Fall 2006 IRB Conference - Human Research Protection Program

Fall 2007 IRB Conference

2007 Fall IRB Conference
TOPIC:	Using the Flexibility Built into the Regulations: Benefits to IRBs and Investigators
Date:	October 19, 2007
Time:	Full day. 8:30 A.M. – 4:30 P.M.
Location:	MSU Union (2nd Floor), East Lansing, MI 48824

KEYNOTE SPEAKER
Charles McCarthy, Ph.D., Adjunct Faculty, Office of Research, Virginia Commonwealth University, 2003 recipient of the Public Responsibility in Medicine and Research (PRIM&R) Lifetime Achievement Award for Excellence in Research Ethics. Dr. McCarthy, the longest serving Director of the federal Office for Protection from Research Risks (OPRR) from 1980 - 1992, helped guide the development of the federal regulations for human research protection.

To learn more about Dr. McCarthy, please click here.

REGISTRATION - Now Closed
The registration deadline was October 15, 2007, and the online registration is now closed. Late registrations may be accepted based on conference capacity. Please contact Kristen Burt at 517-355-2180 ext. 235 for late registration questions.

Registration is required for all attendees.

The registration fee is waived for MSU and CRIRB affiliated individuals. Click here for a list of CRIRB affiliate institutions.

For non-MSU or non-CRIRB affiliated individuals, the registration fee is $75.00. This fee includes materials, continental breakfast and afternoon refreshments.

WHO SHOULD ATTEND
Anyone involved in human subject research, including faculty, students, staff, research administrators, IRB members and IRB staff.

CONTACT PERSON
Please feel free to contact Kristen Burt, Educational Program Coordinator, by phone: (517) 355-2180 ext. 235 or email: IRBEducation@ores.msu.edu with any questions.

TENTATIVE CONFERENCE AGENDA
All conference sessions will be held on the second floor of the MSU Union

2007 Fall IRB Conference Agenda
8:00 A.M.	Registration & Continental Breakfast
8:30 A.M.	Welcome & Introduction
8:45 A.M.	Keynote: A Historical Perspective on the IRB Regulations
9:30 A.M.	Case Studies: Are they Human Subjects? Is it Research? What is Your View?
10:30 A.M.	Break
10:45 A.M.	Using the Flexibility Built into the Regulations
11:30 A.M.	Q&A with Dr. Charles McCarthy
12:00 P.M.	Lunch – On Your Own
1:15 P.M.	Breakout Session 1
	IRB Basics 1: This workshop, designed for new IRB members, provides an introduction to human subjects’ research protections including a historical perspective, and overview of the regulations and techniques for completing project reviews.
	Maximizing the Appropriate Use of Exempt & Expedited Review Categories: When can research be exempt? When can research be expedited? A discussion of these review categories will be provided, highlighting the similarities, differences, and distinguishing characteristics. This session will show you how to maximize use of these categories in an appropriate and regulatory compliant way. Criteria that exclude projects from exempt or expedited review will also be discussed.
	Recent OHRP Compliance Letters: What Can We Learn? This session provides an overview of recent OHRP compliance determination letters, with an emphasis on what lessons you can learn. Potential trends and common issues among institutions will be discussed.
	Waiver of Parental Permission: When is it Allowed? What is a waiver of parental permission? Under what conditions may an IRB grant such a waiver? This session will address these questions and others raised by waivers of parental permission, as well as highlighting other applicable laws, such as the Protection of Pupil Rights Amendment (PPRA). Examples of situations where waiver of parental permission may be granted will be discussed.
2:30 P.M.	Break
2:45 P.M.	Breakout Session 2
	Exceptions to Signed Consent: Waiver of Consent & Waiver of Documentation: When can the requirement to obtain consent or to obtain a signed consent document be waived? This session will discuss the criteria under which such requirements may be waived, as well as discussing terms in the criteria, such as “impracticable.” The recent SACHRP recommendations will be highlighted.
	IRB Basics 2: This session is a continuation of IRB Basics 1 and includes a mock review of an IRB application by participants.
	Legal Perspectives: A Discussion of Recent Court Cases Related to Human Research: Throughout the country, there are judicial decisions that are made relating to the human research protection regulations. This session will highlight several of these recent court decisions.
	Using the Flexibility of the Regulations in Social Science Research: How can we use the flexibility built into the regulations in social science research? Areas such as defining human subject research, using exempt and expedited review categories, and waiving consent, parental consent and documentation of consent will be highlighted.
4:00 P.M.	Break
4:10 P.M.	Closing Remarks
4:30 P.M.	End of Conference