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COI Toolkit
 

Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research

 

 

About the Project

Scope and Objectives

Relationships between academia and industry have benefits and risks. Collaborations between academia and industry in biomedical research benefit society through the development of medical treatments and other products.  However, their rise has been accompanied by increasing concerns about financial conflicts of interest that have the potential to bias research, compromise dissemination of research results, and decrease public trust.  There is ongoing dialogue in the scientific community and the public about how best to manage these relationships to secure the benefits and minimize the risks. 

The community continues to work to improve policies and practices. Current regulation and management involves partnerships between the government, sponsors of research, institutions, investigators, journals, and the public.  It is essential that the various stakeholders work together to study the effectiveness of policies and practices, and strive to balance the need for more common standards with preserving case-by-case analysis and situational-driven decision-making, when warranted. While flexibility is needed, operating under more broadly agreed upon guidelines will benefit the public and ensure future public support for biomedical research.

The investigators' role is critical in this regard. Investigators as a group determine the effectiveness of policies and practices.  Because policy recommendations addressing financial conflicts of interest have focused on the role of academic institutions in reviewing and overseeing investigator relationships with industry, FASEB issued guidelines for individual investigators in 2006 (1).  This was a first step to articulate the perspective of investigators on this issue.  The purpose of this current project is to continue the work of FASEB and other stakeholders, generate a broader discussion of issues, and promote implementation of voluntary policies and practices.

Two major objectives guided our activities.  First, we seek to increase awareness and understanding of financial conflict of interest issues on the part of investigators in order to promote adherence to all relevant policies, encourage scientists to communicate with their institutions about these issues, and facilitate voluntary practices that encourage personal responsibility. Second, we also encourage more standard practices for financial conflict of interest disclosure and management in biomedical research.

Our approach is to provide guidance to address challenges that may occur due to financial relationships between academia and industry, not to judge whether a real or perceived conflict of interest exists.  In fact, we urge those who develop statements and policies in this area to shift the terminology towards “financial relationships” and “financial interests” and away from “conflicts of interest” as much as possible and especially in communications to investigators.  This is discussed further in the Toolkit. Overarching principles to guide individual behavior and policy development are presented and a list of recommended practices is provided to illustrate some ways in which the principles may be achieved. 

(1) Brockway LM and Furcht LT. Conflicts of interest in biomedical research – the FASEB guidelines. FASEB Journal, 20:2435-2438, 2006

 

Advisors

The following individuals contributed to the development of the major guidelines and recommendations in the Toolkit. The Toolkit takes advantage of the power of the web, allowing updating of content and adding new content. Therefore, their participation does not represent an explicit endorsement of the entire content of the Toolkit. FASEB appreciates greatly the following individuals for lending their expertise to this effort.

Leo T. Furcht, M.D., Coalition Chair and FASEB Past President, Allen Pardee Professor and Head of Lab Medicine and Pathology, Univ. of Minnesota School of Medicine

Carol Blum, Ph.D., Director, Research Compliance and Administration, Council on Governmental Relations

Eric G. Campbell, Ph.D., Assistant Professor, Institute for Health Policy, Harvard Medical School

Gail Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company; Representing American Society for Microbiology

Tony DeCrappeo, President, Council on Governmental Relations

Susan Ehringhaus, J.D., Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges

Ezekiel Emanuel, M.D., Ph.D., Director, Dept. of Clinical Bioethics, National Institutes of Health

Mark S. Frankel, Ph.D., Director, Scientific Freedom, Responsibility and Law Program, American Association for the Advancement of Science

Joan Goldberg, Executive Director, American Society for Cell Biology

Todd Margolis, M.D., Ph.D., Chair, Commercial Relationships Committee, Association for Research in Vision and Ophthalmology, Director, FI Proctor Foundation-Ophthalmology, University of California-San Francisco

Barbara Perry, Senior Counselor of Congressional Affairs, NASULGC and Associate VP and Director of Federal Relations, University of Washington

Lawrence J. Rhoades, Director, Division of Education and Integrity, Office of Research Integrity

Norka Ruiz Bravo, Ph.D., Director, Office of Extramural Research, National Institutes of Health

Janet Shoemaker, Director, Public Affairs Office, American Society for Microbiology

Nicholas Steneck, Ph.D., Consultant, Office of Research Integrity and University of Michigan

James A. Severson, Ph.D., Vice Provost of Intellectual Property and Technology Transfer, University of Washington

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