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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) Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts - Dissemination of Research Results

(2) Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials, Association of American Medical Colleges, 2006 (PDF)

(3) Financial disclosure policies of scientific publications. LM Brockway and LT Furcht, JAMA, 2006

(4) Interactions With the Investment Industry: Practical and Ethical Implications, The American Society of Clinical Oncology, 2007

(5) Physicians and the investment industry, EJ Topol and D Blumenthal D, JAMA, 2005

Investigators

Disseminating Research Results

Publish industry-sponsored research in a timely manner. In industry-sponsored research, terms of publication should be negotiated before the start of the study.

Pre-publication review by the sponsor: Pre-publication review by an industry sponsor should take no more than 60 days, consistent with NIH guidance (1). There may be unique situations (e.g., multi-institution studies or for the purpose of protecting intellectual property) when publication preparation and review may need more time, but it should be discussed ahead of time.

Prohibition of publication: Contracts between sponsors and institutions should not give the sponsor the power to prohibit publication even if the outcome of the research may have negative implications for a sponsor (2).

Adhere to policies on disclosure of financial interests in publications and presentations. The dissemination of research results (especially via peer-reviewed scientific journals) affects future research and, in some cases, patient care. Disclosure of relevant financial interests is essential for transparency. Failure to disclose creates the perception that the investigators had something to hide and decreases public trust in medical research (3).

Understand journal requirements: In some cases, full compliance with policies may entail actively seeking out information. If policies are unclear, contact with the editor or similar official is encouraged. Reporting of research funding may or may not be in the same place in the manuscript as other financial disclosures.

Enhance transparency: Transparency entails disclosure of financial interests as required, but it is also enhanced by voluntary disclosure. Therefore, investigators should disclose all "relevant" financial interests in publications and presentations if a policy is not sufficiently transparent. A "relevant" financial interest means having financial interests or relationships with companies or investment firms related to the reported research. Financial interests may include a research grant from a company for the reported research or consulting fees, royalties, equity, or other remuneration from a company that could be directly affected by the reported research. Financial interests of a spouse or dependents should also be considered relevant because these are included in the Federal regulation.

Tool. Sample wording for disclosure of financial interests in publications from Blackwell Publishing


Tool. Funding and disclosure slide (PPT): Investigators can use this template PowerPoint to disclose funding and industry relationships their own research presentations



Ghost authorship (publishing articles under your name that are written in whole or substantial part by an individual not listed as an author, such as a writer paid by a company) is unacceptable. Investigators must adhere to journal policies regarding authorship. An author is someone who has made substantive intellectual contributions to the study and preparation of the manuscript. (Investigators and institutions might also face challenges associated with paid speaking engagements (e.g., speakers bureaus) in which the presentation was prepared by the company).

Do not engage in premature communication of unpublished or unreleased information regarding ongoing research studies, particularly clinical trials, to investors or competitors or the media. A company should not be provided knowledge of or access to the results of research conducted in the institution prior to the time they are made available to the scientific community at large other than to a company sponsoring the research. Investigators should be aware that this includes informal conversations at meetings or social gatherings in addition to consulting contracts. The disclosure of non-public information may influence investment decisions or the price of stock. Investigators who share confidential information of a public company with investment firms in exchange for compensation may violate insider trading laws. Two recent articles discuss these relationships in more detail (4,5).

 






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