IRBMED Monthly Course List - Spring and Summer 2020
May 2020
All Spring and Summer IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
May 15 (Friday), 9 - 10:30 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 subject becomes incarcerated.
May 19 (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.
May 29 (Friday), 9 - 10 am
Federal and Institutional Requirements for Human Subjects Research (Level I)
This course presentation will focus on the basics of conducting human subject 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 subjects 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 subjects and comply with Federal and Institutional Requirements for human subjects 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 2020
All Spring and Summer IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
June 2 (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.
June 9 (Tuesday), 10 - 11:30 am
The Elements of Informed Consent and Use IRBMED Consent Templates (Level 1)
This course offers an overview of informed consent requirements in human subjects 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 16 (Tuesday), 10 - 11:30 am
Waivers, Alterations, and Alternative Forms of Informed Consent Level II)
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, this course will include a discussion on the requirements for obtaining consent from those who are non-fluent speakers or readers of English. The comparison of Waivers of HIPAA Authorization and Waivers of Informed Consent will also be discussed.
June 23 (Tuesday), 10 -11 am
Writing Research Informed Consent Documents (Level I)
This course offers guidance on writing informed consent documents. Discussion will explore strategies for creating documents that are easy to read, easy to understand, and compliant with federal and IRBMED requirements. Brian Seabolt, IRBMED Senior Technical Writer will present this course.
June 26 (Friday), 9 - 10 am
HIPAA Requirement and Waivers and Exceptions to Authorization for Research (Level 1)
This course will review the basic principles of the Health Insurance Portability and Accountability Act (HIPAA) as they apply to human subjects’ research. This will include the requirements necessary to secure a Waiver of HIPAA authorization from the IRB, a comparison of Waivers of HIPAA Authorization and Waivers of Informed Consent and a discussion of other exceptions to the HIPAA Authorization Requirement (review of data preparatory to research, use of limited data sets, or use of de-identified data sets).
June 30 (Tuesday), 10 - 11 am
Secondary Use, Not Regulated and "Umbrella Project" Applications for IRBMED Review (Level 1)
This course will review non-standard applications for 'Not Regulated" research, secondary use projects and for projects lacking immediate plans for involvement of human subjects, 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 subjects, their data, and/or their specimens include activities such as training grants, program projects, center grants, or multi-phase studies not involving human subjects until later years.
July 2020
All Spring and Summer IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance.
July 10 (Friday), 9 - 10 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.
July 14 (Tuesday), 10 - 11 am
Storage and Retention of Human Subjects Research Data (Level 1)
This course will review the fundamentals of maintaining confidentiality of human subject 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.
July 21 (Tuesday), 10 - 11:30 am
Basics of FDA Regulated Research: Human Subjects 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.