 Interview Guide

Att 2 Human Subjects Determination (Harvard T.H. Chan School of Public Health)

Att 3 Exemption memo for CDC exempt study, #6972

Att 4 Invitation Letter for community leaders























A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary



At-risk populations, defined by CDC as “those groups whose needs are not fully addressed by traditional service providers or who feel they cannot comfortably or safely access and use the standard resources offered in disaster preparedness, relief, and recovery" are ,arguably, most susceptible and vulnerable to adverse outcomes following an emergency or disaster. Levels of vulnerability relative to hazard and exposure vary, both within and across communities and segments of the population. Local agencies play a critical role in addressing the needs of at-risk populations in the preparation and response to emergencies. However, this role is often conducted with uncertainty, as there is limited knowledge regarding the best methods to identify and contact specific segments of the population, access community assets, and build effective strategies for community partnerships. This uncertainty causes unnecessary and harmful variations in public health performance, which perpetuates the “progression of vulnerability.”


The Harvard T.H. Chan School of Public Health's Emergency Preparedness Research, Evaluation & Practice Program (www.hsph.harvard.edu/preparedness), in collaboration with CDC (sponsoring and coordinating Federal agency), seeks to engage community leaders to develop a knowledge base on specific local vulnerable populations and the available assets in the community in an effort to develop best practices for meeting the needs of at-risk populations in preparation and response to an emergency. Specifically, the project encompasses formative research to support 1) development of best practices and strategies to support emergency preparedness program activities designed to meet the needs of vulnerable populations during or after a disaster; 2) development of a new mobile app tool that relies upon the creation of new participatory mapping methodology process for mapping community preparedness assets; and 3) development and assessment of a tabletop exercise to test the impact of the participatory mapping results on the decision-making process of local agencies engaged in preparedness planning efforts. This project would thus aim to enhance the ability of local practitioners and policy makers to apply effective methods at identifying vulnerable and at-risk populations, and to increase the ability of these populations to prepare for, withstand, and recover from public health emergencies and disasters.



2. Purpose and Use of Information Collection

This formative research project requires the development and implementation of three data collection instruments, in order to achieve the outlined goals. Due to the sequential development of the instruments that rely on findings from the prior instrument, this GenIC submission is limited to the first data collection tool, a structured qualitative interview of community leaders. The purpose of the interview is to gather information on methods used to identify at-risk populations and available community assets. This data collection will provide CDC and its emergency preparedness and response partners with the information necessary to guide local efforts in addressing the needs of vulnerable communities in preparation and response to emergencies.



Project staff from the Harvard T.H. Chan School of Public Health (henceforth, referred to as Harvard Chan) will interview community leaders from five collaborating community-based organizations (CBOs) about their first-hand knowledge of emergency preparedness needs at the community level. The collaborating CBOs include Santa Rosa County (Florida), San Juan (Puerto Rico), Charleston-Kanawha County (West Virginia), Boston (Massachusetts), and Brockton (Massachusetts). CBOs will identify community leaders to participate as survey respondents. The project seeks to identify respondents from a broad range of professional roles and experiences in order to elicit a broad range of information that may vary based on their community experience and knowledge.

The community leaders will participate as survey respondents to data collection instruments utilized in the development of the deliverables outlined above. Specifically, respondents are needed for qualitative interviews to elicit available assets in the community and effective methods to identify vulnerable and at-risk populations, in order to develop a list of strategies for addressing population needs in preparation and response to an emergency.



3. Use of Improved Information Technology and Burden Reduction

The participating CBOs will assist the Harvard Chan team in developing a list of community leaders to target for participating in structured, qualitative interviews lasting approximately 60 minutes. An interviewer familiar with the community represented by the CBO will be selected jointly by the Harvard Chan team and CBO to assure cultural sensitivity.

In order to minimize the burden on the participants, both in-person and phone-based interviews will be conducted as per the participants' convenience. The structured interview guide used to elicit responses was developed in collaboration with the CBOs to fine-tune the questions so as to ensure easy comprehensibility and elicit focused responses that would inform the specific components of public health emergency preparedness. It is also envisaged that the CBOs will organize a year-end meeting to share interviews findings with the interviewees. Finally, the survey excludes personal and sensitive information.



4. Efforts to Identify Duplication and Use of Similar Information



Not Applicable



5. Impact on Small Businesses or Other Small Entities



Not Applicable









6. Consequences of Collecting the Information Less Frequently



The structured qualitative interviews would be conducted between April and August 2017, and each respondent would be interviewed only once during this process. Subsequently, data analysis will be conducted at the Harvard T.H. Chan School of Public Health between September, 2017 and January, 2018 so that the results can be shared with the partner CBOs and the respondents (community leaders) during February-March, 2018. This approach would ensure most efficient data collection, analysis and dissemination and form the basis of the next phase of the project (testing the mobile app among select respondents).



