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University of Michigan Medical School

IRBMED
2800 Plymouth Road
Building 200, Room 2086
Ann Arbor , MI 48109-2800
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 1234

EDUCATION & TRAINING

Regulations

The Regulations Course Offerings will explore the various regulatory requirements placed on research, with particular emphasis on FDA, OHRP, and DOD.

Registration:

Please register for any sessions you would like to take. You can register by clicking the date below or by visiting the registration site. (Click here for step-by-step instructions on using the Registration System.) Unless otherwise noted, each session will be 50 minutes long.

A Map to the room can be found by clicking on the room number below.

LEVEL 1	Federal and Institutional Requirements for Human Subject Research	Course Objectives: You will learn the basics of human subjects research including federal regulations and institutional practices. Recommended: Related Workshops: CE Credit: Not Offered	4/16/2013, 9:00 – 10:00	UH Cafeteria Dining Room D
	Preparing your IRB Application for Human Subject Research	Course Objectives: You will learn what you need to know before submitting your application in eResearch. Recommended: Please register for Initial Project Applications if you want an overview of eResearch. Related Workshops: CE Credit: Not Offered	4/16/2013, 10:00 – 11:00	UH Cafeteria Dining Room D
	Exempt and Non-Regulated	Course Objectives: We will explore the Exempt and Not- Regulated application types and discuss when each is applicable. Recommended: Related Workshops: Waivers of HIPAA Authorization CE Credit: Not Offered
	Exempt and Non-Regulated

LEVEL 2	Research with Prisoners	Course Objectives: You will learn the special regulations related to research involving prisoners and the steps that you will need to take in order to involve prisoners in your research project. Additionally, we will discuss the necessary steps to take when an already enrolled subject becomes a prisoner. Presenter: Georgia Marvin, JD, Compliance Coordinator Recommended: Related Workshops: CE Credit: Not Offered	PENDING
	Research with Children	Course Objectives: You will learn the special regulations related to research involving children. Presenter: S. Joseph Austin, JD, LL.M Recommended: Related Workshops: CE Credit: Not Offered
	Research with Pregnant Women, Fetuses, and Neonates	Course Objectives: You will learn the special regulations related to research involving pregnant women, fetuses and neonates. Presenter: Recommended: Related Workshops: CE Credit: Not Offered
	Research with Special Populations	Course Objectives: You will learn the special regulations related to research involving special populations which include cognitively impaired, patients, students, etc. Presenter: Carol Hutsko, BBA, Senior Associate Regulatory Analyst Recommended: Related Workshops: CE Credit: Not Offered

LEVEL 3	Drugs and Devices	Course Objectives: Compassionate use, Humanitarian Use Devices (HUDs), Investigational Device Exemptions (IDEs), Investigational New Drugs (INDs) Presenter: Recommended: Related Workshops: CE Credit: Not Offered	PENDING
	Emergency Use	Course Objectives: Consents, compassionate use, and urgent amendments Presenter: Recommended: Related Workshops: CE Credit: Not Offered	PENDING

LEVEL 4	Department of Defense	Course Objectives: Preparing for audits from regulatory oversight entities. Presenter: Recommended: Related Workshops: CE Credit: Not Offered	PENDING

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Page Created on 4/2/12; Updated 6/7/12