U-MIC

University of Michigan
IRB Collaborative

 

The University of Michigan's IRBs are committed to providing educational materials online, as well as in the classroom. The presentations below address topics relating both to ethics in human subjects research and to IRB procedures.

While presentations labeled "IRB Board Tips" are designed primarily for IRB members, researchers may find the information valuable, as well.

       
eResearch: Before We Get Started Description:  This presentation will help you prepare for your first eResearch Offering. You will learn how to log into the system and find the basic eResearch information.                                                   

 

 

Recommended: It is recommended that you view this video prior to attending either of the Level 1 eResearch Course Offerings.

Related Workshops: eResearch Level 1 Courses

CE Credit: Not Offered

Play Presentation                                                    

 

 

Time: At your own pace

eResearch
       
Using Notes as Place Markers in eResearch Description:  This slide presentation explores using eResearch notes as reminders to complete all sections of your application before submitting it to IRBMED.                                                   

 

 

Recommended: N/A

Related Workshops: eResearch Level 1 Courses

CE Credit: Not Offered

Play Presentation                                                   

 

 

Time: 3:50

eResearch
       
The Belmont Report (Part One: Basic Ethical Principles) Description:  The Belmont Report (1979) is a cornerstone document in human subjects research ethics. This first of two video introductions presents the three basic ethical principles put forward in the report.                                                   

 

 

Recommended:. N/A

Related Workshops: N/A

CE Credit: Not Offered

Play Video                                                    

 

 

Time: 5:45

The Belmont Report
       
The Belmont Report (Part Two: Applying the Principles) Description:  The Belmont Report (1979) is a cornerstone document in human subjects research ethics. This second of two video introductions examines ways in which researchers should apply the basic ethical principles.                                                   

 

 

Recommended:. N/A

Related Workshops: N/A

CE Credit: Not Offered

Play Video                                                    

 

 

Time: 5:22

The Belmont Report
       
Privacy and Confidentiality in Human Subjects Research Description:This short video addresses human subjects' rights to privacy and confidentiality.                                                   

 

 

Recommended:. N/A

Related Workshops: N/A

CE Credit: Not Offered

Play Video                                                   

 

 

Time: 5:15

 
       
IRB Board Tip: Viewing Submission Summaries in eResearch Description:  This presentation shows you how eResearch's submission summary pages can help you prepare for your IRBMED meeting. Play Presentation                                                    

 

 

Time: 3:45

eResearch
       
IRB Board Tip: Deception and Concealment in Human Subjects Research Description:  This presentation looks at the ethical use of deception and concealment in research involving human subjects. Play Presentation                                                   

 

 

Time: 2:45

 
       
IRB Board Tip: Certificates of Confidentiality Description:  This presentation provides an overview of Certificates of Confidentiality, which the National Institutes of Health (NIH) issue to protect subjects' sensitive and identifiable information against forced disclosure. Play Presentation                                                   

 

 

Time: 4:03

NIH Certificates of Confidentiality Kiosk
       
IRB Board Tip: Electronic Data Security Description: The Office of Human Research Compliance Revew and the Information Technology Services department offer suggestions for securing study data stored electronically. This presentation offers a summary of their recommendations. Play Presentation                                                   

 

 

Time: 4:01

OHRCR's electronic data security guidance                                                   

 

 

ITS's tips on securiing electronic data during travel

       
IRB Board Tip: Anonymous, Coded, and De-identified Data in Human Subjects Research Description: This voiceover slideshow defines anonymous, coded, and de-identified data, clarifying how the three concepts differ. Play Presentation                                                   

 

 

Time: 3:33

 
       
IRB Board Tip: Protected Health Information (PHI) Description: HIPAA's Privacy Rule regulates how researchers use and disclose PHI. This short slide show outlines PHI requirements for researchers. Play Presentation                                                   

 

 

Time: 3:54

Health Information Privacy
       
IRB Board Tip: ClinicalTrials.gov: Requirements for Registration and Informed Consent Description: Guest presenter Diane Lehman Wilson, from the Office of Regulatory Affairs, provides an overview of the ClinicalTrials.gov registry. Play Presentation                                                   

 

 

