EDUCATION & TRAINING
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 |
Time: At your own pace |
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| 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 |
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 |
Time: 5:45 |
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| 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 |
Time: 5:22 |
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| 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 |
Time: 5:15 |
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IRB Board Tip: |
Description: This presentation shows you how eResearch's submission summary pages can help you prepare for your IRBMED meeting. |
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. |
Time: 2:45 |
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| 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. |
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. |
Time: 4:01 |
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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. |
Time: 3:33 |
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| 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. |
Time: 3:54 |
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| 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. |
Time: 4:06 |
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| 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. |
Time: 4:12 |
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| 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. |
Time: 4:56 |
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| 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. |
Time: 6:00 |
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| 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. |
Time: 3:19 |
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| 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. |
Time: 2:52 |
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| 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. |
Time: 4:26 |
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| 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. |
Time: 4:18 |
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| 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. |
Time: 5:46 |
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| 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. |
Time: 2:14 |
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| 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. |
Time: 3:14 |
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| 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. |
Time: 4:06 |
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| 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. |
Time: 3:16 |
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| 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. |
Time: 3:38 |
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| 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. |
Time: 2:51 |
IRB-HSBS Guidance on Lotteries and Sweepstakes |
COMING SOON |
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| Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs or UaPs) | PENDING |
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| Stacking Documents in eResearch | PENDING | ||
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Page Created on 4/2/2012
Updated on 2/21/2013
