Research@UIC > OHRP Research Community Forum > Program Agenda

Program Agenda

7:00 – 8:00am	Registration and Continental Breakfast The Renaissance Hotel, 1 W. Wacker Dr., Chicago, IL 60601
8:00 – 8:15am	Opening Remarks & Introductions Location: Grand Ballroom Kate-Louise Gottfried, JD, MSPH Senior Director, Research Integrity and Regulatory Affairs Rush University Medical Center Chicago, IL Welcome: Larry J. Goodman, MD President and Chief Executive Officer Professor of Medicine, Department of Infectious Diseases Rush University Medical Center Chicago, IL Joe G.N. Garcia, MD Vice Chancellor of Research Professor of Medicine University of Illinois at Chicago Chicago, IL
8:15 – 9:00am	Keynote Address - "The Future of Personalized Medicine and Public Policy" Speaker: Kathy Hudson, PhD Chief of Staff, Office of the Director National Institutes of Health U.S. Department of Health and Human Services Bethesda, MD
9:00 – 10:15am	“What's New and Important from the Feds?” Location: Grand Ballroom Regulatory updates on human subject protections will be provided by representatives from the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP), the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). Moderator: Elyse I. Summers, JD Director, Division of Education and Development Office for Human Research Protections (OHRP) U.S. Department of Health and Human Service Rockville, MD Speakers: Elyse I. Summers, JD Director, Division of Education and Development Office for Human Research Protections (OHRP) U.S. Department of Health and Human Service Rockville, MD Sara F. Goldkind, MD, MA Senior Bioethicist Office of Good Clinical Practice Office of the Commissioner Food and Drug Administration Maryland, DC Ann Hardy, DrPH NIH Extramural Research Protections Officer Office of Extramural Research National Institutes of Health (NIH) Rockville, MD
10:15 – 10:30am	Break
10:30 – 11:30am	Plenary Session A: “Research with Minority Populations” Location: Grand Ballroom Moderator: Lisa Barnes, PhD Associate Professor, Rush Alzheimer's Disease Center Rush University Medical Center Chicago, IL Panelists: Rick Kittles, PhD Associate Professor Department of Medicine; Section of Genetic Medicine The University of Chicago Chicago, IL Romina Kee, MD, MPH Clinical Investigator Collaborative Research Unit (CRU) Department of Medicine Cook County Health & Hospitals Systems Chicago, IL
11:30 – 11:40am	Travel Time
11:40 – 12:40pm	Break Out Session A: A1) Basic: “Historical Overview” Location: Cuisines Moderator: Judith Blacklidge, MS Director Research Compliance and Safety Loyola University Medical Center Maywood, IL Speakers: Bret Moberg, JD, LLM Rosalind Franklin University of Medicine and Science Chief Compliance Counsel and Assistant Professor North Chicago, IL Anthony Perry, MD Associate Professor of Internal Medicine Director, Johnston R. Bowman Health Center Rush University Medical Center Chicago, IL A2) Socio-Behavioral: “Research Ethics 2.0: Internet Research Ethics and the IRB” Location: Breakout Room IV Drs. Buchanan and Jones will discuss the ethical dimensions of research in virtual worlds. Is email an issue for human subjects research? Do you have a researcher interested in using mechanical turks in a protocol? What do you do about tracking internet addresses so participants' privacy is protected? What about having lifelike avatars interact with others and in some instances stand in for others? Do avatars need to provide consent? Just what is a "tweet" and how should an IRB respond to these emerging forms of technology as they are increasingly used in research? Dr. Jones will assay ethical issues related not only to the development of lifelike avatars but also to interaction with an avatar. Dr. Buchanan will report on projects designed to assist IRBs and researchers find a common ground in the complex and fluid realm of Internet research. Both presentations are based on NSF-funded research. Moderator: Rebecca Ann Lind, PhD Assistant Vice Chancellor for Research Associate Professor of Communications University of Illinois Chicago, IL Speakers: Elizabeth Buchanan, PhD Director, Center for Information Policy Research School of Information Studies University of Wisconsin Milwaukee, WI Steven Jones, PhD Professor, Department of Communication University of Illinois Chicago, IL A3) Advanced: “Providing clinical care in clinical trials: Ethical Dilemmas and Resolutions” Location: Breakout Room V Trying to follow any two principles will almost always create some sort of conflicts in which one must chose one over the other or compromise both principles to some