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Research protocols that require a Full board review must be submitted a minimum of two (2) weeks prior to the scheduled IRB meeting. The dates for the scheduled meetings will be kept on file in the Office of Research Compliance and notice will be posted on the IRB website two weeks or more in advance.  Full review protocols not received by the deadline date will not be reviewed until the following meeting. There is no deadline for submitting research proposals for either Exempt or Expedited review. See MTSU Policy 402 VI /policies/p402/. 

The process for reviewing initial submissions that are categorized under the Exempt or Expedited review category is as follows:   

Prerequisite Check  

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 anything missing initially on the submission from the aforementioned items, the Research Compliance Officer conducting the prerequisite check will send the application back to the researcher with comments.  

Pre-Review or Analysis  

If the protocol passes the Prerequisite Check or when it is returned completed, it will be reassigned to the Research Compliance Officer on the IRB Committee for Analysis. The RCO on the IRB committee will determine if the research is Exempt or not Exempt and may make comments deemed helpful for the review of the protocol as well as complete the Analyst Checklist.   {The IRB Chair or IRB Vice-Chair may also complete this initial analysis or any other protocol (pre-)review task in these written procedures if the RCO on the IRB committee is not available to complete the task}.     

If the protocol is deemed Exempt, the Research Compliance Officer on the IRB will assign it to themselves or the IRB Vice-Chair for review. If the protocol is deemed not Exempt, it will be assigned to the IRB Chair for continued analysis.  The Research Compliance Officer on the IRB will make recommendations with respect to Full Review or designate it as such if required by the regulations.    

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 reviewers based on their determination. If the protocol is Expedited the IRB chair can assign it to any of the IRB members.   (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 protocol.) 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, the researchers should prepare the application in simple language such that a reviewer with a different field of expertise also would understand the protocol.  If the IRB Chair designates the protocol for Full Review, they will then assign the protocol a Primary and Secondary Reviewer. The IRB will aim to have the reviewers assigned with expertise in the area of the research adequate to the scope and complexity of the research.    

Exempt Review 

The Research Compliance Officer on the IRB or IRB Vice-Chair will return the protocol to the researcher with comments if necessary.  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 deems it not ready for review, and/or that they require particular edits deemed necessary for adequate review.  Minor Stipulations letters are reserved for protocols that require specific edits necessary before approval but may admit of a review category designation.  Before sending a final approval letter, the Reviewer will complete the Reviewer checklist.  The Research Compliance Officer on the IRB will complete the Post-Review check on any letter sent to the researcher.    

Expedited Review  

Following their review of the protocol, the assigned Reviewer will return the protocol with comments if necessary.  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, and/or require particular edits deemed necessary for adequate review.  Minor Stipulations letters are reserved for protocols that require specific edits necessary before approval but may admit of a review category determination.  Before giving a final approval decision and selecting the category that matches the review, the Reviewer will complete the Reviewer checklist.  The IRB Chair will then complete the Post-Review check of any letter before sending it to the researcher.   

Full Review Procedures  

Protocols determined to require Full Review are assigned a Primary and Secondary Reviewer by the IRB Chair.  The Reviewers conduct an in-depth review of all pertinent documentation.  

1. The Primary Reviewer will present a summary of the study to the Full IRB Committee highlighting any controversial issues and recommending modifications, if applicable.  

2. The Secondary Reviewer will be prepared to provide any additional information not presented by the Primary Reviewer by highlighting any controversial issues and recommending modifications, if applicable.  

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.  The IRB will aim to acquire both attendance and written recommendations but will aim to best accommodate the time and efforts of the volunteering consultant.  The consultant may not count toward the quorum or vote.  

4. The Reviewers will assess the protocol for both scientific and scholarly merit in relationship to the level of risk.  

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, or 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.  

6. All Committee members are given the opportunity to review, ask questions of the reviewers, and request modifications in the proposal. 

7. The Committee reviews the proposed research, 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 Reviewer checklist detailing how each of these criteria is met.  The IRB Committee will utilize the following 鈥淚RB Reminder List鈥� when discussing their review of the protocol (the abbreviated version appears on the IRB poster review board and what follows in parentheses clarifies the meanings of each of these reminders): 

鈥淧urpose clear?  

