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<p>New changes coming in January for IRB.</p>
<p>thanks</p>
<p>-Dave</p>
<p><br>
</p>
<div id="Signature">
<div id="divtagdefaultwrapper" style="font-size:12pt; color:#000000; background-color:#FFFFFF; font-family:Calibri,Arial,Helvetica,sans-serif">
<div style="color:rgb(136,136,136); font-family:arial,sans-serif; font-size:12.8000001907349px">
<span style="color:rgb(0,0,0)">David Richard Moore Ph.D.</span></div>
<div style="color:rgb(136,136,136); font-family:arial,sans-serif; font-size:12.8000001907349px">
<div><span style="color:rgb(0,0,0)">Secretary to the Board of Trustees and</span></div>
<div><span style="color:rgb(0,0,0)">Professor, Instructional Technology</span></div>
<div><span style="color:rgb(0,0,0)">Ohio University</span></div>
<div><span style="color:rgb(0,0,0)">110 Cutler Office: <span style="font-family:arial,sans-serif; font-size:12.8000001907349px; background-color:rgb(255,255,255)">740.593.2958</span> (Mornings)</span></div>
<div><span style="color:rgb(0,0,0)">S205 Lindley Office: <span style="font-family:arial,sans-serif; font-size:12.8000001907349px; background-color:rgb(255,255,255)">
740.597-1322 </span> (Afternoons)</span></div>
<div><font face="Calibri,sans-serif" size="2"><span style="font-size:11pt"><br>
</span></font></div>
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<div id="divRplyFwdMsg" dir="ltr"><font face="Calibri, sans-serif" color="#000000" style="font-size:11pt"><b>From:</b> Research Compliance<br>
<b>Sent:</b> Friday, December 11, 2015 4:16 PM<br>
<b>To:</b> Research Compliance<br>
<b>Subject:</b> Electronic IRB Announcement</font>
<div> </div>
</div>
<div>
<div>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Dear Colleagues,</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">After over a year of planning, programming, testing, and reviewing, we are pleased to announce that we are now ready to launch the new electronic Institutional Review Board (IRB) program. The Office of Research
Compliance has been testing the electronic IRB program since approximately June 2015. This process has included evaluating all aspects of the software for functionality and accuracy, and to “work out the bugs.” We have reviewed the investigator preparation
and submission process, the activities of the Office of Research Compliance, as well as the activities of the respective IRBs. These processes all appear to be functioning very well.</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Effective January 1, 2016, all IRB documents must be submitted to the Ohio University Office of Research Compliance using the electronic LEO IRB system. The documents will be deemed signed off when the research
team members agree to the stipulations listed on the submission page.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">During the transition to the electronic IRB system, investigators that received approval for a new IRB protocol or a periodic review (renewal) from August 24 through December 31, 2015 (or had a new protocol or periodic
review pending IRB approval as of December 31, 2015), that need to make a modification (amendment) or submit a deviation / event report for the specific protocol (that was approved or is pending from August 24 through December 31, 2015), have the option of
filing using the electronic system (provide all of the required study information in the electronic system) or submitting a hard copy modification or deviation / event report. This transition period is in effect through April 30, 2016.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Effective May 1, 2016, all submissions (of any type) must be made using the electronic system. The investigator will need to update and upload all approved information and any approved documents (for example, consent
forms, assent forms, et cetera) into the electronic LEO IRB system.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Please note that effective January 1, 2016, any investigator(s) / research team(s) that did not obtain approval for a specific IRB protocol or periodic review, from August 24 through December 31, 2015 (or had a new
protocol or periodic review pending IRB approval as of December 31, 2015), and they want to modify the protocol, submit a periodic review, event report or deviation, must submit the request using the electronic LEO IRB system. For example, each new protocol,
periodic review, an amendment to a protocol approved prior to August 24, 2015, et cetera.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">We know that you will be pleased with the new system. Additional information will be posted on the Research Compliance website. Please feel free to share this email to spread the word.
