User Guide October 2013
Contents
1. P RI M C4 R You are logged in as a Ogout PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH Home About Course Contact JE E mm p Wa W PRIM amp R s Online Learning Center Available courses E ROC Ethical Research Oversight Course E ROC Ethical Research Oversight Course formerly the Ethical Oversight of Human Subjects Research online course is a four and a half hour online course that presents an in depth exploration of the function and purpose of institutional review boards IRBs through an interactive realistic interface The course addresses the roles of IRB members who tackle the challenging ethical and regulatory issues of human subjects research You are logged in as Logout Click on the blue hyperlink for E ROC Ethical Research Oversight Course Course Overview Form Home My courses General E ROC TURN EDITING ON progress C Introduction Course Overview Course Units Course Introduction Unit 1 Welcome to the Institutional Review Board Unit 2 Minimizing Research Risks Unit 3 Assessment of Risks and Burdens in Comparison with Benefits Unit 4 Subject Selection and Recruitment Unit 5 Informed Consent Its Not Just a Document Unit 6 Data and Safety Monitoring 6 Unit 7 Privacy and Confidentiality Protections G Unit amp IRB Meeting Dynamics Stepping Into A Group Process In order to access the content of the course you must first read the Course Overview This only has2. oo d R i ch Desi 1 a j 4 a BES m Please indicate whether you would like to mark this Unit as complete in your iscussion 1 P umor Inhibiting rs ee record then click Submit H IRB Discussion 2 Traumatic Stress Study Ihave completed this Unit Summary Ihave not yet completed this Unit Note If you mark this Unit as complete you can still return to it at any time from the Course Menu for review Once you finish a unit make sure that you mark it as complete Select the option and then click Unit Completion Acknowledgement Unit Completion Acknowledgement You ve reached the end of this Unit Please indica yin your record then Complete Thank you This Unit will be marked as complete in Thank you This Unit will b ked plete i o 4 your record You can still review it at any time from the main menu Note If you _ a from the Course Menu for review Once you click that you have completed a unit a appears After you click you can close the unit You will then be brought back to the course table of contents 8 hias Unit 1 Welcome to the Institutional Review Board P IM S ruta sasromncensts m Introduction Move your cursor over the red circles and click on them to familiarize yourself with all the navigation and function buttons within this e learning module Click the x in the upper right of this pop up window to close
3. E ROC Ethical Research Oversight Course User Guide October 2013 www primrelearning com PRIM R PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH Home About 5 44 PRIM amp R s Online Learning Center Available courses E ROC Ethical Research Oversight Course ROC You are not logged in Login You are not logged in Login E ROC Ethical Research Oversight Course formerly the Ethical Oversight of Human Subjects Research online course is a four and a half hour online course that presents an in depth exploration of the function and purpose of institutional review boards IRBs through an interactive realistic interface The course addresses the roles of IRB members who tackle the challenging ethical and regulatory issues of human subjects research and click on Logging In PRIM R snail PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH Home About Course Contact i tm a i p f 2 y J e i TT Eua 5 b a l 7 ry A a d PRIM amp R s Online Learning Center Home gt Login to the site Returning to this web site Login here using your username and password Cookies must be enabled in your browser Username LOGIN O Remember username Forgotten your username or password Your username is your email address and your temporary password Is Pwtemp0O0 Once you type in both your username and password click the red login button Logging In
