David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Graduate Education: Master’s Degree in Medical Ethics; Thesis under Albert Jonsen University of Washington Department of Medical History and Ethics; Seattle, WA 1996 Juris Doctor Degree University of Washington School of Law; Seattle, WA 1996 Fellowship Program in Law, Health Care, and Aging, under Marshall Kapp Wright State University, Office of Geriatric Medicine and Gerontology; Dayton, OH 1996 Undergraduate Education: Bachelor of Arts, Philosophy University of Washington; Seattle, WA 1991 Bachelor of Arts, History; Honors: Graduated Summa Cum Laude Washington State University; Pullman, WA Member of Phi Beta Kappa Honor Society Member of Phi Kappa Phi Honor Society 1984 Professional License: Washington State Bar Association Admitted November 1996 Professional Certifications: Certified Institutional Review Board Professional (C.I.P.) 2001, 2004, 2007 & 2009 Professional Experience: WIRB-Copernicus Group IRB; Olympia, WA Chief Compliance Officer, Office of Compliance February 2013 Western Institutional Review Board; Olympia, WA Chief Compliance Officer, Office of Compliance June 2006—Present Medical History and Ethics Department University of Washington Seattle, WA; Auxiliary Faculty Western Institutional Review Board; Olympia, WA March 21, 2014 2000—Present June 2006—December 2007 1 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Vice President, Office of Compliance Western Institutional Review Board; Olympia, WA Assistant Vice President, Office of Compliance January 2004—May 2006 Western Institutional Review Board; Olympia, WA Director, Regulatory Affairs September 1996—January 2004 Washington Attorney General, Antitrust; Seattle, WA Law Clerk September 1994—April 1996 Fred Hutchinson Cancer Research Center; Seattle, WA Legal Internship March 1995—June 1995 Sisters of Providence Health Care Systems; Seattle, WA Legal Internship March 1995—June 1995 Valley Medical Center; Seattle, WA Legal Internship September 1994—January 1995 Washington Attorney General Consumer Protection; Seattle, WA; Law Clerk June 1994—September 1994 Memberships and Activities: Member Alliance for Clinical Research Excellence and Safety (ACRES) March 2012 – Present Member Council for Certification of IRB Professionals July 2011 – Present Invited Participant June 2011 Novel IRB Model(s) for Efficient Multi-Site Review: Planning Conference Series Vanderbilt University – Nashville, TN Invited Participant March 21, 2014 2 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Ethical Approaches to Genotype-Driven Research Recruitment Duke Institute for Genome Sciences & Policy – Durham, NC May 2011 Member Advisory Review Board of Faculty for the Department of Institutional Review Ethics and Administration in Nicholas Cardinal Cheong Graduate School of Life - The Catholic University of Korea February 2011-Present Member Collaborative Institutional Training Initiative (CITI) Program Developer’s Executive Advisory Committee January 2010–Oct. 2012 Member Harvard Multiregional Clinical Trial Summit Work Group August 2009–Present Member Quality Management and Evaluation Advisory Committee (QMAC) World Health Organization/Special Programme for Research and Training in Tropical Diseases (WHO/TDR) February 2008—June 2010 Member Forum for Institutional Review Boards [IRBs] / Ethics Review Boards [ERBs] in Canada and the United States (FOCUS) Member Secretary’s Advisory Committee on Human Research Protections (SACHRP) Rockville, MD Co-Chair Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization (SOH) Rockville, MD March 21, 2014 August 2007—January 2010 July 2008—October 2012 April 2010—Present 3 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Member Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research (SIIIDR) Rockville, MD Member, Providence St. Peter Medical Ethics Committee; Olympia, WA Member, Columbia Capital Medical Center Ethics Committee; Olympia, WA Member, University of Washington Human Subjects Review Committee; Seattle, WA December 2006—March 2009 September 1997—2000 November 1997—February 2001 September 1994—April 1996 Continuing