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MEMORANDUM OF UNDERSTANDING MEMORANDUM OF UNDERSTANDING FOR THE SHARING OF PUBLIC HEALTH DATA BETWEEN MARICOPA COUNTY BY AND THROUGH ITS DEPARTMENT OF PUBLIC HEALTH AND THE ARIZONA BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA WHEREAS, Maricopa County Department of Public Health (“MCDPH”) is a division of Maricopa County government established to promote and protect public health and welfare through the operation of health-related programs within the county. WHEREAS, The Arizona Board of Regents on behalf of The University of Arizona (“University”) is a land-grant state- controlled institution of higher education. WHEREAS, MCDPH is a public health authority pursuant to the requirements of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) and applicable law. WHEREAS, MCDPH and University recognize the need to set forth and define the terms under which MCDPH will provide data files to University containing public health records for the provision of services pursuant to this agreement. NOW, THEREFORE, in consideration of the mutual promises and representations set forth in this Memorandum of Understanding (MOU), MCDPH and University mutually agree as follows: 1. DEFINITIONS. Capitalized terms used herein shall have the meanings set forth in this Section 1. 1.1. "Authorized Persons" means University employees or contractors who have a need to know or otherwise access Personally Identifying Information to enable MCDPH to perform its mission in conformance with the requirements of this MOU and who are bound in writing by confidentiality obligations sufficient to protect Personally Identifying Information in accordance with the terms and conditions of this MOU and applicable law. 1.2. “Public Health Data” means health information organized and maintained by MCDPH and received by MCDPH under applicable law, including, but not limited to, names, dates of birth and death, gender, race, ethnicity, discharge status, disease codes, procedures performed, and other information reported to MCDPH under applicable law. The elements of data shared and specific restrictions of their use under this MOU are fully described in sections 2.2 (Scope) and 19 (Data Use and Ownership). 1.3. "PHI" means protected health information as defined in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), at 45 C.F.R. §160.103 (and not a Limited Data Set). M C D P H ’s business contact information is not by itself deemed to be PHI. 1.4. “Public Health Practice” means interventions designed solely to enhance the well-being of the specific subject population identified in this MOU, and which have reasonable expectation of success. 1.5. “Research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this MOU, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 1.6. "Security Breach" means: any act or omission that materially compromises either the security, confidentiality or integrity of Personally Identifying Information or the physical, technical, administrative or organizational safeguards put in place by University or any Authorized Persons that relate to the protection of the security, confidentiality or integrity of Personal Information, 1.7. “REDCap” means a secure, web-based application designed to support data capture for research studies. The system was developed by a multi-institutional consortium initiated at Vanderbilt University. REDCap is designed to comply with HIPAA regulations. Page 1 of 9 MEMORANDUM OF UNDERSTANDING 2. PURPOSE AND SCOPE OF AGREEMENT 2.1. Purpose The Safe, Healthy Infants & Families Thrive (SHIFT) Collaborative was created in July 2018 to develop plans for improved care in Maricopa County for babies and families affected by substance use and prenatal exposure to drugs and alcohol. The SHIFT Collaborative is comprised of members from the Superior Court in Maricopa County Juvenile Department Family Treatment Court, Department of Child Safety, substance use disorder treatment providers, Medication Assisted Treatment (MAT) providers, maternal and infant health care providers, and Maricopa County Department of Public Health. Through the SHIFT Collaborative’s work, the Prenatal Coordinated Care Pilot project was formed. Currently intervention for pregnant women with substance use disorder happens at the birth event when a positive screen initiates an investigation by the Department of Child Safety to determine if the child is safe to go home with the parent in a very short period of time. The Prenatal Coordinated Care Pilot facilitates intervention to begin during pregnancy increasing the likelihood of the woman having a healthy pregnancy and a healthy infant by receiving treatment and support services before the birth event. The Prenatal Coordinated Care Pilot seeks to increase cross-systems collaboration in the care of parents with substance use disorder as early as possible in the pregnancy. The premise of the pilot is to improve coordination of care between providers and systems already serving these families. The evaluation of the project hopes to show that using collaborative strategies has an overall positive impact on health and wellbeing outcomes for both the parents and the infant and families. MCDPH agrees to submit data to University via REDCap as outlined in section 2.2.1 of this MOU for purposes of program evaluation. The University shall use the data supplied by MCDPH solely for the SHIFT (Safe, Health Infants & Families Thrive) Statewide Project as well as Institutional Review Board (IRB) approved projects to promote prenatal care under the SHIFT program (the “Project”). It is understood that the University will be collecting, compiling, and analyzing data from a number of different sources as part of the Project. 2.2. Scope MCDPH will submit data to the University, via REDCap , collected from women enrolled in MCDPH Home Visiting programs who have revealed the use of substance use during pregnancy, and who voluntarily consent to participate in the Prenatal Coordinated Care Pilot. Data elements that MCDPH will provide in the data sets may include any data element permitted by this MOU. 2.2.1. Selection Criteria MCDPH will submit data to the University, via REDCap , collected from women enrolled in MCDPH Home Visiting programs who have revealed the use of substance use during pregnancy, and who voluntarily consent to participate in the Prenatal Coordinated Care Pilot. Data elements that MCDPH will provide in the data sets may include any data element permitted by this MOU. 2.2.2. Data Requests MCDPH will submit data to University on a mutually agreed upon schedule (Exhibit A). 