(Is the purpose of the research clearly defined and stated within the protocol?) 

  Recruitment proper? 

(Are recruitment methods appropriate, equitable, and compliant?) 

  Inducement reasonable? 

(Is any form of inducement offered to participants reasonable and proportionate to the research鈥檚 potential risks or burdens?) 

  Researcher鈥檚 experience adequate? 

(Does the researcher possess sufficient training, expertise, and experience to conduct the study appropriately?) 

  Subjects adequately informed? 

(Are participants provided with comprehensive and understandable information about the study鈥檚 procedures, risks, and benefits?) 

  Informed consent documented appropriately? 

(Is informed consent obtained鈥痠n a manner that is properly documented, with signatures and dates as required?) 

Risks necessary? Minimized to extent possible? 

(Are the risks inherent in the study both necessary for achieving research objectives and minimized as much as possible?) 

Benefits? 

(Are the potential benefits of the research to participants or society clearly described and justified in relation to the risks involved?) 

Confidentiality? 

(Are measures in place to protect participants鈥� privacy and maintain the confidentiality of their personal information throughout the study?) 

Data use explained?鈥� 

(Is the intended use of collected data clearly communicated to participants, including any plans for storage, sharing, or publication?) 

8. The Committee determines the review interval appropriate to the degree of risk, but not less than once per year.  

Investigator Responsibilities  

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 carefully and comments on edits and requirements should be addressed promptly and appropriately by the researcher. 

Research protocols reviewed initially by the fully convened IRB as a Full Review are ordinarily reviewed using standard review procedures unless the study has been modified 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 time such that standard review becomes necessary. When conducting continuing 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, and any monitoring or audit reports conducted since the last review. Findings are then presented at a convened Full IRB meeting where the protocol is discussed and voted on by the membership.  

When conducting Expedited 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 in the study 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, and/or if remaining activities are limited to data analysis.  MTSU does not require continuing review for most Expedited studies but reserves the right to do so if the IRB Chair deems it necessary for the adequate protection of human subjects.  

Exempt research activities do not require annual continuing review. However, any proposed changes must be submitted 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 changes the review level, the RCO on the IRB committee forwards it to the IRB Chair or designated member for appropriate review and determination.  

Continuing review must be substantive and meaningful, using the same criteria required at initial review in accordance with 45 CFR 46.111. The IRB must determine that risks remain minimized and reasonable relative to benefits, that subject selection remains equitable, that informed consent continues to be properly obtained and documented, and that adequate provisions remain in place to monitor data safety, protect subject privacy, and ensure confidentiality. The IRB must also confirm that safeguards for vulnerable populations remain appropriate.  

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 expiration 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 submit proposed amendments to the protocol; however, amendments cannot be implemented without IRB approval.  

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 date final approval was granted by the Chair or designated reviewer (for studies originally reviewed by a Full Board or requiring continuing review by the IRB Chair). Approval is not granted until all requested changes are completed and reviewed, and expiration periods are not extended by pending status. The IRB may maintain a constant anniversary date for reviews, provided that reviews occur annually and within 30 days of expiration. Based on its continuing review, the IRB may restrict, modify, or halt a study.  

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 (Food and Drug Administration) 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.  

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 expiration, the Research Compliance Officer on the IRB prepares studies for expiration 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.  

Approval of Continuing Review  

For Full review 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 studies, if it was deemed necessary originally by the IRB Chair, research must be reviewed within one year of the date final approval was granted by the IRB Chair or the designated reviewer. Based on its continuing review, the IRB may restrict, modify, or halt a study. Approval is not granted until all requested changes are completed and reviewed, and expiration periods are not extended by pending status.  

Expiration of IRB Approval  

There is no grace period extending beyond the expiration date of IRB approval. If approval lapses, all study activities must cease until re-approval is granted. The IRB requires investigators to submit a list of participants for whom study expiration would cause harm. The Full IRB may permit continued participation for these individuals if it determines it to be in their best interests. Enrollment of new participants is strictly prohibited once approval has expired.  