Education: WIRB Annual and Quarterly Meetings and Training Seminars, 1996-Present PRIM&R/ARENA Annual Meeting, 1996-2002 and 2004-Present Forum for Institutional Review Boards/Research Ethics Boards in Canada and the United States (FOCUS) Conference, Montreal, Canada, May 2009 Canadian Association of Research Ethics Boards (CAREB), Vancouver, Canada, April 2009 2009 Clinical Trials Conference, New York, NY, February 2009 2009 AAHRPP Conference, Los Angeles, CA, February 2009 Forum for Institutional Review Boards/Research Ethics Boards in Canada and the United States (FOCUS) Conference, Charlotte, North Carolina, May 2008. International Symposium on Clinical Trials, Seoul, Korea, June 2007 DIA Annual Conference, Atlanta, GA, June 2007 Spring Hospital and Health Law Seminar, Washington State Society of Healthcare Attorneys, Seattle, WA, April 2007 2007 AAHRPP Conference, Baltimore, MD, February 2007 Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) Meeting, Bangkok, Thailand, November 2006 Research Compliance Conference, Health Care Compliance Association, Las Vegas, NV, September 2006 Children’s Pediatric Bioethics Conference, Seattle, WA, July 2006 March 21, 2014 4 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Spring Hospital and Health Law Seminar, Washington State Society of Healthcare Attorneys, Seattle, WA, April 2006 Spring Hospital and Health Law Seminar, Washington State Society of Healthcare Attorneys, Seattle, WA, May 2005 Hot Topics & Best Practices for Conduct and Oversight of Human Subject Research, Washington State Society of Healthcare Attorneys, Seattle, WA, March 2005 2005 AAHRPP Conference: Quality Human Research Protection Programs, Atlanta, GA, March 2005 IRB Regional Education Conference, NW Association for Biomedical Research, Bellevue, WA, November 2004 Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Olympia, WA, August 2003 FDLI Roundtable Discussion” Interacting and Communicating with FDA”; Seattle, WA, February 2003 Clinical Gene Transfer, American Society of Gene Therapy, 2001 Protection in Clinical Trials, Barnett International, 2001 Ethics: Professionalism and Civility, The Hard Questions, WSBA, 2000 Hospital and Health Law Seminar, WA Society of Health Care Attorneys, 1999 A Guide to Counseling the Corporation, WSBA, 1999 Using ADR in the Business Setting, WSBA, 1999 Confidentiality of Medical Records, Lorman, 1998 Sexual Harassment Update, Council on Educational Management, 1998 Publications: Pacific Rim Law and Policy Journal, When Body is Soul: Brain Death and Organ Transplantation in Japan. Volume 3, No. 1, June 1994, pp. 103-139. Report To The Washington State Legislature, The Role Of Antitrust Immunity In The Washington State Health Care Market, December 15, 1995 The Journal of Ethics, Law, and Aging, Book Review of Research Ethics: A Reader. Volume 4, No. 1, Spring/Summer 1998; pp. 42-43. Modules for the Collaborative IRB Training Initiative (CITI) On-line Course: (a) Research with Protected Populations—Vulnerable Subjects: A Definition; (b) ICH for Investigators. Institutional Review Board: Management and Function; Chapter 5-6, Privacy and Confidentiality, and Chapter 8-2, International Conference on Harmonisation; September 2001, Second Edition 2006. Drug Information Journal, Volume 36, Issue 2 (2002), Ethical Concerns on PlaceboControlled Studies: An Analytical Approach, Drug Information Association (DIA). Drug Information Journal, Volume 36, Issue 4 (2002), The Cultural Framework for the Ethical Review of Clinical Research in Latin America, Drug Information Association (DIA). March 21, 2014 5 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) Protecting Study Volunteers in Research; Contributing Author; Second Edition 2002, Third Edition 2004. Seton Hall Law Review; Independent Institutional Review Boards; Volume 32, Book 3, June 2003. The Washington Health Law Manual, Third Edition. Washington State Society of Healthcare Attorneys, June 2010. Editorial Review for IRB Ethics and Human Research, Volume 32, Number 6, November – December 2010. Presentations: 2012 2011 2010 MAGI West Clinical Research Conference 2012, “Recent