2.2.3. Data Elements The following data will be provided by MCDPH to University of Arizona College of Medicine under this MOU: A. The Prenatal Coordinated Care Plan will collect the following data elements 1. Name (To check for duplicate participants) Page 2 of 9 MEMORANDUM OF UNDERSTANDING 2. Age 3. Race & Ethnicity 4. Date entering pilot 5. Insurance type 6. Current housing status 7. Date referred to prenatal care 8. Date prenatal care started 9. Estimated date of delivery 10. Prenatal Care visit dates 11. Prenatal complications 12. Date engaged in home visiting 13. Substances Used prenatally 14. Date referred to Substance use treatment 15. Date started substance use treatment 16. Substance Use treatment level of care 17. Substance Use treatment start date 18. Substance Use treatment end date 19. Date referred to Medication Assisted Treatment 20. Date started Medication Assisted Treatment 21. Infant Birth Date 22. Infant length of hospital stay 23. Infant placement at discharge 24. Department of Child Safety Involvement 25. Post-partum visit date i. Data Transfer Methods The method of data transfer will be MCDPH submitting data to University, via REDCap 3. TERM OF THE AGREEMENT The Term of this MOU shall commence upon signature of both parties (“Effective Date”) and shall continue for a period of five (5) years thereafter, unless terminated, or canceled as otherwise provided herein. 4. CONTRACT EXTENSION This MOU shall not exceed a total of five (5) years from the Effective Date of the MOU. 5. TERMINATION 5.1. This MOU remains in effect as provided in Sections 3 and 4 or until the MOU is otherwise terminated under the following terms and conditions: 5.1.1. Termination without Cause Both University and Count y may terminate this MOU at any time with thirty (30) calendar days’ notice, in writing, specifying the termination date. Such notices shall be given by personal delivery or by certified mail, return receipt requested. 5.1.2. Termination for Default The County reserves the right to terminate the MOU in whole or in part due to the failure of University to comply with any material obligation, term or condition of this MOU. C o u n t y agrees to provide University with written notice detailing the area of alleged lack of compliance or non-performance and to provide with thirty (30) days to correct the alleged lack of compliance or non-performance prior to termination for default. 5.1.3. Cancellation for Conflict of Interest Page 3 of 9 MEMORANDUM OF UNDERSTANDING Pursuant to A.R.S. § 38-511, M C D P H o r U n i v e r s i t y may cancel this MOU within three (3) years after MOU execution without penalty or further obligation if any person significantly involved in initiating, negotiating, securing, drafting or creating the MOU on behalf of County is, or becomes at any time while the MOU or an extension of the MOU are in effect, an employee of or a consultant to any other party to this MOU with respect to the subject matter of the MOU. The cancellation shall be effective upon receipt of the written notice of cancellation, unless the notice specifies a later time. 6. SECURITY OF CONFIDENTIAL INFORMATION 6.1. University shall monitor the use of all PHI disclosed by MCDPH under this MOU, including but not limited to PHI, and to carefully restrict the use and disclosure of such information as provided for herein. 6.2. Survival of Duty to Protect Confidential Information It is understood and agreed by the Parties that the obligations set forth in this Section 6, shall survive the expiration or termination of this MOU, except as expressly provided for herein. 6.3. Minimum Safeguards for Personally Identifying Information University shall carefully restrict use and access of MCDPH PHI solely to Authorized Persons and shall ensure that University implements the following minimum safeguards to prevent a Security Breach in a manner consistent with the requirements of this MOU or applicable law. University safeguards shall, at the minimum, require that University and its Authorized Persons: 6.3.1. Prohibit PHI supplied under the terms of this MOU from being released or disclosed to anyone not working on the Project as an Authorized Person. 6.3.2. Ensure that any Authorized Persons, including any agent, or subcontractor to University, to whom University provides PHI under this MOU, agrees to the same restrictions and conditions that apply through this MOU to University with respect to such information. 6.3.3. Secure all printouts containing individual identifiers or confidential data in a locked vault, file cabinet or other method reasonably necessary to protect the confidential information. 6.3.4. Store all PHI shared pursuant to this MOU only on secured servers or encrypted devices within University, which, at the termination of this MOU, shall be securely deleted upon the conclusion of this MOU consistent with the requirements of this MOU and applicable law. 6.3.5. Provide MCDPH with a description of the security measures that are in place to maintain the confidentiality of the data being received under this MOU. 6.3.6. Provide or continue to provide MCDPH with a copy of the University procedure for the notification of MCDPH of any Security Breach, or alleged Security Breach, which shall include a requirement that any user of the PHI shared under this MOU shall immediately notify a designated individual at University of any known or reasonably suspected Security Breach. 6.3.7. Maintain a log of all encrypted devices and identification numbers of those devices that transmit, receive or store the PHI shared under this MOU, until the data is destroyed. The MCDPH may request a copy of the log at any time during the term of the MOU or until the data is destroyed. 6.3.8. Make clear to all Authorized Persons that The Arizona Board of Regents, on behalf of The University of Arizona, is prohibited from storing PHI on non-encrypted flash drives, CDs, external drives, smart phones or other non- networked hard drives. Page 4 of 9 MEMORANDUM OF UNDERSTANDING 6.3.9. Provide MCDPH, upon request, proof of the complete destruction of the original data and any copies or subsidiary data sets containing PHI that are developed from the original data upon the conclusion of this MOU or at such time that such destruction is required by applicable law. 6.3.10. Take all reasonable steps to ensure that Authorized Persons who have access to the PHI shared under this MOU shall maintain the same in strict confidence after the termination of this MOU. 6.3.11. Notwithstanding the foregoing, University obligations set forth above shall not apply to information that: 6.3.11.1. Was already known to, or in the possession of, the receiving party prior to the time of first disclosure, as demonstrated by contemporaneous, written documentation; or 6.3.11.2. Is received without any obligation of confidentiality from a third party having a legal right to disclose the same; or 6.3.11.3. Is independently developed by the receiving party by individuals without access to such information, as demonstrated by contemporaneous, written documentation; or 6.3.11.4. Is, or subsequently becomes, available to the public through no act or omission of the University; or 6.3.11.5. Is required to be disclosed pursuant to a legally enforceable order, subpoena, or other regulation (ORDER), provided, however, that such disclosure s h a l l b e only that information necessary to comply with said ORDER. 