UT Arlington IRB Standard Operating Procedures

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UT Arlington IRBStandard Operating ProceduresLast Updated January 2021

UTA IRB SOPS – Table of ContentsI. Institutional Authority. 7A.Vice President for Research . 7B.Institutional Review Board . 71. Scope. 72. Authority . 7II. Principles & Compliance with Federal Regulations and University Policies . 8III. Definitions . 10IV. Roles and Responsibilities . 17A.Institutional Official (IO) – Vice President for Research (VPR). 17B.Institutional Review Board (IRB) . 17C.IRB Chair & Vice Chair . 17D. IRB Members . 18E.Regulatory Services . 18F.Principal Investigator / Co-Principal Investigator . 18G. Faculty Advisor / Supervising Investigator . 19H. Protocol Personnel / Research Staff . 19V. IRB Membership . 21A.Appointment of IRB Chair . 21B.Appointment of IRB Members and Alternates . 21C.Voting Capacity of Alternate Members at Convened Meetings . 21D. Non-Voting (Ex Officio) Members . 22E.Consultants / Ad-hoc Reviewers . 22F.Compensation of IRB Members . 22G. Member Liability. 22H. IRB Conflicts of Interest . 23I.Training of IRB Members and Alternates . 23VI. IRB Operations and Coordination with Other University Components . 24A.Regulatory Services Structure and Mission . 24B.Responsibilities of IRB Staff. 24C.Appropriation of Required Institutional Resources . 25D. Other Administrative Units and Processes Managed by Regulatory Services . 25Page 2 of 104

E.Review of Research Activities by Other University Offices or Committees . 26VII. Procedures for Processing of New IRB Applications . 28A.Electronic Submission System. 28B.Submission of New Human Subjects Research Applications . 28C.Determination of Appropriate Study Classifications and Type of Review . 281. Determination of “Not Human Subjects Research” . 282. Classification and Initial Review of Non-Federally Funded, Non-FDA Regulated Research Protocols . 293. Classification and Review of Federally Funded and FDA Regulated Research Protocols . 30D. Approval of Protocol Submissions . 391. Approval as Submitted . 392. Approval with Conditions . 393. Requires Significant Modifications Prior To Approval . 404. Disapproval . 40E.Length of Initial Approval Period . 41VIII. Scope of IRB Review and Criteria for IRB Approval . 42A.Scope of IRB Review . 42B.Criteria for IRB Approval of Research . 431. Identification of Risks. 432. Minimization of Risks . 433. Benefits and the Risk/Benefit Ratio. 444. Equitable Selection of Subjects . 445. Informed Consent. 446. Documentation of Informed Consent . 457. Monitoring of Collected Data . 458. Privacy and Confidentiality . 459. Special Considerations for Projects Including Vulnerable Study Populations . 45IX. Procedures for Review of Other Types of IRB Submissions. 47A.Continuing Reviews . 471. Initial Determination of Whether Continuing Review is Required. 472. Determining Intervals for Continuing (or Additional) Review by the IRB . 483. Submission and Review Process for Continuing Reviews . 48Page 3 of 104

4. Lapses in Approval for Studies Requiring Continuing Review . 495. Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review . 506. Determining the Date for the Second and all Subsequent Continuing Reviews . 50B.Modification Requests / Amendments . 511. Pre-Review of Modifications. 512. Review of Major Modifications . 513. Review of Minor Modifications . 524. Administrative Review of Certain Minor Modifications . 53C.Adverse Event Reports and Unanticipated Problems . 541. IRB Review of Adverse Events (AEs) . 542. IRB Review of Serious Adverse Events (SAEs) . 543. IRB Review of Unanticipated Problems (UPs) Involving Risks to Subjects or Others . 55D. Requests for Study Closure. 56X. Study Recruitment and Informed Consent .57A.Recruitment of Human Subjects / Participants in Research . 57B.Informed Consent . 581. General Requirements for Informed Consent. 582. Documentation of Informed Consent . 603. Waivers of Informed Consent or Some Elements of Informed Consent . 604. Waivers of Documentation of Informed Consent . 605. Required Consent Statement for Studies to be Registered on ClinicalTrials.gov . 616. Informed Consent Considerations for DoD-Supported or Conducted Research . 617. Compensation to Research Subjects . 628. Informed Consent Information Regarding Compensation to Subjects . 63XI. IRB Review of Research Including Vulnerable Populations . 64A.Review of Research Involving Children . 641. Determination of Appropriate Risk/Benefit Category . 642. Assent Determination . 673. Inclusion of Wards in Research . 67B.Review of Research Involving Pregnant Women, Human Fetuses, or Neonates . 68C.Review of Research Involving Prisoners . 69D. Review of Research Involving Other Potentially Vulnerable Populations . 70Page 4 of 104