Developments in Human Subjects Protection Regulation and Where are We Going?” San Diego, CA, October 2012. Massachusetts Society for Medical Research 3 Is – IACUCs, IBCs and IRBs, “Research Misconduct and Human Subject Non-Compliance,” Wellesley, MA, October 2012. IRB Summit 2011, “The Challenge of Harmonizing Regulations, Principles and Guidelines for Global Clinical Research,” “Management of IRB Performance and Collaboration for IRB Quality Improvement” and “Recent Global Issues for Human Research Protection,” Daegu, South Korea, April 2011. International Institutional Review Board Conference, “Essentials for IRBs,” “Quality Activities,” “Clinical Equipoise” and “Vulnerable Subjects,” Daegu, South Korea, March 2010. AAHRPP Conference, “Has the Issue of Non-Compliance Increased?” Atlanta, Georgia, April 12-14, 2010. Office of Human Research Protections Keynote Address, “In Pursuit of Harmonization: The SACHRP Subcommittee on Harmonization, Goals and Specific Issues,” Cleveland, Ohio, September 12-15, 2010. Institute of Medicine of the National Academies, “SACHRP Subcommitee on Harmonization,” Washington D.C., October 29, 2010. Taiwan International Conference and IRB Survey Training, “The Role of IRB in Research,” “ World Health Organization Operational Guideline Standards” and “Conducting Audits on Genetic Research and Protocols Using Biobank Materials and Findings,” Taipei, Taiwan, November 2010. 2009 March 21, 2014 6 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 2008 2007 Association for the Accreditation of Human Research Protection Programs, “Components of Model Quality Improvement Programs for Human Research Protection Programs,” Los Angeles, California, February 23, 2009 American Conference Institute, Managing Legal Risks in Structuring and Conducting Clinical Trials, “IRB/Ethics Review of Research in Emerging Regions,” New York City, New York, February 26, 2009 Canadian Association of Research Ethics Boards (CAREB), “Educating REB Members: A Private REB/IRB Perspective,” Vancouver, Canada, May 1, 2009 Good Clinical Practices Workshop, “Ethical Review: Essentials for IRBs and The Role of the IRB in Research,” Beijing, China, June 11, 2009 IRB/EC Surveyor Training, “The Role of the IRB in Research,” “ International Conference on Harmonization and WHO Operational Guideline Standards,” “IRBs and Conflicts of Interest,” Taipei, Taiwan, September 5-11, 2009 PhRMA BRMC Annual Workshop, “Central IRB and Ethics Review in Emerging Growth Regions,” Washington DC, September 22-23, 2009 Public Responsibility in Medicine and Research (PRIM&R), “Is the Era of Local IRBs Over, Particularly in the Setting of Multi-Site Research?” Nashville, Tennessee, November 13-16, 2009 Clinical Investigator Training Program, “IRB Oversight: General Issues, Review of the IRB System and Hot Topics,” Boston, Massachusetts, November 16-17, 2009 Fourth Annual Accreditation Conference, “Education Programs” and “Orienting the IRB Toward Customer Service,” Minneapolis, MD, February 24-26, 2008 ACRP Global Conferences & Exhibition, “Informed Consent – Regulatory Requirements, Process Considerations, and Ongoing Dilemmas,” Boston, Massachusetts, April 25 – 29, 2008 Forum for Institutional Review Boards/Research Ethics Boards in Canada and the United States (FOCUS) 2008, “Scientific Validity,” Charleston, North Carolina, May 30, 2008 Association of Clinical Pharmacology Units (ACPU), “Ethics Case Studies,” Tacoma, Washington, October 21 – 22, 2008 Public Responsibility in Medicine and Research (PRIM&R), “How to Implement Changes During the CQI/Accreditation Process,” Orlando, Florida, November 16 – 19, 2008 Institutions Meeting, Newport Beach, January 19, 2007 Association for the Accreditation of Human Research Protection Programs (AAHRPP) 3rd Annual Conference, “Systems of Oversight for Protocols Reviewed by External IRBs” & “Ongoing management and Implementation of Policies and Procedures,” Baltimore, MD, February 26 & 27, 2007 WIRB Board Member Spring Meeting, “Conflicts of Interest, Bonus Payments, Referral Fees”, Portland, OR, April 20, 2007 March 21, 2014 7 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 