Agenda

Innovation, Inclusiveness, and Informed Consent:
Current Challenges for Institutional Review Boards

May 13-14, 2002
University of Minnesota
Hubert H. Humphrey Center
Minneapolis Minnesota

Institutional Review Boards are facing significant challenges in their review of research involving innovations and new technologies both in the biomedical fields and in the behavioral sciences. Informed consent and the inclusion of diverse populations in these research areas poses additional issues for IRBs and researchers. This two-day workshop designed for researchers, IRB members, IRB administrators and research staff will continue the dialogue with federal regulators on these issues.

Monday May 13, 2002:

7:30-8:30 Registration ---Continental Breakfast

8:30-8:45 Welcome and Introductions
Christine M. Maziar, Frank Cerra, Jeffrey M. Cohen

8:45-10:00 Federal Update

Jeffrey Cohen...Office for Human Research Protection (OHRP)
David A. LePay...Food and Drug Administration (FDA)
Joan Porter...Office of Research Compliance and Assurance (ORCA)
National Institutes of Health (NIH)

10:00-10:15 Break

10:15-12:00 Innovations and IRB Challenges

Stem cell Research and other fast moving areas...Jeff Kahn
Internet Research...Laura Gurak

Federal Commentary--------OHRP/FDA/ORCA

12:00-1:15 Lunch

1:30-2:30 Overview of Federal Regulations and the Common Rule

Jeffrey M. Cohen...Office for Human Research Protection (OHRP)
Bonnie Lee...Food and Drug Administration (FDA)
Joan Porter...Office of Research Compliance and Assurance (ORCA)
National Institutes of Health (NIH)

2:30-3:15 Workshops:

Biological Sciences and Medicine Track

Beyond the consent form -focus on the consent process...Jeffery Cohen OHRP (big room)

Medical Devices and Regulatory compliance challenges for IRBs...Sharon Matson, FDA and Kim Oleson, Medtronic

The Current Climate for VA IRBs...Joan Porter, Cindy Paulsen, Karen Smith, ORCA

Behavioral and Social Sciences Track

Discussion group on Social Science Issues-title pending... Chad Furman

3:15-3:30 Break

3:30-4:30 Workshop

3:30 Compliance Oversight and Investigations-How to Prepare for an Audit

George Pospisil...Office for Human Research Protection (OHRP)
Stan Woollen...Food and Drug Administration (FDA)
Karen Smith...Office of Research Compliance and Assurance (ORCA)
National Institutes of Health

4:30 Adjourn

5:00 Reception

Tuesday May 14, 2002:

8:30-10:00 Conflict of Interest Issues fro IRBs, Investigators and Institutions

Richard Bianco
Barbara Shiels
Jeffrey Kahn, moderator and presenter

Federal Commentary -----OHRP/FDA

10:00 Break

10:15-12:00 Inclusion Issues in Research

Inclusion and Vulnerabilities in Research...Deb DeBruin
Inclusion of Elderly Persons...Stuart Bloom
Inclusion of Women Issues...NIH person
Psychiatric Patients...David Adson

Federal Commentary------OHRP/FDA

12:00-1:00 Lunch (on their own)

1:00- 2:30 Informed Consent Challenges for the IRB

Comprehension Challenges...N. Yasemin Oguz
...Dale Hammerschmidt

Federal Commentary---OHRP/FDA

2:30-2:45 Break

2:45 IRB and Investigator Education-Current Standards and Expectations

Jeffrey Cohen...Office for Human Research Protection(OHRP)
...Food and Drug Administration (FDA)
Cindy Paulsen and Joan Porter...Office of Research Compliance and Assurance (ORCA)
...National Institutes of Health

3:30 "Ask the Feds"

Representatives from:

Office for Human Research Protection (OHRP)
Food and Drug Administration (FDA)
Office of Research Compliance and Assurance (ORCA)
National Institutes of Health (NIH)

4:30 Adjourn