This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.

This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.

This course is intended for those unfamiliar with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch while examining the process for creating and submitting an initial project application.

This course offers an overview of some special situations relating to informed consent. Specifically, waivers and alterations of informed consent, waivers of documentation of informed consent, and obtaining consent from non-English speakers.

This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and how such events impact risk to subjects. Additionally, the course will review the requirements of reporting such events to the IRB and other entities.

This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.

This course is a follow-up to Initial Project Applications and will examine the process for submitting amendments and scheduled continuing reviews to IRBMED using eResearch once a project’s initial application has been approved.

This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data.

This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de- identified datasets.

This course will identify the Single IRB model for Multi-Site research, show the regulatory requirements of sIRB review and the exceptions to sIRB requirements, and explain sIRB requests of IRBMED as sIRB (accepting oversight), External IRB as sIRB (ceding oversight), and UofM as the Coordinating Center.

This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.

This course will examine the additional regulatory requirements for conducting research involving pregnant women, fetuses, neonates, children, and prisoners, including the requirements for these populations in a research project and obtaining informed consent.