6.4. Security Breach University shall promptly notify MCDPH of any Security Breach in writing promptly, and not to exceed twenty-four (24) hours in the event of a Security Breach, following University’s initial awareness of such Security Breach. Notwithstanding any notice provisions in the Agreement, such notice shall be made to MCDPH, Office of Family Health Program Manager, or his/her designee. University shall cooperate in good faith with MCDPH in the investigation of any Security Breach. 7. NON-FINANCIAL This is a non-financial agreement. Neither party shall compensate the other party in any manner. 8. NON-DISCRIMINATION Both parties shall comply with Arizona Executive Order 2009-9, which mandates that all persons, regardless of race, color, religion, sex, age, national origin or political affiliation, shall have equal access to employment opportunities, and all other applicable state and Federal employment laws, rules, and regulations, including the Americans with Disabilities Act. Both parties shall take affirmative action to ensure that applicants for employment and employees are not discriminated against due to race, creed, color, religion, sex, national origin or disability. The parties agree to be bound by all applicable state and federal laws governing equal employment, immigration, and non-discrimination. 9. RECORDS AND RIGHT OF INSPECTION Under A.R.S. § 35-214 and § 35-215, University shall retain all data and other records (“records”) relating to the MOU for a period of five (5) years after the completion of the MOU. All records shall be subject to inspection and audit by MCDHS at reasonable times. University shall provide MCDPH the right of access to University and those servers or drives used for the storage of Personally Identifying Information, at all reasonable times, in order to monitor and evaluate performance, compliance, and/or Page 5 of 9 MEMORANDUM OF UNDERSTANDING quality assurance under this MOU. The parties acknowledge that when fully executed, this Agreement itself cannot be confidential information per the Arizona Public Records Law, Arizona Revised Statutes 39-121 and 41-151.18 (the "Records Statutes"). The University’s confidentiality obligations under this MOU shall be subject in all respects to compliance with Records Statutes. The parties agree to be bound by all applicable state and federal laws governing HIPAA, Public Health Data & PHI. 10. ARBITRATION The parties to this MOU agree to resolve all disputes arising out of or relating to this MOU, after exhausting applicable administrative review, through arbitration to the extent required by A.R.S. §12-1518. 11. AMENDMENT OR MODIFICATIONS No amendment or modifications to this MOU, including any amendment or modification of this Section, shall be effective unless the same is in writing signed by the Parties. 12. ARIZONA LAW The law of Arizona shall apply to this MOU. 13. RELATIONSHIP OF PARTIES Neither party to this MOU shall be deemed to be the employee or agent of the other party to the MOU. 14. SEVERABILITY The Provisions of this MOU are severable. Any term or condition deemed illegal or invalid shall not affect any other term or condition of the MOU. 15. NO PAROLE EVIDENCE This MOU is intended by the parties to be a final and complete expression of their agreement. No course of prior dealings between the parties and no usage of the trade shall supplement or explain any terms used in this document. 16. NO WAIVER Either party’s failure to insist on strict performance of any term or condition of the MOU shall not be deemed a waiver of that term or condition even if the party accepting or acquiescing in the nonconforming performance knows of the nature of the performance and fails to object to it. 17. HEADINGS Headings are for organizational purposes only and shall not be interpreted as having legal significance or meaning. 18. ADVERTISING AND PROMOTION OF CONTRACT Neither University nor MCDPH may use the name, trademark, logo, symbol, or other image or trade name of the other Party or its employees and agents in any advertisement, promotion, or other form of publicity or news release or that in any way implies endorsement without the prior written consent of an authorized representative of the other Party whose name is being used. Any action for commercial benefit is forbidden without prior approval of other party. 19. DATA USE AND OWNERSHIP 19.1. University will use the PHI shared under this MOU exclusively for the Project. 19.2. University activities using the MCDPH data that generate external papers or publications for Page 6 of 9 MEMORANDUM OF UNDERSTANDING dissemination outside of the University must submit such publications to MCDPH at least forty-five (45) calendar days before desired release. University shall allow forty-five (45) calendar days for MCDPH to review each publication for the disclosure of PHI. If MCDPH identifies any PHI in the proposed publication it shall notify University and University shall remove all PHI prior to submitting the paper, or other materials, for publication. 19.3. MCDPH shall be cited as one of the sources of the data in all tables, reports, presentations, and scientific papers, and University or its corresponding authors shall be cited as the source of interpretations, calculations, and/or manipulations of the data. 19.4. MCDPH retains exclusive ownership of the PHI shared with University under this MOU. Any release, or modified re-release of PHI shared under this MOU requires prior MCDPH approval, except for disclosures required by law or court order and obtaining prior approval would be impractical 20. NOTICES, CORRESPONDENCE AND REPORTS 20.1. Notices from MCDPH to University shall be sent to: University of Arizona Research Administration 1670 E. Drachman, 9th Floor P.O. Box 200216 Tucson, AZ 85721 Attn. Lauren Zajac, Assistant VP Phone (520) 626-6000 Email: uahscontracts@email.arizona.edu Copies of Notices, Reports and Correspondence from MCDPH to The Arizona Board of Regents on behalf of The University of Arizona shall be sent to: Maria Manriquez, MD, FACOG Director, Pipeline Admissions Programs & UME Pain and Addiction Curriculum Professor, Department of Obstetrics and Gynecology University of Arizona, College of Medicine – Phoenix 435 N. 5th Street Phoenix, AZ 85004 Phone 602-827-2390 20.2. Notices, correspondence, and reports from University to MCDPH shall be sent to: Maricopa County Department Public Health Attn: Grants/Contracts Administration 4041 North Central, Suite 1400 Phoenix, AZ 85012 Phone: 602-372-0674 Page 7 of 9 MEMORANDUM OF UNDERSTANDING 21. SIGNATURES/APPROVALS: FOR:Maricopa County, by and through its FOR: University Department of Public Health: __________________________ Elisha Johnson, JD Assistant Director/Research Administration _____________________________ ___________________________ Date Date APPROVED AS TO FORM: ___________________________________________ Attorney for County DATE ATTEST: ___________________________________________ Office of the Clerk of the Board DATE Page 8 of 9 MEMORANDUM OF UNDERSTANDING Exhibit A Data Schedule MCDPH shall upload data to REDCap on a Quarterly Schedule for use by the University. MCDPH shall upload the first data sets within 2 weeks of the Effective Date of this MOU and shall supplement those data sets every three (3) months thereafter. Additionally, MCDPH shall upload any data requested by University within two (2) weeks of s data request. Page 9 of 9 1618 E. Helen St. P.O.Box 245137 Human Subjects Tucson, AZ 85724-5137 Protection Program Tel: (520) 626-6721 http://rgw.arizona.edu/compliance/home Current Date: November 10, 2020 Principal Investigator: Maria Manriquez-Sanchez Protocol Number: 2010109636 Protocol Title: Prenatal Coordinated Care Pilot - A Project of the Safe, Healthy Infants & Families Thrive (SHIFT) Collaborative Level of Review: Full Determination: Approved Expiration Date: November 09, 2021 Documents Reviewed Concurrently: Data Collection Tools: Prenatal Family Care Plan Fillable PDF rev 01.14.20.pdf HSPP Forms/Correspondence: PCCP-SHIFT_appendix_vul_pop_v2019-07_11.04.2020.pdf HSPP Forms/Correspondence: PCCP-SHIFT_Research Personnel_11.09.2020.pdf HSPP Forms/Correspondence: PCCP-SHIFT_UA IRB application_11.04.2020_v8.pdf Informed Consent/PHI Forms: DRAFT_PCCP-SHIFT_Father Medical_Consent_Form_11-5-2020_Banner Health.doc Informed Consent/PHI Forms: DRAFT_PCCP-SHIFT_Father Medical_Consent_Form_11-5-2020_Banner Health.pdf Informed Consent/PHI Forms: DRAFT_PCCP-SHIFT_medical_consent_form_11-5-2020_Banner Health.doc Informed Consent/PHI Forms: DRAFT_PCCP-SHIFT_medical_consent_form_11-5-2020_Banner Health.pdf Other: _EXT_Re_ Inquiry for IRB 2010109636 Manriquez New Project (2).msg Other: RE_ _EXT_Re_ Inquiry for IRB 2010109636 Manriquez New Project.msg Other Approvals and Authorizations: COI Certification Complete for 2010109636.msg Other Approvals and Authorizations: PCCP-SHIFT_RIA_Feasibility Approval.pdf Regulatory Determinations/Comments: • Criteria for Approval has been met (45 CFR 46.111): The criteria for approval listed in 45 CFR 46.111 have been met (or if previously met, have not changed) in that (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 46.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by 46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. • Vulnerable Population - Pregnant Women (45 CFR 46.204): As documented in the file, research that where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses; the risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means; any risk is the least possible for achieving the objectives of the research; if the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part; if the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest; each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; for children as defined in 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of 45 CFR 46.; no inducements, monetary or otherwise, will be offered to terminate a pregnancy; individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; individuals engaged in the research will have no part in determining the viability of a neonate. • Vulnerable Population - Children (45 CFR 46.404 and 21 CFR 50.51): As documented in the file, research involving not greater than minimal risk and adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth is 45 CFR 46.408 and 21 CFR 50.55 . • Waiver of Parental Permission for pregnant minors (45 CFR 46.116(d) and 21 CFR 50.55(d)): As documented in the file, the research involves no more than minimal risk to subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation. • Waiver of Assent for newborns (45 CFR 46.408(a) and 21 CFR 50.55(c)(1)): As documented in the file, the IRB has taken into account the ages, maturity, and psychological state of the children involved and determined that the capability of some or all of the children is so limited that they cannot reasonably be consulted; therefore, the assent of the children is not a necessary condition for proceeding with the research. Note that if assent is not obtained from a child, the reason why it was not obtained must be noted on the appropriate Minor's Assent Form. • Vulnerable Population - Neonates (45 CFR 46.205(d)): Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part. • Expedited Continuing Review (45 CFR 46.110 Category 9): Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through eight (8) do not apply but the IRB Committee has determined and documented at the convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. This project has been reviewed and approved by the convened IRB. • No changes to a project may be made prior to IRB approval except to eliminate apparent immediate hazard to subjects. • The University of Arizona maintains a Federalwide Assurance with the Office for Human Research Protections (FWA #00004218). • All research procedures should be conducted according to the approved protocol and the policies and guidance of the IRB. • The current consent with the IRB approval stamp must be used to consent subjects. • The Principal Investigator should notify the IRB immediately of any proposed changes that affect the protocol and report any unanticipated problems involving risks to participants or others. Please refer to Guidance's Investigators Responsibility after IRB Approval and Reporting Local Information. • For projects that wish to continue after the expiration date listed above please submit the Renewal/ Closure of Human Research form, forty-five (45) days before the expiration date to ensure timely review of the project. Application for Human Research Title (If funded, provide exact title of funded project) Prenatal Coordinated Care Pilot – A Project of the Safe, Healthy Infants & Families Thrive (SHIFT) Collaborative Contact information Principal Investigator Name Maria Manriquez, M.D., FACOG Net ID mmanriqu UA Email Address mmanriqu@arizona.edu College/Division College of Medicine Phoenix Department/ Unit Obstetric & Gynecology Status Undergraduate Student Graduate Student Resident/Fellow Faculty Staff Alternate Contact (These individuals will also receive copies of all correspondence): Add Line Name UA Net ID Research Role Institution Email Address Delete Line Kristyn Piñeda, MHI kpineda0621 Alt Contact UA kpineda0621@arizona.edu * List all additional Research Personnel on the Research Personnel Form and attach with your submission General Information What is the expected length of this project? Shall not exceed a total of Five Years from IRB approval date Is this an Investigator-initiated study? Yes No If the research is conducted at one of the Banner University Medical Center sites: Has the Payer Coverage Analysis (PCA) been completed by the University