Achieving Excellence in Clinical Research Scientific, Ethical and Operational Considerations

Transcription

1 Achieving Excellence in Clinical Research Scientific, Ethical and Operational Considerations Thursday, September 17, 2009 McDonald s Hamburger University Oak Brook, Illinois

2 Achieving Excellence in Clinical Research Scientific, Ethical and Operational Considerations Program 7:30 8:15 am Conference Check-in, Continental Breakfast and Exhibit Viewing 8:15 8:30 am Welcome and Opening Remarks Denise Angst, PhD, RN, Director, Advocate Center for Pediatric Research Lee Sacks, MD, Executive Vice President/ Chief Medical Officer Advocate Health Care 8:30 9:15 am Plenary I International Research Ethics: Lessons Learned from HIV and Other Research Ruth Macklin, PhD, Professor of Bioethics, Department of Epidemiology and Population Health, Albert Einstein College of Medicine 9:15 10:00 am Plenary II Public Trust in the Balance: Managing Financial Conflicts of Interest in Human Subjects Research Jordan J. Cohen, MD, Professor of Medicine and Public Health, George Washington University, President Emeritus, Association of American Medical Colleges 10:00 10:15 am Break Refreshments and Exhibit Viewing 10:15 11:00 am Plenary III Where Has Ethics Gone in Clinical Research? Leonard Glantz, JD, Associate Dean for Academic Affairs, Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health 11:00 11:45 am Questions and Answers with Plenary Speakers 11:45 am 1:00 pm Lunch

3 1:00 2:00 pm Breakout Session #1 A. Healthcare Reform and Clinical Research: Catalyst or Obstacle? Jordan J. Cohen, MD, Professor of Medicine and Public Health, George Washington University, President Emeritus, Association of American Medical Colleges B. Clinical Trials on Trial: Potential Legal Liability from Clinical Research (Mock Trial) Mark Hegarty, JD, Partner, Shook, Hardy & Bacon, Kansas City, Missouri C. Financial Incentives for Research Participation: Compensation or Coercion? Ruth Macklin, PhD, Professor of Bioethics, Department of Epidemiology and Population Health, Albert Einstein College of Medicine D. Small Mistakes with Big Consequences: Identifying, Correcting, and Preventing Common Errors in Clinical Research Alicia A. Pouncey, MEd, Managing Director, Aureus Research Consultants, LLC, New Orleans, Louisiana 2:00 2:15 pm Break Refreshments and Exhibit Viewing 2:15 3:15 pm Breakout Session #2 A. Children s Involvement in Research Participation Decisions: Legal and Ethical Considerations Leonard Glantz, JD, Associate Dean Emeritus, Academic Affairs, Professor, Health Law, Bioethics & Human Rights, Boston University B. Statistics Boot Camp: Get Your Figures in Shape Bill King, President, Western Statistical Consulting, Flagstaff, Arizona C. How We Used Research to Change Public Policy: Our Experience in Breast Cancer Carol E. Ferrans, PhD, RN, FAAN, Professor and Associate Dean for Research, College of Nursing, University of Illinois D. Small Mistakes with Big Consequences: Identifying, Correcting, and Preventing Common Errors in Clinical Research Alicia A. Pouncey, MEd, Managing Director, Aureus Research Consultants, LLC, New Orleans, Louisiana

4 3:15 3:30 pm Break Refreshments and Exhibit Viewing 3:30 4:30 pm Breakout Session #3 A. Conducting Research with Older Adults with Cognitive Impairments Madelyn Iris, PhD, Director, Leonard Schanfield Research Institute, Council for the Jewish Elderly, SeniorLife, Chicago B. Clinical Trials on Trial: Potential Legal Liability from Clinical Research (Mock Trial) Mark Hegarty, JD, Partner, Shook, Hardy & Bacon, Kansas City, Missouri C. How We Used Research to Change Public Policy: Our Experience in Breast Cancer Carol E. Ferrans, PhD, RN, FAAN, Professor and Associate Dean for Research, College of Nursing, University of Illinois D. Statistics Boot Camp: Get Your Figures in Shape Bill King, President, Western Statistical Consulting, Flagstaff, Arizona

5 Objectives At the conclusion of this conference, participants will be able to: Describe many of the complex ethical issues involved in international research Identify key issues in the area of financial conflicts of interest and how this impacts public trust in clinical research. Describe how the place of ethics in clinical research has changed over time Identify ways healthcare reform can advance clinical research. Appreciate the potential for legal liability inherent in clinical research Highlight key considerations when compensating research subjects. Identify how to prevent common errors in clinical research. Examine important legal and ethical considerations when children are involved in research participation decisions. Develop a basic understanding of common statistical methods that are used in clinical research. Describe mechanisms to use research to change public health policy. Develop methods for assessing older adults' decisional capacities to consent to research participation and for identifying circumstances when decisionally-impaired adults should not be included. Target Audience: Physicians, nurses, IRB members, industry professionals and others involved or interested in clinical research. Continuing Education Credits Physicians Advocate Health Care is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Advocate Health Care designates this educational activity for a maximum of 6 AMA PRA Category 1 Credits. Physicians should only claim credit commensurate with the extent of their participation in the activity. Nurses Advocate Health Care is an approved provider of continuing nursing education by the Illinois Nurses Association, an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation. Upon successful completion of this continuing education activity, 6.0 contact hours will be awarded.

