A
Agenda
March 19, 2014
Lecture Room
National Academy of Sciences Building
2100 Constitution Avenue, NW
Washington, DC
8:30 a.m. | Welcome Frank Loy, LL.B. Roundtable Chair |
8:40 a.m. | Workshop Overview Lynn Goldman, M.D., M.P.H. Roundtable Vice-Chair Dean, Milken Institute School of Public Health George Washington University |
8:50 a.m. | Session 1: Brief History and Current Legal and Executive Branch Framework for Data Sharing |
Objectives: | Federal rule making routinely involves the use of studies in which there are questions raised about how they were prepared and the reliability of the data and the conclusions drawn. Through the Administrative Procedure Act and the process of judicial review, there is now a reasonably well-developed understanding of how agencies handle those problems and what information must be made available to the public, to the Office of Information and Regulatory Affairs of the Office of Management and Budget, and to the courts (if judicial review is sought as it is for most significant rules). |
The goal of this session is to inform workshop attendees on the basic ground rules of agency decision making in this area and to set the stage for the panels that follow. | |
Moderator: | Alan Morrison, LL.B., Lerner Family Associate Dean for Public Interest and Public Service Law, George Washington University |
8:50 a.m. | Paul R. Verkuil, J.S.D. Chair, Administrative Conference of the United States |
9:10 a.m. | George Gray, Ph.D. Professor Department of Environmental and Occupational Health Director of the Center for Risk Science and Public Health Milken Institute School of Public Health George Washington University |
9:30 a.m. | Discussion (20 minutes) |
9:50 a.m. | Session 2: Benefits and Importance of Data Sharing |
Objectives: | Most researchers and policy makers in environmental health agree that, as in other fields, research data should be shared as freely as necessary, especially when research data are underpinning regulations. Most also recognize that there need to be some limits on when and how data should be shared. The goal of this session is to clarify when, why, and how data sharing is beneficial for the researcher, the regulatory agency, the participants, and the public. The session should distinguish between sharing data for reanalysis and sharing data for facilitation of replication. |
Moderator: | Gwen Collman, Ph.D., Director, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, National Institutes of Health |
9:50 a.m. | Panelist Presentations (30 minutes) Bernard Lo, M.D. President and CEO The Greenwall Foundation Francesca Dominici, Ph.D. Professor of Biostatistics and Senior Associate Dean for Research Harvard University School of Public Health Julia Brody, Ph.D. Executive Director Silent Spring Institute Louis Anthony (Tony) Cox, Jr., Ph.D. Chief Sciences Officer, NextHealth Technologies |
10:20 a.m. | Panel Discussion (60 minutes) |
11:20 a.m. | Session 3: Challenges Associated with Data Sharing |
Objectives: | While data sharing is quickly becoming the norm, especially for federally funded research, challenges exist for the investigator and her or his institution, the person or entity requesting the data, and the research participants, whose identity can be compromised. Concerns of the investigator are ensuring the right to publication and to quality control over reanalyses. |
The goal of the session is to articulate the potential administrative, ethical, financial, and public health drawbacks to data sharing. | |
Moderator: | Glenn Paulson, Ph.D., Science Adviser, Office of the Administrator, U.S. Environmental Protection Agency |
11:20 a.m. | Panelist Presentations (30 minutes) Daniel Barth-Jones, Ph.D., M.P.H. Assistant Professor of Clinical Epidemiology Mailman School of Public Health Columbia University John Howard, M.D., M.P.H., J.D., LL.M. Director, National Institute for Occupational Safety and Health Greg Bond, Ph.D. Dow Masters Fellowship Program University of Michigan Kevin Casey, J.D. Associate Vice President for Public Affairs and Communications Harvard University |
11:50 a.m. | Panel Discussion (60 minutes) |
12:50 p.m. | Lunch Break (60 minutes) |
1:50 p.m. | Session 4: Ways Forward—Practices, Technologies, and Tools for Data Sharing |
Objectives: | As data sharing becomes more common and an accepted practice, tools and best practices need to be identified to ensure the benefits of data sharing and avoid the challenges, as discussed earlier in the program. |
The goal of this session is to identify principles, practices, and programs that could be used more widely for maximizing data sharing. | |
Moderator: | Lynn Goldman, M.D., M.P.H., Roundtable Vice-Chair |
1:50 p.m. | Panelist Presentations (30 minutes) Edward Sondik, Ph.D. Former Director National Center for Health Statistics Centers for Disease Control and Prevention Daniel Greenbaum, M.S. President Health Effects Institute Linda S. Birnbaum, Ph.D., DABT, ATS Director National Institute of Environmental Health Sciences National Institutes of Health George Daston, Ph.D. Victor Mills Society Research Fellow Procter & Gamble |
2:20 p.m. | Panel Discussion (60 minutes) |
3:20 p.m. | Break (20 minutes) |
3:40 p.m. | Session 5: Reflections on the Workshop and Concluding Remarks |
Objective: | The objective of this session is to have reflections on the day, including next steps, from experts with different perspectives. |
Moderator: | Frank Loy, LL.B., Roundtable Chair |
3:40 p.m. | Linda S. Birnbaum, Ph.D., DABT, ATS Director National Institute of Environmental Health Sciences National Institutes of Health |
3:50 p.m. | Jerry Blancato, Ph.D. Director Office of Science and Information Management Office of Research and Development U.S. Environmental Protection Agency |
4:00 p.m. | Joseph Rodricks, Ph.D., DABT Principal, ENVIRON |
4:10 p.m. | Ellen Silbergeld, Ph.D. Editor in Chief Environmental Research Professor Johns Hopkins Bloomberg School of Public Health |
4:20 p.m. | Latanya Sweeney, Ph.D. Professor of Government and Technology in Residence Harvard University |
4:30 p.m. | Discussion (30 minutes) |
5:00 p.m. | Closing Remarks and Adjourn |