IRBMED - UMMS

Currently Enrolling Workshops

IRB Regulations 101 View Schedule
Presenter: June Insco, CIP

See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions

Informed Consent 101 View Schedule
Presenter: June Insco, CIP

Expanded new content: This workshop covers managing informed consent documents in eResearch, needed steps when subjects do not read English, and new informed consent features on the IRBMED website. This workshop also reviews Microsoft Word features, and basic instructions for using the IRBMED informed consent document template. Attendees will learn: * How to download the template * How to upload consents into eResearch for clarity and to maintain regulatory history * Helpful hints for filling out the form * How to print the form in a 'subject friendly' format * What to do when recruiting non-English reading or speaking subjects Workshop attendees will benefit by: * Increasing their knowledge of the template instructions * Improving productivity PLEASE NOTE: To learn more about the content of an informed consent document for research, see Informed Consent 201 (watch for postings quarterly). **********************************************************

IRBMED Applications 101 - eResearch Application View Schedule
Presenter: June Insco, CIP, IRBMED.

This workshop covers basic information about how to submit a human subjects research project to IRBMED for review using the eResearch on-line application. Attendees will learn: * How to log-in to eResearch * How to fill out the application * How to upload documents * Helpful tips for filling out the Application efficiently * How to submit the application and track its progress Also recommended for those new to the University of Michigan: Regulations 101 . **********************************************************

IRBMED Applications 101 - eResearch Application - HANDS ON View Schedule
Presenters: June Insco, IRBMED

See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions.

IRBMED Applications 102—using eResearch for Amendments and Continuing Reviews. View Schedule
Presenter: June Insco, CIP (IRBMED)

See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions

IRBMED Applications 201: Adverse Event Reporting Part I View Schedule
Presenter: June Insco, CIP

See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions

IRBMED Applications 201: Adverse Event Reporting Part II View Schedule
Presenter: June Insco, CIP

Adverse Reporting Part II reviews and explains the eResearch forms for reporting adverse events that involve research subjects or others in the course of a research study. (For a workshop on AE reporting using the Legacy Forms, contact insco@umich.edu to set up a session.) Information covered includes: Determining which form to use How to complete forms * How to prepare AEs for scheduled continuing review (renewal of study) How to track status of an AE Report AE Guidance is covered in Adverse Event Reporting Part I which is a recommended prerequisite for this workshop. Register separately for Adverse Event Reporting Part I. ***************************

IRB Regulations 201 - Special Issues When Children are Subjects in Research View Schedule
Presenter: June Insco, CIP

This workshop takes a comprehensive look at the issues that arise in children's research from the limits on what a local IRB is allowed to approve under the federal regulations, to assent, to the requirements involved when a child is a ward of the state. WORK SHOP CANCELED 4/9/2008

IRB Regulations 103 - Vulnerable Populations View Schedule
Presenter: June Insco, CIP

See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions

Informed Consent 201—Writing an Informed Consent Document for Research View Schedule


See http://www.med.umich.edu/irbmed/education.htm#work for workshop descriptions

IRBMED Applications 202—ORIO Reporting View Schedule
Presenter: June Insco, CIP

While many researchers are familiar with the need to report adverse events to the IRB, they are less familiar with the other types of events or information that federal regulations and institutional policies require be submitted for IRB review. These ‘Other Reportable Information and Occurrences’ (ORIOs) are explained in this workshop. We review the regulatory requirements, IRBMED web posted guidance, and how to submit a report. Attendees will learn: * How to access and apply the IRBMED web-based guidance * Information to provide in an ORIO report * Helpful tips for avoiding common mistakes This educational activity is provided by University of Michigan Health System’s Educational Services for Nursing which is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Contact hours for nursing will be provided. **********************************************************