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.

The University of Michigan Medical School is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

The University of Michigan Medical School designated this educational activity for a maximum of 8.75 AMA PRA Category 1 Credit(s)™.  Physicians should only claim credit commensurate with the extent of their participation in the activity.

YOU CAN ONLY CLAIM CREDIT FOR SESSIONS YOU ATTENDED ON MAY 8.

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

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.

IRBMED Workshop Handouts SECTION IS DOWN FOR MAINTENANCE (Updating Materials)

Applications 101--Initial Project Applications in eResearch

Applications 102 --Amendements, Renewals, and Other Submissions in eResearch

Applications 201--Adverse Event and Unanticipated Problem Reporting

Applications 202--Other Reportable Information and Occurences

IRB Regulations 101--Basic IRB information

IRB Regulations 102--Compassionate Use

IRB Regulations 103--Special Populations (does not include children)

IRB Regulations 201--Children in Research

IRB Regulations 203--Writing a DSMP and AE Reporting Plan (Intended for Minimal to Moderate Risk Studies)

Informed Consent 101--Overview of Informed Consent Issues and Procedures

Informed Consent 201--Writing an Informed Consent Document

IRBMED Member Education

New Member Education

Workshop 1--Overview

Workshop 2--Regulations in Depth

Workshop 3--Special Populations

Regulatory Review


 

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