Time: 4:06

ClinicalTrials.gov
       
IRB Board Tip: Prisoners as Research Subjects (Part One: Federal Requirements) Description: This first of two companion presentations defines key terms and outlines the federal regulations governing enrollment of prisoners as subjects in research. Play Presentation                                                   

 

 

Time: 4:12

 
       
IRB Board Tip: Prisoners as Research Subjects (Part Two: Certification and IRB Review) Description: This presentation--the second of two tips on prisoners in research--summarizes the certifications one must obtain before enrolling prisoners as study subjects, as well as the role of the IRB. Play Presentation                                                   

 

 

Time: 4:56

 
       
IRB Board Tip: Department of Defense Research (Part One) Description: The Department of Defense has its own regulations governing research involving any DoD component. This presentation provides an overview of these regulations. Play Presentation                                                   

 

 

Time: 6:00

32 CFR 219
       
IRB Board Tip: Department of Defense Research (Part Two) Description: This slide show represents the second of two tips summarizing Department of Defense regulations for human subjects research. Play Presentation                                                   

 

 

Time: 3:19

32 CFR 219
       
IRB Board Tip: Epidemiological Research Involving Prisoners as Subjects Description: This tip revisits the subject of prisoners in research, summarizing the Department of Health and Human Services' 2003 waiver permitting prisoner participation in epidemiological studies. Play Presentation                                                   

 

 

Time: 2:52

 
       
IRB Board Tip: Community-based participatory research (CBPR) Description: Community-based participatory research involves the collaboration of academic researchers and members of the general community. This short presentation provides an overview. Play Presentation                                                   

 

 

Time: 4:26

 
       
IRB Board Tip: Genetic Information Nondiscrimination Act (GINA) Description: This slide show provides an overview of GINA, a federal law that prohibits health insurance companies and employers from discriminating based on genetic information. Play Presentation                                                   

 

 

Time: 4:18

 
       
IRB Board Tip: Significant and Nonsignficant Risk Devices in Human Subjects Research Description: Federal regulations guide IRBs in determining whether investigational medical devices present significant or nonsignificant risk to subjects. This short presentation offers an overview. Play Presentation                                                   

 

 

Time: 5:46

 
       
IRB Board Tip: Documentation of Informed Consent Description: This short presentation outlines federal requirements for documenting subjects' consent to take part in research, as well as circumstances under which IRBs may waive the documentation requirement. Play Presentation                                                   

 

 

Time: 2:14

 
       
IRB Board Tip: Assent Requirements and Waivers Description: Federal regulations outline requirements for obtaining the assent of human subjects under 18, as well as cases in which IRBs may waive those requirements. This short presentation offers an overview. Play Presentation                                                   

 

 

Time: 3:14

 
       
IRB Board Tip: The HIPAA Privacy Rule: Requirements and Waivers Description: The HIPAA Privacy Rule guards patients' protected health information (PHI) and governs how researchers may access, use, and disclose PHI in research. This slide show provides a summary. Play Presentation                                                   

 

 

Time: 4:06

HIPAA
Privacy Rule
       
IRB Board Tip: IRB Board Meeting Minutes Description: IRBs maintain meeting minutes to document key elements of convened board meetings.This short presentation summarizes the requirements. Play Presentation                                                   

 

 

Time: 3:16

 
       
IRB Board Tip: Informed Consent for Genetic Sub-Studies Description: This presentation outlines options for obtaining subjects' consent to take part in genetic sub-studies. Play Presentation                                                   

 

 

Time: 3:38

 
       
IRB Board Tip: Lotteries as Incentives in Human Subjects Research Description: This short slide show explores lotteries as incentives for research participation, including a summary of Michigan's legal requirments. Play Presentation                                                   

 

 

Time: 2:51

IRB-HSBS Guidance on Lotteries and Sweepstakes
       
IRB Board Tip: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs or UaPs) Description: Federal regulations require researchers to report unanticipated problems involving risk to subjects or others. This short presentation provides an overview. Play Presentation                                                   

 

 

Time: 5:00

 
       
IRB Board Tip: Data Management and Security Description: This presentation offers recommendations for securing electronic research data. Play Presentation                                                   

 

 

Time: 3:49

 
       
IRB Board Tip: Umbrella Projects Description: Guest presenter Lark Speyer offers an overview of projects lacking immediate plans for involvement of human subjects—known as umbrella projects. Play Presentation                                                   