XII. IRB Review of Research at Schools or Other Educational Institutions . 72A.Legal Requirements for Research at Schools or Educational Institutions . 721. Family Educational Rights and Privacy Act (FERPA) . 722. Pupil Rights Amendment (PPRA) . 74B.Local Approvals for Research at Schools or Educational Institutions . 76C.Ethical Considerations for Research Involving Students as Subjects . 76XIII. IRB Review of International Research . 78A.Addressing the Needs, Issues, and/or Benefits of the Local Community . 78B.Local Context. 78C.Informed Consent . 78D. Approval by the International Institution Where Research Will be Conducted . 79XIV. IRB Review of Biomedical Research . 80A.Research with Biological Specimens . 80B.Research with Protected Health Information (PHI) / HIPAA Considerations . 81C.Research with Investigational Drugs . 82D. Research with Investigational Devices . 83E.Research with Biologics. 84F.Compliance with Good Clinical Practice (GCP) . 84G. Registration of NIH-Funded Clinical Trials and Applicable Clinical Trials (ACTs) on ClinicalTrials.gov . 85H. Genetic Research . 86XV. Protecting Human Subject Data . 87A.Data Security for Paper Research Records . 87B.Data Security of Electronic Research Data. 88C.Certificates of Confidentiality . 88D. Collection of Social Security Numbers . 88XVI. IRB Post-Approval Study Monitoring & Quality Assurance Processes . 90A.Post Approval Study Monitoring . 901. For-Cause Post Approval Study Monitoring . 902. Not-For-Cause Post Approval Study Monitoring . 90B.IRB Quality Assurance Process . 91XVII. Reporting & IRB Review of Non-Compliance . 92A.Reporting of Protocol Violations and/or Allegations of Potential Non-Compliance to the IRB . 92Page 5 of 104

B.Non-Compliance Allegations or Self-Reported Findings . 92C.IRB Review of Protocol Violations and/or Allegations of Potential Noncompliance . 931. Minor Findings of Non-Compliance Requiring No Further IRB Action . 932. Allegations or Findings of Non-Compliance Requiring Additional Investigation . 933. IRB Review of Potentially Serious and/or Continuing Non-Compliance . 944. Possible IRB Corrective Actions for Serious and/or Continuing Non-Compliance . 94D.Reporting to Federal Oversight Agencies . 95XVIII. Appeal of IRB Decisions . 96XIX. Education and Training . 98A.Educational Activities Aimed at the Research Community at Large . 98B.Educational Activities for Members of the IRB . 98C.Required Researcher Education and Training . 98XX. Multi-Site and Collaborative Research Projects . 100A.Reliance through Standing Reciprocity Agreements . 100B.Situational Requests for Reliance through IRB Authorization Agreements. 100C.Acknowledgement Submission Process for UTA Researchers Engaged in External IRB Approved Research . 101D.External Investigators Engaged in UT Arlington IRB Approved Research . 1011. Individuals at Non-Assured Institutions Engaged in UT Arlington IRB Approved Research. 1012. Individuals at Assured Institutions Engaged in UT Arlington IRB Approved Research. 101XXI. Recordkeeping and Retention of Records . 103A.Recordkeeping . 103B.IRB Files . 104C.Record Retention Term . 104D.Confidentiality of Records. 104E.Inspection of Records. 104Page 6 of 104

I. Institutional AuthorityA. Vice President for ResearchThe Vice President for Research (VPR) reports to the President of the University of Texas at Arlington(UT Arlington). The Office of the VPR has the authority to develop and administer all policiesgoverning UT Arlington’s research enterprise. UT Arlington operates a centralized structure for theadministration of research, which includes the institutional review board (IRB) under the oversight ofthe VPR. As such, the leadership of the IRB report directly to the Office of the VPR.B. Institutional Review BoardHuman subjects research conducted at the University or under its auspices must be reviewed andapproved by the UT Arlington IRB prior to the start of the research. The UT Arlington IRB reviewsprojects in a wide range of research disciplines in the social, behavioral, educational, and biomedicalor clinical fields.1. ScopeThe UT Arlington IRB reviews protocols for research involving human subjects when conducted by orunder the direction of any employee, student, or an agent of UT Arlington in connection with his or herinstitutional responsibilities or using any institutional property or facility. Also, the IRB (or RegulatoryServices, as designee) reviews and acknowledges IRB reliance & reciprocity arrangements for researchprotocols of non-UT Arlington investigators when UT Arlington faculty, staff, or students are involved.Details of the scope of IRB review for each protocol is provided in Section VIII.A.2. AuthorityThe authority conveyed to the UT Arlington IRB includes the following:a. Review/approval of new/continuing research protocols involving human participants andassociated informed consent documents (ICD) prior to initiation/continuation of research;b. Monitoring of approved projects including regularly scheduled continuing review at leastevery twelve (12) months for certain non-exempt or greater than minimal risk studies;c. Verification of compliance with approved research protocols and informed consentprocedures;d. Review of all planned changes to approved protocols prior to implementation;e. Review of all serious adverse events (SAEs) and unanticipated problems involving risks tosubjects or others (UPs) occurring in approved projects, or in other projects related in contextto the approved projects;f. Restriction of approved research activities to protect participants when necessary; andg. Suspension/termination of previously approved protocols for substantive new informationthat may affect the safety and welfare of human subjects, the integrity of the study, ornoncompliance with established policies and procedures.Page 7 of 104