2006 2005 Association of Clinical Research Professionals (ACRP) Annual Conference, “Clinical Equipoise and Therapeutic Misconception – How Do We Use Ethical Concepts in IRB Review?” Seattle, WA, April 22, 2007 Washington State Society of Healthcare Attorneys (WSSHA), “Legal and Clinical Ethics: Human Subject Research,” Seattle, WA, April 27, 2007 International Symposium on Clinical Trials, “Models of Central IRB Review in the United States,” Seoul, Korea, June 4-9, 2007. Drug Information Association (DIA) “Misconduct in Clinical Research” and “Institutional Review Board Site Visit Programs;” Atlanta, GA, June 19, 2007 WIRB Annual Board Meeting, “Risk Analysis,” Seattle, WA, September 15, 2007 PRIM&R, “Overseeing Change Control of Written Procedures During the AAHRPP Accreditation Process,” Boston, MA, December 4, 2007 Evergreen Tacoma Campus, “Ethics in International Research,” Tacoma, WA, February 6, 2006 WIRB Board Member Spring Meeting, “Accreditation Observations,” Vancouver BC, Canada, April 21 & 22, 2006 Annual Board Meeting Pre-conference "Working with WIRB," Seattle, WA, September 7, 2006 Annual Board Meeting: "Revised and New Processes," Seattle, WA, September 9, 2006 HCCA’s Research Compliance Conference, “Human Subject Protection 101 – Core Issues to Consider,” Las Vegas, NV, September 17, 2006 Northwest Association for Biomedical Research (NWABR), “ What role do subjects’ circumstances play in the ethical analysis of research?” Seattle, WA, October 12, 2006 Network Meeting, “WIRB International Fellows Program,” Bethesda, MD, October 24, 2006 Forum for Ethical Review Committees in Asia & the Western Pacific (FERCAP), “Addressing Financial Conflicts of Interest during Ethical Review of Protocols,” Ayutthaya, Thailand, November 29, 2006 University of WA, Fall Faculty Forum, Seattle, WA, December 5, 2006 Evergreen Tacoma Campus, “Ethics in International Research,” Tacoma, WA, February 16, 2005 Association for the Accreditation of Human Research Protection Programs (AAHRPP) Conference, “Vulnerable Subjects-Issues for Accreditation,” Atlanta, GA, March 14 & 15, 2005 Washington State Society of Healthcare Attorneys (WSSHA) Winter Quarter Meeting, “Hot topics and best practices for conduct and oversight of human subject research,” Seattle, WA, March 23, 2005 WIRB Board Member Spring Meeting, “Ethics and Regulations in Opposition,” Portland, OR, April 1, 2005 March 21, 2014 8 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 2004 Albany Medical College, “The Role of Bioethics in Society - A View from the Private Sector,” Albany, NY, April 8, 2005 Global Clinical Trials, “Ethical Issues in International Research,” Jersey City, NJ, May 17, 2005 Temple University, “Issues in the Responsible Conduct of Clinical Research,” Philadelphia, PA, June 10, 2005 U.S.-China JCCT Workshop on Pharmaceutical Good Clinical Practices, “Overview of Ethics Requirements under Good Clinical Practices,” Beijing, China, July 13, 2005 Forum for Ethical Review Committees in Asia & the Western Pacific, “Training on WHO Ethics Committee Recognition Standards,” Taipei, Taiwan, July 16-23, 2005 University of Florida, Institutional Review Boards – Educational Retreat – Board Member Training, “Hot Topics Compliance,” Gainesville, FL, August 31, 2005 WIRB Annual Board Meeting, “Board SOP’s & Guidelines Update,” Seattle, WA, September 17, 2005 Environmental Protection Agency (EPA) – Training Workshop on Protection of Human Subjects - “Additional Safeguards for Vulnerable Subjects,” Seattle, WA, September 29, 2005 WIRB EPC/Institutions Meeting, Baltimore, MD, October 13-16, 2005 Northwest Association for Biomedical Research (NWABR), Human Subject’s Conference, “Therapeutic Misconception and Clinical Equipoise: Can They Co-Exist” & “Complex Studies in Social and Biomedical Research,” Seattle, WA, October 17-18, 2005 University of Arizona, “Non-compliance in Clinical Research,” Tucson, AZ, November 10, 2005 2nd Annual Pediatric Clinical Trials Conference, “Ethical and Regulatory Issues in Pediatric Clinical Research,” Boston, MA, December 6-7, 2005 University of Washington, “Bioethics in International