extent. Clinicians implementing clinical trials must try both to provide excellent care of their patient/subjects and follow the protocol that specifies how the trial should be implemented. Many such clinicians report that there are some difficult conflicts involved. This presentation will report some results of interviews and a national survey of clinical researchers. The results identify some of these conflicts. The presentation will suggest some of the problems that these conflicts can cause for the integrity of the research and suggest some ways in which they might be minimized. Speaker: Charles W. Lidz, PhD Research Professor, Department of Psychiatry; Medical School University of Massachusetts Worcester, MA A4) Hot: Translational Research: “How it’s done in Chicago: Efforts to Reduce Regulatory Barriers for Translational and Clinical Research” Location: Breakout VI Moderator: James L. Mulshine, MD Associate Provost for Research Rush University Medical Center Chicago, IL Speakers: Julian Solway, MD Walter L. Palmer Distinguished Service Professor of Medicine and Pediatrics Associate Dean for Translational Medicine, Biological Sciences Division Vice Chair for Research, Department of Medicine Chair, Committee on Molecular Medicine University of Chicago Chicago, IL Phil Greenland, MD Harry W. Dingman Professor of Preventive Medicine and Medicine Sr. Associate Dean for Clinical and Translational Research, Director, Northwestern University Clinical and Translational Sciences Institute, Northwestern University Chicago, IL Mark Stein, PhD Professor of Psychiatry and Pediatrics Director, Regulatory Support and Advocacy Core, CCTS University of Illinois Chicago, IL
12:40 – 1:45pm	Lunch: Networking Opportunity Location: Grand Ballroom
1:45 – 2:45pm	Break Out Session B: B1) Basic: “Human Subjects Protections” Location: Cuisines This beginner’s session will provide an overview of the basic framework of the HHS human subject protection regulations and the ethical principles of The Belmont Report. Topics of discussion will include IRB membership, IRB functions and operations, IRB review of research, approval of research, and the general requirements for informed consent. Moderator: Draco DuShea Forte, M.Ed Manager Sonnenschein Health Care Group Chicago, IL Speaker: Michelle Feige, MSW Public Health Analyst Office for Human Research Protections (OHRP) U.S. Department of Health and Human Services Rockville, MD B2) Socio-Behavioral: “Engaging the Hard to Engage” Location: Breakout Room IV Presenter will describe findings from 10 years of research on strategies for increasing participation rates in prevention programs targeting parents of young children in low-income, urban communities. Emphasis will be on what motivates participation in prevention programs, the effects of financial incentives on participation, and lessons learned along the way. Moderator: Deborah A. Gross, DNSc, RN, FAAN Professor, Leonard and Helen Stulman Endowed Chair in Mental Health and Psychiatric Nursing Johns Hopkins School of Nursing Johns Hopkins School of Medicine Department of Psychiatry and Behavioral Sciences Baltimore, MD Speakers: Deborah A. Gross, DNSc, RN, FAAN Professor, Leonard and Helen Stulman Endowed Chair in Mental Health and Psychiatric Nursing Johns Hopkins School of Nursing Johns Hopkins School of Medicine Department of Psychiatry and Behavioral Sciences Baltimore, MD JoEllen Wilbur, PhD, RN, CS, FAAN Professor and Endowed Independent Foundation Associate Dean Nursing Research & Scholarship College of Nursing, Rush University Medical Center Chicago, IL B3) Advanced: “Non-Compliance versus Scientific Misconduct” Location: Breakout Room V If an investigator fabricates informed consent documents, is this a violation of the Common Rule or research misconduct? To which agency should you report this activity? These and other questions will be addressed in this session, which will provide a comparison of ORI and OHRP jurisdiction, targets and sanctions imposed. This session will also compare the agencies' different investigation styles and philosophies through a discussion of examples and analysis of case studies. Moderator: Clyde Wheeler, PhD Associate Director for Research Compliance Office for the Vice Chancellor for Research University of Illinois at Chicago Chicago, IL Speakers: Laura Odwazny, JD Office for Human Research Protections Office of the General Counsel, Public Health Division U.S. Department of Health and Human Services Rockville, MD Debbie Parrish, JD Parrish Law Offices Pittsburgh, PA B4) Hot/Important Topic: “Data Owed to Research