Education

IRBMED offers presentations on topics important to researchers conducting human subjects research, invites special speakers to present to the UM community, and provides workshops on IRBMED processes throughout the year and upon request. In addtion to the IRBMED offerings, UM offers other research education opportunities.

IRBMED  Upcoming Special Events

No special events are currently scheduled.

 
IRBMED Workshops

We list full descriptions of each workshop below the table (or click the title in the table). We provide workshops on Wednesday afternoons and upon request at department, study team, or unit meetings. To register, click on the workshop date.

Workshop

Content

Date

Time

IRB Regulations 101

Basic Federal Regulations on IRB review (when IRB review is required and what the IRB must consider to approve the research)

9/09/09
2 PM - 4:30 PM
Compassionate Use--Emergency Use, Humanitarian Use, Orphan Drugs, etc.
2 PM - 4:30 PM

IRB Regulations 201

Regulatory Issues When Children are Subjects in Research
2 PM - 4:30 PM
Regulations and Special Consideratins for Vulnerable Populations (other than children) -- pregnant women, fetuses, non-viable/uncertain viablity neonates, prisoners, cognitively and decisionally impaired subjects, students, and patients of the researcher (see IRB Regulations 201 for issues with children in research)
2 PM - 4:30 PM

IRB Regulations 203

Writing a Study Specific AE Reporting Plan and Data & Safety Monitoring Plan (mainly focused on minimal to moderate risk research)

12/02/09
2 PM - 4:30 PM

Applications 101

eResearch Initial Project Application

2 PM - 4 PM

Applications 102

eResearch Amendments and Renewal Applications
2 PM - 4 PM

Applications 201-Part I

THIS MONTH ONLY--Part 1 and Part 2 will be combined in one 2.5 hour session.

PART ONE--Adverse Event and Unanticipated Problem Reporting Guidance

PART TWO--Adverse Event Reporting eResearch Forms
2 PM - 4:30 PM

Applications 201-Part II

THIS MONTH ONLY--Part 1 and Part 2 will be combined in one 2.5 hour session.

PART ONE--Adverse Event and Unanticipated Problem Reporting Guidance

PART TWO--Adverse Event Reporting eResearch Forms
2 PM - 4:30 PM

Other Reportable Information and Occurrences (ORIO) Guidance and eResearch Forms

2 PM - 4 PM

Informed Consent 101

Basic Informed Consent Regulations (see Informed Consent 201 for ‘how to write' content)

2 PM - 4:30 PM

Informed Consent 201

Information on Writing an Informed Consent Document using the IRBMED Standard Template

2 PM - 4:30 PM

Applications 101—Initial Project Application

This workshop, designed for those new to eResearch, covers basic information about how to submit a new human subjects research project to IRBMED. We recommend, but do not require, attending Regulations 101 prior to Applications 101. Presented by Zan Daley.

Back to top

Applications 102—eResearch Amendment and Renewal Applications

This workshop, designed for those new to eResearch, covers the process for submitting amendments and renewals to the IRBMED after a project's initial approval. We recommend attendees attend Applications 101 or have basic knowledge of eResearch prior to attending this workshop.Note, we cover Adverse Events and Other Reportable Information and Occurrences in Application 201 and 202. Presented by Zan Daley.

Back to top

Applications 201—Adverse Event (AE) Reporting

We cover this material in two sessions, You must register for parts 1 and 2 separately. Part 1 presented by June Insco. Part 2 presented by Zan Daley. We review:

Back to top

Applications 202—Other Reportable Information and Occurrences--what must be reported beyond adverse events

We cover the reports and forms that federal regulations and institutional policies require be submitted for IRB review. Presented by: Zan Daley and June Insco. Attendees will learn:

Back to top

IRB Regulations 101

We cover investigator and IRB responsibilities stemming from federal regulations for human subjects research. Presented by June Insco. Attendees will learn:

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

IRB Regulations 102

June Insco covers physician and IRB responsibilities for:

We will discuss applicable federal regulations, including when physicians must contact the IRB, information that must be submitted, and what patients must be told. Attendees will learn about:

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

IRB Regulations 202 (previously named IRB Regulations 103)

In this workshop June Insco provides an overview of the different regulations and ethical considerations for vulnerable populations:

We will discuss federal regulations that apply in these situations, including when researchers must contact the IRB, when IRBs must contact the Department of Health and Human Services, and the additional responsibilities investigators have when involving these populations in a research study. Note--see IRB Regulations 201 if you are interested in information regarding requirements for studies involving children.

