Appendix F: IRB Application & Approval

School of Public Health
Institutional Review Board on Research Involving Human Subjects
APPLICATION FORM FOR NEW PROPOSALS

Date of Application: 9/26/00

Title of Project: Community Diagnosis of Central Durham

Name of Principal Investigator: Elisa Rossetti (student)

Name of co-investigators: Eugenia Eng (Faculty Advisor)
(If the principal investigator is a student, give the name of the faculty advisor).

Department: HBHE CB #: 7400 Position: student

Phone #: 942-5238 Fax #: 966-2921 Email Address: rossetti@email.unc.edu
** Please provide your address for paper mail if not as above **

Funding source or sponsor:
___Federal ___State __industry __foundation __UNC _X_other (specify):

Name of funding source or sponsor: No funding

Date of submission for funding: NA

Dates of proposed funding: NA

Research will be conducted: At UNC or a UNC-affiliated institution X Other site
Name/location of site: Durham , North Carolina

Are minors involved? [ ] yes [ X ] no

Does research use questionnaire(s)? [ ] yes [ X ] no

Questionnaire(s): Final version with application Draft version with application
To be submitted at later date

Project Duration. Projects subject to IRB approval must, by Federal law, be re-approved every year during which they are active, even if there is no change to the protocol. It is the responsibility of the investigator to submit an IRB Renewal Application prior to each anniversary of the approval. In order for the IRB to anticipate renewals, please indicate whether your project is expected to take more than one year from the date of IRB approval.

Project duration is expected to be: X One year or less More than one year

Signature of Principal Investigator

Signature of Advisor, if PI is a student.

Note: By signing, you are indicating that you have read and approved the attached application for IRB review, and that the student's research project has been reviewed and approved by yourself.

Central Durham Community Diagnosis IRB Application (2000)

I. Research Protocol:

1. Purpose and Rationale:

   The purpose of this Community Diagnosis is to understand the strengths and weaknesses of a community in Durham, North Carolina facing the increasing presence of homelessness and to help identify future program directions for promoting the health and well-being of Durham's residential and homeless members. Community members, including the homeless and service providers, will be interviewed. Results of our Community Diagnosis will then be summarized and made available to the public.

2. Description of Human Subjects:

   The human subjects for this study will include adult community members (i.e.: leaders, members, the homeless, and service providers) of Central Durham, NC. Only members of this community and those who provide services to these members will be asked to participate in the study. All participants will be over the age of 18. Minority status and sex are not relevant factors in selecting participants.

3. Methods of Recruitment

   Community leaders and service providers will be identified using public records or listings and will be contacted about their availability and interest in participating in this study. Other potential informants (community members and groups of community members) will be identified and contacted by community leaders, health department staff, and service providers and asked if they would be willing to participate in the project. Only after a potential informant has agreed to participate in the study will a member of the research team contact that person to request participation in an interview or a focus group. Contact will be made by Rachel Davis, Suzanne Donoghue, Clayne Felix, Hang Nguyen and Elisa Rossetti, and all potential informants will be told that they are under no obligation to participate in the study. It is anticipated that a total of approximately 50 community members and 15 service providers will be contacted for interviews or focus groups.

4. Research Protocol:

   Interview participants will be asked similar questions during key informant interviews and focus groups (please refer to attached draft discussion guides). Elisa Rossetti, Rachel Davis, Suzanne Donoghue, Clayne Felix, and Hang Nyugen will conduct the interviews. Responses will be kept confidential and interviewees will remain anonymous unless permission is given by the interviewees to use their names. General identifiers such as age, sex, race, and number of years residing in Durham, may be used when summarizing data.

5. Compensation and costs:

   Interviewees will not be compensated, nor will they be given inducements, for their participation. The only costs to participants will be the time spent in interviews. These interviews are expected to last no more than 60 minutes.

6. Risks to Subjects:

   Physical, psychological, and social risks should be negligible. Interviews will focus on the strengths and weaknesses of the Durham community, the increasing presence of homelessness in Durham, and identifying future program directions for promoting the health and well-being in the community.

7. Confidentiality of Data:

   Names and personal identifiers of all persons contacted for interviews will be kept confidential. Instead of using names, general descriptions will be provided (i.e., white, middle aged female, has resided in community for ten years) in preparing the final document. However, if a service provider grants permission for use of her or his name, researchers may choose to use these names. Audiotaping is preferred for all interviews. Permission will be secured from the interviewee prior to taping. All participants will be told of their right to stop taping at any time. All tapes will be recycled or destroyed after their use for this class is complete.

8. Benefits:

   An assessment of the strengths and weaknesses of the community in regards to the increasing presence of homelessness with recommendations for future program directions will be presented in a written document as well a community wide forum at the completion of this Community Diagnosis.

9. Procedures for Obtaining Informed Consent:

   Verbal consent will be solicited prior to each interview by reading aloud the fact sheet (please refer to attached Sample Fact Sheet for Potential Interviewees). Participants will then be asked if they have any questions. After making certain all questions have been answered, researchers will proceed to ask interview questions. As outlined above, permission for audiotaping will also be requested.

10. Public Release of Data:

    As stated previously, the results of this research will be made available in a written public document and a community forum. The purpose of this project is to fulfill course requirements for HBHE 240 and HBHE 241: Action Oriented Community Diagnosis; it is not to produce a publishable report.

ID #
(IRB use only) Version 2-16-00

School of Public Health
Institutional Review Board on Research Involving Human Subjects
APPLICATION FORM FOR NEW PROPOSALS

Date of Application: September 26, 2000

Title of Project: Community Diagnosis of East Durham, NC

Name of Principal Investigator: Lee Hartsell

Name of co-investigators: Eugenia Eng (Faculty Advisor)
(If the principal investigator is a student, give the name of the faculty advisor).

