Office of Regulatory Affairs

Human Research Protection Program

2007 Fall IRB Educational Conference

Using the Flexibility Built into the IRB Regulations:

Benefits to IRBs and Investigators

Friday, October 19, 2007

8:30 A.M. – 4:30 P.M.

MSU Union, East Lansing, MI

KEYNOTE SPEAKER

We are pleased to announce that Charles McCarthy, Ph.D., Adjunct Faculty, Office of Research, Virginia Commonwealth University and the 2003 recipient of the Public Responsibility in Medicine and Research (PRIM&R) Lifetime Achievement Award for Excellence in Research Ethics, will be the conference keynote speaker. 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 visit http://www.primr.org/AboutUs.aspx?id=372 .

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

REGISTRATION FEE

The registration fee is waived for Michigan State University (MSU) and Community Research Institutional Review Board (CRIRB) affiliated individuals. If you are not affiliated with MSU or CRIRB, there is a registration fee of $75.00. The registration fee includes materials, continental breakfast, and afternoon refreshments. Lunch is on your own for all participants.

Affiliated with MSU is defined as an MSU faculty member, staff, student or IRB member. Affiliated with CRIRB is defined as a faculty member, staff, student or IRB member from a CRIRB affiliated institution. For a listing of CRIRB institutions, please visit http://www.humanresearch.msu.edu/crirbpartnerinstitutions.html

REGISTRATION – ENDS SOON!   
It is not too late to register for the 2007 MSU Fall IRB Conference! Registration is open through Monday, October 15. Online registration will close at the beginning of business on Tuesday, October 16.

To register, please visit the human research web site, http://www.humanresearch.msu.edu/conferences.html and click on the link “Registration – Now Open Online”.

A confirmation will be emailed when your registration is processed. If you register and are unable to attend, please notify Kristen Burt by phone: 517-355-2180 ext. 235 or email: IRBEducation@ores.msu.edu. Please feel free to contact Kristen Burt with any questions.

SESSIONS

The agenda for the 2007 Fall IRB Educational Conference includes a plenary morning session and two afternoon breakout sessions.  Please note that the tentative agenda is posted on the conference website, http://www.humanresearch.msu.edu/conferences.html. During the morning plenary session, keynote speaker Dr. Charles McCarthy will give two presentations and participate in a Q&A session. In the afternoon, participants will have a choice of breakout sessions to attend.  

     Breakout Session 1 - 1:15 P.M. - 2:30 P.M.

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 and 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.

Breakout Session 2 - 2:45 P.M. - 4:00 P.M.

Exceptions to Signed Consent: Waiver of Consent and 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 permission and documentation of consent will be highlighted. 

CONTACT PERSON
For answers to questions about the 2007 Fall IRB Educational Conference, please feel free to contact Kristen Burt, Educational Program Coordinator by phone: (517) 355-2180 ext. 235 or email: IRBEducation@ores.msu.edu. 

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