 |
|
* This is a tentative agenda.
| January 6 |
 |
| 7:00 p.m. - 9:00 p.m. |
Reception/Dinner
Welcoming Keynote Address—"Reality Strikes: Rethinking the
Ethics of Inclusion in Clinical Research"
Jeremy Sugarman, M.D., M.P.H., Director, Center for the Study of
Medical Ethics and Humanities, Duke University Medical Center
|
| |
| January 7 |
|
| 8:00 a.m. |
Continental Breakfast |
| 8:50 a.m. - 9:20 a.m. |
Opening Keynote Address—Bernadine Healy, M.D., Former CEO
and President of the American Red Cross, Former Director of the
National Institutes of Health, Medical and Health Columnist and
Senior Writer, U.S. News and World Report |
| 9:20 a.m. - 10:20 a.m. |
Lessons Learned: The Importance of Recruitment and
Retention in Clinical Trials
The Women's Health Initiative, Strong Heart, AIDS Trials,
Diabetes Studies, and others
Chairs: Joan A. McGowan, Ph.D., National Institute of Arthritis
and Musculoskeletal and Skin Diseases, Marianne J. Legato, M.D.,
Columbia University
Speakers: Susan E. Cohn, M.D., University of Rochester Medical
Center, Jennifer Hays, Ph.D., Baylor College of Medicine, Barbara
V. Howard, Ph.D., MedStar Research Institute, Kwame Osei, M.D.,
Ohio State University College of Medicine |
| 10:30 a.m. - 11:30 a.m. |
Lessons Learned: The Importance of Recruitment and
Retention in Prevention and Longitudinal Research
The Breast Cancer Prevention Trial, Study of Women Across the
Nation, and PLCO Cancer Screening Trial
Chair: Amelie G. Ramirez, Dr.P.H., Baylor College of Medicine
Speakers: Worta McCaskill-Stevens, M.D., National Cancer
Institute, Sally A. Shumaker, Ph.D., Wake Forest University,
MaryFran R. Sowers, Ph.D., University of Michigan |
| 11:30 a.m. - 12:30 p.m. |
Nuts and Bolts of Sex and Gender Analyses
A point-counterpoint discussion, "Where sex and gender really
matter"
Chair: Janet Wittes, Ph.D., Statistics Collaborative, Inc.
Speakers: Barnett S. Kramer, M.D., M.P.H., Journal of the
National Cancer Institute, Steven Piantadosi, M.D., Ph.D., Johns
Hopkins University, Karen Weiss, M.D., U.S. Food and Drug
Administration |
| 12:30 p.m. - 1:30 p.m. |
Luncheon Keynote—Antonia C. Novello, M.D., Dr.P.H., M.P.H.,
New York State Department of Health (invited) |
| 1:30 p.m. - 2:30 p.m. |
Informed Consent: The New Landscape
Inclusion of pregnant women and vulnerable populations as well
as other bioethical challenges
Chair: Joan Rachlin, J.D., M.P.H., Public Responsibility in
Medicine and Research
Speakers: Paula A. Johnson, M.D., M.P.H., Brigham and Women's
Hospital, Greg Koski, M.D., Ph.D., U.S. Department of
Health and Human Services, Anna C. Mastroianni, J.D.,
M.P.H., University of Washington School of Law and Institute for
Public Health Genetics, D. Heather Watts, M.D.,
National Institute of Child Health and Human Development |
| 2:45 p.m. - 3:45 p.m. |
Recruitment and Retention of Women and Minorities in Clinical Studies
The continuing need for improvement and innovative strategies
used to address this ongoing challenge
Chairs: Edith Mitchell, M.D., Thomas Jefferson University, Jackson
T. Wright, Jr., M.D., Ph.D., Case Western Reserve University
Speakers: Judy Bigby, M.D., Harvard Medical School, Diane
Brown, Ph.D., University of Medicine and Dentistry of New Jersey |
| 3:45 p.m. - 4:30 p.m. |
Inclusion: Policy, Ethics, or Justice—Is It Time To Reexamine the Guidelines?
Health policy, ethics, and justice in research
Chair: Darlene Yee-Melichar, Ed.D., CHES, San Francisco State University
Speakers: R. Alta Charo, J.D., University of Wisconsin at Madison,
Jeffrey P. Kahn, Ph.D., M.P.H., University of Minnesota, Ruth Katz,
J.D., M.P.H., Yale University, Anne Drapkin Lyerly, M.D., Duke
University Medical Center |
| |
| January 8 |
|
| 8:00 a.m. |
Continental Breakfast |
| 8:30 a.m. - 9:30 a.m. |
Pharmacogenomics and Implications for Clinical Research: Is It
Time for a Paradigm Shift?
