IOM Committee Calls for Centralized Financial Disclosure Database

A single, harmonized database for disclosing conflicts of interest could save academic centers, researchers, and the entities that fund their work a myriad of headaches.

Rather than completing disparate disclosure forms for every research application or journal submission, users would enter their baseline information into a central system and update it as needed. Every time the information is required, those who request permission could pull a digital copy and format it according to their needs.

A new system could be launched as early as late 2013 or early 2014, said Dr. Allen Lichter, a member of the committee charged with its framing.

"The time has come for such a harmonized, centralized disclosure system to be created for the benefit of everyone who must produce or receive disclosure information," Dr. Lichter wrote in a viewpoint published Nov. 28 in JAMA (2012;308:2093-94). "Such a system can be designed and implemented as one element in a process to help ensure that research can progress in a trusted, transparent fashion, thereby increasing trust among the public and health care professionals in new medical products that are brought to the benefit of patients."

The centralized system was published in a discussion paper from the Institute of Medicine (IOM), which last year convened a stakeholders’ meeting to explore the possibility.

According to the committee’s paper, a centralized system would be similar to the common application for undergraduate college admission, in which students enter all application and supporting materials in a central database, and can submit that package to any college or university. This benefits students by cutting down on repetitive paperwork, and institutions by allowing receipt of a standardized, digital application.

"The harmonized system must encompass the full scope of reporting indicated by statute and regulation and most, if not all, of the reporting currently requested by organizations," the committee wrote. "A thoughtfully constructed system that meets these needs, allows institutions to filter for information relevant to them, and maintains a nimble updating capacity has the best chance to be broadly accepted by individual and organizational users."

The committee painted with a rather broad brush those who would need to report their financial conflicts of interest. Reporting should be required not only of the physician or researcher, but also of close family members who receive any remuneration that could be construed as a conflict.

Not only would such a system simplify and clarify the disclosure process, it also would fulfill at least some of the requirements of the Physician Payment Sunshine Act, a part of the Affordable Care Act. The Sunshine Act requires manufacturers whose products are covered by federal health care programs including Medicare and Medicaid to report gifts and payments made to teaching hospitals, physicians, and their immediate family members.

That law likely portends a great increase in the complexity of financial disclosure, wrote Dr. Lichter, lead author of the IOM discussion paper.

Before such a system can be designed, however, some groundwork is necessary. Different bodies have different definitions of the same financial reporting requirement. The National Institutes of Health defines it as salary, payment, stocks and options, and ownership. The International Committee of Medical Journal Editors defines it as resources received directly or indirectly that supported work on any given manuscript.

The IOM committees suggested that data be reported separately for each financial relationship, including the beginning and ending dates of the relationship, the name of a drug or device, and the value of each relationship.

Administering the database is an entirely different – and just as complicated – matter, according to the committee. Those who are obliged to report conflicts need to feel confident that their data can’t be compromised, so each person should have full ownership and control of their information.

A centralized system is one option. In this scenario, all data are stored and managed in a single repository from which users could enter and request information. While this would require a large up-front investment, it offers several advantages, the committee said.

• It would be easy to manage and operate.

• It could be easily changed as reporting requirements change.

• When linked to organizational systems, data transfer would be quick and easy.

A second option is a federated system which would link many now-separate databases that would then be available through one portal. Since this approach is based on existing systems, the initial investment would probably be less. However, it would require reconfiguring almost every one of those databases in order to link them.

In either scenario, data should be accessible not only via computer but also via mobile devices.

As with any large project, a harmonized reporting system will create its own personnel requirements, the committee wrote. These could be served by an existing entity, or by something entirely new.

"Creation of a new entity provides the opportunity for de novo formulation of practices and processes; however, the cost may be high. Developing the activity under the roof of an existing organization allows for building on existing infrastructure, thereby decreasing costs up-front. Over time, a freestanding operation could be established if indicated," the committee wrote.

The system would also need the guidance of a secretariat composed of stakeholders. That group would ensure that the database continued to serve members to the fullest.

The committee also addressed funding such centralized system. "The revenue stream ... might flow from several sources: grants from interested organizations and/or philanthropies, membership dues, subscription fees, licensing, or a hybrid of multiple sources."

Subscription fees would likely be tiered, depending on the required level of service. Committee members envisioned this as being similar to the different subscription levels for online income tax programs, with the lowest fee corresponding for the simplest returns.

The current system of repeated and disparate disclosure submissions is destined to become an unwieldy dinosaur, Dr. Lichter wrote in his editorial.

"It would be difficult to imagine a more cumbersome and confusing system, one in which even the most diligent investigator runs the risk of producing an inaccurate report," wrote Dr. Lichter, who is also chief executive officer of the American Society of Clinical Oncology.

Committee meetings will continue, and independent contractors are working on the specific details, according to Dr. Lichter.

"Outside consultants have been engaged to create a full business plan, including the system’s technical specifications, software needs, hosting opportunities, data governance, cost, and opportunities for a revenue stream that would allow the system to self-sustain."