of Arizona Health Sciences Administration? If you are unsure, please contact crc@email.arizona.edu. Are we participating in a multi-site study? Yes No Will the University of Arizona be the coordinating center for a multi-site study? Yes No *Complete and submit Appendix for Multi-Site study. Will the University of Arizona be the IRB of Record for multiple sites? Yes No *Complete and submit Appendix for Multi-Site study and Multi-Site Personnel Form. Is the research utilizing a Single IRB for review that is not the UA IRB? Yes No Is this project strictly a review of data or specimens? No recruitment, interaction, or consent? Yes No Does this project involve investigating a Drug, Device (including in-vitro diagnostics, software or new novel technology used for one or more medical purposes) or Biologic? Yes No Does this project involve medical procedures which the PI is not licensed to conduct? Yes No Is this project a Clinical Trial? Yes No *A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funding Information Will the project be supported by any funding? Yes No Federal funding (e.g., NIH, NSF, DoE, DoD) Application for Human Research v Dec 2019 Page 1 of 11 Application for Human Research Foundation Funding Children's Bureau (Federal) awarded the Children and Family Futures (Foundation) a grant to become the national center, the National Quality Improvement Center for Collaborative Community Court Teams (QIC-CCCT), funding was then awarded to the Superior Court of Arizona in Maricopa County, Juvenile Department – Family Treatment Court, who then awarded the University of Arizona College of Medicine Phoenix funding. Departmental Funds Gift Funds Industry Funded Location of Research Banner - University Medical Center Phoenix Campus Biological specimens Clinical Data *Make sure that all individuals accessing PHI have taken the HIPAA 101 training course. Tucson Campus South Campus *Submit a copy of the UAHS Research feasibility review approval. University of Arizona Cancer Center University of Arizona Campus Data Warehouse CATS Outside the US Online Other *If research activities will take place at a private location, site authorization is required before approval can be granted. List all participating entities: 1. Maricopa County Department Public Health 2. Superior Court of Arizona in Maricopa County, Juvenile Department – Family Treatment Court 3. Hushabye Nursery – Recovery Center for Neonatal Abstinence Syndrome 4. Community Medical Services – Opiate Treatment Program for Opiate Use Disorder. 5. Banner Health (Dr. Maria Manriquez, Dr. Luke Peterson) – ObGyn and FM who provide prenatal care for patients with substance use disorder These sites will be added via an amendment once the institutional agreements and personnel lists are finalized. Application for Human Research v Dec 2019 Page 2 of 11 Application for Human Research Financial Conflict of Interest Disclosure Each Investigator must complete the University's Conflict of Interest (“COI”) requirements. Once this protocol has been entered into the IRB system, each key investigator will receive an email to complete their COI training and disclosure. Investigator is defined in the University's Individual Conflict of Interest in Research Policy, and generally means anyone with responsibility for the design, conduct or reporting of the research. If you are filling this out on behalf of other investigators, you will need to confirm the answers to this and any following COI questions in this form directly with each Investigator. Each Investigator can log on to the COI Disclosure System to view the current status of their disclosures. For an overview of the COI disclosure process for IRB submissions, see the COI FAQ webpage. 1. Is each Investigator on the project up-to-date with COI disclosures? Yes No *To be up-to-date, an Investigator must have submitted a disclosure through the COI Disclosure System since the prior June 1. 2. Has any Investigator disclosed any outside financial or personal interest Yes No though the COI Disclosure System? 3. Is a drug, device or other investigational product being used or evaluated in this project? Yes No Project Abstract Background: Provide the scientific or scholarly background for the proposed Human Research. Discuss relevant prior experience or preliminary data (e.g., existing literature). (Limit 10000 Characters including spaces) In response to the nation’s prescription drug and opioid epidemic, Congress passed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Section 503 of CARA aims to help states address the effects of substance use disorders on infants and families by amending provisions of the Child Abuse Prevention and Treatment Act (CAPTA), first enacted in 1974, that are related to infants with prenatal substance exposure. Specifically, CAPTA tasked states with developing policies and procedures that require health care providers to notify the child protective services system if they are involved in the delivery and care of an infant born and identified as being affected by substance abuse or withdrawal symptoms resulting from prenatal substance exposure, or a Fetal Alcohol Spectrum Disorder. The recent legislation, CARA, expanded “substance exposure” to include both illegal and legal substances. CARA requires states to define what population of infants and families are identified as “substance affected”, what a Plan of Safe Care is, and who is responsible for developing and monitoring the Plan of Safe Care. A recognized national model of collaboration is the North Carolina Plan of Safe Care Interagency Collaborative (NC POSCIC), a group that was developed to draft the necessary responses of the federal requirements as well as ongoing monitoring. The collaborative is made up of Department of Health and Human Services (DHHS) Agencies, community agencies and subject matter experts. Overall, NC's implementation of CARA is an effort to better link infants and families to services and resources. Pregnancy can be an opportunity for women and those close to them to change behaviors and seek treatment around alcohol and substance use. It is important for all providers to understand the complexity of a woman's social, environmental, mental and physical conditions to best provide support throughout pregnancy, in the postpartum period and throughout parenting. Purpose: Describe the purpose, specific aims, objectives, questions to be answered, hypotheses, and/or primary and secondary study endpoints of the Human Research. The purpose of the pilot project is to increase coordinated care during pregnancy that will work to identify at-risk pregnant women and their partners with substance use disorders to engage them in services and community supports as early as possible in and during their pregnancy while increasing collaboration and planning with community partners. The intended outcomes are to decrease trauma for both the infant and parents at the birth event and