{"id":2217,"date":"2026-05-15T21:24:37","date_gmt":"2026-05-15T21:24:37","guid":{"rendered":"https:\/\/www.mtsu.edu\/irb\/?page_id=2217"},"modified":"2026-05-30T10:16:23","modified_gmt":"2026-05-30T10:16:23","slug":"mtsu-irb-written-procedures","status":"publish","type":"page","link":"https:\/\/www.mtsu.edu\/irb\/mtsu-irb-written-procedures\/","title":{"rendered":"MTSU IRB Written Procedures"},"content":{"rendered":"\n<p>In accordance with\u00a0<strong>45 CFR 46.108(3-4)<\/strong>\u00a0the following written procedures specify the processes of the Institutional Review Board\u2019s (IRB) review of human subjects\u2019 research: initial and continuing review, the determination of review frequency, the management of modifications, and the reporting of unanticipated problems, adverse events, and noncompliance.<\/p>\n\n\n\n<p><strong>IRB and Research Compliance Office Overview:&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>All investigators who plan to&nbsp;participate&nbsp;in research activities involving human subjects must&nbsp;submit&nbsp;an IRB protocol for review in the Human Ethics section of the Cayuse platform for review and approval. Research can only be conducted after IRB approval.&nbsp;&nbsp;<\/p>\n\n\n\n<p>These procedures apply to all research involving human subjects conducted at ÀÖ²¥´«Ã½Èë¿Ú. The Principal Investigator (PI) holds primary responsibility for&nbsp;submitting&nbsp;protocols, adhering to approved procedures, reporting unanticipated problems,&nbsp;and&nbsp;submitting&nbsp;progress or final reports. If the PI is a student, the Faculty Advisor assumes oversight responsibility for ensuring compliance with these procedures.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>The Office of Research Compliance works in tandem with the Institutional Review Board to achieve the following: determine the appropriate category of review, maintain official records, conduct reviews, require modifications where necessary, suspend or terminate research activities when warranted, and report determinations to institutional officials and federal agencies as required.&nbsp;<\/p>\n\n\n\n<p><strong>Review Categories<\/strong><\/p>\n\n\n\n<p>Once it has been determined that an activity is human subjects\u2019\u00a0research, it will be reviewed under one of three categories: Exempt review, Expedited review, or Full review. See\u00a0<strong>MTSU Policy 402 VIII<\/strong>\u00a0https:\/\/www.mtsu.edu\/policies\/p402\/.\u00a0<\/p>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-block accordion expandable-group expandable-group-faq\" id=\"newExpandable\">\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstronginitial-review-procedures-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestronginitial-review-procedures-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestronginitial-review-procedures-strong\"><strong>Initial Review Procedures<\/strong>\u00a0<\/button><\/h2><div id=\"collapsenewExpandablestronginitial-review-procedures-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstronginitial-review-procedures-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>Research protocols&nbsp;that require a Full board review&nbsp;must be&nbsp;submitted&nbsp;a minimum of two (2) weeks prior to the scheduled IRB meeting. The dates&nbsp;for&nbsp;the scheduled meetings will be kept on file in the Office of Research Compliance and notice will be posted&nbsp;on the IRB website&nbsp;two weeks or more in advance.&nbsp;&nbsp;Full review protocols&nbsp;not received by the deadline date will not be reviewed until the following meeting. There is no deadline for&nbsp;submitting&nbsp;research proposals for either&nbsp;Exempt&nbsp;or Expedited review. See&nbsp;<strong>MTSU Policy 402 VI<\/strong>&nbsp;https:\/\/www.mtsu.edu\/policies\/p402\/.&nbsp;<\/p>\n\n\n\n<p>The process for reviewing initial submissions that are categorized under the Exempt or Expedited review category is as follows:&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Prerequisite Check&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>A Research Compliance Officer will check to make sure that researchers completed and documented all required trainings, followed the directions for each section of the application, and included all necessary documents. If there is&nbsp;anything&nbsp;missing&nbsp;initially&nbsp;on the submission from&nbsp;the aforementioned items, the Research Compliance Officer conducting the prerequisite check will send the application back to the researcher with comments.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Pre-Review or Analysis&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>If the protocol passes the Prerequisite Check or when it is returned&nbsp;completed, it will be reassigned to the Research Compliance Officer on the IRB Committee for Analysis. The RCO on the IRB committee will&nbsp;determine&nbsp;if the research is Exempt or not Exempt and may make comments&nbsp;deemed&nbsp;helpful for the review of the protocol as well as&nbsp;complete&nbsp;the Analyst Checklist.&nbsp;&nbsp;&nbsp;{The IRB Chair or IRB Vice-Chair may also complete this&nbsp;initial&nbsp;analysis or any other protocol&nbsp;(pre-)review task in these written procedures if the RCO on the IRB committee is not available to complete the&nbsp;task}.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>If the protocol is&nbsp;deemed&nbsp;Exempt, the Research Compliance Officer on the IRB will assign it to themselves&nbsp;or the IRB Vice-Chair&nbsp;for review. If the protocol is&nbsp;deemed&nbsp;not Exempt, it will be assigned to the IRB Chair for continued analysis.&nbsp;&nbsp;The Research Compliance Officer on the IRB will make recommendations with respect to Full Review or&nbsp;designate&nbsp;it as such if required by the regulations.&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>The IRB Chair will then decide whether the protocol is considered Expedited or Full, complete the Analyst checklist, and assign the protocol to a reviewer or&nbsp;reviewers&nbsp;based on their determination. If the protocol is&nbsp;Expedited&nbsp;the IRB chair can assign it to any of the IRB members.&nbsp;&nbsp;&nbsp;(If the IRB Chair has a conflict of interest with respect to the protocol, the IRB Vice-Chair will perform the tasks above and any other designated task described in these written procedures with respect to a&nbsp;protocol.)&nbsp;Although every effort will be made by the IRB Chair to designate reviewers who have the necessary working knowledge on the subject matter of the application,&nbsp;the researchers should&nbsp;prepare the application in simple language such that a reviewer with a different field of expertise&nbsp;also&nbsp;would&nbsp;understand the protocol.&nbsp; If the IRB&nbsp;Chair&nbsp;designates&nbsp;the protocol for Full Review, they will then assign the&nbsp;protocol&nbsp;a Primary and Secondary Reviewer. The IRB will aim to have the reviewers assigned with&nbsp;expertise&nbsp;in the area of&nbsp;the research adequate to the scope and complexity of the research.&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Exempt Review<\/strong>&nbsp;<\/p>\n\n\n\n<p>The Research Compliance Officer on the IRB or IRB Vice-Chair will return the protocol&nbsp;to the researcher&nbsp;with comments if necessary.&nbsp;&nbsp;Return to PI letters are typically reserved for protocols that require further information to make a category determination, require so many edits that the Reviewer&nbsp;deems&nbsp;it not ready for review,&nbsp;and\/or&nbsp;that they&nbsp;require&nbsp;particular edits&nbsp;deemed&nbsp;necessary for adequate review.&nbsp;&nbsp;Minor Stipulations letters are reserved for protocols&nbsp;that require&nbsp;specific&nbsp;edits necessary before approval but may admit of a&nbsp;review&nbsp;category designation.