Research,” Seattle, WA, February 5, 2004 Harvard University Clinical Investigator Training Program, “Research Ethics and Regulations,” Boston, MA, April 6, 2004 Pfizer GCP Symposium, “Review of Good Clinical Practices in the United States,” Beijing, China April 13, 2004 WIRB Quarterly Board Meeting, “Legally Authorized Representatives for Adults” & “Therapeutic Misconception,” Vancouver, B.C., April 23, 2004 WHO/SIDCER/FERCAP Workshop, “Surveying and Evaluating Ethical Review Practices,” Bangkok, Thailand, May 3, 2004 Association of Clinical Research Professionals (ACRP) Annual Conference, “IRBs Around the Globe,” San Diego, California, May 18, 2004 Swedish Medical Center, “FDA Oversight of Clinical Investigations with Medical Devices,” Seattle, WA, June 2, 2004 March 21, 2014 9 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 2003 2002 Clinical Trial Summit, “IRB Management and Legal Issues in Clinical Trials,” La Quinta, California, September 13, 2004 WIRB Annual Board Meeting, “Board SOP’s & Guidelines Update,” Seattle, WA, September 17, 2005 Secretary's Advisory Committee on Human Research Protections (SACHRP), “Panel on 45 CFR 46, Subpart A” & “Models of IRB Review,” Alexandria, Virginia, October 5, 2004 PRIM&R and Arena, “Independent IRBs: Contributors or Detractors to Public Trust,” San Diego, CA, October 29, 2005 Research Compliance Conference, “Ethics in International Research,” Las Vegas, Nevada, November 9, 2004 University of Medicine and Dentistry of New Jersey (UMDNJ), “Models of IRB Review: Independent IRB,” Newark, NJ, November 13, 2004 NW Association for Biomedical Research IRB Conference, “Multi-Site Research Coordination: IRB Perspective,” Bellevue, WA, November 15, 2004 Evergreen Tacoma Campus, “Research Ethics and Regulations,” Tacoma, WA, December 1, 2004 Columbia University, IRB Training; New York, NY; January 2003. Food and Drug Law Institute (FDLI) Conference “Introduction to Device Law and Regulation,” IND Workshop; Presentation: “Understanding How The FDA Regulates The Medical Device Industry”; Seattle, WA; February 2003. Regulatory Affairs Professionals Society (RAPS) “Medical Device Conference and Table Top Exhibition,” IDE Workshop; Presentation: “Role of the Institutional Review Board (IRB)”; San Francisco, CA; March 2003. WSSHA Hospital & Health Law Seminar; Presentation:” Update on Human Subject Research Issues”; Seattle, WA; May 2003. ACRP’s 27th Annual North American Conference and Exposition, Presentation: “What Makes Clinical Research Ethical”; Philadelphia, PA; April 2003. Thai FDA Conference, Bangkok, Thailand, Presentation: “Best Ethical Review Practice: Lessons and Experiences from Western Institutional Review Board”; July 25, 2003. Fall IRB Conference (Swedish, Fred Hutchinson Cancer Research Center, UW, NWABR); Seattle, WA; Presentation: “The Application of Ethical Principles in Research Review”; October 27, 2003. University of Arizona, Bioethics Symposium, Presentation “Bioethics in International Research”; Tucson, AZ; October 31, 2003 IRB, Coordinator, and Investigator training, Albany Medical College, November 13, 2003. Drug Information Association (DIA) Data Monitoring Committee (DMC)/IRB Conference “Questions, Cases, Examples;” Bethesda, MD; January 2002 March 21, 2014 10 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 2001 2000 University of Washington, 2002 Ethics of Research with Humans: Past, Present & Future; “The Federal Regulations on Human Subject Protection,”Seattle, WA; June 2002 OHRP Expert Panel Meeting, “Compensation for Injury”; Faculty Member of Planning Committee, Seattle, WA; August 2002 University of Arizona, Bioethics Symposium “Bioethics in International Research”; Tucson, AZ; September 5, 2002 Regulatory Affairs Professionals Society (RAPS) Annual Conference; Baltimore, MD; “Hot Topics in the IRB World” and “What Industry Needs to Know About Litigation Against Investigators, Universities, and IRBs”; October 2002 IRB Member Training, St. Joseph Medical Center, Tacoma, WA, January 2001 Barnett Latin America 2001 Conference, “Preparing for the IRB and Ethical Review Process in Latin America”, Washington, DC, January 