{"id":62,"date":"2024-09-17T20:30:43","date_gmt":"2024-09-17T20:30:43","guid":{"rendered":"https:\/\/www.mtsu.edu\/irb\/?page_id=62"},"modified":"2026-04-12T06:31:59","modified_gmt":"2026-04-12T06:31:59","slug":"exemptpaperwork","status":"publish","type":"page","link":"https:\/\/www.mtsu.edu\/irb\/exemptpaperwork\/","title":{"rendered":"EXEMPT Procedures"},"content":{"rendered":"\n<hr class=\"wp-block-separator has-text-color has-accent-1-color has-alpha-channel-opacity has-accent-1-background-color has-background is-style-wide\" style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" \/>\n\n\n\n<ul class=\"wp-block-list is-style-compact-list\">\n<li>Allow a minimum of 5 business days BEFORE&nbsp;you call us regarding the status of your&nbsp;petition.<\/li>\n\n\n\n<li>Please allow at least 2 weeks for protocols to be reviewed AFTER your application is &#8220;complete.&#8221;<\/li>\n\n\n\n<li>Expect longer processing time during the months of September-October and February-March.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-accent-1-color has-alpha-channel-opacity has-accent-1-background-color has-background is-style-wide\" style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" \/>\n\n\n\n<h2 class=\"wp-block-heading\">Exemption Definition<\/h2>\n\n\n\n<p>&#8220;Exempt&#8221; does not mean that the study is excluded from IRB oversight; it only means that the proposed activities meet lower levels of oversight requirement. &nbsp;Moreover, research activities are exempt from &#8220;full-length&#8221; regulations for the protection of human research subjects when they are considered minimal risk (the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance&nbsp;of routine physical or psychological examinations or tests [as defined by 45 CFR 46.102(i)]) and the ONLY involvement of human subjects falls within one or more of the <a href=\"https:\/\/www.mtsu.edu\/irb\/exemptioncategories\/\" data-type=\"page\" data-id=\"64\">exemption categories<\/a> listed on the checklist.<\/p>\n\n\n\n<p>The IRB will not consider any research exempt that involves prisoners, that involves a test article regulated by the FDA, unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6) and 21 CFR 56.104(d). Additionally, the research must fulfill MTSU&#8217;s ethical standards to be considered exempt.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Before you fill your application<\/h2>\n\n\n\n<p>First determine if your research qualifies for exemption. &nbsp;This would lead you to a different set of forms.&nbsp;Follow this simple decision chart to decide if you qualify for an exemption:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Screening Questions to Determine Exemption&nbsp;Qualification<\/strong><\/td><td colspan=\"2\"><strong>Response<\/strong><\/td><\/tr><tr><td>1. Are the subjects from a vulnerable group (prisoners, minors, pregnant women, seriously ill or cognitively impaired)?<\/td><td>Yes<\/td><td>No<\/td><\/tr><tr><td>2. Do you plan to collect behavior information that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the individual&#8217;s financial standing, employability or reputation?<\/td><td>Yes<\/td><td>No<\/td><\/tr><tr><td>&nbsp;3. Will you collect <strong>sensitive<\/strong> information or personal aspects of the subject&#8217;s behavior (drug\/alcohol use, illegal conduct, sexual behavior, mental health, etc)?<\/td><td>Yes&nbsp;<\/td><td>No<\/td><\/tr><tr><td>&nbsp;4. Except for researching normal education practices, will this study involve minors (<strong>under 18<\/strong>)? Refer to below for clarification on &#8220;education practices&#8221;<\/td><td>&nbsp;Yes<\/td><td>No<\/td><\/tr><tr><td>&nbsp;5. Will this research expose the subjects to discomfort&nbsp;or stress beyond the levels encountered in daily life?<\/td><td>Yes<\/td><td>No<\/td><\/tr><tr><td>6. Do you plan to (or analyze)&nbsp;<strong>video <\/strong>and\/or<strong> audiotape<\/strong> the participants (in some qualifying cases audiotaping may qualify for exemption when no other means of data collection is available, like speech studies)?<\/td><td>Yes<\/td><td>No<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>If you answered Yes to any of the above questions, then you WILL NOT qualify for an exemption. &nbsp;You &nbsp;have to file a petition through either the EXPEDITED or the FULL REVIEW process.