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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

 

 

 

References and Resources

(1) "Investigator" is defined as any individual responsible for the design, conduct or reporting of research, which is consistent with the PHS/NSF regulation on conflicts of interest for grantees

(2) "Industry" includes public and private pharmaceutical, biotechnology, medical device, and research supply companies as well as entities that deal directly with these companies, such as investment firms

(3) Eric G. Campbell, presentation to FASEB Board of Directors, June 15, 2005

(4) More than 3,600 new products based on academic inventions have been produced from 1989 to 2005 according to the Association of University Technology Managers 2005 Licensing Survey

(5) Scope and impact of financial conflicts of interest in biomedical research: A systematic review, JE Bekelman et al, JAMA, 2003

(6) 42 CFR Part 50, Subpart F - Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought

(7) NSF Grant Policy Manual, Chapter V - Grantee Standards, 510 - Conflict of Interest Policies

(8) "Significant financial interests" are defined according to the PHS/NSF definition of anything of monetary value, including but not limited to, salary or other payments for services, equity interests, and intellectual property rights, when aggregated for the investigator and the investigator's spouse and dependent children are greater than or equal to $10,000 in value and 5% ownership interest in any single entity

(9) 21 CFR 54, Financial Disclosures by Clinical Investigators

(10) D Armstrong, Financial ties cloud major depression study, Wall Street Journal, July 11, 2006, Page A1

(11) Financial conflicts of interest in research - Shared Responsibility, Individual Integrity, FASEB

(12) Financial Conflicts of Interest in Clinical Research, AAMC

(13) Report on Individual and Institutional Financial Conflicts of Interest, AAU Task Force on Research Accountability, 2001 (PDF)

(14) RBM Project Description - Improve consistency of Federal-wide policies for Research Conflict of Interest, Working Group on Stewardship and Accountability

(15) Institute of Medicine, Board on Health Sciences Policy, Conflict of Interest in Medical Research, Education, and Practices

See also

Fact Sheet: Academia-industry-government relations in research, Created for FASEB meeting on conflicts of interest in research, 2005 (PDF)

 

Introduction

Benefits of Academic-Industry Relationships

Academic-industry relationships are arrangements in which academic investigators (1), administrators, and institutions carry out research for, or provide intellectual property to, industry (2) in return for research support, honoraria, consulting fees, royalties, equity, or other forms of compensation (3). They are a fundamental and beneficial part of modern biomedical science.

Benefits to society. Academic-industry relationships benefit society by leading to the development of new medical treatments, diagnostic tools, and other practical ramifications of research (4). 

Benefits to investigators. Investigators benefit by interchanges with industry colleagues that facilitate the flow of knowledge and materials, expedite application of research, and employment opportunities for students. These relationships can also result in research support for laboratories and personal financial outcomes.


Financial Conflicts of Interest in Science

Financial conflicts of interest in science are situations in which financial considerations may compromise an investigator's professional judgment. The rise in academia-industry relationships has been accompanied by increasing concerns about financial conflicts of interest (5). 

Potential negative outcomes of academic-industry relationships. As the number and complexity of academic-industry relationships in biomedical research has increased, there has been a corresponding increase in concerns about financial conflicts of interest that have the potential to introduce bias into research, compromise efficient and wide dissemination of research results, delay trainee progress, and decrease public trust in medical research.

Implications for public trust of science. The presence of a conflict of interest is not an indictment of an individual, but rather an acknowledgement of a potentially challenging situation. However, the perception of bias that results from having a financial interest can be damaging to the credibility of biomedical research. Because the public trust is crucial to the ongoing success of the research enterprise, investigators should be aware of how their actions maybe perceived.


Current Regulation and Policies

Regulations and policies guide academic-industry relationships, and investigators must comply with all of these relevant policies.  In addition to the ones discussed below, many non-governmental organizations that fund research, scientific societies, and journals also have requirements or guidelines for individual financial conflicts of interest.

Public Health Service (PHS) and National Science Foundation (NSF). In 1995, the PHS (6) and the NSF (7) enacted regulations to ensure that the design, conduct, or reporting of research funded by the agencies will not be biased by any conflicting financial interest of investigators responsible for the research. Under this rule, investigators must disclose any significant financial interests (8) to the institution that would reasonably appear to be affected by the proposed research.

Significant financial interests are defined as anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights) when aggregated for the investigator and the investigator's spouse and dependent children are greater than or equal to $10,000 in value and 5% ownership interest in any single entity. Some institutions may use a lower threshold for disclosure.

Institutions determine whether or not these interests could directly and significantly affect the design, conduct, or reporting of the research (present conflicts of interest) and how to proceed (eliminate, reduce, or manage the interests). "Managing" means finding a way to assure that the financial interests do not adversely influence the research and may include public disclosure, institutional monitoring, and removing the investigator from some aspects of the research. For public institutions, state laws may impact their policies and procedures for financial conflicts of interest.

 

Food and Drug Administration. The FDA (9) requires financial disclosures for new marketing applications.  Applicants (e.g. the company for industry-sponsored research) must submit disclosure of financial interests in excess of $25,000 for clinical investigators involved in the study  and any steps taken to minimize the potential for bias resulting from any of the disclosed interests. The investigator shall provide to the sponsor of the sufficient accurate financial information to allow the sponsor to submit complete and accurate certification or disclosure statements . The investigator shall promptly update this information if any relevant changes occur in the course of the investigation or for 1 year following completion of the study.
 

Ongoing Challenges

While relationships between industry and academic investigators can produce many positive outcomes, there are also potential challenges. There is an increasing body of data that indicate industry sponsorship of research may influence the outcome of the research or the decision to publish (5).

 

Lack of clear and consistent practices. Many policies and procedures exist for the review and oversight of investigators' outside financial interests. While flexibility in policies and case-by-case assessment is important, the lack of clear and uniform practices may cause confusion and non-compliance. This has been especially evident in a recent case involving journal disclosure (10).

 

Lack of sufficient, widespread awareness. Investigators may lack sufficient awareness or understanding of potential challenges and requirements for academic-industry relationships. In addition, sensitivity on the part of investigators may be lacking about the importance of this issue to the public and other stakeholders. How do investigators ensure objectivity in research and operate with transparency and accountability when relationships with industry exist?

Ongoing activities to address these challenges. The scientific community has been working diligently to address these issues. Institutions, sponsors of research, the Office of Research Integrity, publishers, institutions, and scientific and professional societies - FASEB (11) and others - have developed policies, recommendations, codes of conduct, and educational activities.  On-going efforts are reassessing current practices for the oversight of conflicts of interest in research and finding ways to improve upon them. For example, the Association of American Medical Colleges (AAMC) (12) and the Association of American Universities (AAU) (13) have been active in addressing conflicts of interest in clinical research from the institutional perspective. The Research Business Models Subcommittee (of the National Science and Technology Council) is currently working to improve consistency of Federal-wide policies for research conflict of interest (14). The Institute of Medicine has recently undertaken a study of COI in medical education, research, and practice (15).

Role of investigators. Investigators as a group determine the effectiveness of policies and practices. Therefore, investigators should be involved in discussions that shape these policies. Policies and statements have been developed by some scientific and professional societies. Some of these are discussed further in the Toolkit. It is essential that all of these efforts are complementary and work towards common goals.


Need for National Guidelines

Many policies and procedures from sponsors of research, institutions, journals, industry contracts, and professional societies exist for the review and oversight of investigators' outside financial interests. While flexibility in policies and case-by-case assessment is important, the lack of clear and uniform practices may cause confusion and non-compliance.





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