Financial Interest and Disclosure Reporting 

Document version: 2.0
Date: 08 March 2021
Author: Johmarx Patton (jpatton@aamc.org)

Mission

The relationships between health professions educators, researchers, and industry are complex. Collaboration with industry is often essential for bringing new treatments and devices to the healthcare marketplace in a scalable fashion. In some cases, financial ties and other commitments or relationships can unduly influence the content of education, published research, or care delivery. To address this concern, journals, continuing education providers, schools, societies, teaching hospitals and government agencies often require that authors and faculty disclose their financial interests and other relevant commitments or relationships. Many then work to manage any conflicts. Active researchers and faculty members find themselves spending large amounts of time completing duplicative disclosure statements for the various organizations with which they work, taking time away from their research and education activities. In some cases organizations define terms differently, making reporting more complicated.

Context

In 2009 the Institute of Medicine (IOM) Committee on Conflict of Interest in Medical Research, Education, and Practice published a report calling for a more effective, centralized system for reporting financial interests. The Association of American Medical Colleges has developed a harmonized central system that provides a single mechanism for individuals to input, update, and disclose information to requesting organizations. The platform integrates with existing institutional systems and all field elements will be accommodated and information provided to entities based on their own individual requirements.

Goals

Institutions could streamline the reporting of financial interests and other disclosure requirements by using a centralized system for collecting data on financial interest and other required disclosures. This would eliminate duplicative work on disclosure forms. A technology standard for financial interest and disclosure reporting is essential to enable sharing of this data and relieve clinicians and researchers of the administrative burden of sending duplicative data to the organizations that require this data. Such a system could also improve the accuracy and clarity of information reported by ensuring the consistency of data definitions used among organizations.

Scope

The following represents the current set of revisions being requested of this working group:

From the American College of Physicians:

The request has been presented to review the “Other” field as it is currently listed as a subcategory of “Independent Contractor”. The rationale from the organization is stated as follows.

The issue is the “Other” is currently listed as a subcategory of “Independent Contractor.” Our committee members render “professional service” for our organization and do not receive any financial compensation, it is strictly volunteer. While our Board members are fiduciaries of the organization, our committee members are not. Therefore, the only option they can choose is the “Other” under “Independent Contractor.” However, federal employees are barred from being “independent contractors” and therefore refuse to complete this. What we need is just a true “Other” category that is on its own rather than as a subcategory of independent contractor.

However, I would think that volunteer committee service would be common among all professional societies who would use this system, as well as other entities, and thus note that there is no option other than an “other” that is currently listed and could be chosen instead of that. The other thing that isn’t listed is an authorship. We need to know if someone has published an article on a topic that, for example, our clinical guidelines committee may be considering developing guidelines on. Again, there is no appropriate role for this within the company/organization that is specified, and the Intellectual Property is a little off the mark in that you would have to select “Other Intellectual Property” and it really provides financial options which are not applicable to authorships.

The ask is not to add a new field but rather to relabel the “Independent Contractor” to enable federal employees to complete their disclosures.

From University of Wisconsin-Madison:

The request has been presented to add an additional sub-field within those interest types where “Compensation” is collected. In the instance the discloser selects “paid” as the compensation type, the organization needs to not only know the total value but the “Hourly Rate” for the engagement to assess fair market value. Currently only the total value is being collected for compensation. The request is to add “Hourly Rate” as a sub-field.

Standards Environmental Scan

At present the author of this proposal does not know of any direct conflicts with existing standards development efforts.



Work Plan

Please describe the anticipated timeline for this project and any anticipated resources needed by members of the working group.

This working group will be meeting monthly for approximately 6 months.

The following set of resources will be made available to MedBiquitous working groups.



Business Case

Intended Outcomes

Implementation and Adoption Plan

Validating Business Case