<\/strong><\/p>\n\n\n\n<p><strong>Additional questions on projects that involve&nbsp;minors and other protected individuals for determining exemption:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list is-style-compact-list\">\n<li>Will the study involve the participation of protected individuals?\n<ul class=\"wp-block-list\">\n<li>Minors (less than 18 years of age) &#8211; <a href=\"https:\/\/www.mtsu.edu\/irb\/workinwithminors\/\" data-type=\"page\" data-id=\"67\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a> to know more about research with minors<\/li>\n\n\n\n<li>Pregnant women<\/li>\n\n\n\n<li>Prisoners<\/li>\n\n\n\n<li>Protected minority races<\/li>\n\n\n\n<li>Subjects who are incapable of providing consent<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>If you answered &#8220;YES&#8221; to &#8220;minor children&#8221; go to the next question, and if you answer &#8220;YES&#8221; to any of the remaining questions, then you will have to fill out an expedited or a full review form.<\/p>\n\n\n\n<ol class=\"wp-block-list is-style-compact-list\">\n<li>Other than non-identifiable demographics, will the data collection involve name(s), addresses and other types of personal information, including health data of the minors or their relatives?\n<ol class=\"wp-block-list\">\n<li>YES \u2013 the study is NOT exempt<\/li>\n\n\n\n<li>NO \u2013 go to question 2<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Will the study involve the delivery of education?\n<ol class=\"wp-block-list\">\n<li>NO \u2013 the study is NOT exempt<\/li>\n\n\n\n<li>YES \u2013 go to question 3<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Does the education delivery entail typical curriculum and activities involving testing?\n<ol class=\"wp-block-list\">\n<li>NO \u2013 the study is NOT exempt<\/li>\n\n\n\n<li>YES go to 4<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Will the data collection involve videotaping or recording the voices of the minors?\n<ol class=\"wp-block-list\">\n<li>YES \u2013 the study is NOT exempt<\/li>\n\n\n\n<li>NO \u2013 go to 5<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Will an evaluation assessment be conducted to address a \u201cresearch\u201d question? (Refer to the FAQ page on OHRP\u2019s definition of \u201cresearch\u201d)\n<ol class=\"wp-block-list\">\n<li>YES \u2013 the study is NOT exempt<\/li>\n\n\n\n<li>NO \u2013 the testing is done to evaluate an education method or technique \u2013 go to question 6<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Will the students in class do the same activity\/activities?\n<ol class=\"wp-block-list\">\n<li>NO \u2013 the study MAY NOT BE exempt AND go to question 7<\/li>\n\n\n\n<li>YES \u2013 go to question 7<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>Regardless of your response to question 6, Will you be recruiting participants randomly or through purposeful selection\n<ol class=\"wp-block-list\">\n<li>YES \u2013 the participants will be selected randomly through a clear acceptable inclusion criteria<\/li>\n\n\n\n<li>NO \u2013 the participants will be selected purposefully \u2013 you will need parental consent and child assent<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">New&nbsp; Exemption Requests<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Essential Forms and Attachments:<\/h3>\n\n\n\n<p>Visit <a href=\"https:\/\/www.mtsu.edu\/irb\/forms\/\" data-type=\"page\" data-id=\"19\">IRB Forms<\/a> for Forms &amp; Templates)<\/p>\n\n\n\n<ul class=\"wp-block-list is-style-compact-list\">\n<li>Exempt Application Form<\/li>\n\n\n\n<li>Recruitment script (Email, Flyer, verbal script, Etc)<\/li>\n\n\n\n<li>Informed Consent Form for exempt research\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=URo4x4pv68A&amp;index=12&amp;list=PL5965CB14C2506914\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a> to watch an OHRP video on informed consent<\/li>\n\n\n\n<li>Different versions of informed consent templates are offered by the IRB.