The Institute of Medicine supported the work. Dr. Lichter had no financial disclosures.

A single, harmonized database for disclosing conflicts of interest could save academic centers, researchers, and the entities that fund their work a myriad of headaches.

Rather than completing disparate disclosure forms for every research application or journal submission, users would enter their baseline information into a central system and update it as needed. Every time the information is required, those who request permission could pull a digital copy and format it according to their needs.

A new system could be launched as early as late 2013 or early 2014, said Dr. Allen Lichter, a member of the committee charged with its framing.

"The time has come for such a harmonized, centralized disclosure system to be created for the benefit of everyone who must produce or receive disclosure information," Dr. Lichter wrote in a viewpoint published Nov. 28 in JAMA (2012;308:2093-94). "Such a system can be designed and implemented as one element in a process to help ensure that research can progress in a trusted, transparent fashion, thereby increasing trust among the public and health care professionals in new medical products that are brought to the benefit of patients."

The centralized system was published in a discussion paper from the Institute of Medicine (IOM), which last year convened a stakeholders’ meeting to explore the possibility.

According to the committee’s paper, a centralized system would be similar to the common application for undergraduate college admission, in which students enter all application and supporting materials in a central database, and can submit that package to any college or university. This benefits students by cutting down on repetitive paperwork, and institutions by allowing receipt of a standardized, digital application.

"The harmonized system must encompass the full scope of reporting indicated by statute and regulation and most, if not all, of the reporting currently requested by organizations," the committee wrote. "A thoughtfully constructed system that meets these needs, allows institutions to filter for information relevant to them, and maintains a nimble updating capacity has the best chance to be broadly accepted by individual and organizational users."

The committee painted with a rather broad brush those who would need to report their financial conflicts of interest. Reporting should be required not only of the physician or researcher, but also of close family members who receive any remuneration that could be construed as a conflict.

Not only would such a system simplify and clarify the disclosure process, it also would fulfill at least some of the requirements of the Physician Payment Sunshine Act, a part of the Affordable Care Act. The Sunshine Act requires manufacturers whose products are covered by federal health care programs including Medicare and Medicaid to report gifts and payments made to teaching hospitals, physicians, and their immediate family members.

That law likely portends a great increase in the complexity of financial disclosure, wrote Dr. Lichter, lead author of the IOM discussion paper.

Before such a system can be designed, however, some groundwork is necessary. Different bodies have different definitions of the same financial reporting requirement. The National Institutes of Health defines it as salary, payment, stocks and options, and ownership. The International Committee of Medical Journal Editors defines it as resources received directly or indirectly that supported work on any given manuscript.

The IOM committees suggested that data be reported separately for each financial relationship, including the beginning and ending dates of the relationship, the name of a drug or device, and the value of each relationship.

Administering the database is an entirely different – and just as complicated – matter, according to the committee. Those who are obliged to report conflicts need to feel confident that their data can’t be compromised, so each person should have full ownership and control of their information.

A centralized system is one option. In this scenario, all data are stored and managed in a single repository from which users could enter and request information. While this would require a large up-front investment, it offers several advantages, the committee said.

• It would be easy to manage and operate.

• It could be easily changed as reporting requirements change.

• When linked to organizational systems, data transfer would be quick and easy.

A second option is a federated system which would link many now-separate databases that would then be available through one portal. Since this approach is based on existing systems, the initial investment would probably be less. However, it would require reconfiguring almost every one of those databases in order to link them.

In either scenario, data should be accessible not only via computer but also via mobile devices.

As with any large project, a harmonized reporting system will create its own personnel requirements, the committee wrote. These could be served by an existing entity, or by something entirely new.

"Creation of a new entity provides the opportunity for de novo formulation of practices and processes; however, the cost may be high. Developing the activity under the roof of an existing organization allows for building on existing infrastructure, thereby decreasing costs up-front. Over time, a freestanding operation could be established if indicated," the committee wrote.

The system would also need the guidance of a secretariat composed of stakeholders. That group would ensure that the database continued to serve members to the fullest.

The committee also addressed funding such centralized system. "The revenue stream ... might flow from several sources: grants from interested organizations and/or philanthropies, membership dues, subscription fees, licensing, or a hybrid of multiple sources."

Subscription fees would likely be tiered, depending on the required level of service. Committee members envisioned this as being similar to the different subscription levels for online income tax programs, with the lowest fee corresponding for the simplest returns.

The current system of repeated and disparate disclosure submissions is destined to become an unwieldy dinosaur, Dr. Lichter wrote in his editorial.

"It would be difficult to imagine a more cumbersome and confusing system, one in which even the most diligent investigator runs the risk of producing an inaccurate report," wrote Dr. Lichter, who is also chief executive officer of the American Society of Clinical Oncology.

Committee meetings will continue, and independent contractors are working on the specific details, according to Dr. Lichter.

"Outside consultants have been engaged to create a full business plan, including the system’s technical specifications, software needs, hosting opportunities, data governance, cost, and opportunities for a revenue stream that would allow the system to self-sustain."

The Institute of Medicine supported the work. Dr. Lichter had no financial disclosures.

