AAHRPP -2010 Conference Agendas: Quality Human Research Protection Programs Advancing Your HRPP to the Next Level

2010 Conference Agendas:
Quality Human Research Protection Programs

Advancing Your HRPP to the Next Level


Workshop Agenda

Monday, April 12
9:00 A.M. – 4:00 P.M.	All-day Workshops	W1	Getting Started toward Accreditation
			Michael Pagliaro, B.A., R.N., AAHRPP Nicholas C. Slack, M.B.E., AAHRPP Peter Vasilenko, Ph.D., AAHRPP
		W2	Mastering Organizational (Domain I) Responsibilities in Your HRPP - Case Studies
			Sharon K. Friend, M.S., C.I.P., University of California, Los Angeles Karen Hale, R.Ph., M.P.H., C.I.P., The Ohio State University Maureen Oostendorp, B.A., M.M., Spectrum Health Lynn M. Veatch, Ph.D., and Stephen M. Lanier, Ph.D., Medical University of South Carolina
		W3	Improving Relationships between the IRB and Social Scientists
			Judy Birk, J.D., University of Michigan Yvonne K. Higgins, C.I.P., University of Pennsylvania Moira A. Keane, M.A., C.I.P., University of Minnesota Monika S. Markowitz, Ph.D., M.A., M.S.N., Virginia Commonwealth University Susan L. Rose, Ph.D., University of Southern California David L. Wynes, Ph.D., Emory University
		W4	Training Clinicians to Meet Research Responsibilities
			Elan Czeisler, New York University Scott Lipkin, D.P.M., C.I.P, Lehigh Valley Hospital Martha F. Jones, Washington University in St. Louis

Conference Agenda

Tuesday, April 13
8:00 A.M.			Welcome and Greetings
			Brent C. Miller, Ph.D., Utah State University
			Advancing Your HRPP to the Next Level – The AAHRPP Accreditation Standards
			Marjorie A. Speers, Ph.D., AAHRPP
8:30 A.M.	Plenary Session	P1	Funding HRPPs and Research in the Current Era of Health Care Reform
			Ann Bonham, Ph.D., Association of American Medical Colleges Moderator: Brent C. Miller, Ph.D., Utah State University
9:30 A.M.	Break
9:40 A.M.	Concurrent Sessions	A1	Fundamentals of Accreditation for New Applicants
			Sujatha Sridhar, M.B.B.S., C.I.P., The University of Texas Health Science Center at Houston
		A2	Educational Activities that Enhance the HRPP
			Scott Lipkin, D.P.M., C.I.P., Lehigh Valley Hospital Monika S. Markowitz, Ph.D., M.A., M.S.N., R.N., Virginia Commonwealth University
		A3	Streamlining the NCI Central IRBs: Working More Effectively with Local IRBs
			Jeffrey S. Abrams, M.D., National Cancer Institute
		A4	Leveraging Your Electronic System to Meet the Accreditation Standards
			Judith Carrithers, J.D., M.P.A., C.I.P., The Johns Hopkins University Kathleen Lawry, The MetroHealth System Nicholas C. Slack, M.B.E., AAHRPP
		A5	Evaluating IRB Chairs, Members, and Staff
			Lauri Carlile, M.S., C.I.P, Chesapeake Research Review, Inc.
		A6	Participant Stipends: Ethics and Pitfalls
			Dennis Swearingen, M.D., C.P.I., MDS Pharma Services Inc.
10:40 A.M.	Break
11:00 A.M.	Concurrent Sessions	B1	Engaging the Community in Planned Emergency Research
			Michelle H. Biros, M.D., M.S., University of Minnesota
		B2	Preparing for and Achieving Reaccreditation
			Karen L. Smarr, Ph.D., Harry S Truman Memorial Veterans’ Hospital Yvonne K. Higgins, C.I.P., University of Pennsylvania
		B3	Negotiating Care and Cost-coverage for Research-related Injury in Sponsored Research
			Mont Brownlee, J.D., The Johns Hopkins University
		B4	Post-approval Monitoring of Research
			June Merwin, Ph.D., Pfizer Kathleen Recchiuti, Pfizer
		B5	Marketing Your Accredited Research Organization to Sponsors
			William Chrvala, B.S., HOPE Research Institute Amanda Drake, M.S., C.C.R.C., HUNT Services
		B6	Assessing Risk in Behavioral and Social Science Research
			Aryeh D. Stein, Ph.D., Emory University Peter Vasilenko, Ph.D., AAHRPP
12:00 P.M.	Lunch
1:00 P.M.	Plenary Session	P2	Community-based Participatory Research and IRBs
			Daniel S. Blumenthal, M.D., M.P.H., The Morehouse School of Medicine Mary Anne McDonald, Dr.P.H., M.A., Duke University Lainie Friedman Ross, M.D., Ph.D., University of Chicago
2:10 P.M.	Concurrent Symposia	S1	New Accreditation Element: Involving Community Members in Research
			Daniel S. Blumenthal, M.D., M.P.H., The Morehouse School of Medicine Mary Anne McDonald, Dr.P.H., M.A., Duke University Lainie Ross, M.D., Ph.D., University of Chicago Stephen Olufemi Sodeke, Ph.D., M.A., Tuskegee University National Center for Bioethics in Research and Health Care
		S2	New Accreditation Elements: Implementing Metrics for Your HRPPs
			Tracy Harmon Blumenfeld, M.B.A., RapidTrials, Inc. Eugene A. Gallagher, M.S.P.H., Vanderbilt University Jenice N. Longfield, M.D., M.P.H., The University of Texas Health Science Center at San Antonio
		S3	New Accreditation Element: Organizational Conflict of Interest Policies – Learning from Those Who Have Implemented Policies
			Wesley G. Byerly, Pharm.D., Duke University Gary Chadwick, Pharm.D., M.P.H., C.I.P., University of Rochester Wayne Patterson, Ph.D., The University of Texas at Austin
4:00 P.M.	Break
4:15 P.M.	Plenary Session	P3	Working with the Federal Agencies
			Patricia Decot, Department of Defense Jody Klein-Saffran, Ph.D., Bureau of Prisons Warren E. Lux, M.D., Environmental Protection Agency Jeffery Rodamar, Department of Education Elizabeth White, M.P.H., M.B.A., Department of Energy Moderator: Peter Vasilenko, Ph.D., AAHRPP
5:30 P.M. – 6:30 P.M.			Reception and Posters Presented by Organizations The Earned Distinctions from the Council on Accreditation in 2009