&nbsp; Please visit&nbsp;<a href=\"https:\/\/www.mtsu.edu\/irb\/forms\/\" data-type=\"page\" data-id=\"19\">https:\/\/mtsu.edu\/irb\/forms<\/a>&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>CITI training certificate if new to MTSU &#8211;<a href=\"https:\/\/www.mtsu.edu\/irb\/typesoftraining\/\" data-type=\"page\" data-id=\"76\"> click here<\/a> to know more about how to obtain this<\/li>\n\n\n\n<li>Survey Instrument(s)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Other&nbsp;Documents<\/h3>\n\n\n\n<ul class=\"wp-block-list is-style-compact-list\">\n<li>Recruitment details (flyer, email transcript, etc.) &#8211; Refer to the Recruitment Page for more information\n<ul class=\"wp-block-list\">\n<li>Refer <a href=\"https:\/\/www.mtsu.edu\/irb\/recruitment\/\" data-type=\"page\" data-id=\"77\" target=\"_blank\" rel=\"noreferrer noopener\">Recruitment Pag<\/a>e for more information&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Permission letter(s) if the study is conducted at a non-MTSU facility\n<ul class=\"wp-block-list\">\n<li>Studies that would take place outside MTSU will require appropriate permission letters from the facility on &#8220;official letter heads&#8221; signed by an individual who has the authorization to do so.&nbsp;<\/li>\n\n\n\n<li>For instance, researchers conducting studies in a church or a library would a&nbsp;letter of support on official stationary from a representative who is entitled to approve your activity provided &#8211; Send scan of the letter for IRB review and keep the original for your records<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Mutual Agreemets and Approvals\n<ul class=\"wp-block-list\">\n<li>This is similar to the permission letter described above, but the difference being the research is not only conducted by MTSU representative(s) but also include workers from other Institution. &nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>ADVERSE EVENT NOTIFICATION<\/li>\n\n\n\n<li>Other study-specific documents<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">All essential and optional materials should be emailed to <a href=\"mailto:irb_submissions@mtsu.edu\">irb_submissions@mtsu.edu<\/a>. &nbsp;<\/h4>\n\n\n\n<div class=\"wp-block-mtsu-blocks-alert-box web_alert_group\"><div class=\"web_alert\"><h2 class=\"alert-title\">Be advised that the necessary documents are not restricted to the above list but IRB and the Office of Research Compliance may\u00a0require other types of documents depending on your study. \u00a0<\/h2><p class=\"alert-text\"><\/p><\/div><\/div>\n\n\n\n<div class=\"wp-block-mtsu-blocks-alert-box web_alert_group\"><div class=\"web_alert\"><h2 class=\"alert-title\">INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED. \u00a0The timeline for review starts only after the application is complete.<\/h2><p class=\"alert-text\"><\/p><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Amendments to an&nbsp;Existing Exempt Protocol&nbsp;<\/h2>\n\n\n\n<p>Starting from August 2015 (Protocols starting with 16 or later), amendments to exempt protocols will be restricted to only minor changes. &nbsp;The changes include minor typographical changes to the protocol\/instrument\/informed consent. &nbsp;Other allowed changes would be addition or removal of investigators. &nbsp;The Office of Research Compliance will no longer be able to complete major changes in the instruments or the protocol that have originally been approved as exempt.<\/p>\n\n\n\n<p>Completed amendment request forms should be sent to <a href=\"mailto:irb_submissions@mtsu.edu\">irb_submissions@mtsu.edu<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Document Submission&nbsp;<\/h2>\n\n\n\n<p>The Office of Research Compliance now follows an updated process by which documents are received for IRB review. &nbsp;The following two email accounts are designated&nbsp;to correspond IRB matters with the researchers:<\/p>\n\n\n\n<ul class=\"wp-block-list is-style-compact-list\">\n<li><a href=\"mailto:irb_submissions@mtsu.edu\">irb_submissions@mtsu.edu<\/a>&nbsp;&#8211; send all IRB applications and documents to this&nbsp;address<\/li>\n\n\n\n<li><a href=\"mailto:irb_information@mtsu.edu\">irb_information@mtsu.edu<\/a>&nbsp;&#8211; send your questions and inquiries to this address<\/li>\n<\/ul>\n\n\n\n<p>The applications MUST be submitted by a faculty member. &nbsp;Students cannot request for a protocol. &nbsp;Please <a href=\"https:\/\/www.mtsu.edu\/irb\/submissionprocess\/\" data-type=\"page\" data-id=\"84\">click here<\/a> for an overview the most recent&nbsp;document submission process<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Review Process<\/h2>\n\n\n\n<p>The application and the supporting documents will be administratively reviewed for completeness. &nbsp;Incomplete