Amend No. 1 041524

Pass-Through Entity (PTE) Subrecipient Subrecipient Principal Investigator (PI): Awarding Agency Project Title Amount Funded This Action Total Amount of Funds Obligated to Date Amendment(s) to Original Terms and Conditions This Amendment revises the above-referenced Subaward Agreement as follows: All other terms and conditions of this Subaward Agreement remain in full force and effect. By an Authorized Official of PTE: By an Authorized Official of Subrecipient: Name Date Title Name Title Date Subaward No For clarity: all amounts stated in this amendment are in United States Dollars. Subrecipient Cost Share Start Date: End Date: FDP Subaward Amendment Amendment No Additional Budget Period No Cost Extension Additional Funding Deobligation Carryover is Revised 2/2021 PTE/Prime Award No. Entity Name Contact Email Principal Investigator Subject to FFATA Carryover Authorized Subrecipient UEI Detailed Budget/Scope of Work/Notice of Award Attached Other (See Below) (Unique Entity Identifier -May leave blank if unchanged from prior Agreement) (Specify if the Budget and Scope of Work are "New", "Revised", or "Supplemental" in dropdown or "Other") Cumulative Budget Period(s) (Agreement Start Date) (End Date of Latest Budget Period) FSU Project # 102619 R000003157 1 R000003157 Florida State University City and County of San Francisco, Public Health Department [email protected] [email protected] Lisa Hightow-Weidman Susan Buchbinder Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Scientific Leadership Center 5UM2HD111102-02 National Institutes of Health (NIH) 01/25/2023 11/30/2024 $ 138,434.00 $ 173,063.00 n DCTNHRGU1K75 nn Additional budget period 12/01/2023 -11/30/2024 is hereby added to this Subaward. Additional funding in the amount of $ 138,434.00 is hereby obligated to this Subaward. Not Automatic Carryover across budget periods requires prior approval. If carryover is not automatic, the "Total Amount of Funds Obligated to Date" stated above may not reflect the actual balance available. The Subrecipient is responsible for tracking unobligated balances and subsequent carryover approvals from prior budget periods. In the event that funding was not fully expended by the Subrecipient during the prior period, the Subrecipient is not authorized to use funds from any prior periods, unless approval is granted by the PTE. nn A Notice of Award and Budget is incorporated by attachment to this Amendment. 1. The FSU project number for this increment is 102619. Invoices that do not reference both the subaward number and the project number may be subject to delay. 2. Attachment 2: Data Sharing Agreement is hereby replaced with the attached Data Sharing and Management Plan below. 3. In Attachment 4: Annual Technical /Progress reports due date is changed from "60 days prior" to "75 days prior". 4. Attached Year 2 Budget and Budget Justification are hereby added to Attachment 5. 5. Notice of Award 5UM2HD111102-02 is hereby added to Attachment 6. 6. Attachment 7, "Human Subjects Data Transfer and Use Terms" is hereby added to this subaward agreement. Vice President for Research Stacey Patterson DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 Approved as to form, David Chiu, City Attorney By: Director of Health 4/12/2024 | 1:34 PM Grant Colfax, MD 4/15/2024 | 9:39 AM EDT ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 1 of 8 NUMBER: PP 3 TITLE: ATN Data Sharing and Management Plan EFFECTIVE DATE: Change History Log: Effective Date Version Revisions 01 New Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 2 of 8 I. PURPOSE The purpose of this policy and procedure is to provide a data sharing and management plan (DSMP) for within the ATN and outside the network for future use. II. RESPONSIBILITY ? ATN Scientific Leadership Center (SLC) and Operations and Collaboration Center (OCC) Principal Investigators are responsible for ensuring that the policy and procedures are followed. III. ACRONYMS ? American Public Health Association (APHA) ? Adolescent Trials Network for HIV Interventions (ATN) ? Communication and Dissemination Hub (C-D Hub) ? Case report forms (CRFs) ? Conference on Retroviruses and Opportunistic Infections (CROI) ? Data sharing and management plan (DSMP) ? Electronic data capture (EDC) ? Food and Drug Administration (FDA) ? Florida State University (FSU) ? Health Insurance Portability and Accountability Act (HIPAA) ? International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) ? NICHD Data and Specimen Hub (N-DASH) ? Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ? National Institute on Drug Abuse (NIDA) ? National Institutes of Health (NIH) ? Nation Institute of Mental Health (NIMH) ? Operations and Collaborations Center (OCC) ? Protected Health Information (PHI) ? Personally Identifiable Information (PII) ? Society for Behavioral Medicine (SBM) ? Statistical and Data Management Center (SDMC) ? Single IRB (sIRB) ? Scientific Leadership Center (SLC) ? University of North Carolina (UNC) IV. BACKGROUND The Adolescent Trials Network for HIV Interventions (ATN) is a multi-component collaborative research enterprise in which all components contribute essential functions necessary to support a large-scale, complex clinical research program. Such a complex structure requires thoughtful, ethical, and legal policies for data management and sharing a) within the ATN for data management, monitoring and analyses, and b) outside of the network for future use. Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 3 of 8 V. PROCEDURE A. Data sharing within the ATN All individuals within any component of the ATN are required to adhere to this networkwide DSMP. The ATN is comprised of the following components through which participant data will flow in multi-directional ways: • Scientific Leadership Center (SLC) – led by Florida State University (FSU); • Operations and Collaborations Center (OCC) – led by Westat; • Statistical and Data Management Center (SDMC) – led by FSU, and inclusive of University of North Carolina (UNC), Emmes and other SDMC components; • Site Consortiums – 12 clinical sites in the U.S. under subaward from Westat; • Protocol Teams – researchers at various U.S. institutions including ancillary groups collaborating on study data collection and analysis, under subaward from FSU; • Central Laboratory – led by Johns Hopkins Laboratory under subcontract from FSU; and • Authorized representatives of the sponsor (NICHD, NIMH, NIDA), representatives of the single IRB (sIRB) of Record (Sterling), and regulatory agencies. Methods for Protecting Participant Data and Privacy Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Participant confidentiality and privacy is strictly held in trust by all components of the ATN. This confidentiality is extended to cover testing of biological specimens and genetic tests in addition to the clinical information relating to participants. No information concerning the study, or the data will be released to any unauthorized third party outside of the ATN without prior written approval and formal data sharing agreements. The ATN will ensure that the use and disclosure of PHI obtained during any research study complies with the HIPAA Privacy Rule. The rule provides U.S. federal protection for the privacy of PHI by implementing standards to protect and guard against the misuse of individually identifiable health information of participants participating in clinical trials. National Institutes of Health (NIH) Policy NOT-OD-17-109 – Certificate of Confidentiality Per Section 2012 of the 21st Century Cures Act as implemented in the 2017 NIH Certificates of Confidentiality Policy, all ongoing or new research funded wholly or in part by NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information is automatically deemed to be issued a CoC.. These Certificates protect the privacy of subjects by limiting the disclosure of identifiable, sensitive information (PII) outside of the network. This Certificate applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH, whether supported through grants, cooperative agreements, contracts, other transaction awards, or conducted by the NIH Intramural Research Program, which collects or uses identifiable, sensitive information. For the purposes of this Policy, consistent with subsection 301(d) of the Public Health Service Act (42 U.S.C 241), the term “identifiable, sensitive information” means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur: • Through which an individual is identified; or Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 4 of 8 • For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual. Informed Consent All study participants from ATN clinical trial Site Consortiums will be provided with informed consent forms that outline data sharing within the network and include study-specific disclosures. The Privacy Rule permits covered entities to use or disclose PHI for research purposes when a research participant authorizes the use or disclosure of information about themself provided the authorization satisfies the requirements of 45 CFR 164.508. Authorization is required from each research participant (i.e., specific permission granted by an individual for the use or disclosure of an individual’s PHI) or parent/legal guardian when applicable. A valid authorization must meet the implementation specifications under the HIPAA Privacy Rule. Authorization may be combined in the informed consent document (if approved by the sIRB). sIRB approval will be obtained for each ATN clinical trial, corresponding consent forms and HIPAA authorizations. Informed consent documents will include disclosure information for both PHI and PII. Data Systems Data will be entered into a password protected, 21 CFR Part 11-compliant web-based EDC system provided by Emmes. Each participating Site Consortium will maintain appropriate medical and research records for ATN studies in compliance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2), Section 4.9 and 21 CFR 312.62, and regulatory and institutional requirements for the protection of confidentiality of participants. Each Site Consortium will permit authorized representatives of the sponsor, its designees, and appropriate regulatory agencies to examine (and, when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety and progress. Qualitative interviews and focus groups will be digitally recorded and transcribed. All digital audio files will be transmitted to and stored on a secured server maintained by FSU. FSU authorized individuals or a third-party HIPAA-compliant transcription service company will transcribe digital audio files under the supervision of FSU. Transcripts will only be labeled with Participant ID. IRB-approved FSU team members will also review the transcripts to ensure that any personally identifying information is removed before providing the electronic transcripts to coders and analysts. The electronic transcript files will be stored on a secured server at FSU until it is transmitted to the SDMC to be stored with the rest of the study data. The digital audio files will be destroyed within the protocol-specified timeframe. A HIPAA-compliant qualitative data analysis software (e.g., Atlas.ti, Dedoose) will be used to perform all qualitative analyses. These programs employ HIPAA-compliant data encryption and allow for password-protected, project specific access. Only approved study staff will have access to these data. Study participant research data will be transmitted to and stored at the SDMC. All participantrelated study information will be identified through the Participant ID on all case report forms (CRFs), laboratory reports, clinical assessments, surveys, and questionnaires (paper and electronic). Participant ID may be linked with name, email, phone number, and address for specific studies and laboratory reports. The study data entry and study management systems used by Site Consortiums and the ATN collaborators are secured, and password protected. Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 5 of 8 As part of the Pre-Screening Survey and the Advantage eClinical Cloud (AEC) ePRO, the SDMC will collect participant name, address, email, phone number and IP address. Participants may be asked to upload photos of rapid test results within AEC ePRO. There is no guarantee that a photo with the participant's face or other identifying information will not be uploaded. This information is needed for sites to contact potential participants for screening, to send reminders for data entry, facilitate shipment of lab specimen collection kits, and allow Site Consortium staff to evaluate rapid test results for remote participants. Participant contact information will be collected but access limited to applicable Site Consortium staff within AEC. This data will be encrypted within the affiliated datasets. All PII will be kept confidential and secure with access limited to only needed project staff and site staff as applicable. PII in AEC will be controlled by user access rights, PII on the servers will either be encrypted or stored in a location with access limited to applicable programmers and statisticians. PII on the website will be controlled by user access rights and files with name, address, email and phone number will be password protected. Any PII collected may be shared with network members listed in the HIPAA data authorization components of the signed informed consent forms. Any PII will only be shared through secure, password-protected mechanisms, typically either the SDMC website or AEC. Data Records at the ATN Site Consortiums including Other Participating Sites Study documents will be kept locked in a limited access area. At each Site Consortium, a list of Participant IDs that links the numbers to the participant names will be kept under double locks separate from all study documents or secure electronic system, accessible only to Site Consortium study staff and representatives from (NICHD, site monitors on behalf of NICHD, and regulatory authorities (e.g., local IRB, Sterling IRB, U.S. Food and Drug Administration (FDA)). Screening Logs will also be stored in the same manner and accessible only to those personnel noted above. Original source documents for individual participants will be maintained at the respective Site Consortium and will be accessible only to ATN study staff. The participant’s contact information will be securely stored at each Site Consortium for use during the ATN project period. At the end of the project period, all records will continue to be kept in a secure location for as long a period as dictated by the sIRB, the local IRB, Institutional policies, and/or Sponsor requirements. Both the Site Consortium Project Lead and the Institution at which the studies are conducted will hold the responsibility to maintain custody of all study records until the Sponsor permits their destruction. Personal Data Protection by ATN components Per this ATN DSMP, all grantees within any of the ATN components are responsible for ensuring their compliance with any applicable data protection laws related to its services. To the extent that any grantee staff member shares any personal data, as defined by applicable data protection laws, on behalf of the ATN, grantees shall: 1. Act only on instructions from the ATN when sharing personal data and keep records of all activities; 2. Take all appropriate technical and organizational measures to protect against unauthorized or unlawful sharing of, or accidental loss, destruction, or damage to, personal data; Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6 ATN Policy and Procedure File Name: ATN Data Management and Sharing Plan Document Version: 1.0 Page 6 of 8 3. Share personal data in accordance with applicable data protection laws; 4. Not do or permit anything to be done which might cause the ATN or any of its affiliates to be in violation of applicable data protection laws; 5. Immediately inform the ATN SLC and OCC Principal Investigators if they believe performance of the services or compliance with any ATN instruction violates or might reasonably be considered to violate any applicable data protection laws; 6. Notify the ATN SLC and OCC Principal Investigators promptly and without undue delay upon becoming aware of any unauthorized loss, corruption, damage, destruction, alteration, disclosure, or access to, or unauthorized or unlawful processing of, any personal data (“Personal Data Breach”), or any circumstances that are likely to give rise to a Personal Data Breach, providing the ATN with sufficient information for it to meet its obligation, if any, to report a Personal Data Breach under applicable data protection laws; and 7. Cooperate with the ATN and take reasonable steps as may be directed by the ATN to assist in the investigation, mitigation, and remediation of any Personal Data Breach. B. Future Sharing of De-Identified Data Public dissemination of ATN scientific results can facilitate the creation of collaborative efforts with domestic and international collaborators resulting in novel ideas that could benefit the research and medical community, medical education providers and accreditors, and the public at large. Therefore, research data will be shared openly, proactively, and timely in accordance with the most recent NIH guidelines while being mindful that the confidentiality and privacy of participants in research must always be protected. NICHD requires that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. The NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. The ATN will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule (NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information | grants.nih.gov). As such, applicable studies will be registered at ClinicalTrials.gov, and results will be submitted to ClinicalTrials.gov. After the ATN study’s analyses are completed, information including study data will be submitted to the NICHD Data and Specimen Hub or DASH (https://dash.nichd.nih.gov). With NICHD approval, the data submitted to DASH may be used by other researchers for additional, unrelated research. NICHD will review any request prior to release of the data to ensure that all appropriate approvals have been obtained. The study data submitted to DASH will be deidentified, meaning it will not include any direct or indirect identifiers linking the data to the participant’s identity so there is no potential for deductive disclosure. With SLC approval, the Protocol Teams may also share the de-identified study data with other researchers. When the participant’s de-identified study data are provided to other researchers for the purposes of future Attachment 2: Data Sharing and Management Plan FSU Project # 102619 R000003157 DocuSign Envelope ID: 245909DC-478C-4608-9C27-0377811F25B6