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

Informed Consent 101—The IRBMED Templates and Guidance

June Insco will review:

Note, to learn more about writing the content of an informed consent document for research, see Informed Consent 201.

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

Informed Consent 201—Writing an Informed Consent Document for Research

June Insco reviews how to turn the technical language of a scientific protocol into a lay-language document. Examples illustrate the necessary steps. We will discuss the research subject's point of view and how that influences needed content, as well as the federal regulations that must be considered. Attendees will learn:

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

IRB Regulations 201--Regulatory Issues When Children are Subjects in Research

June Insco provides a comprehensive look at the issues that arise in children's research including:

Continuing Education Information: The University of Michigan Health System’s Educational Services for Nursing 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.

Back to top

IRB Regulations 203--Writing a Study Specific Adverse Event (AE) Reporting Plans and Data and Safety Monitoring Plan (DSM) for Minimal to Moderate Risk Studies

All studies benefit from having a plan that addresses the safety of subjects and/or the safety of subjects' data. Complexity of a plan depends upon the risks involved in the research. The IRBs standard AE reporting guidance and timetable are written in accordance with the most stringent federal requirements—those that cover interventions involving drugs, biologics, or devices. All studies under IRB's oversight are required to follow that plan unless a study specific plan is submitted and approved. A study specific plan may be more appropriate when either:

We will discuss federal guidance and regulations that apply, how the nature of the research relates to the content of the plans, and IRB requirements. Presented by June Insco.

Back to top

Other UM Human Subjects Research Education

Investigator 101: Investigator 101 by the organization, Public Responsibility in Medicine and Research, is a CD based training module. It includes, "The History and Ethics of Human Subject Research," with Dr. Jeffrey Cooper and "The Top 10 Responsibilities of Investigators" with Ms. Ada Sue Selwitz. To sign out a copy of the computer CD "Investigator 101" email June Insco.

Back to top

PEERRS

UM requies this web-based Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) be completed by anyone engaged in or associated with human subjects research. Key personnel--principal investigators, co-investigators, faculty advisors, study coordinators, and project managers--must complete PEERRs before the IRB can approve a study. Responsiblity for assuring all others complete PEERRS falls to the principal investigator .For more information, visit the PEERRS Web site.

On NIH applications where it asks for information about certifying your human subjects training, enter your PEERRS certification expiration date for the human subjects module and a one sentence description of PEERRS, such as, "PEERRS consists of educational modules and short tests covering basic rules, procedures and professional norms for the responsible conduct of research by anyone involved in research and scholarship at the University of Michigan.

Upon request, OVPR will consider a waiver of equivalency for investigators from other institutions who have completed human subjects courses like the UM PEERRS modules. Email peerrs@umich.edu to request a waiver and include:

1. Name and university/institution of the investigator
2. Role on UM study
3. Description of course completed and a link to it if available on the web
4. Electronic copy of the completion certificate (if available)

Email the peerrs@umich.edu if you have additional questions.

Back to top

Michigan Institute of Clinical and Health Research (MICHR)

The Michigan Institute of Clinical and Health Research Education and Certification Core (ECC) offers clinical research and Good Clinical Practices (GCPs) educational opportunities and resources to faculty and staff within the University of Michigan. For more information, visit the MICHR Web site.

Back to top

HIPAA Training for UM Researchers

The UM Health System offers a web based training module for those conducting research that involves Protected Health Information (PHI). For more information, visit the HIPAA Web site.

Back to top

Statistics

The Center for Statistical Consultation and Research (CSCAR) is a service and research unit of the University of Michigan, administratively located in the Office of the Vice President for Research. Its staff provides statistical services to faculty, primary researchers, graduate students and staff of the University. To learn more about educational opportunities about statistical analysis in biomedical and behavioral research, visit the CSCAR Web site.

Back to top

Advanced Human Subject Research Modules

Collaborative IRB Training Initiative (CITI): This nationally recognized web course provides advanced educational modules that supplement those in PEERRS. A certificate issued upon completion of each module. This course is free, but there is a charge to obtain CME. For more information, visit the CITI Web site. Click here for instructions on accessing CITI.

Back to top

General Computer Education

IT Education Services: IT Education Services provides education and training programs for the UM community. Courses offered include Microsoft Word, Excel, and Other Programs. For for more information, visit the IT Education Services Web site.

Back to top