&nbsp;&nbsp;Before sending a final approval letter, the Reviewer will complete the Reviewer checklist.&nbsp; The Research Compliance Officer on the IRB will complete the&nbsp;Post-Review&nbsp;check on any&nbsp;letter sent to the researcher.&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Expedited&nbsp;Review&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>Following their review of the protocol, the assigned Reviewer will return the protocol with comments if necessary.&nbsp; Return to PI letters are typically reserved for protocols that either require further information to make a category designation, require so many edits that the Reviewer deems it not ready for review,&nbsp;and\/or require particular edits deemed necessary for adequate review.&nbsp; Minor Stipulations letters are reserved for protocols that require&nbsp;specific&nbsp;edits necessary before approval but may admit of a&nbsp;review&nbsp;category determination.&nbsp; Before&nbsp;giving a final approval decision and selecting the category that matches the review, the Reviewer will complete the Reviewer checklist.&nbsp; The IRB Chair will&nbsp;then&nbsp;complete the Post-Review check of&nbsp;any&nbsp;letter&nbsp;before sending it to the researcher.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Full Review Procedures&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>Protocols determined to require Full Review are&nbsp;assigned a Primary and Secondary Reviewer&nbsp;by the IRB Chair.&nbsp; The Reviewers conduct an in-depth review of all pertinent documentation.&nbsp;&nbsp;<\/p>\n\n\n\n<p>1. The Primary Reviewer&nbsp;will present a summary of the study&nbsp;to the Full IRB Committee highlighting any controversial issues and recommending modifications, if applicable.&nbsp;&nbsp;<\/p>\n\n\n\n<p>2. The Secondary Reviewer&nbsp;will be&nbsp;prepared to provide any additional information not presented by the Primary Reviewer&nbsp;by&nbsp;highlighting any controversial issues and recommending modifications, if applicable.&nbsp;&nbsp;<\/p>\n\n\n\n<p>3. If the Committee does not have a member available with expertise adequate to the scope and complexity of the research, a consultant with expertise in the area of research will be asked to review the study and provide written recommendations or may be asked to attend the Committee meeting.&nbsp; The IRB will aim to acquire both attendance and written recommendations but will aim to best accommodate the&nbsp;time and efforts of the volunteering&nbsp;consultant.&nbsp;&nbsp;The consultant may not count toward the quorum or vote.&nbsp;&nbsp;<\/p>\n\n\n\n<p>4. The Reviewers will assess the protocol for both scientific and scholarly merit in relationship to the level of risk.&nbsp;&nbsp;<\/p>\n\n\n\n<p>5. 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,&nbsp;or&nbsp;economically or educationally disadvantaged persons, the IRB Committee determines if additional safeguards need to be included in the study to protect the rights and welfare of these subjects.&nbsp;&nbsp;<\/p>\n\n\n\n<p>6. All Committee members are given the opportunity to review, ask questions of the reviewers, and request modifications in the proposal.&nbsp;<\/p>\n\n\n\n<p>7. The Committee reviews the proposed research,&nbsp;informed consent documentation, and applicable documents to determine whether the study meets criteria 45 CFR 46.111 for approval. In order to provide written documentation of these criteria, the Primary Reviewer completes the&nbsp;Reviewer checklist&nbsp;detailing how each of these criteria is met.&nbsp;&nbsp;The IRB Committee will utilize the following \u201cIRB Reminder List\u201d when discussing their review of the protocol&nbsp;(the abbreviated version appears on the IRB poster review board and what follows in&nbsp;parentheses clarifies the meanings of each of these reminders):&nbsp;<\/p>\n\n\n\n<p>\u201cPurpose clear?&nbsp;&nbsp;<\/p>\n\n\n\n<p>(Is the purpose of the research clearly defined and stated within the protocol?)&nbsp;<\/p>\n\n\n\n<p>&nbsp; Recruitment proper?&nbsp;<\/p>\n\n\n\n<p>(Are recruitment methods appropriate, equitable, and compliant?)&nbsp;<\/p>\n\n\n\n<p>&nbsp; Inducement reasonable?&nbsp;<\/p>\n\n\n\n<p>(Is any form of inducement offered to participants reasonable and proportionate to the research\u2019s potential risks or burdens?)&nbsp;<\/p>\n\n\n\n<p>&nbsp; Researcher\u2019s experience adequate?&nbsp;<\/p>\n\n\n\n<p>(Does the researcher possess sufficient training, expertise, and experience to conduct the study appropriately?)&nbsp;<\/p>\n\n\n\n<p>&nbsp; Subjects adequately informed?&nbsp;<\/p>\n\n\n\n<p>(Are participants provided with comprehensive and understandable information about the study\u2019s procedures, risks, and benefits?)&nbsp;<\/p>\n\n\n\n<p>&nbsp; Informed consent documented appropriately?&nbsp;<\/p>\n\n\n\n<p>(Is informed consent obtained\u202fin a manner that is properly documented, with signatures and dates as required?)&nbsp;<\/p>\n\n\n\n<p>Risks necessary? Minimized to extent possible?&nbsp;<\/p>\n\n\n\n<p>(Are the risks inherent in the study both necessary for achieving research objectives and minimized as much as possible?)&nbsp;<\/p>\n\n\n\n<p>Benefits?&nbsp;<\/p>\n\n\n\n<p>(Are the potential benefits of the research to participants or society clearly described and justified in relation to the risks involved?)&nbsp;<\/p>\n\n\n\n<p>Confidentiality?&nbsp;<\/p>\n\n\n\n<p>(Are measures in place to protect participants\u2019 privacy and maintain the confidentiality of their personal information throughout the study?)&nbsp;<\/p>\n\n\n\n<p>Data use explained?\u201d&nbsp;<\/p>\n\n\n\n<p>(Is the intended use of collected data clearly communicated to participants, including any plans for storage, sharing, or publication?)&nbsp;<\/p>\n\n\n\n<p>8. The Committee determines the review interval appropriate to the degree of risk, but not less than once per year.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Investigator Responsibilities&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>Throughout the review process for each category, the researcher may receive letters via their MTSU email or comments on the online review platform. Letters should be read&nbsp;carefully&nbsp;and comments on edits and requirements should be&nbsp;addressed&nbsp;promptly and appropriately by the researcher.&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongcontinuing-review-procedures-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongcontinuing-review-procedures-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongcontinuing-review-procedures-strong\"><strong>Continuing Review Procedures<\/strong><\/button><\/h2><div id=\"collapsenewExpandablestrongcontinuing-review-procedures-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongcontinuing-review-procedures-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>Research protocols&nbsp;reviewed initially&nbsp;by the&nbsp;fully&nbsp;convened IRB&nbsp;as a Full Review&nbsp;are ordinarily reviewed using standard review procedures unless the study has been&nbsp;modified&nbsp;such that it qualifies for Expedited review under Federal regulations. Research activities that previously met criteria for Exempt or Expedited review may also change over&nbsp;time&nbsp;such that standard review&nbsp;becomes necessary. When conducting&nbsp;continuing&nbsp;review at a Full IRB meeting, the Board uses a primary reviewer system. The primary reviewer receives and reviews the complete protocol, including any modifications previously approved,&nbsp;and any monitoring or audit reports conducted since the last review. Findings are then presented&nbsp;at a convened Full IRB meeting&nbsp;where the protocol is discussed and voted on by the membership.