Beyond disclosure: The necessity of trust in biomedical research

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Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Correspondence: Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, N504 Boyn HS, 410 Church Street SE, Minneapolis, MN 55455; kahnx009@umn.edu

Dr. Kahn reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Correspondence: Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, N504 Boyn HS, 410 Church Street SE, Minneapolis, MN 55455; kahnx009@umn.edu

Dr. Kahn reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Correspondence: Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, N504 Boyn HS, 410 Church Street SE, Minneapolis, MN 55455; kahnx009@umn.edu

Dr. Kahn reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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Cleveland Clinic Journal of Medicine 2007 March;74(suppl 2):S49-S50
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Applications in the real world: Case studies in defining boundaries and managing innovation

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Moderator and Author of Case Study 2
Claudia R. Adkison, JD, PhD

Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq

Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)

Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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S51-S59
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Claudia R. Adkison, JD, PhD

Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq

Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)

Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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Moderator and Author of Case Study 2
Claudia R. Adkison, JD, PhD

Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq

Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)

Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

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Applications in the real world: Case studies in defining boundaries and managing innovation
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Conflicts, compliance, and enforcement: Government priorities and initiatives

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Jeffrey P. Kahn, PhD, MPH

Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD

Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

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S68-S69
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Moderator
Jeffrey P. Kahn, PhD, MPH

Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD

Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

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Moderator
Jeffrey P. Kahn, PhD, MPH

Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD

Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

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Conflicts, compliance, and enforcement: Government priorities and initiatives
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