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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) Association of American Universities, , Report on Individual and Institutional Financial Conflict of Interest (PDF)

(2) Association of American Medical Colleges, Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research, 2001 (PDF)

(3) Association of American Medical Colleges, Principles and Recommendations for Oversight of an Institution's Financial Interests in Humans Subjects Research, 2002 (PDF)

(4) American Council on Education, Working Paper on Conflict of Interest, 2008 (PDF)

(5) Council on Governmental Relations, Publications on COI

(6) Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research, A report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research, 2008 (PDF)

(7) Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council, 2008

(8) The Triple Helix: University, Government, and Industry Relationships in the Life Sciences, EG Campbell et al, AEI-Brookings Joint Center for Regulatory Studies Working Paper, 2004

(9) Mary Ellen Sheridan, presentation to the Council on Government Relations, February 22, 2007

Institutions

Common Guidelines

The institutional community should work towards harmonization of policies and practices.
It is appropriate for academic institutions to develop and enforce their own mechanisms of review and oversight of investigator relationships with industry that are appropriate for the institution and applicable state laws. The discretion given to institutions by the federal regulation has allowed needed flexibility and experimentation with policy models.

Benefits: Harmonization of some elements of policies and practices would be beneficial. Institutions would benefit by implementation of tested and effective practices. Industry partners would have more clearly defined guidelines, allowing more efficient and transparent partnering for the public good. Investigators would benefit through more consistent and clear national messages.  Institutional groups  have been active in promoting guidelines and sharing practices with regard to academic-industry relationships in research, education, and other activities (1-7).

Guiding principles: As institutions consider more consistent policies and practices, the principles of objectivity, transparency, and accountability should guide their development.

Terminology: Policies and communications to investigators should avoid the terminology "financial conflicts of interest" and instead use "financial relationships" and "financial interests" as much as possible. We believe this will help investigators be more forthcoming about these relationships.

Communication to investigators: Institutions should communicate to investigators and sponsors the relevant institutional policies and what the policies attempt to achieve. These communications to investigators should be clear, consistent, and efficient and the scope carefully defined (e.g., a "need to know" model). The conduct of academic-industry relationships is a shared duty involving reciprocal responsibilities between investigators, institutions, and sponsors of research. To achieve the best outcome and to protect all stakeholders, full disclosure and an open, problem-solving approach is desired.

Tool. "Who-to-contact" card (Microsoft Word): A template for institutional contacts on industry relationships and technology transfer that investigators and institutions can use as a quick reference 


Culture of integrity: Administrators and senior investigators play a key role in promoting a culture of research integrity, including strict compliance with institutional policies.

Financial Reporting

As a first step, institutions should work towards consistent policies and procedures on financial reporting (8).

When and to whom: These policies should be consistent in describing when reporting occurs and to whom (e.g., institutional committee, Dean, department Chair). It is recommended that institutions ask all research investigators responsible for the conduct or reporting of research (including adjunct or visiting research investigators) to annually report whether or not they have significant financial interests (as defined by the PHS/NSF regulation or institutional policy) and to update this information upon starting, ending, or modifying such relationships.

Need for flexibility: Such a standard should incorporate flexibility for state or local requirements.

Methods: Institutions should use simple, clear, and easily accessible forms and instructions to investigators (ideally electronic).


Review of Reported Financial Interests

Institutions should consider incorporating the following elements in the financial interest review process.

Human subjects research: All institutions should use the AAMC rebuttable presumption for human subjects research (2). 

Types of human subjects research: There are many types of research involving human participants from basic research to clinical trials. Even within the realm of clinical trials, different benefits, risks, and protections occur. For example, medical device and surgery research can have different profiles of risks and rewards than pharmaceutical research. Phase III trials may pose greater potential for financial gain; however, there are more protections against bias due to the fact that they are larger, conducted at multiple centers, and are double or triple blinded. Phase I trials may be more susceptible to the influence of single investigators, but may be impossible without a committed investigator who also comes with financial interests (for example, the inventor of the technology being tested).

Expertise: Even when it is possible to exclude an investigator with financial interests, it may not be in the best interest of the public if that conflicted investigator has the most knowledge and expertise to carry out the study. For example, the researcher may be a surgeon who has developed a unique surgical technique. All of these issues should be considered.

Appeals process: Institutions should have a process for investigators to appeal decisions made by individuals or committees reviewing reported interests. The appeals process is an important safeguard for investigators.

Timeliness: Institutions should review new reports in a timely manner so research projects can proceed.

Communications to investigators: Institutions should list and make available to investigators statements or points for consideration that are taken into account when deciding whether to approve or reject investigator relationships with industry and how to manage those relationships which can be managed, including: phase of clinical trial, whether stock is privately held or publicly traded, size of company, kind of intervention (diagnostic vs. therapeutic), if faculty have any influence in the company, and whether a financial relationship is fixed (e.g. fixed payment) or variable (e.g. equity, stock options).

Balance: Innovation should be managed to keep inventors engaged (9) while preserving objectivity, transparency, and accountability.


Institutional Conflicts of Interest

While the Toolkit does not make recommendations on institutional conflicts of interest - a situation in which the financial interests of an institution or institutional official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research, education, clinical care, business transactions, or other activities of the institution - institutions should consult the 2008 AAMC-AAU report which provides guidance and model policies (6).

 

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