4. _g links to the documents referenced throughout the course Glossary TT J ABCDEFGHI JKLMNOPOQRS TUVWXYZ GLOSSARY f mare select a term Beneficence Intending ta do right or good by someone as through treating them with courtesy and respect Also aiming to aid or assist an individual in their best interest to ensure their well being by maximizing possible Adverse event AE Aneurysm Anonymous data collection Autonomous Behavioral Gn benetits and minimizing potential harms in addition to ensuring their rights and welfare This Belmont principle refers to the ethical obligations in research 1 to do no harm and 2 to maximize possible benefits and minimize possible harms Beneficence Biostatistician Blinding CBER CFR Chemotherapy Clinical trial Cnaanitive The Glossary defines key terms and acronyms referenced in the course There is also an audio feature on the top right hand corner of the glossary window If you click on it the narrator reads the definition aloud Unit Completion Feature Unit 2 Minimizing Research Risks HISTORICAL TIMELINE RESOURCE DIRECTORY HELP GLOSSARY RETURN TO COURSE MEN PRIMOR aes Unit Completion Acknowledgement E ROC Ethical Research Oversight Course AN ONLINE TRAINING COURSE FOR IFE MEMBERS Outline Thumbnails Audio Text Unit 2 Minimizing Research Risks Introduction aos futsal You ve reached the end of this Unit P What is Risk
5. ht back to the course menu table of contents You will notice that all of your data has transferred from the previous learning management system Changing Your Password First click on the breadcrumb L EEFIN E SALLE LeeL LLLE wkr LELEL Home My courses P General P E ROC block click on and then click PRIM amp R s Online Learning Center Home amp hy home Course Course overview E ROC Ethical Research Oversight Course E ROC Ethical Research Oversight Course Change password Messaging Navigating the Course PRIVIAK 5 VIINe LEALMIS CCHULET Home My courses E General E ROC TURN EDITING ON Your progress Introduction Course Overview Course Units Course Introduction Unit 1 Welcome to the Institutional Review Board Unit 2 Minimizing Research Risks Unit 3 Assessment of Risks and Burdens in Comparison with Benefits Unit 4 Subject Selection and Recruitment Unit 5 Informed Consent Its Not Just a Document Unit 6 Data and Safety Monitoring Unit 7 Privacy and Confidentiality Protections Frana i i i fana Fana Fana i ee bA b hA hA bA hA h Unit 8 IRB Meeting Dynamics Stepping Into A Group Process Course Wrap Up Course Assessment Course Feedback Survey From the course menu table of contents you will notice that all of your data has transferred from the previous learning management system MViodules ning com mod scorm player php a 3 am
6. it ae E ROC gt Ethical Research Oversight Course AN ONLINE TRAINING COURSE FOR IRB MEMBERS Course Introduction The screen offers an overview of how the course works To explore a feature just click or hover over the red dot Course Assessmen PRIM GR tiene ano nesen E ROC Ethical Research Oversight Course AN ONLINE TRAINING COURSE FOR IRB MEMBERS Outline Thumbnails Audio Text Introduction Overview End of Course Assessment HISTORICAL TIMELINE RESOURCE DIRECTORY HELP GLOSSARY RETURN TO COURSE MENU Course Assessment Question 1 of 29 Which of the following best describes the responsibilities of the IRB O To ensure that the hospital facilities are clean and maintained in accordance with applicable regulations To ensure that the institution s researchers conduct themselves in a manner that is compliant with all federal regulations To ensure that the basic ethical principles of the Belmont Report are upheld To ensure that adequate information is disclosed to mentally competent research subjects In order to receive a certificate of completion you must take the and achieve a score of at least 80
7. p currentorg Unit_2_Minimizing_Research_Risks_ORG amp scoid 31 amp sesskey UXJ6araLdT amp display popup Unit 2 Minimizing Research Risks HISTORICAL TIMELINE RESOURCE DIRECTORY HELP GLOSSARY RETURN TO COURSE MENU PRI M 5 R PUBLIC RESPONSIBILITY IN al MEDICINE AND RESEARCH ce M E y R O C Introduction Ethical Research Oversight Course AN ONLINE TRAINING COURSE FOR IRB MEMBERS Outline Thumbnails Audio Text What is Risk Unit 2 Minimizing Research Risks 2 Chance of b Introduction Risk Probability and magnitude of harm or death w What is Risk discomfort Introduction to Risk May vary from minimal to very high Introduction to Risk continued 4 me s ANEO HE O Enue Regulations define minimal risk as Types of Risk How do Know if Risks are Minimized gt Sound Research Design gt IRB Discussion 1 New Tumor Inhibiting 50 Chance of Drug Study headaches gt IRB Discussion 2 Traumatic Stress Study Summary gt Unit Case Study Unit Completion Acknowledgement End of Unit 2 4 SCREEN 5 OF 30 PLAYING Each module is narrated and can be stopped or paused at any time using the controls at the bottom of the screen Left Screen loolbar Unit 2 Minimizing Research Risks The Outline screen acts as a E sROC un table of contents for the unit Ihe Thumbnails screen previews each slide How do Know if Risks are Minimized Sound Research Design gt IRB Discu