Wednesday, April 14
8:00 A.M.	Plenary Session	P4	Current Perspectives on Conflict of Interest
			Jilda D. Garton, Georgia Tech Research Corporation Mark A. Goldberg, M.D., Genzyme Coprporation Dorit Zuk, Ph.D., National Institutes of Health Moderator: James Weyhenmeyer, Ph.D., The Research Foundation of the State University of New Yok
9:00 A.M.	Break
9:10 A.M.	Concurrent Sessions	C1	Review of the AAHRPP Accreditation Standards
			Peter Vasilenko, Ph.D., AAHRPP
		C2	Accreditation of Small HRPPs: Overcoming the Challenges and Earning Accreditation
			Francis J. DiMario, Jr., J.D., Connecticut Children’s Medical Center Corporation Jeanne Freeman, J.D., M.A., Connecticut Children’s Medical Center Corporation Sarah Kiskaddon, J.D., M.A., Connecticut Children’s Medical Center Corporation Jedd Nelson, M.B.A., Southern Arizona VA Health Care System Michael Pagliaro, B.A., R.N., AAHRPP Hope M. Violette, R.Ph., C.I.P., Newton-Wellesley Hospital William W. Yeniscavich, J.D., Southern Arizona VA Health Care System
		C3	Has the Incidence of Non-compliance Increased?
			David G. Forster, J.D., M.A., C.I.P., WIRB
		C4	Negotiating Contract Provisions with Research Sites to Protect Research Participants: The Sponsor’s Perspective
			Demetrios L. Kouzoukas, Covington & Burling, L.L.P. Martha Nielsen, Pfizer
		C5	Simplified Consent Documents – Report from the AAMC Working Group on Informed Consent
			Edward Goldman, J.D., University of Michigan
		C6	On the Fringe of Human Research – Oral History, Journalism, Business, and More
			Kathleen King, Ph.D., Syracuse University Peter Knupfer, Ph.D., Michigan State University
10:10 A.M.	Break
10:30 A.M.	Concurrent Sessions	D1	Applying Equivalent Protections When the Federal Regulations Do Not Apply
			Judy Birk, University of Michigan Marjorie A. Speers, Ph.D., AAHRPP
		D2	Contingency Planning to Ensure Continuity for HRPPs
			Moira A. Keane, M.A., C.I.P., University of Minnesota Wayne Patterson, Ph.D., The University of Texas at Austin
		D3	Maintaining Quality in the HRPP with Diminishing Resources
			Sharon K. Friend, M.S., C.I.P, University of California, Los Angeles
		D4	Conducting Multisite Clinical Trials: The Sponsor's Perspective
			Lindsay McNair, M.D., M.P.H., Equipoise Consulting
		D5	Protections for Adults Who Have Diminished Decision-making Capacity – It’s More than a Consent Issue
			David H. Strauss, M.D., New York Psychiatric Institute
		D6	Waivers of Parental Permission in Behavioral and Social Science Research
			Ivor A. Pritchard, Ph.D., Office of Human Research Protections
11:30 A.M.	Networking Lunch
1:00 P.M.	Concurrent Symposia	S4	New Accreditation Standard: Applying Equivalent Protections in Transnational Research
			Moira A. Keane, M.A., C.I.P., University of Minnesota Marc Wilenzick, Pfizer Delia Wolf, M.D., J.D., M.S.C.I., Harvard University
		S5	Building Collaborations with Other Organizations
			Barbara E. Bierer, M.D., Brigham and Women’s Hospital David G. Forster, J.D., M.A., C.I.P, Western Institutional Review Board Robert Hood, Ph.D., C.I.P., Florida Department of Health
		S6	Trends in HRPPs for VA-sponsored Research
			K. Lynn Cates, M.D., Office of Research and Development Charlotte Karen Jeans, Office Of Research and Development Joan Porter, M.Sc., D.P.A., M.P.H., C.I.P., C.I.P.P./G. J. Thomas Puglisi, Ph.D., C.I.P., Office of Research Oversight
2:55 P.M.	Break
3:00 P.M. – 4:00 P.M.	Closing Plenary Session	P5	Multisite Research – Does Review by One IRB Adequately Protect Research Participants?
			Barbara E Bierer, M.D., Brigham and Women's Hospital Mark A. Goldberg, M.D., Genzyme Corporation Stephen Rosenfeld, M.D., Western Institutional Review Board Moderator: Elizabeth Cothran, M.S., C.I.P., Baylor Research Institute

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