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Applications 101—Initial Project Application

This workshop covers basic information about when and how to submit a new human subjects research project to IRBMED for initial review using eResearch. It is primarily designed for research faculty and staff who are new to the IRBMED and to eResearch.

Presenter: Zan Daley

Recommended prerequisite: Regulations 101

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Applications 102—Previously Approved Project Application

This workshop covers the process and timing for submitting amendments, renewals, and reports to the IRBMED after a project's initial approval. It is designed primarily for research faculty and staff who are new to the IRBMED forms and reporting or new to eResearch.

NOTE: Reporting AEs (Adverse Events) and ORIOs (Other Reportable Information and Occurrences) are briefly covered in this workshop. For detailed information attend Application 201 and 202.

Presenter: Zan Daley

PREREQUISITE: Applications 101 or basic knowledge of eResearch

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Applications 201—Adverse Event (AE) Reporting (register for two sessions seperately, see below)

This information is covered in two separate workshops, You must register for parts 1 and 2 separately.

Information covered includes:

Adverse Event Reporting Part 1 reviews and explains IRBMED guidance for reporting adverse events that involve research subjects or others in the course of a research study. Presenter: June Insco

Adverse Event Reporting Part 2 reviews and explains the eResearch forms for reporting adverse events. Presenter: Zan Daley

 

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Applications 202—ORIO Reporting

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:

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IRB Regulations 101

This workshop covers investigator and IRB responsibilities stemming from federal regulations for human subjects research. We review the different stages of research, from initial idea to final data analysis, and when researchers must contact an IRB during those stages. We discuss the motivators and drivers of researchers and

Attendees will learn:

IRB Regulations 102

This workshop covers physician and IRB responsibilities when an investigational agent is used for clinical, rather than research, purposes. Common terms for the application of investigational agents in the clinical setting include:

We will discuss federal regulations that apply in these situations, including when physicians must contact the IRB, what patients should be told about the difference between an investigational and an FDA-approved agent, and how informed consent is affected by such situations.

We review :

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IRB Regulations 103

This workshop 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 special populations in a research study. Note--see IRB Regulations 201 if you are interested in information regarding requirements for studies involving children.

Presenter: June Insco

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.

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Informed Consent 101—The IRBMED Templates and Guidance

We review :

• Federal regulations about informed consent, parental permission and children's assent; waivers, exceptions, and alterations
• Federal regulations for recruiting non-English reading or speaking subjects
• The importance of version control in managing regulatory documents
• Working with eResearch to achieve compliance with federal informed consent regulations
  
  

Presenter: June Insco

PLEASE 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.

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Informed Consent 201—Writing an Informed Consent Document for Research

Workshop reviews how to turn the technical language of a scientific protocol into a lay-language document. Real life examples illustrate the necessary steps. We discuss the research subject's point of view and how that influences needed content, as well as the federal regulations that must be considered. Material is based on previous presentation by Ana Austin of the Michigan Institute for Clinical and Health Research (MICHR).

We will review :

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.

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

This workshop takes a comprehensive look at the issues that arise in children's research including:

• Limits on what a local IRB is allowed to approve under the federal regulations
• Importance of risk level in children's research
• Laws regarding informed consent including which studies requires two parent signatures
• Laws regarding assent of children
• Federal requirements involved when a child is a ward of the state.

Presenter: June Insco

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.

 

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

DSMPs:

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. This workshop offers suggestions primarily for minimal to moderate risk studies but provides an outline appropriate for all studies.

AE Reporting Plans:

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.

Presenter: June Insco

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Investigator 101

Investigator 101 is a CD based training module. This CD is based on PRIM&R's (Public Responsibility in Medicine and Research) highly acclaimed "IRB 101 - On the Road" training program. 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.

PEERRS

PEERRS: The Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) is a web-based foundational instruction and certification program for faculty and staff engaged in or associated with research at the University of Michigan. Completion of a human subjects module is required for principal investigators, co-investigators, faculty advisors, study coordinators/project managers involved in human subjects research. 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."

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.

HIPAA

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.

Statistics

CSCAR: 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.

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.

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.