applications will be sent back to the researcher(s) without any administrative action. &nbsp;Those applications that are considered to be &#8220;complete&#8221;will be assigned a new IRB ID which will resemble the pattern ##-1###. &nbsp;The researchers will be corresponded by email if further information is needed to make a determination. &nbsp;In the event that the reviewer determines that the protocol may not qualify for exempt status, the application may be sent for a consultation. &nbsp;The researcher will be directed to submit an expedited or a full member application once the Office of Research Compliance confirms non-exemption decision. &nbsp;<\/p>\n\n\n\n<p>Researchers please be aware that all IRB decisions are final and may not retracted. \u00a0 The researcher can appeal a decision by making a written request to the Chair of IRB (Please visit the <a href=\"https:\/\/www.mtsu.edu\/irb\/membership\/\" data-type=\"page\" data-id=\"39\">IRB Membership<\/a> page). \u00a0The decision of the IRB Chair is final and cannot be appealed. \u00a0Moreover, under no circumstances the research team can involve MTSU Administration or ranking officials in a review process. \u00a0The University&#8217;s Federal-Wide Assurance and the PHS policies preclude the involvement of administrative members to influence the approval process. \u00a0However, the Institutional Officials reserve the right to cancel an approved IRB protocol. \u00a0<\/p>\n\n\n\n<p><a href=\"https:\/\/www.mtsu.edu\/irb\/submissionprocess\/\" data-type=\"page\" data-id=\"84\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a> to learn more about the review steps.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Protocol Approval&nbsp;<\/h2>\n\n\n\n<p>The researchers will receive an Exempt Approval Notice from the Office of Research Compliance. &nbsp;It is important that the researchers store the document in a safe location along with their study-related documents. &nbsp;The approval notice should be sent to appropriate funding agency by the researcher. &nbsp;At the present, there is no date of expiration for&nbsp;exempt protocols. &nbsp;The researchers are required to follow the methods listed by them in the protocol application. &nbsp;Any deviation will have to be reported immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Post-Approval Responsibilities&nbsp;<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Reporting Adverse Events:<\/h3>\n\n\n\n<p>Depending on how serious the information is, the researchers are advised to send an initial email to <a href=\"mailto:compliance@mtsu.edu\">compliance@mtsu.edu<\/a> describing the nature of the event. &nbsp;Any study-related injuries or other types of events that could have resulted in compromising the safety of the participants qualify as &#8220;adverse events.&#8221; &nbsp; The initial notification should reach the Office of Research Compliance within 48 (FORTY EIGHT) hours after the event took place. &nbsp;Subsequently, the researcher will submit an Adverse Event Form by providing specifics on the event and what course of action was taken to mitigate the risk(s).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Investigator Change Notification(s):<\/h3>\n\n\n\n<p>All addition and removal of investigators should be reported to the Office of Research Compliance prior to commencing research. &nbsp;The PI or the faculty advisor (if the PI is a student) should submit an Addendum Request to initiate the addition\/removal of investigators. &nbsp; Additionally, the new investigator who will be added to the protocol should have completed proper CITI training at the time of the request. &nbsp;Data collected by an individual who is not included in the protocol would not be permissible&nbsp;and may lead to the cancellation of the protocol. &nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Study Complete Notification and Protocol Cancellation:<\/h3>\n\n\n\n<p>The researcher is required to notify the Office of Research Compliance once a study has been completed and data collection will no longer be conducted. \u00a0The researchers should bear in mind that they are responsible for all of the study-related documents for up to three (3) years once the data collection has ended. \u00a0For Exempt protocols, the researcher can simply send an email to request the cancellation of a protocol.