Investigator Responsibilities  

Investigators must complete a progress report and provide all continuing review materials at least four weeks before expiration. If a study expires, the investigator must cease all activities and either submit the required documents for review or notify the IRB of study closure. 

The Research Compliance Officer on the IRB Committee,听IRB Chair, and IRB Vice-Chair听will听utilize听official letters from the Cayuse system听regarding听decisions made with respect to the review of research protocols听submitted听through Cayuse.听听These听include听Initial Review, Continuing Review, Modifications, Closure, and official responses to Incidents, or the letter template downloaded for customization for official responses to miscellaneous inquiries,听(for example, requests by external researchers with IRB approval obtained already from their host institution to recruit participants at MTSU).听 Email may be听utilized听for responses that do not require an official formal听response such as email inquiries on听whether or not听an activity even requires an application to the IRB or various inquiries made by the research community at MTSU.听听The IRB Vice-Chair will听assist听with communication efforts to the research community at MTSU, particularly in addressing complaints and noncompliance.听听The 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听decisions听as necessary.听The IRB Chair editorship听coextends听with 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;听though, again,听the IRB Chair may oversee these letters if听the situation arises for any听appropriate听reason.听听听

The IRB, with the assistance of the Research Compliance Officer on the IRB, will report its findings and actions to the institution in the following three ways: 

1. The official email notification system in Cayuse will always include the current Director of听ORSP听(the Office of Research and Sponsored Projects)听on behalf of the institution听regarding听correspondence听with the official decisions made by the IRB.听听The Director听of ORSP听will have access to Cayuse to be able to reference these decisions as necessary and appropriate.听听听

2. The Research Compliance Officer on the IRB Committee will prepare and present an IRB Annual Report to the Institutional Official at MTSU听that听reviews听the activities of the IRB over the course of the academic year.听听听

3. The Research Compliance Officer on the IRB Committee will听forward听any required reporting to听the Office for Human Research Protections听to the Director of听ORSP听and/or the Institutional Official.听听The听immediate chain of reporting to the Institutional Official will typically be done in consultation with the听Director of ORSP听or as necessary听depending on听the urgency of the situation.听听听听听

The convened IRB must require continuing review at intervals less than one year when the research meets one or more of the following criteria: 

路 Heightened Risk: The research involves procedures associated with high or significantly elevated risk to subjects, or the level of risk is highly uncertain. 

路 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. 

路 Initial Implementation Phase: The research is in the early enrollment phase where potential risks or adverse events have not yet been fully established or understood. 

路 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. 

路 Safety/Monitoring Plan: The IRB determines that the complexity of the data safety monitoring plan or the research design requires more frequent review to ensure subject safety. 

路 Regulatory Requirements: The study is subject to specific regulatory requirements mandating a shorter review cycle. 

The IRB approval letter must document the specific criteria and the rationale for assigning an approval period less than one year. 

External verification is defined as a non-routine compliance audit, site visit, or monitoring activity performed by a Research Compliance Officer or a third-party monitor designated by the IRB. 

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: 

路 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). 

路 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. 

路 High-Risk Logistics: The study involves complex logistics, off-site locations (especially international sites), or novel procedures that make direct IRB oversight difficult. 

路 High-Risk/High-Visibility Research: The research is highly visible, presents a high-profile risk to the institution, or involves complex financial arrangements. 

路 Suspension or Termination: Verification is required as a condition for resuming a study that was previously suspended or terminated by the IRB. 

路 External Concerns: Concerns or allegations have been raised by study participants, staff, or external bodies regarding the conduct of the research. 

When the IRB determines that external verification is necessary, the decision and rationale must be documented in the meeting minutes. 

The verification will be conducted by the Research Compliance Officer on the IRB or a member of the IRB, and may include, but is not limited to: 

路 Reviewing source documents (consent forms). 

路 Observing the consent process. 

路 Reviewing regulatory binders and investigator files. 

路 Interviewing study staff and/or participants. 

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. 

The PI will be informed of the requirement for verification and any conditions resulting from the verification findings. 