8. r and a half hour online course that presents an in depth exploration of the function and purpose of institutional review boards IRBs through an interactive realistic interface The course involves watching and listening to eight course modules and then completing a test that will assess your comprehension of the information presented To successfully complete this CME activity clinicians are required to complete the entire course submit the post test achieve a score of 80 or better and complete a course evaluation You will then be brought back to the top of the page Click on the plue hyperlink to the table of contents course menu Access to Modules PRIWIAK 5 UDINE LEALMEN Center Home My courses P General P E ROC TURN EDITING ON Your progress Introduction Course Overview Course Units Fig I rn I I I I I 4 Course Introduction F l ka Unit 1 Welkome to the Institutional Review Board Unit 2 Minimizing Research Risks K Fg I Unit 3 Assessment of Risks and Burdens in Comparison with Benefits F l kba Unit 4 Subject Selection and Recruitment Eag Fig I Unit 5 Informed Consent lts Not Just a Document F l ba Unit 6 Data and Safety Monitoring 1S Unit 7 Privacy and Confidentiality Protections a 1 4 ro I I katl Unit 8 IRB Meeting Dynamics Stepping Into A Group Process Course Wrap Up Course Assessment Course Feedback Survey You are now broug
9. ssion 1 New Tumor Inhibiting Drug Study The Audio lext screen msa transcribes what the narrator Is End of Unit 2 sayl ale l Top screen Toolbar th_Risks_ORGS amp sscold sl amp sesskey UA 6araLal Gdisplay popup HISTORICAL TIMELINE RESOURCE DIRECTORY HELP GLOSSARY RETURN TO COURSE MENU The and links appear at the top of each unit Historical li meline s Timeline Google Chrome 5 www primrelearning com pluginfile php 25 mod_scorm content 3 resources timeline htm details important events in the history of research ethics dating back to 1900 You can navigate using the arrows on the side of each slide or you can click on the red dots that appear at the bottom of the screen Resource Directory Resource Directory The following are links to documents that are referenced within the course Reference Document or Link Unit First Cited Office for Human Research Protections OHRP Basic HHS Policy for Protection of Human Research Subjects includes the Common Rule FDA Regulations on the Protection of Human Subjects Office for Human Research Protections OHRP Decision Charts U S Food and Drug Administration Comparison of FDA and Common Rule Provisions Table Federalwide Assurance FWA for the Protection of Human Subjects httonwww hh govionrprassurances assurances Tasunt_ntm Common Findings OHRP Compliance Oversight Activities Determinations of Noncompliance tto iiiar ggs comolanec gmags gngs
10. to be done once Course Overview Form Macintosh users Safari 3 and later Firefox 1 x and later or Google Chrome Other Requirements o Flash Player 6 0 79 or later Flash Player 7 or later recommended You can download it for free at http www adobe com go getilash tis important that you have pop ups enabled to run the multimedia courseware PRIM amp R Privacy Policy BUSM CME Privacy Policy If you have questions please contact BUSM CME by email at cme bu_edu or visit http www bu edu cme Acknowledgement bi Indicate that you have fully read the Course Overview in order to take the course SAVE CHANGES CAN There are required fields in this form marked Please read the disclosure documents When you scroll to the bottom of the screen you must mark that you have fully read the Course Overview Form Then please click Course Overview Form i ym Nt a zs PRIM amp R s Online Learning Center Home amp My courses gt General gt E ROC Introduction Course Overview Course peN ii o Course Overview E ROC Ethical Research Oversight Course Jointly sponsored by PRIM GR ENON PUBLIC RESPONSIBILITY IN UNIVERSITY MEDICINE AND RESEARCH You indicated that you have fully read the Course Overview Click here to access the Course This Continuing Medical Education CME activity E ROC Ethical Research Oversight Course formerly the Ethical Oversight of Human Subjects Research online course is a fou
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