&nbsp;&nbsp;<\/p>\n\n\n\n<p>When conducting&nbsp;Expedited&nbsp;review, the IRB Chair or a designated IRB member conducts the review on behalf of the Full Board. Protocols originally reviewed using Expedited procedures may continue to receive Expedited review unless the research no longer meets the required criteria. Protocols initially reviewed by the Full IRB may become eligible for Expedited review if enrollment&nbsp;in the study&nbsp;is permanently closed, all interventions have been completed and the research remains active only for long-term follow-up, if no participants were enrolled and no additional risks have been identified,&nbsp;and\/or if remaining activities are limited to data analysis.&nbsp; MTSU does not&nbsp;require&nbsp;continuing review for most Expedited studies but reserves the right to do so if the IRB Chair&nbsp;deems&nbsp;it necessary for the adequate protection of human subjects.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Exempt research activities do not require annual continuing review. However, any proposed changes must be&nbsp;submitted&nbsp;to the IRB for approval prior to implementation. Amendments to Exempt protocols are reviewed and approved by the Research Compliance Officer on the IRB committee. If the amendment&nbsp;changes&nbsp;the review level, the RCO on the IRB committee&nbsp;forwards&nbsp;it to the IRB Chair or designated member for&nbsp;appropriate review&nbsp;and determination.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Continuing review must be substantive and meaningful, using the same criteria required at&nbsp;initial&nbsp;review&nbsp;in accordance with&nbsp;45 CFR 46.111. The IRB must&nbsp;determine&nbsp;that risks&nbsp;remain&nbsp;minimized and reasonable&nbsp;relative&nbsp;to benefits, that subject&nbsp;selection&nbsp;remains&nbsp;equitable, that informed consent continues to be properly obtained and documented, and that adequate provisions&nbsp;remain&nbsp;in place to&nbsp;monitor&nbsp;data safety, protect subject privacy, and ensure confidentiality. The IRB must also confirm that safeguards for vulnerable populations&nbsp;remain&nbsp;appropriate.&nbsp;&nbsp;<\/p>\n\n\n\n<p>To allow adequate time for review, principal investigators are expected to provide a progress report and continuation request to the IRB preferably four weeks before the&nbsp;expiration&nbsp;date. The application must include information such as the maximum number of participants approved, total participants enrolled to date, numbers enrolled since the previous review, completions, withdrawals, and details regarding adverse events, monitoring reports, complaints, relevant literature, interim findings, progress reports, multicenter updates, recruitment difficulties, benefits, and any other relevant information. At the time of continuing review, investigators may also&nbsp;submit&nbsp;proposed amendments to the protocol; however, amendments cannot be implemented without IRB approval.&nbsp;&nbsp;<\/p>\n\n\n\n<p>For Full review, research must be reviewed within one year of the convened IRB meeting at which it was approved, regardless of whether activities have begun. For Expedited review, research must be reviewed within one year of the&nbsp;date&nbsp;final approval was granted by the Chair or designated reviewer&nbsp;(for studies originally reviewed by a Full Board or requiring continuing review by the IRB Chair).&nbsp;Approval is not granted until all requested&nbsp;changes are completed and reviewed, and&nbsp;expiration&nbsp;periods are not extended by pending status. The IRB may&nbsp;maintain&nbsp;a constant anniversary date for reviews,&nbsp;provided&nbsp;that&nbsp;reviews occur annually and within&nbsp;30 days&nbsp;of&nbsp;expiration. Based on its continuing review, the IRB may restrict,&nbsp;modify, or halt a study.&nbsp;&nbsp;<\/p>\n\n\n\n<p>The IRB may require verification from outside sources on a case-by-case basis, particularly for randomly selected protocols, for complex protocols involving unusual risks, studies conducted by investigators with prior noncompliance, or when concerns are raised about unapproved material changes. Independent verification may include FDA&nbsp;(Food and Drug&nbsp;Administration)&nbsp;audits, site visits, reports from subjects, or directed audits. The Board determines appropriate continuing review intervals based on risk, compliance concerns, use of vulnerable populations, international research, recombinant DNA use, waiver of consent, classified research, novel procedures, risks of confidentiality breaches, phase I studies, prior adverse events, administrative holds, or recommendations from other institutional committees.&nbsp;&nbsp;<\/p>\n\n\n\n<p>The Research Compliance Officer on the IRB ensures that investigators receive notification of upcoming continuing review, either by phone call or email. If required materials are not received prior to&nbsp;expiration, the Research Compliance Officer on the IRB prepares studies for&nbsp;expiration&nbsp;review by the Full IRB (for Full Board protocols) or by the IRB Chair\/designated reviewer (for Expedited protocols). If a study expires, the IRB Chair or designated reviewer issues a notification letter requiring cessation of activities. Expired studies may be re-approved through Expedited procedures if they were initially reviewed that way, or through a Full meeting if originally reviewed by the Full IRB. The IRB may allow continuation of participation where ceasing would seriously jeopardize subject safety.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Approval of Continuing Review&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>For&nbsp;Full&nbsp;review&nbsp;studies, research must be reviewed within one year of the date of the Full IRB meeting at which it was approved, regardless of whether activities had begun. For Expedited review&nbsp;studies,&nbsp;if&nbsp;it was&nbsp;deemed&nbsp;necessary&nbsp;originally by the IRB Chair,&nbsp;research must be reviewed&nbsp;within one year of the date final approval was granted by the&nbsp;IRB&nbsp;Chair or&nbsp;the&nbsp;designated reviewer. Based on its continuing review, the IRB may restrict,&nbsp;modify, or halt a study. Approval is not granted until all requested changes are completed and reviewed, and&nbsp;expiration&nbsp;periods are not extended by pending status.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Expiration of IRB Approval&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>There is no grace period extending beyond the&nbsp;expiration&nbsp;date of IRB approval. If approval lapses, all study activities must cease until re-approval is granted. The IRB requires investigators to&nbsp;submit&nbsp;a list of participants for whom study&nbsp;expiration&nbsp;would cause harm.&nbsp;The Full IRB may&nbsp;permit&nbsp;continued participation for these individuals if&nbsp;it&nbsp;determines&nbsp;it&nbsp;to be in their best interests.&nbsp;Enrollment of new participants is&nbsp;strictly prohibited&nbsp;once approval has expired.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Investigator Responsibilities&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>Investigators must complete a progress report&nbsp;and&nbsp;provide all continuing review materials at least four weeks before&nbsp;expiration. If a study expires, the investigator must cease all activities and either&nbsp;submit&nbsp;the required documents for review or notify the IRB of study closure.