Special considerations with respect to Modifications 

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 the content viewed by participants.  The IRB will make sure researchers know this procedure via included statements on Initial Approval letters and Return to PI or Minor Stipulations letters to Modification submissions, as well as the posting of these written procedures on the IRB website.  The IRB will ensure compliance with this written procedure by treating any and all deviations from the procedure as possible noncompliance.  For procedures handling noncompliance see below.  The IRB recognizes two types of Modification, major or substantive, and minor or non-substantive, defined below:   

Major/Substantive Modification: A proposed change in research-related activities that materially affects the assessment of risks and benefits or substantially changes the specific aims, design, or methodology of the study. 

• Indicators:听听

• Any change that potentially increases the probability or听magnitude听of harm,听听

• decreases participant privacy,听听

• or听shifts听the study’s core听objectives.听

• Examples:听

• Introducing new procedures that involve more than minimal risk (e.g., invasive physical tests).听

• Adding sensitive or “high-risk” questions to a survey (e.g.,听regarding听illegal behavior, mental health, or trauma).听

• Expanding the study population to include vulnerable groups (e.g., minors, prisoners, or individuals with impaired decision-making capacity).听

• Collecting听new identifiable information,听using听less secure data storage, or sharing data with external parties not previously听disclosed听to the participant.听

• 听

Minor/Non-Substantive Modification: A proposed change in research-related activities that does not materially affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study. 

• Indicators:听听

• Administrative听updates or听

• Procedural changes that do not exceed the minimal听risk听threshold.听

• Examples:听

• Updating contact information on recruitment materials or consent forms.听

• Correction of typographical, spelling, or grammatical errors in the protocol.听

• Changes in study personnel.听

• Minor increases in the sample size (provided the recruitment methods听remain听the same).听

• Adding a new听study听site that follows the exact same procedures.听

Prerequisite Check (Major/Minor Modifications) 

For protocols involving a change in personnel, 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 anything missing with respect to training, the Research Compliance Officer conducting the prerequisite check will send the application back to the researcher with comments. 

Pre-Review or Analysis (Major/Minor Modifications) 

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 determine if the research remains Exempt or is not Exempt, based on the proposed changes. The RCO provides comments that guide the review of the protocol and completes the Analyst Checklist.  

Review of Minor Modifications 

If the RCO deems that a modification maintains the study’s Exempt status, the review is conducted by the RCO or the IRB Vice-Chair. For studies previously approved under the Expedited or Full categories, the RCO and the IRB Vice-Chair maintains the authority to review and approve minor changes directly. Throughout this process, a “Return to PI” or a “Minor Stipulations” letter may be issued to the researchers, depending on the revisions needed for approval. Before issuing the final approval letter, the Reviewer Checklist must be completed, followed by a Post-Review check of the correspondence by either the RCO or the IRB Chair. 

Review of Major Modifications 

When the RCO determines that a modification is Non-Exempt and Major, the protocol is escalated to the IRB Chair for further analysis. The RCO provides recommendations on the necessity of a Full Board Review in accordance with regulatory requirements. The IRB Chair then determines the appropriate review level (Expedited or Full) based on the proposed changes, completes the Analyst Checklist, and assigns the protocol accordingly. If designated 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 expertise, researchers are expected to prepare applications in an accessible language so that reviewers from different fields can understand the protocol. If the Chair designates the protocol for Full Review, both a Primary and Secondary Reviewer will be assigned, with a focus on matching the reviewers’ expertise to the scope and complexity of the research. 

Researcher Responsibilities for Prompt Reporting of Unanticipated Problems to the IRB 

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 in an email notification), or via email, sharing as much information as possible about the problem.  An unanticipated problem would be an unforeseen risk related to the research or at least not clearly unrelated from the perspective of a critical third or neutral party. 