beyond, decrease for the need for removal from the parent’s care, and an increase in reunification for children removed from their parent’s care with tracking characteristics of prenatal substance exposure on mother Application for Human Research v Dec 2019 Page 3 of 11 Application for Human Research and infant. To increase community support resource collaboration for parents through coordination of care. Lay Summary: Provide a brief description of the proposed research using terms that someone who is not familiar with the science or your discipline can understand. (Limit 2000 Characters including spaces) This project is a collaborative data collection project in which all sites will proceed with their standard of care/ operations, but will submit data about their patient/client into a REDCap database that Dr. Manriquez will operate. The data being collected for research and entered into the database can be found in the prenatal family care plan document, which is collected regardless of the research. Each site will only have access to their own data they are putting in, except for Dr. Manriquez, who will have access to all data. The data will be entered into REDCap coded, and each site will maintain their code, but also provide the code to Dr. Manriquez. Mr Manriquez will analyze the data and will provide each site with a de-identified analysis. This solely is just a collection of data to see how well collaboration efforts are working; this program evaluation will not take data and make suggestions for a patients/ clients direct care. While it is intended to evaluate this specific program, we do intend to make generalizable statements. Currently, we are finalizing all multi-site documents for the protocol; all sites will be added via an amendment after the project is approved. Resources: Describe the resources (personnel, facilities, time, emergency resources, etc.) available to recruit, consent, conduct study procedures, and analyze data. Each site will recruit, consent, and add data to the REDCap database about their patient/client. UACOMP will house data on REDCap and UA Box Health. Dr. Manriquez will use her time to analyze the data and provide de-identified reports to each site. Population & Recruitment Maximum number of participants to be enrolled in the study: 200 Please check all the categories of participants that will be included in the research: Children (1-17 yrs old) Prisoners Cognitively Impaired Subjects Refugees Adults UA Staff/ Faculty Native Americans UA Students Pregnant Woman/ Neonates (0-2 yrs old) Other – please explain below *Complete and submit Appendix for Vulnerable Populations What are the inclusion and exclusion criteria for study participation? Inclusion Criteria: - Women of childbearing Age < 18 years, OR >/= 18 years of age - Pregnant women - Parents (pregnant women and their partners) - Substance Use Disorder - Participating /enrolled in one or more of the Collaborative partners' programs - Voluntarily consent to participate in the Prenatal Coordinated Care Pilot – A Project of the Safe, Healthy Infants & Families Thrive (SHIFT) Collaborative Exclusion Criteria: - Women who are not pregnant Indicate age range, gender, and ethnicity of your research population: Pregnant or Postpartum Women, no exclusion based on ethnicity or age (we would like to include pregnant minors). Application for Human Research v Dec 2019 Page 4 of 11 Application for Human Research Pregnant or Postpartum Women >/= 18 years of age And their partners >/= of 18 years of age All Race/Ethnicity eligible Please select the methods that will be used to recruit individuals. Provide copies of documents, as applicable. Email Social Media Flyers Online Advertisements TV, Radio, Print SONA System In Person Presentations Phone Calls Face to Face Screening of the Electronic Medical Record (EMR) Other – please explain below Telemedicine, Televisit, Video Conferencing, Text Messaging, Electronic Forms of Presentation (i.e. Zoom, Skype, Webinar) Explain the recruitment process: Each collaborating site will be identifying their own potential participants that meet inclusion criteria. As each site will have rapport with their own patients/clients, designated staff from that site will use the ICF as a script to explain the research to the potential participant. Where will recruitment take place? Each collaborating site will recruit at their area of business: 1. Maricopa County Department Public Health 2. Superior Court of Arizona in Maricopa County, Juvenile Department – Family Treatment Court 3. Hushabye Nursery – Recovery Center for Neonatal Abstinence Syndrome 4. Community Medical Services – Opiate Treatment Program for Opiate Use Disorder 5. Banner Health (Dr. Maria Manriquez, Dr. Luke Peterson) – ObGyn and FM who provide prenatal care for patients with substance use disorder Please confirm that recruitment will not begin until after IRB approval has been granted: I confirm Informed Consent Please indicate the informed consent process(es) and/or document(s) to be used in the study.Check all that apply. Provide copies of documents, as applicable. Informed Consent (ICF)– written form Informed Consent – oral script/online/unsigned Assent (participants under 18) – written form Assent – oral script/online/unsigned Parental Permission – written form Parental Permission – oral script/online/unsigned Translated Consent/Assent – written form(s) Translated Consent/ Assent- oral script/online/unsigned Combined ICF/PHI Authorization- form Waivers of consent or waiver or alteration of PHI Exception From Informed Consent (EFIC) Broad Consent for future research Debriefing Script Protected Health Information (PHI) Authorization-written form Short Consent Form- written from Other – please explain below Describe in detail the consent processes checked above, including any waiting period for subjects to sign the consent, steps to minimize the possibility of coercion or undue influence, and the language used by those obtaining consent. Designated staff at each site will consent potential participants in a private room. Banner will use an ICF/PHI Application for Human Research v Dec 2019 Page 5 of 11 Application for Human Research Authorization form as Dr. Manriquez may obtain some of the information found on the prenatal family care plan document for her patients from the EMR. If collection of data from an EMR is an option for another site, the collaborating site will use their site specific PHI Authorization form. There will not be a waiting period for participants to sign the consent. This is a voluntary program. If the client/ patient declines participation they would still benefit from the resources being given. Data Collection Procedures Please select the methods of data collection that will be employed in this study (select all that apply): Anthropometric measures (e.g., height, weight, waist circumference, Audio/Video recording etc.) Biological Specimens (urine/feces, tissue, saliva, skin, hair, nails, nasal Benign Interventions swab) Biological Specimens- Blood Draws Biological Specimens- Clinical discarded of blood or specimens Cognitive or behavioral measures, including daily diaries (Note- if surveys Clinical Data Warehouse will also be administered,please select the appropriate option above.) CT Scans Data previously collected for research purposes Data collected using other communication/electronic devices (e.g., cell Deception phones, pagers and texting devices) Interviews- Focus groups Interviews- In person MRI/ Ultrasound with contrast MRI/ Ultrasound without contrast Participant Observation Non- invasive instruments(e.g. external sensors applied to the body) Screening Data Self health monitoring (e.g., pedometers, food diaries, etc.) Surveys- Paper Surveys- Internet (including online and email based data collection) Surveys- Telephone Randomization with Control and Experimental Groups Records- Billing Records- Educational Records- Employee Records- Lab, pathology and/or radiology results Records- Medical Review Records- Mental Health Records- Physician/Clinical Records- Substance Abuse Use of recombinant DNA Use of Social Networking Sites Use of Stem Cells X-ray Scans Other activities or interventions- Describe below Please provide details of the research procedures, including a description of procedures already being performed on subjects for diagnostic or treatment purposes. Be clear to identify which procedures are specifically for research, and which study population will be completing each study procedure. Each collaborating site will follow their standard of care/operations protocols pertaining to identifying their at-risk pregnant women and partners with substance use disorders to help engage them in services and community supports as early as possible in and during their pregnancy. The only research occurring from this standard of care/ operations is the collection of data from the Prenatal Family Care Plan document, which will be collected at the patients/clients standard visits with their respective doctor/agency. This information on the prenatal family care plan would be collected regardless of research, but for research purposes, this data will now be entered into REDCap by the respective doctor/agency. As the document is fairly long, the data collected on that form could be at several different standard visits. This is to help not overwhelm the patient/client. Due to COVID, this may also be Application for Human Research v Dec 2019 Page 6 of 11 Application for Human Research collected over the phone as the patient/client may not be coming into the office for their appts. Please state the estimated time commitment for subject participation. It will take about 10-25 minutes for recruitment/consent, but the rest of the patients/clients participation is done during their standard visits with their respective sites. The collection of data is occurring from prenatal care and postpartum care up to 18 months. If "Biological Specimens" is checked above, please state the amount and frequency at which it will be collected? N/A Benefits, Costs, Compensation & Risks Describe the anticipated benefits of this study to society, academic knowledge or both. There is no direct benefit to the participants if their data is shared. Describe any benefits that individuals may reasonably expect from participation. Coordination of services provided medical, behavioral and AZ state community. Describe any costs, monetary and non-monetary, that subjects may incur. Please note, time is considered a cost. The only cost to the participant is the added time for consent. All other visits and data collection will happen regardless of research. Discuss the amount of compensation (monetary and/or non-monetary) subjects may receive. Describe if compensation will be prorated. No monetary compensation to participants will be given. Please describe all physical, psychological, social, legal, and/or economic risk you feel are associated with participation in this research. NOTE: Risks not directly related to the research need not be included in this section. None anticipated, however every study has a risk of breech of confidentiality. Discuss what steps have been taken to minimize risk to subjects/data. Educate the participant to the utility of coordinated care. Provide opportunities to ask questions throughout the pilot. The data will be housed in a secure portal UA Box Health and REDCap. To minimize risk, consent process will occur in a private space/room. Staff conducting consenting and research procedures (data collection) will complete human subject research training. Describe the provisions for medical care and available compensation in the event of research related injury. If the Human Research has a clinical trial agreement, this language should reflect what is stated in the agreement. All medical care will be done according to Standard of Care. There will be no compensation set aside for research injury, as injury is not anticipated. Privacy and Confidentiality Will the research team be accessing medical records, educational records or employee records Yes No during the research? Substance Abuse records Medical records (HIPAA) Please check all the elements that will be used in the research: Name Address (all geographic subdivisions smaller than state, including street address, city county, and zip code) All elements (except years) of dates related to an individual (including birthdate, admission date, discharge date, date of death, and exact age if over 89) Telephone numbers Application for Human Research v Dec 2019 Page 7 of 11 Application for Human Research Fax number Email address Social Security Number Medical record number Health plan beneficiary number Account number Certificate or licence number Any vehicle or other device serial number Web URL Internet Protocol (IP) Address Photographic image - Photographic images are not limited to images of the face Biometric identifiers, including finger and voice prints Device identifiers and serial numbers Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data) *The PI is responsible for accessing or using only the information that is the minimum necessary to accomplish your research. The use, access and disclosure of the information will be limited to the research purposes described in the research protocol/application. Who will access the information? PI: Maria Manriquez, M.D. , Research staff listed on list of personnel. How will the information be obtained? EMR and Cerner Educational records (FERPA) Employee records Where will the data be stored? REDCap Clinical Data Warehouse Box@UA Health Box@UA Password Protected Drive Encrypted Drive External Drive (USB, Flash drive) Department Drive Cloud Server UA Records Management & Archives Departmental Office Other – please explain below Collaborating sites locked in secured cabinets For each of the storage location checked above, discuss the