Protecting
Human Subjects
in Social, Behavioral and Educational Research
Program
8:15am
Welcome Remarks
Elizabeth
Ambos - Associate Vice President for Research and External
Support; California State University, Long Beach
Gary Reichard - Provost and Senior Vice President
for Academic Affairs; California State University, Long Beach
8:30am
Federal Perspectives on the Human Subject Protections Enterprise: Special
Emphasis on Social, Behavioral and Educational Research
This panel will provide unique federal
perspectives on the human subject protections enterprise. Representatives
from the federal government will address how their respective organizations
implement the Human Subject Protections regulations and ethical principles
of The Belmont Report in order to maximize the protection of human subjects
in federally funded protocols involving social, behavioral and educational
research. This forum will conclude with a question-and-answer session.
Moderated by Jim Till - Director for
Research Compliance; California State University, Long Beach
Paul Hammond
- Director, Western Regional Office; Office of Research Oversight;
U.S. Department of Veterans Affairs
Shirley
Hicks - Director, Division of Education & Development;
Office for Human Research Protections; U.S. Department of Health and
Human Services
Stuart
Plattner - Program Director for Cultural Anthropology
and National Science Foundation Human Subjects Research Office; National
Science Foundation
Ivor Pritchard
- Senior Fellow, Office for Human Research Protections; U.S.
Department of Health and Human Services
10:30am Break
10:45am
Keynote Address: Ten Ways to Promote Valid Science and Protection of
Human Subjects
Unthinking compliance with federal regulations can lead to
unethical treatment of human subjects and to invalid research. The federal
regulations were deliberately designed to permit creative ethical problem
solving when the "default" regulatory requirements seem inappropriate.
However, researchers and IRBs often fail to take full advantage of the
flexibility they might exercise. This Keynote Address will examine ten
ways to foster good science, improve the operation of Institutional
Review Boards, and maximize the protection of human subjects. Many useful
materials, websites, and references will be provided. This Keynote Address
will conclude with a question-and-answer session.
Joan Sieber
- Professor of Psychology, Emerita; California State University, Hayward
Disseminated materials:
12:15pm Lunch
1:30pm
Human Subject Protections: Nuts & Bolts
This plenary session will: 1) provide information on the historical
foundation of the human subject protections regulation; 2) discuss the
flexibilities of the regulation; 3) provide guidance regarding the application
of the regulations to social, behavioral and educational research. Questions
are welcome at the end of this session.
Ivor
Pritchard - Senior Fellow, Office for Human Research
Protections; U.S. Department of Health and Human Services
2:15pm
Listen to the Perspectives of Local Experts on: Data Safety and Monitoring
Boards; Interim Analysis for Social/Behavioral Studies; Equivalent Determination
of Two Social/Behavioral Interventions
A panel of local experts will provide their views and experiences on
conducting social/behavioral research studies. Perspectives will be
provided on: balancing the Data Safety and Monitoring Boards; the interim
analysis for social/behavioral studies; and the determination of whether
two social/behavioral interventions are equivalent. This panel discussion
will conclude with a question-and-answer session.
Moderated by Jim Till - Director for
Research Compliance; California State University, Long Beach
Dennis
Fisher - Professor of Psychology; Director, California
State University, Long Beach Center for Behavioral Research and Services:
"Data Safety and Monitoring Boards for Behavioral Trials"
Scott Hershberger - Professor of Psychology;
California State University, Long Beach: "Introduction to Interim
Analysis for Behavioral Studies"
Brian Wiens
- Senior Manager, Biostatistics; AMGEN: "How to Determine Whether
Two Behavioral Interventions are Equivalent"
3:15pm Break
3:30pm
Advice and Guidance for Conducting Safe and Effective Social/Behavioral
Research Studies
Representing academia and the federal government, this panel
will offer advice and guidance on how to conduct safe and effective
social/behavioral research studies. This session provides an opportunity
for robust interaction between both panel members and forum participants.
Moderated by Jim Till - Director for Research Compliance;
California State University, Long Beach
Dennis Fisher - Professor of Psychology; California
State University, Long Beach
Paul Hammond - Director of the Western Regional Office;
Office of Research Oversight; U.S. Department of Veterans Affairs
Scott Hershberger - Professor of Psychology; California
State University, Long Beach
Shirley Hicks - Director; Division of Education &
Development; Office for Human Research Protections, U.S. Department
of Health and Human Services
Stuart Plattner - Program Director for Cultural Anthropology
and National Science Foundation Human Subjects Research Office, National
Science Foundation
Ivor Pritchard - Senior Fellow; Office for Human
Research Protections; U.S. Department of Health and Human Services
Joan Sieber - Professor of Psychology, Emerita; California
State University, Hayward
Brian Wiens - Senior Manager, Biostatistics; AMGEN
4:00pm
Future Horizons for Social, Behavioral and Educational Research:
What have we learned? What's the action plan now? This session will
help attendees examine the information just presented and help them
develop proactive plans for change in the processes supporting social,
behavioral and educational research. The discussion will conclude with
a question-and-answer session.
Moderated by Sid Kushner - Director
of Research and Sponsored Programs; California State University, San
Bernardino
Joseph Lovett - Professor of Health Science and Human
Ecology; Chair IRB; California State University, San Bernardino
4:30pm Adjourn
Co-Sponsors
of this Forum: the American Association of State Colleges and Universities;
Office for Human Research Protections; the National Science Foundation;
and the U.S. Department of Veterans Affairs |
