Education Archive
Please contact our office or the noted speaker(s) of a particular presentation before using materials here-in. Information may be copyrighted or may not reflect the most up-to-date guidance.Please note that many of these materials were designed to accompany an oral presentation. Some details may not be explicitly clear via the visual element alone. If you have questions regarding the information herein, please email IRBMED@umich.edu. For other educational resources be sure to check out our Guidance page.
2008 Education Symposium Materials
On Thursday, May 8, 2008, 9:00 a.m. to 6:00 p.m., the IRBMED held its annual symposium. Handouts from each of the presentations can be printed by clicking on the session title (listed in chronological order of presentation). Other handouts provided at the event are also listed below.
Introduction to William Coon Memorial Lecture, John G. Weg, M.D., UMMS IRBMED Co-Chair, Professor Emeritus
William Coon Memorial Lecture—Making Informed Consent Count, Jeremy Sugarman, M.D., M.P.H, M.A., Harvey M. Meyerhoff Professor of Bioethics and Medicine, Deputy Director for Medicine, Johns Hopkins Berman Institute of Bioethics
Communicating the Results of Research to Study Participants, David Shalowitz, A.B, UMMS Student
IRBs and the Regulation of Trust, Raymond G. DeVries, Ph.D, UMMS Bioethics Program, Associate Professor
QI/QA and Innovation, Rachel Nosowsky, J.D., UMHS Legal Office, Assistant General Counsel
Engaging Minority Populations in Clinical Research—Who is Going to be in my Study? Tahnee C. H. Prokopow, M.P.H., UMMS Diversity and Career Development Office, Assistant Director
Misconduct and Questionable Research Practices, Nick H. Steneck, Ph.D., Director of the Research Ethics and Integrity Program of the Michigan Institute for Clinical and Health Research and Professor Emeritus of History at the University of Michigan. He is also a consultant to the Federal Office of Research Integrity, HHS.
Protecting Your Electronic Research Data, Joe Saul, J.D., UMHS Privacy Office, Staff Specialist
Top Ten Tips: Clinical Research Billing and IRBMED Informed Consent Requirement, Julie N. Wietzke, M.L.S., UMHS Clinical Research Billing Unit, Manager; and Jan L. Hewett, J.D., UMMS IRBMED, Director
Assent of Children Participating in Research , R. Alex Blackwood, M.D., Ph.D., UMMS, Associate Professor of Pediatric Infectious Diseases; and June A. Insco, C.I.P., UMMS IRBMED, Education Coordinator
Closing Remarks, Jan L. Hewett, J.D., UMMS IRBMED, Director
Meet Your IRBMED Staff Brochures
Team A1 serving the following departments: Behavioral Medicine, Complementary Medicine, Family Medicine, Graduate Medical Education, Internal Medicine, Psychology, Neuro Psychology, Radiology, fMRI Studies, Social Work, Social Sciences
Team A2 serving the following departments: Geriatrics, Kinesiology, Neurology, Neurosurgery, Pathology, Obstetrics & Gynecology, Ophthalmology, Otolaryngology, Orthopedics, Physical Medicine & Rehabilitation, Surgery (Non Cancer): General, Orthopedic, Head & Neck, Pediatric and Plastic
- Play the IRB Genius Game
Team B1 serving the following departments: Anesthesiology, Dentistry, Dermatology, Emergency Medicine, Gastroenterology, Hepatic, Hematology, Nursing, Urology
Team B2 serving the following departments: Allergy, Cardiology, / Cardiac Electrophysiology / Cardio- Thoracic Surgery, Endocrinology / Metabolism / Diabetes, Genetics / Microbiology, Hypertension / Vascular Surgery, Infectious Disease, Nephrology, Pulmonology, Pharmacokinetics / Pharmacy, Radiology Devices, Rheumatology, Transplant: Heart / Lung / Kidney / Liver
Team C1 serving the following departments: Adult Oncology, Bone Marrow Transplant, Pediatric Oncology, Hematology/Oncology, Medical Oncology, Clinical Trial Office, Radiation Oncology, Surgical Oncology
2007 Education Symposium Materials
On Wednesday, February 7, 2007, 10:00 a.m. to 3:00 p.m., the IRBMED held our annual symposium. Copies of each presentation can be printed by clicking on the session title.
- Issues Encountered by IRBMED with Recent Compliance Cases
- Perspectives of a Community Member on the IRBMED
- Problem Children? Federal Regulations for Research Involving Children
- Who is going to be in my study? Engaging Special and Vulnerable Populations in Clinical Research
- eResearch Tips for a Timely Turn-around
Applications 101--Initial Project Applications in eResearch
Applications 102 --Amendements, Renewals, and Other Submissions in eResearch
Applications 201--Adverse Event Reporting
- PowerPoint
- Also see eResearch instructions for submitting AEs/ORIOs
- Standard AE Reporting Timetable
- Study Specific AE Reporting Timetable
- Writing a Study-Specific AE Reporting Plan Information Sheet
Applications 202--Other Reportable Information and Occurences
IRB Regulations 101--Basic IRB information
- PowerPoint
- Sample eResearch Application for "Non-Exempt" Retrospective Data Analysis Study
- Sample DSMP for a Blood Draw Study
- Sample DSMP for a Chart Review Study
IRB Regulations 102--Compassionate Use
IRB Regulations 103--Special Populations
Informed Consent 101--Overview of Informed Consent Issues and Procedures
Informed Consent 201--Writing an Informed Consent Document
New Member Education
Workshop 1--Overview
Workshop 2--Regulations in Depth
Workshop 3--Special Populations
Regulatory Review
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