 

 

Time: 2:42

 
       
IRB Board Tip: Document Review and Finalization at Scheduled Continuing Review Description: As part of their review of renewal applications, IRBs must review and approve supporting documents as long as they are in use. This presentation provides a summary. Play Presentation                                                   

 

 

Time: 3:40

 
       
IRB Board Tip: Humanitarian Use Devices (HUDs) Description: Humanitarian Use Devices (HUDs) are used to treat conditions that affect fewer than 4,000 Americans per year. This short slide show outlines the requirements for HUD use and research. Play Presentation                                                   

 

 

Time: 4:50

 
       
IRB Board Tip: Third Parties in Human Subjects Research Description: When research subjects make reference to individuals who are not involved in the study at hand and with whom researchers have no interaction, we call these individuals third parties. This presentation provdies a summary. Play Presentation                                                   

 

 

Time: 3:06

 
       
IRB Board Tip: Human Subjects Enrollment Description: IRBs and other research administration committees at U-M are adopting a single standard definition of enrolled. Guest presenter Lark Speyer summarizes enrollment reporting in eResearch. Play Presentation                                                   

 

 

Time: 3:51

Enrolled for Human Subjects Studies in eResearch
       
IRB Board Tip: FDA Inspections of Institutional Review Boards Description: FDA conducts periodic, scheduled inspections of IRBs, to determine whether they are complying with FDA regulations and laws and following their own written procedures. This short presentation gives an overview. Play Presentation                                                 

 

Time: 6:19

FDA guidance on IRB inspections
       
Writing Informed Consent Documents — Part One: Fundamentals Description: In the first of two presentations on writing informed consent documents, IRBMED's technical writer offers some basic recommendations for crafting documents that are both readable and comprehensible to subjects. Play Presentation                                                 

 

Time: 6:35

 
       
Writing Informed Consent Documents — Part Two:
Exhibit
Description: The previous presentation offered recommendations for creating effective informed consent documents. This instructional presentation applies these principles in the revision of a problematic consent passage. Play Presentation                                                 

 

Time: 9:53

 
       
Speciality Informed Consent Templates: One-time blood or tissue sample and eligibility screening Description: IRBMED has recently begun to offer specialty informed consent templates, tailored to specific study scenarios. This short presentation introduces two new specialty templates. Play Presentation                                                 

 

Time: 4:32

 
       
IRB Regulatory Determinations Description: For each application it reviews—whether during a convened Board meeting or by expedited review—the IRB must make certain regulatory determinations. This slide show offers a summary. Play Presentation                                                 

 

Time: 5:55

 
       
FDA Guidance: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Description: In 2009, the Food and Drug Administration published guidance on the responsibilities of investigators conducting drug, biologic, and device trials. This short presentation provides an overview. Play Presentation                                                 

 

Time: 5:38

 FDA Guidance
       
Expedited Review: Category 5 Description: For minimal-risk research that falls under one of nine categories, federal regulations allow review by an IRB Chair or designee, with no vote by the full IRB. This short presentation outlines category 5: research involving materials collected for non-research purposes. Play Presentation                                                 

 

Time: 2:11

HHS Guidance
HHS Category 5 Clarification
       
Informed Consent in an Emergency Care Setting Description: In certain cases, it is possible to obtain legally effective informed consent in an urgent or emergency care setting. This presentation examines the variables that IRBs and researchers must consider when determining whether consenting emergency care patients for research is appropriate. Play Presentation                                           

 

Time: 2:50

OHRP Frequently Asked Questions
       
IRB Membership Requirements and Quorum Description: Federal regulations and the University of Michigan Human Research Protection Program's Operations Manual address requirements for IRB membership and approval of proposed research at convened IRB meetings. This short slide show offers a summary. Play Presentation                                          

 

Time: 4:44

 
       
Site-specific Protocol Addenda Description: In certain circumstances, IRBMED may permit the University of Michigan’s participation in a multi-site study only if U-M–specific protocol modifications are implemented. This presentation outlines procedures. Play Presentation                                         

 

Time: 3:46

 
       

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Stacking Documents in eResearch PENDING    
       

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Page Created on 4/2/2012

Updated on 2/21/2012


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