David G. Forster, JD, MA, CIP

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:
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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)
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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:
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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)
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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
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2011
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2010
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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)
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2008
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2007
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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)
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2006
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2005
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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)
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2004
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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)
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2003
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2002
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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)
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2001
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2000
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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)
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1999
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1998
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1997
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1996
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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