Events requiring reporting include but do not exhaust the following list (when in doubt, report): 

-Any event that, in the Investigator鈥檚 opinion, was unanticipated, involved risk to participants or others, and was possibly related to the research procedures 

-Any event that requires prompt reporting, according to the protocol, to the sponsor 

-Any accidental or unintentional change to the IRB-approved protocol that increases risk or decreases benefit, affects participants鈥� rights, safety, or welfare, or affects the integrity of resultant data 

-Any accidental or unintentional change to the IRB-approved protocol that has the potential to reoccur  

-Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result, or other finding that indicates an unexpected change to the risk/benefit ratio of the research.  

-Any adverse event that is both serious and unexpected, and which, in the Investigator鈥檚 opinion, or the likely opinion of a critical neutral party, is more likely than not to be related to the research procedures 

-A breach in confidentiality that may involve risk to an individual or others 

-Any complaint of a participant that indicates an unanticipated risk or cannot be resolved by the research staff 

After notification, the researcher, within an additional 48 hours, must submit an Incident report in Cayuse ensuring a complete report of the unanticipated problem.  The report must include as much information as possible about the context prior to the unanticipated problem, the actual event itself, and the steps taken between its occurrence and reporting it to the IRB.  After 48 hours the IRB Vice-Chair will reach out to the researcher for comment.  If the researcher proves unresponsive the IRB Vice-Chair may forward the concern to the IRB Chair and Research Compliance Officer on the IRB as a potential issue of noncompliance.     

IRB and Research Compliance Officer Responsibilities for Prompt Reporting of Unanticipated Problems to the Institutional Official, the Office of Human Research Protections, and any other Relevant Federal Agencies or Departments  

Upon notice of an unanticipated problem, 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-脿-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.  The Research Compliance Officer will consult the most current reporting requirements to OHRP for analysis:  . 

Upon determination that the unanticipated problem meets the reporting requirements to the Office of Human Research Protections, the Research Compliance Officer on the committee will draft a report in consultation with the IRB Chair and IRB Vice-Chair and notify the Institutional Official via the Director of the Office of Research and Sponsored Programs upon completion of the draft.  This action may proceed irrespective of a receipt of an Incident submission on Cayuse by the researcher if the initial notification presents facts that warrant the event be reported to the Office of Human Research Protections.  The reporting process will adhere to the following given by OHRP and with an initial report submitted no later than 10 business days upon the initial notification of the unanticipated problem to the Research Compliance Officer: 

鈥淭he 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 “prompt” 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: 

any unanticipated problems involving risks to subjects or others; 

any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB;  

and any suspension or termination of IRB approval. 

In some instances, it may be appropriate for an institution or IRB to submit an initial report to fulfill the regulatory requirement for prompt reporting. Subsequent reports should be submitted when new information is available or as the institution鈥檚 evaluation of the incident progresses. 

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 appropriate to send an initial report, and indicate that a follow-up or final report will follow by the earlier of: 

a specific date;  

or when an investigation has been completed, or a corrective action plan has been implemented.鈥�  

Upon receipt of the Incident submission in Cayuse, the Research Compliance Officer on the Committee will complete an Analysis of the Incident and forward it to the IRB Chair with comments given on the Analyst checklist.  Incident submissions will automatically take precedent in the task till on Cayuse.   

The IRB Chair will then review the Incident submission on Cayuse along with comments by the Research Compliance Officer on the committee.  If the IRB Chair determines that the Incident submission is incomplete or missing any relevant information, the IRB Chair will send a Return to PI letter to the researcher(s) with follow up questions.  Upon receiving a satisfactory report, the IRB Chair will issue a Noted letter.  The Research Compliance Officer on the committee will utilize and compare the final report by the researcher as Noted by the IRB Chair to any initial report already made to OHRP or any other relevant institution to see if it requires a follow up report.  The Research Compliance Officer on the committee will submit any necessary follow ups to OHRP within 10 business days of a Noted decision reached by the IRB Chair.   

Upon notice to either the IRB or Research Compliance Office of any noncompliance, the Research Compliance Officer on the IRB will consult with the IRB Chair and IRB Vice-Chair, or vice versa to determine the seriousness of the alleged non-compliance 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.   

The IRB Chair, IRB Vice-Chair, and Research Compliance Office will assess whether or not the alleged noncompliance meets any of the following definitions: 

1. Non-compliance: Failure to comply with Federal regulations, MTSU IRB Policy, or the determinations or requirements of the MTSU IRB. 