Sex, gender, and minority issues relevant to the emerging field of
pharmacogenomics and implications for recruitment of women
and minorities
Chair: Rosalie Sagraves, Pharm.D., University of Illinois
Speakers: Leslie Z. Benet, Ph.D., University of California, San
Francisco, Lucio Miele, M.D., Ph.D., University of Illinois at
Chicago, Susan F. Wood, Ph.D., U.S. Food and Drug
Administration |
| 9:30 a.m. - 10:30 a.m. |
Continuing Challenges in Recruitment, Retention, and Relevance
The need to recruit often-overlooked populations including
adolescents, rural participants, the homeless, and lesbian and
gay persons in clinical research
Chair: Susan E. Cohn, M.D., University of Rochester Medical Center
Speakers: Sallyann Margaret Bowman, M.D., University of
Pennsylvania, Victoria A. Cargill, M.D., M.S.C.E., Office of the
Director, Jonathan D. Klein, M.D., M.P.H., University of
Rochester, Kathryn Whetten-Goldstein, Ph.D., M.P.H., Duke
University |
| 10:45 a.m. - 12 noon |
Community-Based Participatory Research
The emerging importance of community-based participatory
research, where community representatives actively participate
in all stages of research
Chairs: Glorian Sorensen, Ph.D., Harvard University, Cynthia
Pearson, National Women's Health Network
Speakers: Byllye Avery, M.Ed., Avery Institute for Social Change,
Wilma Brakefield-Caldwell, Karen M. Emmons, Ph.D., Harvard
School of Public Health, Barbara A. Israel, Dr.P.H., University of
Michigan School of Public Health |
| 1:00 p.m. - 1:30 p.m. |
Special Invited Address—Inclusion of Women in Research at NIH:
A Look Back and View to the Future—Ruth L. Kirschstein, M.D., Deputy Director, National Institutes of Health |
| 1:30 p.m. - 2:30 p.m. |
Recruitment Is Only Half the Challenge: The Essentials of Retention
How retention is critical to study success—exploring the problem
and effective solutions
Chair: Marian C. Limacher, M.D., University of Florida College of
Medicine
Speakers: Ruth M. Greenblatt, M.D., University of California, San Francisco,
Shiriki Kumanyika, Ph.D., M.P.H., University of Pennsylvania School of Medicine,
Judith K. Ockene, Ph.D., M.A., M.Ed., University of Massachusetts Medical School,
Daniel Scharfstein, Sc.D., Johns Hopkins University |
| 2:45 p.m. - 4:00 p.m. |
Keynote—Point-Counterpoint: The Critical Role of Relevance
Raynard S. Kington, M.D., Ph.D., Office of Behavioral and Social Sciences Research,
National Institutes of Health
Lewis H. Kuller, M.D., M.P.H., University of Pittsburgh |
| |
| January 9 |
|
| 8:00 a.m. |
Continental Breakfast |
| 9:00 a.m. - 11:00 a.m. |
Concurrent Expert Panels
Workshop participants will be able to select from among these
concurrent sessions featuring expert panels that will address
current topics in open interactive sessions involving all attendees:
Mistrust, Skepticism, and Bias in Recruitment and Retention:
Reality and the Five Core Elements of Outreach From the ORWH
Outreach Network
Moderator: J.Taylor Harden, Ph.D., R.N., National Institute on Aging
The Inclusion of Vulnerable Populations With Questionable
Capacity To Consent in Clinical Research: Ethical Issues and
Approaches
Moderators: David Shore, M.D., and Mary Blehar, Ph.D., National Institute of Mental Health
Recruitment and Retention of Children in Clinical Research: Science Meets Reality
Moderators: Judy Whalen, Ph.D., and George Giacoia, M.D., National Institute of Child Health and Human Development
Observational Studies vs. Clinical Trials: Why Conclusions Can Be Inconsistent
Moderator: Barbara Alving, M.D., National Heart, Lung, and Blood Institute
Recruitment and Retention of Participants in Drug Abuse Research: Incentives, Ethics, and Practical Considerations
Moderator: Cora Lee Wetherington, Ph.D., National Institute on Drug Abuse |
|
|
|