&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongreporting-findings-and-actions-to-investigators-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongreporting-findings-and-actions-to-investigators-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongreporting-findings-and-actions-to-investigators-strong\"><strong>Reporting Findings and Actions to Investigators<\/strong><\/button><\/h2><div id=\"collapsenewExpandablestrongreporting-findings-and-actions-to-investigators-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongreporting-findings-and-actions-to-investigators-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>The Research Compliance Officer on the IRB Committee,\u00a0IRB Chair, and IRB Vice-Chair\u00a0will\u00a0utilize\u00a0official letters from the Cayuse system\u00a0regarding\u00a0decisions made with respect to the review of research protocols\u00a0submitted\u00a0through Cayuse.\u00a0\u00a0These\u00a0include\u00a0Initial Review, Continuing Review, Modifications, Closure, and official responses to Incidents, or the letter template downloaded for customization for official responses to miscellaneous inquiries,\u00a0(for example, requests by external researchers with IRB approval obtained already from their host institution to recruit participants at MTSU).\u00a0 Email may be\u00a0utilized\u00a0for responses that do not require an official formal\u00a0response such as email inquiries on\u00a0whether or not\u00a0an activity even requires an application to the IRB or various inquiries made by the research community at MTSU.\u00a0\u00a0The IRB Vice-Chair will\u00a0assist\u00a0with communication efforts to the research community at MTSU, particularly in addressing complaints and noncompliance.\u00a0\u00a0The IRB Chair will be the final editor for letters with respect to Initial and Continuing Full and Expedited Reviews, non-minor substantive Modifications to Full and Expedited studies, and Incidents, and other\u00a0decisions\u00a0as necessary.\u00a0The IRB Chair editorship\u00a0coextends\u00a0with the typical editorship by the Research Compliance Officer on the IRB who will typically be the final editor for the remaining official letters of the IRB, particularly for Exempt studies, minor Modifications, and Closures;\u00a0though, again,\u00a0the IRB Chair may oversee these letters if\u00a0the situation arises for any\u00a0appropriate\u00a0reason.\u00a0\u00a0\u00a0<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongreporting-findings-and-actions-to-the-institution-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongreporting-findings-and-actions-to-the-institution-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongreporting-findings-and-actions-to-the-institution-strong\"><strong>Reporting Findings and Actions to the Institution<\/strong><\/button><\/h2><div id=\"collapsenewExpandablestrongreporting-findings-and-actions-to-the-institution-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongreporting-findings-and-actions-to-the-institution-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>The IRB,&nbsp;with the&nbsp;assistance&nbsp;of the Research Compliance Officer on the IRB,&nbsp;will report its findings and actions to the institution in the following three ways:&nbsp;<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>The official email notification system in Cayuse will always include the current Director of\u00a0ORSP\u00a0(the Office of Research and Sponsored Projects)\u00a0on behalf of the institution\u00a0regarding\u00a0correspondence\u00a0with the official decisions made by the IRB.\u00a0\u00a0The Director\u00a0of ORSP\u00a0will have access to Cayuse to be able to reference these decisions as necessary and appropriate.\u00a0\u00a0\u00a0<\/li>\n<\/ol>\n\n\n\n<ol start=\"2\" class=\"wp-block-list\">\n<li>The Research Compliance Officer on the IRB Committee will prepare and present an IRB Annual Report to the Institutional Official at MTSU\u00a0that\u00a0reviews\u00a0the activities of the IRB over the course of the academic year.\u00a0\u00a0\u00a0<\/li>\n<\/ol>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li>The Research Compliance Officer on the IRB Committee will\u00a0forward\u00a0any required reporting to\u00a0the Office for Human Research Protections\u00a0to the Director of\u00a0ORSP\u00a0and\/or the Institutional Official.\u00a0\u00a0The\u00a0immediate chain of reporting to the Institutional Official will typically be done in consultation with the\u00a0Director of ORSP\u00a0or as necessary\u00a0depending on\u00a0the urgency of the situation.\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n<\/ol>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongdetermining-the-frequency-of-continuing-review-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongdetermining-the-frequency-of-continuing-review-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongdetermining-the-frequency-of-continuing-review-strong\"><strong>Determining\u00a0the Frequency of Continuing Review<\/strong>\u00a0<\/button><\/h2><div id=\"collapsenewExpandablestrongdetermining-the-frequency-of-continuing-review-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongdetermining-the-frequency-of-continuing-review-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>The convened IRB must&nbsp;require&nbsp;continuing review at intervals less than one year when the research meets one or more of the following criteria:&nbsp;<\/p>\n\n\n\n<p>\u00b7 Heightened Risk: The research involves procedures associated with high or significantly elevated risk to subjects, or the level of risk is highly uncertain.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Vulnerable Populations: The research involves a vulnerable population (e.g., children, prisoners, pregnant women, or individuals with an impaired decision-making capacity) coupled with high-risk interventions or where the prospect of direct benefit to the individual participant is minimal or absent.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Initial Implementation Phase: The research is in the early enrollment phase where potential risks or adverse events have not yet been fully&nbsp;established&nbsp;or understood.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Investigator Experience: The PI or key research personnel are inexperienced with the specific intervention, population, or site, or the PI has a history of recurrent non-compliance.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Safety\/Monitoring Plan: The IRB&nbsp;determines&nbsp;that the complexity of the data safety monitoring plan or the research design requires more frequent review to ensure subject safety.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Regulatory Requirements: The study is subject to specific regulatory&nbsp;requirements&nbsp;mandating a shorter review cycle.&nbsp;<\/p>\n\n\n\n<p>The IRB approval letter must document the specific criteria and the rationale for assigning an approval&nbsp;period&nbsp;less than one year.&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongverification-of-no-material-changes-from-external-sources-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongverification-of-no-material-changes-from-external-sources-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongverification-of-no-material-changes-from-external-sources-strong\"><strong>Verification of No Material Changes from External Sources<\/strong>\u00a0<\/button><\/h2><div id=\"collapsenewExpandablestrongverification-of-no-material-changes-from-external-sources-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongverification-of-no-material-changes-from-external-sources-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>External verification is defined as a non-routine compliance audit, site visit, or monitoring activity performed by&nbsp;a&nbsp;Research Compliance Officer&nbsp;or a third-party monitor&nbsp;designated&nbsp;by the IRB.&nbsp;<\/p>\n\n\n\n<p>The IRB must consider and document the need for verification from sources other than the investigator when one or more of the following criteria are met:&nbsp;<\/p>\n\n\n\n<p>\u00b7 History of Non-Compliance: The PI or study team has a documented history of serious or continuing non-compliance (e.g., conducting research without approval, failure to obtain\/document consent, recurrent significant protocol deviations).