<a href=\"https:\/\/www.mtsu.edu\/irb\/datesanddeadlines\/\" data-type=\"page\" data-id=\"57\" target=\"_blank\" rel=\"noreferrer noopener\"> Click here<\/a> for deadline dates.\u00a0\u00a0<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Other\u00a0Important\u00a0Conditions:<\/h3>\n\n\n\n<p>The applicant of the protocol or the faculty advisor (if the applicant is a student) take full responsibility that the study will be conducted in the guidelines listed by the research team in the protocol. &nbsp;Any alteration to the protocol can be done only after obtaining written approval from the IRb or the Office of Research Compliance. &nbsp;Starting from August, 2015, major changes to the procedures and the instruments will not be allowed and the researchers will be directed to complete a new application.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Protocol Expiration and Reporting:<\/h3>\n\n\n\n<p>The applicant of the protocol or the faculty advisor (if the applicant is a student) must complete and submit reports in a timely manner.\u00a0 Refer to the <a href=\"https:\/\/www.mtsu.edu\/irb\/datesanddeadlines\/\" data-type=\"page\" data-id=\"57\" target=\"_blank\" rel=\"noreferrer noopener\">Dates and Deadlines<\/a> page for more information. Refer to the <a href=\"https:\/\/www.mtsu.edu\/irb\/datesanddeadlines\/\" data-type=\"page\" data-id=\"57\" target=\"_blank\" rel=\"noreferrer noopener\">Dates &amp; Deadlines<\/a> page for more information.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other IRB Actions<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Denial of Exemption:<\/h3>\n\n\n\n<p>A protocol may be denied approval due to either noncompliance or the proposed study may not qualify the exemption status. &nbsp;In both cases, the Office of Research Compliance will make every effort to help the researchers to address the compliance concerns. &nbsp;In rare instances, where the proposed study could not be achieved under the exemption criteria, the researcher will be asked to resubmit a fresh application to be reviewed under either expedited or full committee mechanism.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Refer to Expedited:<\/h3>\n\n\n\n<p>As explained above, a study may not qualify for IRB exemption and it will have to be reviewed by one of the more stringent classifications. &nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Appeal Process:<\/h3>\n\n\n\n<p>All IRB decisions are final and may not be changed under most circumstances. \u00a0 A researcher may nonetheless appeal a decision by making a written request with proper justification to the Chair of IRB (<a href=\"https:\/\/www.mtsu.edu\/irb\/membership\/\" data-type=\"page\" data-id=\"39\">Click here<\/a>\u00a0for a list of current IRB members). \u00a0The decision of the IRB Chair is final and cannot be appealed and there are no exceptions. \u00a0The researchers MUST NOT INVOLVE OTHER UNIVERSITY OFFICIALS. \u00a0Be advised that involving MTSU Administration or ranking officials to influence an IRB approval process is a violation of University&#8217;s Federal-Wide Assurance and PHS policies governing human subject research. \u00a0In contrast however, an authorized\u00a0Institutional Official reserves the right to cancel a protocol that has been previously approved by the IRB.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Exemption Definition &#8220;Exempt&#8221; does not mean that the study is excluded from IRB oversight; it only means that the proposed activities meet lower levels of oversight requirement. &nbsp;Moreover, research activities are exempt from &#8220;full-length&#8221; regulations for the protection of human research subjects when they are considered minimal risk (the probability or magnitude of harm or [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-bannernosidebar.php","meta":{"footnotes":""},"class_list":["post-62","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/62","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/comments?post=62"}],"version-history":[{"count":1,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/62\/revisions"}],"predecessor-version":[{"id":1968,"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/pages\/62\/revisions\/1968"}],"wp:attachment":[{"href":"https:\/\/www.mtsu.edu\/irb\/wp-json\/wp\/v2\/media?parent=62"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}