6 Advocate Health Care recognizes that provider status by INA/ANCC Commission on Accreditation refers only to its nursing continuing education activities and does not imply approval or endorsement of any commercial products. Faculty Disclosure Acknowledgement of all disclosures will be made at each session. Conflicts of interests will be identified and resolved prior to the conference. Location Hamburger University McDonald s Office Campus Oak Brook, Illinois Registration Fees: On or before On or after 9/3/09 9/4/09 Advocate Associates, Residents and Fellows $75.00 $90.00 Advocate Attending Physicians $ $ Non-Advocate Trainees and Full Time Students $ $ (proof required) Non-Advocate Attendees $ $ Registration Deadline: September 10, 2009 Attendance is limited and registration will be taken on a first come first served basis; please sign up early. Fees include program materials, continental breakfast, refreshment breaks and sit-down lunch. How to Register: Register with your credit card via the internet at: or Complete reverse side of this registration form, include a check payable to Advocate Health Care and return to: Advocate Center for Pediatric Research Attn: Sandy Maki Advocate Lutheran General Children s Hospital 1775 Dempster Street 2 South Park Ridge, IL 60068

7 Registration Form: Achieving Excellence in Clinical Research Scientific, Ethical and Operational Considerations Thursday, September 17, 2009 On or before On or after 9/5/09 9/6/09 Advocate Associates, Residents and Fellows $75.00 $90.00 Advocate Attending Physicians $ $ Non-Advocate Trainees and Full-Time $ $ Students (proof required) Non-Advocate Attendees $ $ Intended Breakout Sessions (Circle one choice for each session) Breakout Session #1 A B C D Breakout Session #2 A B C D Breakout Session #3 A B C D Name Title Institution Department / Division Telephone Preferred Mailing Address, Street City, State, Zip Completion Certificate Requested: CME Nursing Contact Hours Generic Continuing Education Check enclosed Please return this form to: Registration Deadline: September 10, 2009 Sandy Maki 2 South Advocate Center for Pediatric Research Luncheon Meal Choice: Lutheran General Children s Hospital 1775 Dempster Street Chicken Park Ridge, IL Vegetarian For Additional Information Contact: Advocate Center for Pediatric Research

8 Hamburger University McDonald s Office Campus 2815 Jorie Boulevard Oak Brook, IL MAP (insert map here) From the North: From the South: I-294 South to 1-88 (West to Aurora). Exit I-88 at 83 I-294 North to I-88 (West to Aurora). Exit I-88 at 83 North (Cermak Road) 1 st exit after toll booth. At North (Cermak Road) 1 st exit after toll booth. At stoplight (22 nd Street/Cermak Road), turn right and stoplight (22 nd Street/Cermak Road), turn right and go two stoplights to Jorie Boulevard. Turn right on go two stoplights to Jorie Boulevard. Turn right on Jorie Blvd. to the third stoplight (Kroc Drive). Turn Jorie Blvd. to the third stoplight (Kroc Drive). Turn left. At stop sign turn left on Ronald Lane. Hotel is left. At stop sign turn left on Ronald Lane. Hotel is on left and parking is on the right. on left and parking is on the right. From the East (Downtown): From the West (I-355 from North or South or I-88 from West): I-290 West (Eisenhower Expressway) to I-88 (East- From either direction take I-88 exit (East to Chicago). West Tollway to Aurora). Exit I-88 at 83 North Take I-88 to Midwest Road exit. At stoplight turn (Cermak Road) 1 st exit after toll booth. At stoplight left. Take Midwest Road to 31 st Street (next light). (22 nd Street/Cermak Road), turn right and go two Turn left. Take 31 st Street to Jorie Blvd. Turn left. stoplights to Jorie Boulevard. Turn right on Jorie Take Jorie Blvd. To 2 nd stoplight, (Kroc Drive) turn Blvd. to the third stoplight (Kroc Drive). Turn left. right. At stop sign turn left onto Ronald Lane. Hotel At stop sign turn left on Ronald Lane. Hotel is on the left is on the left and parking is on the right. and parking is on right.

9 Advocate Center for Pediatric Research Non-Profit Org. Lutheran General Children s Hospital 1775 Dempster Street Park Ridge, IL Park Ridge, IL Permit No. 502 U.S. Postage PAID