&nbsp;<\/p>\n\n\n\n<p>\u00b7&nbsp;Late\/Inaccurate Reporting: The PI has a history of late, incomplete, or inconsistent reporting of unanticipated problems, serious adverse events, or non-compliance on current or other protocols.&nbsp;<\/p>\n\n\n\n<p>\u00b7 High-Risk Logistics: The study involves complex&nbsp;logistics, off-site locations (especially international sites), or novel procedures that make direct IRB oversight difficult.&nbsp;<\/p>\n\n\n\n<p>\u00b7 High-Risk\/High-Visibility Research: The research is highly visible, presents a high-profile risk to the institution, or involves complex financial arrangements.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Suspension or Termination: Verification is&nbsp;required&nbsp;as a condition for resuming a study that was previously suspended or&nbsp;terminated&nbsp;by the IRB.&nbsp;<\/p>\n\n\n\n<p>\u00b7 External Concerns: Concerns or allegations have been raised by study participants, staff, or external bodies&nbsp;regarding&nbsp;the conduct of the research.&nbsp;<\/p>\n\n\n\n<p>When the IRB&nbsp;determines&nbsp;that external verification is necessary, the decision and rationale must be documented in the meeting minutes.&nbsp;<\/p>\n\n\n\n<p>The verification will be conducted by the Research Compliance Officer on the IRB&nbsp;or a member of the IRB, and may include, but is not limited to:&nbsp;<\/p>\n\n\n\n<p>\u00b7 Reviewing source documents (consent forms).&nbsp;<\/p>\n\n\n\n<p>\u00b7&nbsp;Observing&nbsp;the consent process.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Reviewing regulatory binders and investigator files.&nbsp;<\/p>\n\n\n\n<p>\u00b7 Interviewing study staff and\/or participants.&nbsp;<\/p>\n\n\n\n<p>The findings of the external verification must be reported back to the convened IRB or the reviewing body for further action, which may include requiring modifications, suspension, or termination of the study.&nbsp;<\/p>\n\n\n\n<p>The PI will be informed of the requirement for verification and any conditions resulting from the verification findings.&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongmodifications-to-previously-approved-protocols-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongmodifications-to-previously-approved-protocols-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongmodifications-to-previously-approved-protocols-strong\"><strong>Modifications to Previously Approved Protocols<\/strong><\/button><\/h2><div id=\"collapsenewExpandablestrongmodifications-to-previously-approved-protocols-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongmodifications-to-previously-approved-protocols-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p><strong>Special considerations with respect to Modifications<\/strong>&nbsp;<\/p>\n\n\n\n<p>Researchers must submit a Modification submission in Cayuse for all and any proposed changes to a previously approved protocol and receive approval via an official Cayuse decision letter before implementation except a) when necessary to eliminate apparent immediate hazards to the subject or b) correcting small grammatical mistakes the editing of which would not alter the meaning of&nbsp;the&nbsp;content viewed by participants.&nbsp; The IRB will make sure researchers know this procedure via included statements on Initial&nbsp;Approval letters and Return to PI or Minor Stipulations letters&nbsp;to Modification submissions,&nbsp;as well as&nbsp;the posting of these written procedures on the IRB website.&nbsp;&nbsp;The IRB will ensure compliance with this written procedure by treating&nbsp;any and all&nbsp;deviations from the procedure as&nbsp;possible&nbsp;noncompliance.&nbsp;&nbsp;For procedures handling&nbsp;noncompliance&nbsp;see below.&nbsp;&nbsp;The IRB recognizes two types of Modification, major or substantive, and minor or non-substantive, defined below:&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>Major\/Substantive&nbsp;Modification:&nbsp;A proposed change in&nbsp;research-related activities that materially affects&nbsp;the&nbsp;assessment of risks and benefits or&nbsp;substantially changes&nbsp;the specific aims,&nbsp;design,&nbsp;or&nbsp;methodology&nbsp;of the study.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Indicators:\u00a0\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Any change that potentially increases the probability or\u00a0magnitude\u00a0of harm,\u00a0\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>decreases participant privacy,\u00a0\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>or\u00a0shifts\u00a0the study&#8217;s core\u00a0objectives.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Examples:\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Introducing new procedures that involve more than minimal risk (e.g., invasive physical tests).\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adding sensitive or &#8220;high-risk&#8221; questions to a survey (e.g.,\u00a0regarding\u00a0illegal behavior, mental health, or trauma).\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Expanding the study population to include vulnerable groups (e.g., minors, prisoners, or individuals with impaired decision-making capacity).\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Collecting\u00a0new identifiable information,\u00a0using\u00a0less secure data storage, or sharing data with external parties not previously\u00a0disclosed\u00a0to the participant.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Minor\/Non-Substantive Modification:&nbsp;A proposed change in&nbsp;research-related activities that does not materially affect an assessment of the risks and benefits of the study and does not&nbsp;substantially change&nbsp;the specific aims or design of the study.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Indicators:\u00a0\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Administrative\u00a0updates or\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Procedural changes that do not exceed the minimal\u00a0risk\u00a0threshold.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Examples:\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Updating contact information on recruitment materials or consent forms.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Correction of typographical, spelling, or grammatical errors in the protocol.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Changes in study personnel.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Minor increases in the sample size (provided the recruitment methods\u00a0remain\u00a0the same).\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adding a new\u00a0study\u00a0site that follows the exact same procedures.\u00a0<\/li>\n<\/ul>\n\n\n\n<p><strong>Prerequisite Check&nbsp;(Major\/Minor Modifications)<\/strong>&nbsp;<\/p>\n\n\n\n<p>For protocols involving a change in personnel,&nbsp;a Research Compliance Officer will verify that all added personnel have successfully completed all required training modules and that the Principal Investigator has verified and documented their credentials. If there is&nbsp;anything&nbsp;missing with respect to training, the Research Compliance Officer conducting the prerequisite check will send the application back to the researcher with comments.&nbsp;<\/p>\n\n\n\n<p><strong>Pre-Review or Analysis&nbsp;(Major\/Minor Modifications)<\/strong>&nbsp;<\/p>\n\n\n\n<p>If the protocol passes the Prerequisite Check or when it is returned, it will be reassigned to the Research Compliance Officer on the IRB Committee for Analysis. The RCO on the IRB committee will&nbsp;determine&nbsp;if the research&nbsp;remains&nbsp;Exempt or&nbsp;is&nbsp;not Exempt<s>,<\/s>&nbsp;based on the proposed changes. The RCO&nbsp;provides&nbsp;comments&nbsp;that guide&nbsp;the review of the protocol&nbsp;and&nbsp;completes&nbsp;the Analyst Checklist.