2. Serious Non-compliance: An action or omission taken by an Investigator that any other reasonable and critical neutral party would have foreseen as compromising the rights and welfare of a participant. 

3. Continuing Non-compliance:听A pattern of repeated actions or omissions taken by an听Investigator that听indicates听a deficiency in the ability or willingness of an Investigator to听comply with听Federal regulations, MTSU IRB Policy, or determinations or requirements of the MTSU IRB.听

If the IRB Chair, IRB Vice-Chair and/or Research Compliance Office 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.  The IRB Committee may confirm or dispute by majority vote the finding of the alleged noncompliance as either serious or continuing. (See also MTSU Policy 402, IX Violation of Policy, B. 4., concerning the overlap of noncompliance with research misconduct, the investigation of which is distinct from standard IRB procedures and is handled by the Institutional Official.) 

If the IRB Chair and IRB Vice-Chair or Research Compliance Office 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.  

The IRB Chair and IRB Vice-Chair, on the recommendation of the Research Compliance Office, or because of their own determination, may require additional training to be completed by the research team, up to a session of an hour and a half, specifically tailored to avoid continuing noncompliance, with the Research Compliance Officer on the IRB and the IRB Vice-Chair.  For possible corrective actions taken by the entire IRB Committee, see MTSU IRB Policy IX. Violation of Policy Section B.   

Upon determination that the noncompliance meets the reporting requirements to the Office of Human Research Protections as either serious or continuing (if the noncompliance also involves an unanticipated problem then the reporting will defer to the procedures described above under 鈥淩eporting Unanticipated Problems with the Research鈥�), the Research Compliance Officer on the committee will draft a report in consultation with the IRB Committee and notify the Institutional Official via the Director of the Office of Research and Sponsored Programs upon completion of the draft.  The reporting process will adhere to the following given by OHRP and with an initial report submitted no later than 10 business days upon the determination of serious or continuing noncompliance: 

鈥淭he 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 “prompt” 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: 

any unanticipated problems involving risks to subjects or others; 

any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB;  

and any suspension or termination of IRB approval. 

In some instances, it may be appropriate for an institution or IRB to submit an initial report to fulfill the regulatory requirement for prompt reporting. Subsequent reports should be submitted when new information is available or as the institution鈥檚 evaluation of the incident progresses. 

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 appropriate to send an initial report, and indicate that a follow-up or final report will follow by the earlier of: 

a specific date;  

or when an investigation has been completed, or a corrective action plan has been implemented.鈥� https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html     

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, the IRB Chair will notify the researcher to immediately suspend all research activities until the IRB Committee can deliberate with respect to the report.  This does not mean that all reports of unanticipated problems or serious or continuing noncompliance result in an immediate suspension.  This applies only to those studies in which the IRB Chair, in conjunction with the IRB Vice-Chair and Research Compliance Officer on the IRB, have a reasonable belief that if they don鈥檛 suspend the study immediately it could result in harms to participants. 

Otherwise, the IRB Committee may by vote elect to suspend or terminate an IRB approval in response to any reportable event to OHRP, i.e. an unanticipated problem or serious or continuing noncompliance.   

Upon determination 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) and notify the Institutional Official via the Director of the Office of Research and Sponsored Programs upon completion of the draft.  The reporting process will adhere to the following given by OHRP and with an initial report submitted no later than 10 business days upon the determination of a suspension or termination of IRB approval: 

鈥淭he 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 “prompt” 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: 

any unanticipated problems involving risks to subjects or others; 

any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB;  

and any suspension or termination of IRB approval. 

In some instances, it may be appropriate for an institution or IRB to submit an initial report to fulfill the regulatory requirement for prompt reporting. Subsequent reports should be submitted when new information is available or as the institution鈥檚 evaluation of the incident progresses. 

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 appropriate to send an initial report, and indicate that a follow-up or final report will follow by the earlier of: 

a specific date;  

or when an investigation has been completed, or a corrective action plan has been implemented.鈥� https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html