Subjects” Location: Breakout Room VI This presentation will address the reasons for caution in returning individual research results to participants. These include uncertainty about the clinical significance of research results, debate about whose perspective regarding utility ought to govern and what types of uses ought to considered, what kinds of disclosures ought to be made before the research begins, what kinds of procedures ought to be applied to decide which results to return and how best to do so, issues about scope to responsibility in time and distance, the impact of the Clinical Laboratory Improvement Amendments of 1988, and the recognition that practice begets legal duty. Moderator: Ellen Wright Clayton, MD, JD Rosalind E. Franklin Professor of Genetics and Health Policy Director, Center for Biomedical Ethics and Society Professor of Pediatric; Professor of Law Vanderbilt University Nashville, TN Speakers: David Kaufman, PhD Director of Research of Statistics Genetics and Public Policy Center Johns Hopkins University Washington, DC Stephanie Malia Fullerton, DPhil Assistant Professor Department of Bioethics and Humanities University of Washington School of Medicine Seattle, WA Ellen Wright Clayton, MD, JD Rosalind E. Franklin Professor of Genetics and Health Policy Director, Center for Biomedical Ethics and Society Professor of Pediatric; Professor of Law Vanderbilt University Nashville, TN
2:45 – 3:00pm	Travel Time
3:00 – 4:00pm	Break Out Session C: C1) Basic: “Informed Consent in Research” Location: Cuisines This session will provide an in-depth basic discussion of the informed consent process, including discussion of the Federal regulatory requirements for obtaining and documenting informed consent and when an IRB appropriately may waive informed consent or documentation of informed consent. This session also will address some of the common (and sometimes confusing) informed consent scenarios, such as whether consent by telephone is permissible, how to consent non-English speaking subjects, and consent requirements in studies involving child subjects or decisionally incapacitated individuals. Moderator: Stephanie Guzik, RN, BSN, MBA Assistant Director, Research Integrity and Regulatory Affairs Rush University Medical Center Chicago, IL Speakers: Laura Odwazny, JD Office for Human Research Protections Office of the General Counsel, Public Health Division U.S. Department of Health and Human Services Rockville, MD Emily E. Anderson, PhD, MPH Project Director, Illinois Prevention Research Center Institute for Health Research and Policy University of Illinois at Chicago Chicago, IL C2) Social-Behavioral: “Data Security and Mobile Devices: What Should Institutional Policy Say about Laptops and Other Devices That Move Between Your Office and Home” Location: Breakout Room IV Moderator: Jaime Parent, MA, MHS Vice President, Information Technology Rush University Medical Center Chicago, IL Speakers: Stuart Horowitz Huron Consulting Chicago, IL Jeffrey Cooper, MD Huron Consulting Chicago, IL C3) Advanced Topic: “Special Populations” Location: Breakout Room V Moderator: Raj Shah, MD Assistant Professor, Rush Alzheimer's Disease Center Rush University Medical Center Chicago, IL Speakers: Brian James, PhD "Informed Consent along the Cognitive Spectrum: Research Issues in Mild Cognitive Impairment and Dementia" Instructor, Post-doctoral fellow, Rush Alzheimer’s Disease Center Rush University Medical Center Chicago, IL Research in dementia often involves the exposure of persons with cognitive impairments to the risks of research participation. Participants can range across a wide spectrum of cognitive ability that can affect their capacity to provide valid informed consent for research. These abilities do not necessarily coincide with diagnostic labels. Persons with early stage dementia or mild cognitive impairment (MCI), a transitional stage between normal cognition and dementia, may have the capacity to make their own decisions about research, while persons with severe dementia may require someone else to make this decision for them. This talk will briefly outline some of the issues involved in enrolling subjects with dementia and MCI in research, including 1) how we determine whether a person with cognitive impairments has the capacity to make decisions for themselves, and 2) when, who, and how another person can provide consent for a person without decision making capacity (i.e. proxy consent). Data will be presented demonstrating the decision-making abilities of persons with both dementia and MCI to provide informed consent. Data