&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>Review of Minor Modifications<\/strong><strong><\/strong>&nbsp;<\/p>\n\n\n\n<p>If the RCO deems that a modification&nbsp;maintains&nbsp;the study&#8217;s Exempt status, the review is conducted by the RCO or the IRB Vice-Chair.&nbsp;For studies previously approved under the Expedited&nbsp;or Full&nbsp;categories, the RCO&nbsp;and&nbsp;the IRB Vice-Chair&nbsp;maintains&nbsp;the authority to review and approve minor changes directly.&nbsp;Throughout this process, a &#8220;Return to PI&#8221; or a &#8220;Minor Stipulations&#8221; letter&nbsp;may be issued to the researchers,&nbsp;depending on the revisions needed for approval. Before&nbsp;issuing the&nbsp;final approval letter, the Reviewer Checklist&nbsp;must be completed, followed by a&nbsp;Post-Review&nbsp;check of the correspondence by either the RCO or the IRB Chair.&nbsp;<\/p>\n\n\n\n<p><strong>Review of Major Modifications<\/strong>&nbsp;<\/p>\n\n\n\n<p>When the RCO&nbsp;determines&nbsp;that a modification is Non-Exempt and Major, the protocol is escalated to the IRB Chair for further analysis. The RCO provides recommendations&nbsp;on&nbsp;the necessity of a Full Board Review&nbsp;in&nbsp;accordance with&nbsp;regulatory requirements. The IRB Chair then&nbsp;determines&nbsp;the&nbsp;appropriate review&nbsp;level (Expedited or&nbsp;Full) based on the proposed changes, completes the Analyst Checklist, and assigns the protocol accordingly. If&nbsp;designated&nbsp;as Expedited, the Chair may assign the review to any IRB member. While the Chair makes every effort to select reviewers with relevant subject matter&nbsp;expertise, researchers are expected to prepare applications in&nbsp;an&nbsp;accessible language so that reviewers from different fields can understand the protocol. If the Chair&nbsp;designates&nbsp;the protocol for Full Review, both&nbsp;a Primary&nbsp;and Secondary Reviewer will be assigned, with a focus on matching the reviewers&#8217;&nbsp;expertise&nbsp;to the scope and complexity of the research.&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongreporting-unanticipated-problems-with-the-research-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongreporting-unanticipated-problems-with-the-research-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongreporting-unanticipated-problems-with-the-research-strong\"><strong>Reporting Unanticipated Problems with the Research<\/strong><\/button><\/h2><div id=\"collapsenewExpandablestrongreporting-unanticipated-problems-with-the-research-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongreporting-unanticipated-problems-with-the-research-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p><strong>Researcher Responsibilities&nbsp;for&nbsp;Prompt Reporting&nbsp;of Unanticipated Problems&nbsp;to the IRB<\/strong>&nbsp;<\/p>\n\n\n\n<p>Researchers must report any unanticipated problems involving risks to subjects or others within 24 hours to a Research Compliance Officer at MTSU either by leaving a detailed voice message (currently transcribed as text&nbsp;in an&nbsp;email&nbsp;notification),&nbsp;or via email,&nbsp;sharing as much&nbsp;information as possible about the problem.&nbsp;&nbsp;An unanticipated problem would be an unforeseen risk related to the research or at least not clearly unrelated from the perspective of a critical&nbsp;third or neutral&nbsp;party.&nbsp;<\/p>\n\n\n\n<p>Events requiring reporting include but do not exhaust the following list (when in doubt, report):&nbsp;<\/p>\n\n\n\n<p>-Any event that, in the Investigator\u2019s opinion, was unanticipated, involved risk to participants or others, and was&nbsp;possibly related&nbsp;to the research procedures&nbsp;<\/p>\n\n\n\n<p>-Any event that requires prompt reporting, according to the protocol, to the sponsor&nbsp;<\/p>\n\n\n\n<p>-Any accidental or unintentional change to the IRB-approved protocol that increases risk or decreases benefit, affects participants\u2019 rights, safety, or welfare, or affects the integrity of resultant data&nbsp;<\/p>\n\n\n\n<p>-Any accidental or unintentional change to the IRB-approved protocol that has the potential to reoccur&nbsp;&nbsp;<\/p>\n\n\n\n<p>-Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result, or other finding that&nbsp;indicates&nbsp;an unexpected change to the risk\/benefit ratio of the research.&nbsp;&nbsp;<\/p>\n\n\n\n<p>-Any adverse event that is both serious and unexpected, and which, in the Investigator\u2019s opinion, or the&nbsp;likely opinion&nbsp;of a critical&nbsp;neutral&nbsp;party,&nbsp;is more likely than not to be related to the research procedures&nbsp;<\/p>\n\n\n\n<p>-A breach in confidentiality that may involve risk to an individual or others&nbsp;<\/p>\n\n\n\n<p>-Any complaint of a participant that&nbsp;indicates&nbsp;an unanticipated risk or cannot be resolved by the research staff&nbsp;<\/p>\n\n\n\n<p>After notification, the researcher, within&nbsp;an&nbsp;additional&nbsp;48 hours, must&nbsp;submit&nbsp;an Incident report in Cayuse ensuring a complete report of the unanticipated problem.&nbsp;&nbsp;The report must include as much information as possible about the context prior to the&nbsp;unanticipated problem, the actual event itself, and the steps taken between its occurrence and reporting it to the IRB.&nbsp;&nbsp;After&nbsp;48&nbsp;hours&nbsp;the IRB Vice-Chair will reach out to the researcher for comment.&nbsp;&nbsp;If the researcher proves&nbsp;unresponsive&nbsp;the IRB Vice-Chair may&nbsp;forward&nbsp;the concern to the IRB Chair and Research Compliance Officer on the IRB as a potential issue of noncompliance.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>IRB&nbsp;and Research Compliance Officer&nbsp;Responsibilities&nbsp;for&nbsp;Prompt Reporting of Unanticipated Problems to the Institutional Official, the Office of Human Research Protections, and any other Relevant Federal Agencies or Departments&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p>Upon notice of an unanticipated problem,&nbsp;the Research Compliance Officer will notify the IRB Chair and IRB Vice Chair of the problem via email and initiate an analysis of the event vis-\u00e0-vis reporting requirements to the Office of Human Research Protections, and if funded, any other reporting requirements with respect to other relevant departments and agencies of the federal government, and any other applicable government and sponsor reporting requirements.&nbsp; The Research Compliance Officer will consult the most current reporting requirements to OHRP for analysis:&nbsp;&nbsp;<a href=\"https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html<\/a>.&nbsp;<\/p>\n\n\n\n<p>Upon determination that the unanticipated problem meets the reporting requirements to the Office of Human Research Protections,&nbsp;the Research Compliance Officer on the committee will draft a report in consultation with the IRB Chair and IRB Vice-Chair&nbsp;and notify the&nbsp;Institutional&nbsp;Official&nbsp;via the Director of the Office of Research and Sponsored Programs&nbsp;upon completion of the draft.&nbsp; This action may&nbsp;proceed&nbsp;irrespective of a receipt of an Incident submission on Cayuse by the researcher if the&nbsp;initial&nbsp;notification presents facts that&nbsp;warrant&nbsp;the event&nbsp;be&nbsp;reported to the Office of Human Research Protections.