Att 6a_Florida State University IRB Letter of Approval

FLORIDA STATE UNIVERSITY
OFFICE of the VICE PRESIDENT for RESEARCH

APPROVAL
January 9, 2023
Lisa Hightow-Weidman
850-644-5260
lbh22c@fsu.edu
Dear Lisa Hightow-Weidman:
On 12/15/2022, the IRB reviewed the following submission:
Type of
Review:
Title:
Investigator:
Submission
ID:
Study ID:
Funding:
IND, IDE,
or HDE:
Documents
Reviewed:

Full Committee
Expanding PrEP in Communities of Color (EPICC+)
Lisa Hightow-Weidman
STUDY00003652
STUDY00003652
None
None
• EPICC+ClinicAssessment_Baseline-Final_11.01.2022.pdf,
Category: Other;
• EPICC+ClinicAssessment_Every6Months_11.01.2022.pdf,
Category: Other;
• EPICC+Cohort_BaselineMRA_CRF_11.01.2022.pdf, Category:
Other;
• EPICC+Cohort_BaselineSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Cohort_BaselineSurvey_Spanish_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Cohort_BloodCollectionInstructions_11.01.2022.pdf,
Category: Other;
•
EPICC+Cohort_BloodCollectionInstructions_Spanish_11.01.2022.pdf,
Category: Other;
• EPICC+Cohort_Consent_11.01.2022.pdf, Category: Consent Form;
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• EPICC+Cohort_Consent_Spanish_11.01.2022.pdf, Category:
Consent Form;
• EPICC+Cohort_ContactInfoSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Cohort_ContactInfoSurvey_Spanish_11.01.2022.pdf,
Category: Survey/Questionnaire;
• EPICC+Cohort_ExitInterview_Guide_11.01.2022.pdf, Category:
Other;
• EPICC+Cohort_ExitInterview_Guide_Spanish_11.01.2022.pdf,
Category: Other;
• EPICC+Cohort_FollowUpMRA_CRF_11.01.2022.pdf, Category:
Other;
• EPICC+Cohort_FollowUpSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Cohort_FollowUpSurvey_Spanish_11.01.2022.pdf,
Category: Survey/Questionnaire;
• EPICC+Cohort_HIPAAForm_SAMPLE_11.01.2022.pdf, Category:
Other;
• EPICC+Cohort_HIPAAForm_Spanish_SAMPLE_11.01.2022.pdf,
Category: Other;
• EPICC+Cohort_RecruitmentPlan_11.01.2022.pdf, Category:
Recruitment Materials;
• EPICC+Cohort_RecruitmentPlan_Spanish_11.01.2022.pdf,
Category: Recruitment Materials;
• EPICC+Cohort_Screener_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Cohort_Screener_Spanish_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+FocusGroup_Consent_11.01.2022.pdf, Category: Consent
Form;
• EPICC+FocusGroup_Guide_11.01.2022.pdf, Category: Other;
• EPICC+FocusGroup_PreSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+FocusGroup_RecruitmentPlan_11.01.2022.pdf, Category:
Recruitment Materials;
• EPICC+Training&Cohort_Protocol_11.01.2022.pdf, Category: IRB
Protocol;
• EPICC+Training_Consent_11.01.2022.pdf, Category: Consent Form;
• EPICC+Training_PostSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Training_PreSurvey_11.01.2022.pdf, Category:
Survey/Questionnaire;
• EPICC+Training_RecruitmentPlan_11.01.2022.pdf, Category:
Recruitment Materials;
• FSU IRB_Verification_of_Translation_Signed[1].pdf, Category:
Other;