7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

Relevant portions of the Guidelines of 5 CFR 1320.5 are met through the submission of the formative research GenIC package.



8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies

Not Applicable



9. Explanation of Any Payment or Gift to Respondents

The Harvard T.H. Chan School of Public Health research group has sub-contracts with the participating CBOs, which will be responsible for providing culturally appropriate incentives to the respondents and participants to augment recruitment efforts for one-hour interviews conducted either in-person or by phone. During year 1, a $40 incentive (monetary or otherwise) per person will be provided to participants electing the in-person interview, while $20 incentive (monetary or otherwise) per person will be provided to participants electing the phone interview.

Providing culturally appropriate incentives is necessary as our target population is a diverse group that may otherwise be difficult to engage in hour-long interviews. The interviews will require an unusual level of mental effort as respondents consider their expansive history and experiences in working with vulnerable populations and community assets, or describe personal and/or family hardships during a past public health emergency. Thus, incentives serve as a token of appreciation for their time and active, in-depth engagement in this research process.



10. Protection of the Privacy and Confidentiality of Information Provided by Respondents.

Participation is absolutely voluntary. We will not obtain names of prospective participants; yet, participants are encouraged to share our contact information with others so that those who might be interested in taking part of the study can contact us. No personal questions will be asked, and no sensitive information will be collected.

We would look to learn about the respondent's community (and not individual-level data) through asking questions on geographic area, socio-economic status, educational levels, general health, key cultural aspect and values. This descriptive insight would help us in better analyzing and interpreting the actual interview data and formulating the list of strategies for the community.

Participants are free to skip any questions that they do not feel comfortable answering. We do not anticipate any reasonably foreseeable risks/discomforts to the prospective participants. To protect individuals' privacy, we are not collecting signatures in the consent form, and will remind participants and prospective participants to avoid using personal email accounts. De-identified interview transcripts will be stored on the principal investigator’s and senior manager’s encrypted computer to keep the data secure.



11. Institutional Review Board (IRB) and Justification for Sensitive Questions



Exemption for IRB approval has been obtained from Harvard University, while the CDC Human Subjects Determination is pending. No sensitive questions would be asked in the data collection process.



A.12. Estimates of Annualized Burden Hours and Costs



The annualized response burden is estimated at 100 hours.



Exhibit A.12.A Annualized Burden Hours

Type of Respondents

Form

Name

No. of Respondents


No. of Responses per Respondent


Avg. Burden per Response (in hrs.)


Total Burden

(in hrs.)


Community leaders identified by local CBO partners

Interview questionnaire

100

1

1

100

Total

-

100

-

-

100




A.12.B Estimated Annualized Costs



Exhibit A.12.B. Annualized Cost to Respondents



Activity

Total Burden Hours

Hourly Wage Rate

Total Respondent Cost

Data collection

100

$20.00

$2000





A.13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers



Not Applicable



A.14. Annualized Costs to the Government



No additional cost is incurred by the federal government. This cost is incurred by Harvard Chan staff as recipients of the Broad Agency Announcement 2016-N-17770—Public Health Emergency Preparedness and Response Applied Research (PHEPRAR) contract and hence, will be solely responsible for the execution of the data collection.



A.15. Explanation for Program Changes or Adjustments



This is a new generic information collection.



A.16. Plans for Tabulation and Publication and Project Time Schedule



Between April and August 2017, it is estimated that 20 respondents per community would be interviewed, for a total of approximately 100 individuals. The interview is expected to last approximately 60 minutes delivered by the respondent’s preferred method (i.e. by phone or in-person). Subsequently the data analysis would be conducted at the Harvard T.H. Chan School of Public Health between September, 2017 and January, 2018 so that the results can be shared with the partner CBOs and the respondents (community leaders) during February-March, 2018.





A.17. Reason(s) Display of OMB Expiration Date is Inappropriate



The display of the OMB expiration date is not inappropriate.



A.18. Exceptions to Certification for Paperwork Reduction Act Submissions



There are no exceptions to the certification.



REFERENCE



Office of Management and Budget, Statistical Policy Directive No. 2: Standards and Guidelines for Statistical Surveys; Addendum: Standards and Guidelines for Cognitive Interviews. Published in the Federal Register, October 12, 2016, vol. 81, no. 197, pp. 70586.

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