Department: Health Behavior & Health Education CB #: 7400 Position: Student

Phone #: 919-968-9989 Fax #: 919-966-2921 Email Address: fhartsel@email.unc.edu
** Please provide your address for paper mail if not as above **

Funding source or sponsor:
___Federal ___State __industry __foundation __UNC _X other (specify): no funding source

Name of funding source or sponsor: No funding source.

Date of submission for funding: N/A

Dates of proposed funding: N/A

Research will be conducted: ____At UNC or a UNC-affiliated institution X Other site

Name/location of site: Government agencies, social service agencies, homeless shelters and community kitchens, private residences, and other various community agencies

Are minors involved? [ ] yes [ X ] no

Does research use questionnaire(s)? [ ] yes [ X ] no

Questionnaire(s): Final version with application Draft version with application
To be submitted at later date

Project Duration. Projects subject to IRB approval must, by Federal law, be re-approved every year during which they are active, even if there is no change to the protocol. It is the responsibility of the investigator to submit an IRB Renewal Application prior to each anniversary of the approval. In order for the IRB to anticipate renewals, please indicate whether your project is expected to take more than one year from the date of IRB approval.

Project duration is expected to be: X One year or less More than one year

Signature of Principal Investigator

Signature of Advisor, if PI is a student.

Note: By signing, you are indicating that you have read and approved the attached application for IRB review, and that the student's research project has been reviewed and approved by yourself.

East Durham CD IRB application (2000):

1) Research Protocol
2) Focus Group Fact Sheet
3) Focus Group Fact Sheet (referral)
4) Interview Fact Sheet
5) Interview Fact Sheet (referral)
6) Informed Consent Verbal Statement
7) Community Member Interview Guide
8) Community Member Focus Group Guide
9) Service Provider Interview Guide
10) Service Provider Focus Group Guide

Research Protocol Information:

1. Purpose and rationale:

   The purpose of this research project is to understand the strengths and weaknesses of a community in Durham, NC facing the increasing presence of homelessness, and to help identify future program directions for promoting the health and well-being of the residential and the homeless members of this community. Community leaders, community members, and those who provide services to the community will be interviewed individually and in focus groups to obtain information. Results of the interviews and focus groups will then be summarized and made available to community members and service providers.

2. Description of human subjects:

   The human subjects for this study include community leaders, local service providers, and members of the East Durham community in North Carolina. Only members of this community and those who provide services to the community will be asked to participate in the study. Only individuals who are over 18 years of age who agree to participate will be interviewed. Minority status and sex are not relevant factors in selecting participants.

3. Methods of recruitment

   Community leaders and service providers identified through public records and listings, will be identified using public records or listings and will be contacted about their availability and interest in participating in this study. Other potential informants (community members and groups of community members) will be identified and contacted by community leaders, health department staff, and service providers and asked if they would be willing to participate in the project. Only after a potential informant has agreed to participate in the study will a member of the research team contact that person to request participation in an interview or a focus group. Contact will be made by Lee Hartsell, Jenny Koenig, Mary Decoster, Grace Han, and Kate Shirah; and all potential informants will be told that they are under no obligation to participate in the study. It is anticipated that a total of approximately 50 community members and 15 service providers will be contacted for key informant interviews or focus groups.

4. Research Protocol:

   Community leaders, members, and service providers will be asked similar, yet slightly different questions during key informant interviews and focus groups (please refer to attached protocols). Grace Han, Lee Hartsell, Jennifer Koenig, Kate Shirah, and Mary DeCoster will conduct the interviews and focus groups. Responses will be kept confidential and interviewees will remain anonymous; however general identifiers such as age, sex, race, and number of years residing in the East Durham community may be used when summarizing data. Data will be stored in a secure, locked file cabinet.

5. Compensation and costs:

   Interviewees will not be compensated nor given inducements for their participation. The only costs to participants will be the time spent in interviews. These interviews and focus groups are expected to last 60-90 minutes.

6. Risks to subjects:

   This research is solely based upon verbal responses of the participants. Physical, psychological, and social risks should be negligible. Interviews will focus primarily on the strengths, weaknesses, and future program directions for promoting the health and well being of residential and homeless members of the East Durham community. Results will be summarized and made available to the community leaders, members, and service providers in a written document and through a public forum.

7. Confidentiality of data:

   Names and personal identifiers of all persons contacted for interviews will be kept confidential. A description will be provided instead (i.e. white, middle aged female, has resided in community for 10 years) in preparing the document. However, if a service provider does not care to remain anonymous and grants permission for use of her or his name, researchers may choose to use these names. Regardless, all community members will remain anonymous.

   Audio taping is preferred for all interviews and focus groups. Permission will be secured from the interviewee prior to taping. All participants will be told of their right to stop tape recording at any time, and that tapes will be recycled or destroyed after their use for this class is complete
.

8. Benefits:

   A written summary of the strengths and weaknesses of, and suggested future program directions for the East Durham community will be made available to community leaders, community members, and service providers. Material produced will be used to facilitate community forums; help raise the awareness of community leaders and service providers to the needs and voices of the community members; and ultimately, allow members and the general public to benefit from an improved understanding. This would provide the basis for future guidelines to optimize quality of life and access to community and health services.

9. Procedures for obtaining informed consent:

   The verbal consent form (please refer to attached protocols) will be read aloud to each participant, who will then be asked if they have any questions. After making certain all questions have been answered, researchers will proceed to ask interview questions. Permission for audio taping will also be secured prior to taping.

10. Public release of data:

    Researchers do not plan to release collected data. The purpose of this project is to fulfill course requirements for HBHE 240 and HBHE 241: Action-Oriented Community Diagnosis.

Appendix E: List of Resources

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