&nbsp;&nbsp;The reporting process will adhere to the following given by OHRP and with&nbsp;an initial&nbsp;report&nbsp;submitted&nbsp;no later than 10 business days upon the&nbsp;initial&nbsp;notification of the unanticipated problem to the Research Compliance Officer:&nbsp;<\/p>\n\n\n\n<p>\u201cThe reporting requirements found in the 2018 Common Rule at 45 CFR 46.108(a)(4) and 45 CFR 46.113 (for research conducted under the pre-2018 Common Rule at 45 CFR 46.103(b)(5) and 45 CFR 46.113) do not specify a time frame for reporting, except to say this must be done in a &#8220;prompt&#8221; manner. The regulations require that institutions must establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of the following:&nbsp;<\/p>\n\n\n\n<p>any unanticipated problems involving risks to subjects or&nbsp;others;&nbsp;<\/p>\n\n\n\n<p>any serious or continuing noncompliance with this policy or the requirements or determinations of the&nbsp;IRB;&nbsp;&nbsp;<\/p>\n\n\n\n<p>and any suspension or termination of IRB approval.&nbsp;<\/p>\n\n\n\n<p>In some instances, it may be&nbsp;appropriate for&nbsp;an institution or IRB to&nbsp;submit&nbsp;an initial report to fulfill the regulatory requirement for prompt reporting.&nbsp;Subsequent&nbsp;reports should be&nbsp;submitted&nbsp;when&nbsp;new information&nbsp;is available or as the institution\u2019s evaluation of the incident progresses.&nbsp;<\/p>\n\n\n\n<p>For a more serious incident, this may mean reporting to OHRP within days. For a less serious incident, a few weeks may be sufficient. Depending on the incident it may be&nbsp;appropriate to&nbsp;send&nbsp;an initial&nbsp;report, and&nbsp;indicate&nbsp;that a follow-up or final report will follow by the earlier of:&nbsp;<\/p>\n\n\n\n<p>a specific&nbsp;date;&nbsp;&nbsp;<\/p>\n\n\n\n<p>or when an investigation has been&nbsp;completed,&nbsp;or a corrective action plan has been implemented.\u201d&nbsp;<a href=\"https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html<\/a>&nbsp;<\/p>\n\n\n\n<p>Upon receipt of the Incident submission in Cayuse, the Research Compliance Officer on the Committee will complete an Analysis of the Incident and&nbsp;forward&nbsp;it&nbsp;to the IRB Chair with comments given on the Analyst checklist.&nbsp;&nbsp;Incident submissions will automatically take precedent in the task&nbsp;till on&nbsp;Cayuse.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>The IRB Chair will then review the Incident submission on Cayuse&nbsp;along with&nbsp;comments by the Research Compliance Officer on the committee.&nbsp;&nbsp;If the&nbsp;IRB&nbsp;Chair&nbsp;determines&nbsp;that&nbsp;the Incident submission&nbsp;is&nbsp;incomplete or missing any relevant information, the IRB Chair&nbsp;will send a Return to PI letter to the researcher(s) with follow up questions.&nbsp;&nbsp;Upon&nbsp;receiving&nbsp;a satisfactory report,&nbsp;the IRB Chair will issue a Noted letter.&nbsp;&nbsp;The Research Compliance Officer on the committee will&nbsp;utilize&nbsp;and compare the final report by the researcher as Noted by the IRB Chair to any&nbsp;initial&nbsp;report already made to OHRP or any other relevant institution to see if it requires a follow up report.&nbsp;&nbsp;The Research Compliance Officer on the committee will&nbsp;submit&nbsp;any necessary&nbsp;follow ups&nbsp;to OHRP&nbsp;within 10 business days of a Noted decision reached by the IRB Chair.&nbsp;&nbsp;&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstronginvestigating-and-reporting-noncompliance-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestronginvestigating-and-reporting-noncompliance-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestronginvestigating-and-reporting-noncompliance-strong\"><strong>Investigating and Reporting Noncompliance<\/strong>\u00a0<\/button><\/h2><div id=\"collapsenewExpandablestronginvestigating-and-reporting-noncompliance-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstronginvestigating-and-reporting-noncompliance-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>Upon notice&nbsp;to&nbsp;either the IRB or Research Compliance Office&nbsp;of any noncompliance,&nbsp;the Research Compliance Officer on the IRB will consult with the IRB Chair and IRB Vice-Chair, or vice versa&nbsp;to determine the seriousness of the alleged non-compliance&nbsp;and set up a plan, if further information is needed, for the Research Compliance Officer on the IRB and the IRB Vice-Chair to investigate and gather more evidence with respect to the allegation of noncompliance.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>The&nbsp;IRB Chair, IRB Vice-Chair, and Research Compliance Office&nbsp;will assess&nbsp;whether or not&nbsp;the alleged noncompliance meets any of the following definitions:&nbsp;<\/p>\n\n\n\n<p>1.&nbsp;Non-compliance:&nbsp;Failure to&nbsp;comply with&nbsp;Federal regulations, MTSU IRB Policy, or the determinations or requirements of the MTSU IRB.&nbsp;<\/p>\n\n\n\n<p>2.&nbsp;Serious Non-compliance:&nbsp;An action or omission taken by an Investigator that any other reasonable&nbsp;and critical neutral party&nbsp;would have foreseen as compromising the rights and welfare of a participant.&nbsp;<\/p>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li>Continuing Non-compliance:\u00a0A pattern of repeated actions or omissions taken by an\u00a0Investigator that\u00a0indicates\u00a0a deficiency in the ability or willingness of an Investigator to\u00a0comply with\u00a0Federal regulations, MTSU IRB Policy, or determinations or requirements of the MTSU IRB.\u00a0<\/li>\n<\/ol>\n\n\n\n<p>If&nbsp;the IRB Chair, IRB Vice-Chair and\/or Research Compliance Office&nbsp;finds that there is sufficient evidence that the alleged noncompliance is either serious (definition 2) or continuing (definition 3), the IRB Chair will call a special meeting of the IRB to deliberate and vote on the findings and develop a corrective action plan for the researcher.&nbsp; The IRB Committee may confirm or dispute by majority&nbsp;vote&nbsp;the finding of the alleged noncompliance as either serious or continuing.&nbsp;(See also MTSU Policy 402, IX Violation of Policy, B. 4., concerning the overlap of noncompliance with research misconduct, the investigation of which&nbsp;is distinct from standard IRB procedures and is handled by the Institutional Official.)&nbsp;<\/p>\n\n\n\n<p>If the&nbsp;IRB Chair and IRB Vice-Chair or Research Compliance Office&nbsp;finds sufficient evidence of noncompliance that is neither serious nor continuing, the IRB Vice Chair will correspond with the research team about the findings, emphasizing the significance of compliance and repercussions of continuing noncompliance.&nbsp;&nbsp;<\/p>\n\n\n\n<p>The&nbsp;IRB Chair and IRB Vice-Chair, on the recommendation of the Research Compliance Office, or because of their own determination,&nbsp;may require&nbsp;additional&nbsp;training&nbsp;to be completed by the research team,&nbsp;up to a session of an hour and a half, specifically tailored to&nbsp;avoid&nbsp;continuing noncompliance,&nbsp;with the Research Compliance Officer on the IRB and the IRB Vice-Chair.&nbsp; For possible corrective actions taken by&nbsp;the entire IRB Committee,&nbsp;see MTSU IRB Policy&nbsp;IX. Violation of Policy&nbsp;Section&nbsp;B.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>Upon determination that the&nbsp;noncompliance&nbsp;meets the reporting requirements to the Office of Human Research Protections&nbsp;as either serious or continuing&nbsp;(if the noncompliance also involves an unanticipated problem then the reporting will defer to the procedures described above under \u201cReporting Unanticipated Problems with the Research\u201d),&nbsp;the Research Compliance Officer on the committee will draft a report in consultation with the IRB&nbsp;Committee&nbsp;and notify the Institutional Official via the Director of the Office of Research and Sponsored Programs upon completion of the draft.