also will be presented regarding the attitudes of AD patients, their family caregivers, and a general sample of older persons about proxy consent. Paul Song, PhD “End of Life Research with the Homeless” Professor, Center for Bioethics University of Minnesota Minneapolis, MN Regarding homeless persons from the perspective of the analytic model of vulnerability suggests that these individuals may be particularly vulnerable in some research settings. They are susceptible to states of economic need, poor health, and institutional dependency. Qualitative research exploring end of life care, death, and dying also raises potential ethical dilemmas. This talk will outline these issues, then report on the experience and findings of qualitative end of life research with homeless persons. Lainie Friedman Ross, MD, PhD “Children in Medical Research: Access versus Protection” Carolyn and Matthew Bucksbaum Professor of Clinical Ethics Professor, Departments of Pediatrics, Medicine, and Surgery Associate Director, MacLean Center for Clinical Medical Ethics Department Pediatrics, University of Chicago Chicago, IL The Report, “Research on Children” by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) reflected the tension between protecting children and promoting pediatric medicine. The focus on protection was incorporated into Federal Regulations, although currently there is a shift towards access. Part of the support for increasing pediatric participation in research, particularly pharmaceutical research, is that major advances have been made during the past half century in adult medicine, but only more modest advances in pediatrics. More than 80% of drugs prescribed to children have never been tested on them. Unless tested in children, every child’s treatment lacks adequate information on safety and efficacy. This session will focus on ethical issues related to the tension between access and protection in pediatric research. C4) Hot/Important: “Emergency Research without Informed Consent” Location: Breakout Room VI Regulations allowing emergency medicine research without consent in unusual circumstances were finalized in 1996. These regulations allow research on life-threatening conditions if a number of predicate conditions are satisfied without informed consent from subjects, even when the research risks are substantial. This presentation will focus on experiences implementing a dozen clinical trials with an IRB-approved waiver of consent for emergency medicine research under DHHS and FDA regulations. The presenters will discuss this type of research from the perspective of the investigator (addressing IRB concerns, implementing community consultations, kinds of feedback from subjects and family members), the IRB Chairperson (evaluating the IRB application, evaluating the results of community consultations, continuing review), and a bioethicist participating in the IRB review process (questions raised beyond the regulatory knowns). Moderator: David Clark, PhD Assistant Dean for Clinical Research Professor of Psychiatry Medical College of Wisconsin Milwaukee, WI Speakers: Norman Fost, MD, MPH University of Wisconsin, Madison Professor, Pediatrics and Medical History and Bioethics Director, Program in Bioethics, Department of Pediatrics University of Wisconsin Hospital Madison, WI Tom Aufderheide, MD Professor of Medicine Associate Chair of Research Affairs Medical College of Wisconsin Milwaukee, WI Ryan Spellecy, PhD Associate Professor of Ethics and Psychiatry Chairman, Institutional Review Board Center for the Study of Bioethics Medical College of Wisconsin Milwaukee, WI
4:00 –4:15pm	Break
4:15 –5:30pm	Plenary Session B:“Managing Financial Conflicts of Interest in Human Subjects Research” Location: Grand Ballroom Moderator: Kate Gottfried, JD, MSPH Senior Director, Research Integrity and Regulatory Affairs Rush University Medical Center Chicago, IL Speakers: Jordan Cohen, MD Professor of Medicine George Washington University School of Medicine Washington, DC Jorge O. Galante, MD, DMedSci Professor of Orthopedic Surgery The Granger Director of the Rush Arthritis and Orthopedics Institute Rush Arthritis and Orthopedics Institute Chicago, IL Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Berman Institute of Bioethics and Department of Medicine John Hopkins University Baltimore, MD
5:30 – 7:00pm	Thank You & Reception

OHRP is not providing funding for any refreshments or food associated with this event. The co-sponsors of this OHRP Community Forum will not be selling any educational materials associated with this event to make a profit.