</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Regards, </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Office of Research Compliance Staff</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
</div>
</div>
</div>
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</body>
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<head>
<meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1">
<style type="text/css" style="display:none;"><!-- P {margin-top:0;margin-bottom:0;} --></style>
</head>
<body dir="ltr">
<div id="divtagdefaultwrapper" style="font-size:12pt;color:#000000;background-color:#FFFFFF;font-family:Calibri,Arial,Helvetica,sans-serif;">
<p>New changes coming in January for IRB.</p>
<p>thanks</p>
<p>-Dave</p>
<p><br>
</p>
<div id="Signature">
<div id="divtagdefaultwrapper" style="font-size:12pt; color:#000000; background-color:#FFFFFF; font-family:Calibri,Arial,Helvetica,sans-serif">
<div style="color:rgb(136,136,136); font-family:arial,sans-serif; font-size:12.8000001907349px">
<span style="color:rgb(0,0,0)">David Richard Moore Ph.D.</span></div>
<div style="color:rgb(136,136,136); font-family:arial,sans-serif; font-size:12.8000001907349px">
<div><span style="color:rgb(0,0,0)">Secretary to the Board of Trustees and</span></div>
<div><span style="color:rgb(0,0,0)">Professor, Instructional Technology</span></div>
<div><span style="color:rgb(0,0,0)">Ohio University</span></div>
<div><span style="color:rgb(0,0,0)">110 Cutler Office: <span style="font-family:arial,sans-serif; font-size:12.8000001907349px; background-color:rgb(255,255,255)">740.593.2958</span> (Mornings)</span></div>
<div><span style="color:rgb(0,0,0)">S205 Lindley Office: <span style="font-family:arial,sans-serif; font-size:12.8000001907349px; background-color:rgb(255,255,255)">
740.597-1322 </span> (Afternoons)</span></div>
<div><font face="Calibri,sans-serif" size="2"><span style="font-size:11pt"><br>
</span></font></div>
</div>
<div style="color:rgb(136,136,136); font-family:arial,sans-serif; font-size:12.8000001907349px">
<span style="font-size:10pt"><br>
</span></div>
<p><br>
</p>
</div>
</div>
<br>
<br>
<div style="color: rgb(0, 0, 0);">
<hr tabindex="-1" style="display:inline-block; width:98%">
<div id="divRplyFwdMsg" dir="ltr"><font face="Calibri, sans-serif" color="#000000" style="font-size:11pt"><b>From:</b> Research Compliance<br>
<b>Sent:</b> Friday, December 11, 2015 4:16 PM<br>
<b>To:</b> Research Compliance<br>
<b>Subject:</b> Electronic IRB Announcement</font>
<div> </div>
</div>
<div>
<div>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Dear Colleagues,</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">After over a year of planning, programming, testing, and reviewing, we are pleased to announce that we are now ready to launch the new electronic Institutional Review Board (IRB) program. The Office of Research
Compliance has been testing the electronic IRB program since approximately June 2015. This process has included evaluating all aspects of the software for functionality and accuracy, and to “work out the bugs.” We have reviewed the investigator preparation
and submission process, the activities of the Office of Research Compliance, as well as the activities of the respective IRBs. These processes all appear to be functioning very well.</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Effective January 1, 2016, all IRB documents must be submitted to the Ohio University Office of Research Compliance using the electronic LEO IRB system. The documents will be deemed signed off when the research
team members agree to the stipulations listed on the submission page.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">During the transition to the electronic IRB system, investigators that received approval for a new IRB protocol or a periodic review (renewal) from August 24 through December 31, 2015 (or had a new protocol or periodic
review pending IRB approval as of December 31, 2015), that need to make a modification (amendment) or submit a deviation / event report for the specific protocol (that was approved or is pending from August 24 through December 31, 2015), have the option of
filing using the electronic system (provide all of the required study information in the electronic system) or submitting a hard copy modification or deviation / event report. This transition period is in effect through April 30, 2016.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Effective May 1, 2016, all submissions (of any type) must be made using the electronic system. The investigator will need to update and upload all approved information and any approved documents (for example, consent
forms, assent forms, et cetera) into the electronic LEO IRB system.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<ul type="disc" style="margin-top: 0in; margin-bottom: 0in;">
<li style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Please note that effective January 1, 2016, any investigator(s) / research team(s) that did not obtain approval for a specific IRB protocol or periodic review, from August 24 through December 31, 2015 (or had a new
protocol or periodic review pending IRB approval as of December 31, 2015), and they want to modify the protocol, submit a periodic review, event report or deviation, must submit the request using the electronic LEO IRB system. For example, each new protocol,
periodic review, an amendment to a protocol approved prior to August 24, 2015, et cetera.</span></li></ul>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">We know that you will be pleased with the new system. Additional information will be posted on the Research Compliance website. Please feel free to share this email to spread the word.
</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Regards, </span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif">Office of Research Compliance Staff</span></p>
<p style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;">
<span style="font-family:"Arial",sans-serif"> </span></p>
</div>
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