25-26, 2001 Barnett Conference - Subject Protection in Clinical Trials, Panel Chair: ““What Are the Auditors Looking for when Auditing an IRB”, “Differences and Inconsistencies Among IRBs: Perspectives from the Academic, Independent, and Community Hospital IRBs”, Philadelphia, PA, March 19-20, 2001 Regulatory Affairs Professionals Society (RAPS), “Life Cycle of a Clinical Study, Clinical Trials”, Seattle, WA April 2, 2001 Association of Clinical Research Professionals (ACRP), 25th Annual Meeting; “The Race to the Bottom: Ethical Dilemmas for Recruiting Study Subjects in Today’s Competitive Clinical Research Environment”, San Francisco, CA; 4/28-5/3/01 Oregon Health Science University (OHSU) Conference, “Conflict of Interest in Clinical Trials,” Portland, OR, June 8, 2001 University of Washington 2001 – Faculty “Ethics of Research with Humans: Past, Present & Future,” Seattle, WA; 6/11-15/01 Washington State Bar Association (WSBA) 2nd Annual Health Care Law Institute Conference, “Research Involving Human Subjects: Legal—Medical Ethical Issues and Impacts on Research Funding”, Seattle, WA, September 13, 2001 University of Washington IRB Training “Conflict of Interest”; Seattle, WA; October 19, 2001 University of Washington Biomed Course “The Role of the IRB in the Life Cycle of a Clinical Study”; Seattle, WA; October 30, 2001 Regulatory Affairs Professional Society (RAPS) 2001 “IRBs: A System in Jeopardy?”; Baltimore, MD; November 4-7, 2001 Seton Hall University Symposium “Perspectives from a For-Profit IRB”; Newark, NJ; November 9, 2001 Harvard Clinical Investigator Training Program “International Research, The Declaration of Helsinki, and IRB Oversight”; Boston, MA; December 4, 2001 Neeman Training, Costa Rica, April 2000 March 21, 2014 11 David G. Forster, JD, MA, CIP 2513 Fir Street SE Olympia, Washington 98501 (360) 705-1984 (h) · (360) 252-2428 (w) 1999 1998 1997 1996 IRB Member Training, Fred Hutch, Seattle, WA, October 2000 “Bench to Bar to Bedside” Presentation, University of South Florida, Gainesville, FL, November 2000 “Ethical Principles in Clinical Research and the Purpose of an IRB/IEC” “Informed Consent Process” “Frequently Asked Questions: IRBs/IECs” “IRB/IEC Disapprovals: Case Studies” Harvard Medical International Course on Good Practices in Clinical Research, August 2000, Mexico City, Mexico; October 2000, San Jose, Costa Rica; October 2000, Caracas, Venezuela; November 2000, Sao Paulo, Brazil OHRP National Human Subject Protections Workshop: Ethical Research in the New Millennium, “Conflicts in Clinical Trials,” Oregon Health Sciences University, August 2000, Portland, OR Ethics: Human Subject Issues and Drawing the Line between Patient Safety, Regulatory Compliance, and Company Profit, University of Washington, December, 2000 “Global Hormone Replacement Therapy Trials – Ethical Considerations,” Drug Information Association (DIA) Thirty-Fifth Annual Meeting, Baltimore, MD June 1999 Association of Clinical Research Professionals (ACRP) Annual Meeting, Anaheim, CA, Aril 1998 ICIC Training Course, Costa Rica, April 1998 “Vulnerable Subjects: Definitions and Significance,” Drug Information Association (DIA) Thirty-Fourth Annual Meeting, Boston, MA, June 1998 “When the Regulations Do Not Provide an Answer: A Practical Method for Applying Ethics in the Review of Research,” Human Subject Protections Workshop - Culture and Community: Consultation and Communication in Research, August 1997, Seattle, WA “From Beneficence to Autonomy: Euthanasia and Physician-Assisted Suicide Bills in the United States,” American Public Health Association (APHA) 125th Annual Meeting and Exposition, November 1997, Indianapolis, IN “When the Regulations Do Not Provide an Answer: A Practical Method for Applying Ethics in the Review of Research,” Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA) Meetings, December 1997, Boston, MA “New FDA Regulations: Emergency Research Informed Consent Waiver and Humanitarian Use Devices,” Organization of Regulatory and Clinical Associates (ORCA), November 1996, Seattle, WA March 21, 2014 12
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