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The IRB approved the protocol, effective from 12/14/2022 to 12/13/2023 inclusive.
Before 12/13/2023 or within 30 days of study close, whichever is earlier, you are to
submit a completed continuing review and required attachments to request continuing
approval or closure.
If continuing review approval is not granted before the expiration date of 12/13/2023,
approval of this protocol expires on that date.
COVID-19 Information for Research Involving Human Subjects: Note that the U.S. is
operating under the national emergency Proclamation 9994 concerning the COVID-19
pandemic and that this national emergency remains in effect until rescinded or terminated
by the President of the U.S. (go here for the Proclamation letter). Conditions are dynamic
and related policies or guidance evolve accordingly; as applicable, refer to the U.S.
Centers for Disease Control and Prevention website specific for universities or refer to
our COVID-19 and Human Research Studies web page to learn more about how you
should or may protect persons (whether vaccinated or unvaccinated) involved in any of
your in-person research activities.
Other Information:
This study meets the definition of a clinical trial as it involves the assignment of one or
more human subjects to one or more interventions (procedure, device, or drug, including
use of placebo or control) to evaluate the effects of the interventions on biomedical or
behavioral health outcomes. Please note that the approved IRB consent form must be
posted to a publicly available Federal web site by an awardee of federal department or
agency funding and for any study that is an applicable clinical trial under FDA
regulations. The consent must be posted after the research has been closed to recruitment
and no later than 60 days after the last study visit of any subject. Visit this FSU Office for
Clinical Research Advancement (OCRA) page and related procedure for additional and
OCRA contact information as well as specific instructions.
You are advised that any change or revision to the protocol for this project must, through
a study modification, be reviewed and approved by the IRB prior to implementation of
the proposed modification(s).
Federal regulations require that the Principal Investigator promptly report, through a
Report of New Information, any incident involving, for example, the following: a new or
increased risk or safety issue; harm experienced by a study participant; non-compliance
with federal regulations or the determinations of the IRB; audits, monitoring reports or
inspections by study sponsors, monitors or federal agencies; breach of confidentiality;
complaint of a study participant; etc.) (see the Investigator Manual (HRP-103), which can
be found in RAMP IRB, under the IRB, Library and General tabs).
You are required to submit a Continuing Review at least 60 days before the protocol
expiration date of 12/13/2023 to request continuing approval or closure. If the continuing

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review approval is not granted before the expiration date, approval of this protocol
expires on that date.
In conducting this protocol, you are required to follow the requirements listed in the
Investigator Manual (HRP-103).
FSU IRB standard operating procedures (HRP-090) require that investigators use only
the most current IRB-approved (i.e., “stamped”) version of consent, assent and parental
permission forms as well as other materials given to research participants or used for
study purposes, and that are applicable to the specific study and study activity. IRBapproved materials for this study are located in the study’s RAMP IRB workspace; to
find your IRB-approved materials, first navigate through the IRB and Submissions in the
top row, then under Submissions, navigate to the table below and click the Active tab and
search for this study by study ID or study Name. Second, select this study by clicking on
the study Name. Once in this study’s workspace, navigate to the Resource tabs located
under the workflow diagram and click the “Documents” tab; there, in the Study or Site
Related Documents section, locate the IRB-approved materials by category (e.g., Consent
Form, IRB Protocol, Recruitment Materials), and for study activities use only the most
current IRB-approved version listed in the “Final” column.
Note that in accordance with applicable federal law and FSU policy, all approved or
cleared studies are subject to post-IRB approval monitoring throughout a study’s life
cycle. Studies are subject to random as well as other assessments (audits) to ensure ongoing protection of study participants and adherence to applicable law, ethics, policy and
the IRB-approved/cleared study protocol. For additional information about this
monitoring, refer to the FSU IRB’s HRP-059 Standard Operating Procedure (SOP) – Post
Approval Compliance Monitoring, available in RAMP IRB, under the IRB, Library and
Standard Operating Procedures tabs.
Sincerely,
Office for Human Subjects Protection (OHSP)
Florida State University Office of Research
2010 Levy Avenue, Building B Suite 276
Tallahassee, FL 32306-2742
Phone: 850-644-7900
Email: humansubjects@fsu.edu
OHSP Web: https://ohsp.fsu.edu

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