II. Principles & Compliance with Federal Regulations and University PoliciesAll research at UT Arlington that involves human subjects is guided by the ethical principles set forth in thereport of the National Commission for the Protection of Human Participants of Biomedical and BehavioralResearch entitled “Ethical Principles and Guidelines for the Protection of Human Subject of Research(Belmont Report)”. This document is listed as the guiding statement of ethical principles as part of UTArlington’s Federalwide Assurance for the Protection of Human Subjects with the federal government.All human subjects research conducted and reviewed by the UT Arlington IRB must comply with applicablefederal and state laws/regulations and UT Arlington policies and procedures governing the conduct ofresearch, including but not limited to the following:a. UT Arlington has filed a Federalwide Assurance (FWA) with the Department of Health and HumanServices (DHHS) Office for Human Research Protections (OHRP) affirming that the University is incompliance with 45 CFR 46. This assurance applies to all research involving human subjects that isconducted, supported or otherwise subject to regulation by any federal department or agency asdefined and regulated by the “Common Rule” – (DHHS regulations incorporate the RevisedCommon Rule as Subpart A of 45 CFR 46);b. The Department of Education Family Education Rights and Privacy Act (FERPA) for studies involvingeducational and/or student records;c. Food and Drug Administration (FDA) regulations; the UT Arlington IRB complies with therequirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 600, and 21 CFR 812 for studiesinvolving investigational drugs, biologics, devices, or diagnostic tests;d. Department of Defense (DoD) regulations and directives, including those at 32 CFR 219, 10 UnitedStates Code 980, and DoDI 3216.02, for studies funded or supported by DoD, and/or studies inwhich the subject population will intentionally include personnel (military and/or civilian) from acomponent of DoD;e. Texas State Law, including Section 261.101 of the Texas Family Code for mandatory reporting ofchild and elder abuse or neglect; and,f. UT Arlington institutional policies and procedures governing research, including UT Arlington’spolicy 5-705, Statement of Principles and Policies Regarding Human Subjects in Research, and thisSOP document.The purpose of the UT Arlington IRB is to assure that the rights and welfare of human subjects areadequately protected in research. The UT Arlington IRB advises investigators in the design of researchprojects in order to minimize potential harm to human participants; reviews all planned research involvinghuman subjects prior to initiation of the research; approves research that meets established criteria forprotection of human subjects; and monitors approved research protocols to ascertain whether humansubjects are indeed protected.The UT Arlington IRB also informs and assists UT Arlington faculty, staff, and students of ethical andprocedural issues related to the use of human participants in research in order to facilitate compliancewith relevant federal regulations and to provide a framework suitable for continued support by federalfunding agencies, private foundations, and industry.Page 8 of 104

Primary responsibility for assuring that the rights and welfare of research participants are protectedcontinues to rest with the Principal Investigator (PI) conducting the research. Others engaged in theresearch share this responsibility. Faculty who assign or supervise research conducted by students or staffhave an obligation to consider carefully whether those individuals are qualified to safeguard adequatelythe rights and welfare of participants in the research.Page 9 of 104

III. Definitionsa. Administrative Modification - Changes proposed to the IRB for an approved study that are minor andnon-substantive in nature and for which the IRB has delegated authority to IRB staff to conductAdministrative Review and approval, regardless of the study’s initial level of review or funding source.b. Adverse event - Any unfavorable or harmful occurrence to a human subjec

Food and Drug Administration (FDA) regulations; the UT Arlington IRB complies with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 600, and 21 CFR 812 for studies . UT Arlington institutional policies and procedures governing research, including UT Arlington's . Page . of . 104. Page . of 104.

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