type of data to be stored (including if the data is identifiable), who may have access to the data, and how long the data will be kept. *NOTE: You are responsible for following University policy and guidelines for proper transmission and storage of Confidential or Regulated Data, including PHI. All sites will input their data collected from the prenatal Family Care Plan document into REDCap. This data will be coded and each site will maintain their code. Dr. Manriquez will also have access to the codes. Sites will only see their own data they have put in; they will not have access to any other sites data. Box@UA Health, which is HIPAA compliant, will be used to "house" patient consent forms and Prenatal Family Care Plans. Application for Human Research v Dec 2019 Page 8 of 11 Application for Human Research Will you be transmitting/receiving any subject data to/from an outside group? Yes No Describe the data to be transmitted/received, name of outside party institution and how the data will be transmitted/received (e.g., secure file transfer, encrypted email). *NOTE: If you will be transmitting or receiving any PHI or a Limited Data Set as a part of your project, Please go to the following link to review the Data Use Agreement (DUA) from the HIPAA Privacy Program. Each collaborative partner, will be granted access to the REDCap Database, to input their own data. Each collaborative partner will enter Data Elements as outlined above and will only have access to their own clients. Each collaborator, who will be transmitting data to UofArizona will enter into a Data Use Agreement (DUA), with UofArizona. Discuss how, when and why subjects/data may be removed from the study. If abrupt withdrawal is necessary, discuss how subjects will be withdrawn so that they are not put at increased risk. Discuss what happens if a subject is withdrawn from one part of the study but asked to continue with other parts, such as ongoing follow-up. There is no foreseen risk to a participant/subject if they withdrawal from this project. The consent to allow researchers access to the participants and baby(ies) data is voluntary, and a participant may withdrawal at any time. If a participant withdrawals, and their data has already been used in statistical analysis, this data will remain, and no further data will be collected. Participant/subjects may be categorized as lost follow-up (LTF) due to unknown status, such as death or moved out of county or state, which will result in missing data. LTF participants data will be used and reported where applicable in outcomes. Describe steps, if any, to protect the privacy of the subjects throughout their participation in the Human Research (e.g. during the recruitment process, consent process, and/or research procedures). Participant privacy and confidentiality will be maintained by original consents being kept in locked office or cabinet at collaborating sites. Participants' data collected will be be maintained in REDCap, and UA Box health. REDCap is a secure web application for building and managing online surveys and databases, maintained by the UofArizona. REDCap is used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and HIPAA-compliant environments). Use of Data/Specimens In which of the following formats will the data be stored? Identifiable Coded De-Identifed Please list the identifiers that will be stored: Refer to the Prenatal Family Care Plan. Who will maintain the code and where will it be stored? Each collaborating site with maintain their code and the PI, Maria Manriquez, MD, will have access to the code. What security controls (e.g. administrative, physical, technical) are in place to make sure data/ specimens are secure? Secure pass-code with Virtual Private Network (VPN) will be used Will data/ specimens be kept for future research, including unspecified future Yes No research, genetics and/or whole genome sequencing? Will subjects receive results for any future research? Yes No Will the data /specimens be stored in a repository? Yes No Will the data/specimens be shared with collaborating entities? Yes No Will the data/specimens be sold to pharmaceutical companies? Yes No Application for Human Research v Dec 2019 Page 9 of 11 Application for Human Research Please discuss the information management plan if required by your funding agency. NA Provide a brief lay discussion of the plan to monitor for subject safety, if applicable. Describe what safety information will be collected, including serious adverse events, how safety information will be collected, the frequency of collection including a timeline of when the data and review(s) will occur, who will review the information, and the plan for reporting findings. If there will not be a way to monitor for subject safety, please explain. A Data Safety Monitoring Board (DSMB) will not be used for this project. Collaboratives will transmit data in to REDCap, UA Box Health and original ICFs will be stored at each individual collaborative site, in a secure location. Remember to attach the following documentation to your submission email: • PI/Co-PI CV or Biosketch • List of Project Personnel (located on the forms page) • Appendices (if applicable) • Recruitment Material • Informed Consent Documentation • Data Collection Tools • Email confirmations from Advisor (required for all students and residents), Scientific/ Scholarly Reviewer and Department Head. Principal Investigator I certify that the information I provide in this application is correct and complete. Attestation of Principal Investigator Maria Manriquez, M.D. 10/30/2020 Typed name of Principal Investigator Date Scientific/Scholarly Review (See HSPP Guidance on requirements for Scientific/Scholarly Assessment) SELECT ONE TO DOCUMENT THIS SIGNATURE Nationally based, federal funding organization (NIH, NSF) subject to full peer review Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer review Locally constituted peer review (signature required) Department/Center/Section Review I have reviewed this application and determined that all departmental requirements are met and that the investigator has adequate resources to conduct the Human Research. 9/22/2020 Signature of Department/ Center/ Section Review Date Michael R. Foley, MD, Chair, Department of Obstetrics and Gynecology Print Name and Title Application for Human Research v Dec 2019 Page 10 of 11 Application for Human Research NOTE: Actual signature is not required. The HSPP Office will accept either email confirmation or an actual signature. This means that all signatures might not be on the same document. Attach email confirmations with your submission. You have now completed this form. Next steps: 1) Please save a copy of this document for your records. 2) Once ready, email the application and all additional documents and approvals to vpr-irb@email.arizona.edu inbox. Please limit your submission to one email. Application for Human Research v Dec 2019 Page 11 of 11