IRBMED Monthly Course Schedule: June-August 2021
June 2021
IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
June 2 (Wednesday), 10-11 am
Federal and Institutional Requirements for Human Research (Level I)
This course presentation will focus on the basics of conducting human research in compliance with federal regulations and institutional practices. We will examine the history of medical experimentation in humans and reflect on the development of the ethical principles upon which federal human research requirements are based. This course will also discuss some of the ethical and regulatory requirements that study teams must adhere to throughout the conduct of a research project in order to protect the rights and welfare of human participants and comply with Federal and Institutional Requirements for human research. In particular, this course will focus on the requirements at Subpart A of 45 CFR Part 46: Basic HHS Policy for Protection of Human Subjects, also known as the "Common Rule".
June 8 (Wednesday), 10-11:30 am
This course will examine the regulatory requirements for conducting research involving children, pregnant women, fetuses, neonates, and prisoners. These requirements, at 45 CFR 46 Subparts B, C and D are in addition to the basic requirements required at 45 CFR 46 Subpart A. The course will include the requirements for enrolling these populations in a research project, obtaining informed consent, assent, and obtaining parental permission, and the required procedures when an already enrolled participant becomes incarcerated.
June 10 (Thursday), 9-10:30 am
Completing eResearch Applications for IRBMED Review (Level 1)
This course is intended familiarize attendees with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch. The course will examine the process for creating and submitting initial project applications, amendments and scheduled continuing reviews to IRBMED.
June 18 (Friday), 10-11 am
Single IRB Requirements for Multi-Site Research Involving Human Participants (Level III)
In 2018, NIH policy and in 2020, HHS federal regulations, require certain types of federally-funded research projects involving multi-site research using the same research protocol to use a Single IRB (sIRB) model to accomplish IRB review for all participating institutions. This IRBMED course will provide an in-depth overview of sIRB requirements for multi-site research involving human subjects. In this course, you will learn the requirements for requesting IRBMED to serve as the sIRB of record for external sites (accepting oversight) and for requesting IRBMED to approve the use of an external IRB to be the sIRB of record for U-M (ceding oversight).
June 22 (Tuesday), 10-11:30 am
The Elements of Informed Consent and HIPAA Requirements (Level 1)
This course offers an overview of informed consent requirements in human research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal and institutional requirements. This course also includes a discussion of the basic requirements for HIPAA Authorization as part of the consent document and process.
June 29 (Tuesday), 10-11:30 am
Waivers, Alterations, and Alternatives for Research Informed Consent and HIPAA Authorization
This course offers an overview of exceptions to the requirement for informed consent in human subjects research. Specifically, the regulations allow an IRB to grant waivers and alterations of informed consent, and waivers of documentation of informed consent, when specified criteria have been met. Additionally, Waivers and other exceptions for the requirements of HIPAA Authorization will also be discussed.
July 2021
IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
July 13 (Tuesday), 10-11 am
Secondary Use and "Umbrella Project "Applications for IRBMED Review
This course will review non-standard applications for 'Not Regulated" research, secondary use projects and for projects lacking immediate plans for involvement of human participants, their data, and/or their specimens. These latter projects are sometimes referred to as "umbrella projects". The course will examine the appropriate application types for these types of projects and an overview of the submission process. "Secondary research" includes studies that involve only the re-use of private information and/or biospecimens that are collected for some other primary or initial activity. The application for projects lacking immediate plans for involvement of human participants, their data, and/or their specimens include activities such as training grants, program projects, center grants, or multi-phase studies not involving human participants until later years.
July 21 (Wednesday) 10-11:30 am
This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and review the requirements of reporting such events to the IRB in eResearch. This session will also include a discussion on when it may be appropriate to use a study specific AE reporting plan instead of the U-M standard time table for reporting adverse events to the IRB.
July 26 (Monday), 10-11:30 am
Basics of FDA Regulated Research: Human Research Involving Drugs and Devices (Level III)
This course will provide and introduction to the FDA requirements for conducting research with a drug or medical device, including conducting research under an IND (Investigational New Drug Application) and an IDE (Investigational Device Exemption). This course will also include an introductory discussion on the FDA's Expanded Access Program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.
August 2021
IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
August 4 (Wednesday), 10-11 am
Data Safety Monitoring Boards (DSMB) and Data Safety Monitor Plans (DSMP) (Level II)
This course will review when studies are required to have a DSMP, who should implement or oversee the DSMP, and offer suggestions for developing an appropriate DSMP. In addition, the course will examine when a study is required to establish a DSMB.
August 13 (Friday), 10-11 am
Storage and Retention of Human Research Data (Level 1)
This course will review the fundamentals of maintaining confidentiality of human research data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de-identified datasets. General best practices for protecting privacy and confidentially will also be discussed.
August 17 (Tuesday), 10-11:30 am
Completing eResearch Applications for IRBMED Review (Level 1)
This course is intended familiarize attendees with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch. The course will examine the process for creating and submitting initial project applications, amendments and scheduled continuing reviews to IRBMED.
August 24 (Tuesday), 10-11:30 am
This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and review the requirements of reporting such events to the IRB in eResearch. This session will also include a discussion on when it may be appropriate to use a study specific AE reporting plan instead of the U-M standard time table for reporting adverse events to the IRB.