A single, harmonized database for disclosing conflicts of interest could save academic centers, researchers, and the entities that fund their work a myriad of headaches.

Rather than completing disparate disclosure forms for every research application or journal submission, users would enter their baseline information into a central system and update it as needed. Every time the information is required, those who request permission could pull a digital copy and format it according to their needs.

A new system could be launched as early as late 2013 or early 2014, said Dr. Allen Lichter, a member of the committee charged with its framing.

"The time has come for such a harmonized, centralized disclosure system to be created for the benefit of everyone who must produce or receive disclosure information," Dr. Lichter wrote in a viewpoint published Nov. 28 in JAMA (2012;308:2093-94). "Such a system can be designed and implemented as one element in a process to help ensure that research can progress in a trusted, transparent fashion, thereby increasing trust among the public and health care professionals in new medical products that are brought to the benefit of patients."

The centralized system was published in a discussion paper from the Institute of Medicine (IOM), which last year convened a stakeholders’ meeting to explore the possibility.

According to the committee’s paper, a centralized system would be similar to the common application for undergraduate college admission, in which students enter all application and supporting materials in a central database, and can submit that package to any college or university. This benefits students by cutting down on repetitive paperwork, and institutions by allowing receipt of a standardized, digital application.

"The harmonized system must encompass the full scope of reporting indicated by statute and regulation and most, if not all, of the reporting currently requested by organizations," the committee wrote. "A thoughtfully constructed system that meets these needs, allows institutions to filter for information relevant to them, and maintains a nimble updating capacity has the best chance to be broadly accepted by individual and organizational users."

The committee painted with a rather broad brush those who would need to report their financial conflicts of interest. Reporting should be required not only of the physician or researcher, but also of close family members who receive any remuneration that could be construed as a conflict.

Not only would such a system simplify and clarify the disclosure process, it also would fulfill at least some of the requirements of the Physician Payment Sunshine Act, a part of the Affordable Care Act. The Sunshine Act requires manufacturers whose products are covered by federal health care programs including Medicare and Medicaid to report gifts and payments made to teaching hospitals, physicians, and their immediate family members.

That law likely portends a great increase in the complexity of financial disclosure, wrote Dr. Lichter, lead author of the IOM discussion paper.

Before such a system can be designed, however, some groundwork is necessary. Different bodies have different definitions of the same financial reporting requirement. The National Institutes of Health defines it as salary, payment, stocks and options, and ownership. The International Committee of Medical Journal Editors defines it as resources received directly or indirectly that supported work on any given manuscript.

The IOM committees suggested that data be reported separately for each financial relationship, including the beginning and ending dates of the relationship, the name of a drug or device, and the value of each relationship.

Administering the database is an entirely different – and just as complicated – matter, according to the committee. Those who are obliged to report conflicts need to feel confident that their data can’t be compromised, so each person should have full ownership and control of their information.

A centralized system is one option. In this scenario, all data are stored and managed in a single repository from which users could enter and request information. While this would require a large up-front investment, it offers several advantages, the committee said.

• It would be easy to manage and operate.

• It could be easily changed as reporting requirements change.

• When linked to organizational systems, data transfer would be quick and easy.

A second option is a federated system which would link many now-separate databases that would then be available through one portal. Since this approach is based on existing systems, the initial investment would probably be less. However, it would require reconfiguring almost every one of those databases in order to link them.

In either scenario, data should be accessible not only via computer but also via mobile devices.

As with any large project, a harmonized reporting system will create its own personnel requirements, the committee wrote. These could be served by an existing entity, or by something entirely new.

"Creation of a new entity provides the opportunity for de novo formulation of practices and processes; however, the cost may be high. Developing the activity under the roof of an existing organization allows for building on existing infrastructure, thereby decreasing costs up-front. Over time, a freestanding operation could be established if indicated," the committee wrote.

The system would also need the guidance of a secretariat composed of stakeholders. That group would ensure that the database continued to serve members to the fullest.

The committee also addressed funding such centralized system. "The revenue stream ... might flow from several sources: grants from interested organizations and/or philanthropies, membership dues, subscription fees, licensing, or a hybrid of multiple sources."

Subscription fees would likely be tiered, depending on the required level of service. Committee members envisioned this as being similar to the different subscription levels for online income tax programs, with the lowest fee corresponding for the simplest returns.

The current system of repeated and disparate disclosure submissions is destined to become an unwieldy dinosaur, Dr. Lichter wrote in his editorial.

"It would be difficult to imagine a more cumbersome and confusing system, one in which even the most diligent investigator runs the risk of producing an inaccurate report," wrote Dr. Lichter, who is also chief executive officer of the American Society of Clinical Oncology.

Committee meetings will continue, and independent contractors are working on the specific details, according to Dr. Lichter.

"Outside consultants have been engaged to create a full business plan, including the system’s technical specifications, software needs, hosting opportunities, data governance, cost, and opportunities for a revenue stream that would allow the system to self-sustain."

The Institute of Medicine supported the work. Dr. Lichter had no financial disclosures.