&nbsp; The reporting process will adhere to the following given by OHRP and with&nbsp;an initial&nbsp;report&nbsp;submitted&nbsp;no later than 10 business days&nbsp;upon the&nbsp;determination of serious or continuing noncompliance:&nbsp;<\/p>\n\n\n\n<p>\u201cThe reporting requirements found in the 2018 Common Rule at 45 CFR 46.108(a)(4) and 45 CFR 46.113 (for research conducted under the pre-2018 Common Rule at 45 CFR 46.103(b)(5) and 45 CFR 46.113) do not specify a time frame for reporting, except to say this must be done in a &#8220;prompt&#8221; manner. The regulations require that institutions must establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of the following:&nbsp;<\/p>\n\n\n\n<p>any unanticipated problems involving risks to subjects or&nbsp;others;&nbsp;<\/p>\n\n\n\n<p>any serious or continuing noncompliance with this policy or the requirements or determinations of the&nbsp;IRB;&nbsp;&nbsp;<\/p>\n\n\n\n<p>and any suspension or termination of IRB approval.&nbsp;<\/p>\n\n\n\n<p>In some instances, it may be&nbsp;appropriate for&nbsp;an institution or IRB to&nbsp;submit&nbsp;an initial report to fulfill the regulatory requirement for prompt reporting.&nbsp;Subsequent&nbsp;reports should be&nbsp;submitted&nbsp;when&nbsp;new information&nbsp;is available or as the institution\u2019s evaluation of the incident progresses.&nbsp;<\/p>\n\n\n\n<p>For a more serious incident, this may mean reporting to OHRP within days. For a less serious incident, a few weeks may be sufficient. Depending on the incident it may be&nbsp;appropriate to&nbsp;send&nbsp;an initial&nbsp;report, and&nbsp;indicate&nbsp;that a&nbsp;follow-up or final report will follow by the earlier of:&nbsp;<\/p>\n\n\n\n<p>a specific&nbsp;date;&nbsp;&nbsp;<\/p>\n\n\n\n<p>or when an investigation has been completed, or a corrective action plan has been implemented.\u201d https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-expandable-item accordion-item expandable-heading expandable-heading-faq\"><h2 class=\"accordion-header\" id=\"headingstrongconducting-and-reporting-suspension-or-termination-of-irb-approval-strong\"><button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#collapsenewExpandablestrongconducting-and-reporting-suspension-or-termination-of-irb-approval-strong\" aria-expanded=\"false\" aria-controls=\"collapsenewExpandablestrongconducting-and-reporting-suspension-or-termination-of-irb-approval-strong\"><strong>Conducting and Reporting Suspension or Termination of IRB Approval\u00a0<\/strong>\u00a0<\/button><\/h2><div id=\"collapsenewExpandablestrongconducting-and-reporting-suspension-or-termination-of-irb-approval-strong\" class=\"accordion-collapse collapse expandable-content expandable-content-faq\" aria-labelledby=\"headingstrongconducting-and-reporting-suspension-or-termination-of-irb-approval-strong\" data-bs-parent=\"#newExpandable\"><div class=\"accordion-body\">\n<p>If in the course of the reporting process of an unanticipated problem or serious or continuing noncompliance the IRB Chair, IRB Vice-Chair, and Research Compliance Officer on the IRB have a reasonable belief that if the study is not suspended immediately that it could result in harm to participants,&nbsp;the IRB Chair will notify the researcher to immediately suspend all research activities until the IRB Committee can deliberate with respect to the report.&nbsp;&nbsp;This does not mean that all reports of unanticipated problems or serious or continuing noncompliance result in an immediate suspension.&nbsp;&nbsp;This applies only to&nbsp;those&nbsp;studies&nbsp;in which the IRB Chair,&nbsp;in conjunction with the IRB&nbsp;Vice-Chair and Research Compliance Officer on the IRB,&nbsp;have a reasonable belief that if they&nbsp;don\u2019t&nbsp;suspend the study&nbsp;immediately&nbsp;it could result in harms to participants.&nbsp;<\/p>\n\n\n\n<p>Otherwise, the IRB Committee may by vote elect to suspend or&nbsp;terminate&nbsp;an IRB approval in response to any reportable event to OHRP,&nbsp;i.e.&nbsp;an unanticipated problem or serious or continuing noncompliance.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>Upon determination&nbsp;of the suspension or termination of an IRB approval, the Research Compliance Officer on the committee will draft a report in consultation with the IRB Chair and IRB Vice-Chair (for immediate suspensions to prevent further harm to participants) or the IRB Committee (for suspensions and terminations decided by the IRB Committee)&nbsp;and notify the&nbsp;Institutional Official via the Director of the Office of Research and Sponsored Programs upon completion of the draft.&nbsp; The reporting process will adhere to the following given by OHRP and with&nbsp;an initial&nbsp;report&nbsp;submitted&nbsp;no later than 10 business days upon the determination of&nbsp;a suspension or termination of IRB approval:&nbsp;<\/p>\n\n\n\n<p>\u201cThe reporting requirements found in the 2018 Common Rule at 45 CFR 46.108(a)(4) and 45 CFR 46.113 (for research conducted under the pre-2018 Common Rule at 45 CFR 46.103(b)(5) and 45 CFR 46.113) do not specify a time frame for reporting, except to say this must be done in a &#8220;prompt&#8221; manner. The regulations require that institutions must establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for&nbsp;Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of the following:&nbsp;<\/p>\n\n\n\n<p>any unanticipated problems involving risks to subjects or&nbsp;others;&nbsp;<\/p>\n\n\n\n<p>any serious or continuing noncompliance with this policy or the requirements or determinations of the&nbsp;IRB;&nbsp;&nbsp;<\/p>\n\n\n\n<p>and any suspension or termination of IRB approval.&nbsp;<\/p>\n\n\n\n<p>In some instances, it may be&nbsp;appropriate for&nbsp;an institution or IRB to&nbsp;submit&nbsp;an initial report to fulfill the regulatory requirement for prompt reporting.&nbsp;Subsequent&nbsp;reports should be&nbsp;submitted&nbsp;when&nbsp;new information&nbsp;is available or as the institution\u2019s evaluation of the incident progresses.&nbsp;<\/p>\n\n\n\n<p>For a more serious incident, this may mean reporting to OHRP within days. For a less serious incident, a few weeks may be sufficient. Depending on the incident it may be&nbsp;appropriate to&nbsp;send&nbsp;an initial&nbsp;report, and&nbsp;indicate&nbsp;that a follow-up or final report will follow by the earlier of:&nbsp;<\/p>\n\n\n\n<p>a specific&nbsp;date;&nbsp;&nbsp;<\/p>\n\n\n\n<p>or when an investigation has been completed, or a corrective action plan has been implemented.\u201d https:\/\/www.hhs.gov\/ohrp\/compliance-and-reporting\/guidance-on-reporting-incident\/index.html&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In accordance with\u00a045 CFR 46.108(3-4)\u00a0the following written procedures specify the processes of the Institutional Review Board\u2019s (IRB) review of human subjects\u2019 research: initial and continuing review, the determination of review frequency, the management of modifications, and the reporting of unanticipated problems, adverse events, and noncompliance. IRB and Research Compliance Office Overview:&nbsp;&nbsp; All investigators who plan [&hellip;]<\/p>\n","protected":false},"author":223,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2217","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/2217","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/users\/223"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/comments?post=2217"}],"version-history":[{"count":2,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/2217\/revisions"}],"predecessor-version":[{"id":2222,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/2217\/revisions\/2222"}],"wp:attachment":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/media?parent=2217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}