Health and Science Policy Committee

Conflict of Interest Policy and Frequently Asked Questions

Introduction
In the United States, considerable attention focuses on potential conflicts of interest (COI) that may introduce bias into scientific documents. The American College of Chest Physicians (ACCP), through its Health and Science Policy (HSP) Committee, strives to produce high-quality, unbiased evidence-based guidelines. As such, ACCP mandates that HSP routinely review, monitor, and manage any and all real or perceived COIs of all guideline panelists and reviewers. This policy is designed to ensure high-quality, evidence-based, nonbiased guideline recommendations and protect the integrity of the guidelines, the guideline panelists, and the ACCP.

Process
Potential guideline panelists and reviewers must disclose COIs on the HSP’s COI disclosure form, when and as instructed. The HSP Policies and Procedures Subcommittee reviews the disclosures and approves or rejects potential reviewers. With respect to potential panelists, the subcommittee takes one of the following actions: (1) recommends appointment; (2) recommends appointment with specific contingencies; (3) recommends rejection; or (4) tables a decision and requests additional specific information. Next, the decision of the Policies and Procedures Subcommittee is presented to HSP for consideration and a formal vote. Potential guideline panelists and reviewers may appeal the decision of the HSP and request a rereview by submitting additional information and potential justification for a different decision. In such cases, the review process specified here is repeated. An appeal of the second decision may be made to the ACCP Conflicts of Interest Committee, which serves as the final arbiter on the issues.

Once appointed to an HSP guideline panel, panelists must sign a Panel Member Agreement form. This form includes several provisions and requires individuals to agree to maintain the highest level of integrity and avoid all actual, perceived, and potential conflicts of interest, including, solely by way of example, affiliations with pharmaceutical companies, device manufacturers, or other organizations that sponsored or otherwise contributed (financially or otherwise) to a study included in the Guideline. During the entire participation in the guidelines panel, the panelist agrees to notify the ACCP in writing of new or changed circumstances that create actual, perceived, or potential conflicts of interest. The panelist agrees to complete and sign the conflicts of interest disclosure statements, as requested for future reviews, and deliver the signed copies to the ACCP.

Panelists must complete updated COI disclosure forms twice yearly for the HSP subcommittee’s deliberations. All COIs will be supplied to the guideline panel at the time of the planning meeting and final conference, as necessary for conference calls, and published with the guidelines according to policies of the CHEST journal.

While HSP recognizes that commercial enterprises value contributions from individuals who are recognized as content experts, certain activities create COI. HSP recommends that panelists and reviewers avoid activities that are supported by marketing departments of device manufacturers and pharmaceutical companies. Keep in mind, however, that even nonfinancial relationships and activities may create COIs. HSP may terminate an individual’s participation in a guideline project, and/or disqualify an individual from involvement in future ACCP guideline projects.

Documentation of COIs and Process

The HSP staff maintains a database of each guideline panel, including all disclosed COIs and additional information provided by the panelists at the time of their nomination or application and at each COI update. If an individual is approved with contingencies, those contingencies are recorded in the database. The actions of the Policies and Procedures Subcommittee and the HSP Committee also are recorded in the database. Finally, if there are any appeals, the nature of the appeal(s) and the actions taken also are documented in the database.

Conflict of Interest Disclaimer

The American College of Chest Physicians (ACCP) makes every effort to produce nonbiased, independent, evidence-based clinical practice guidelines (CPGs) and requires that all participants in a guideline disclose any and all potential conflicts of interest (COI). The ACCP Health and Science Policy (HSP) Committee reviews COI disclosures and approves (those without any conflicts of interest relevant to the project), disapproves (those whose conflicts are relevant and not manageable), or approves, with specific management, those who have COIs relevant to the topic of the project.

Panelists routinely report COIs on a semi-yearly basis, before each meeting and at the time of publication. Chapters with recommendations are chaired by nonconflicted editors; whenever possible these should be nonconflicted methodologists. Individuals must recuse themselves from final discussions and voting on recommendations about topics where they have a COI. All drafts are reviewed by nonconflicted panelists, the HSP Liaison, the HSP Committee, members of relevant ACCP NetWorks, members of the ACCP Board of Regents, and peer-reviewers selected by the CHEST journal to review and approve the final content. This usually amounts to 30 or more individuals, all of whom must pass the COI vetting process.

The ACCP firewalls separate the process of guideline development from funding. No sponsors are allowed access to the manuscripts, recommendations, meetings, or conference calls. The first version they see is the final publication in print or online. The panel members, including the chair, and members of HSP have no knowledge of the sponsorship. Funders may not recommend panelists or topics and play no role in the guideline development. The HSP Conflict of Interest Policy can be viewed at http://www.chestnet.org/education/hsp/Policies.php.

FAQs

To provide some guidance for potential panelists, we have assembled a series of questions that commonly arise when completing COI disclosure forms. These questions and answers are general in nature and might not cover any individual’s particular circumstances.

Exactly what should I disclose?
We suggest that, if you have any doubt, you should disclose rather than withhold information. If a person is rejected, the COIs are not shared with anyone.

How does the Policies and Procedures Subcommittee handle disclosed conflicts?
The Policies and Procedures Subcommittee asks three questions:

1. Is the disclosure a disqualifying or potentially disqualifying conflict?
2. Are there multiple potential conflicts that, in totality, could result in possible bias?
3. If the answer to #1 or #2 is “yes,” can anything be done to allow the person to participate (ie, eliminate the conflict(s) or manage the conflict(s))?

Do honoraria or fees derived from academic speaking opportunities, lawsuits, or research institutes constitute conflicts of interest? Please provide some guidance.
It is the nature of the relationship that an individual has with a commercial enterprise that is important, rather than a specific financial arrangement. The following are some general guidelines:

• There is no minimum threshold for reporting COI. All fees paid to individuals should be disclosed.


• Giving lectures when sponsored by marketing divisions of commercial enterprises is considered a major conflict of interest that may be disqualifying.


• Giving lectures as a member of a speaker’s bureau for a commercial enterprise is considered a major conflict that may be disqualifying.


• Lectures delivered as part of a sponsored professional society meeting are conflicts of interest that are generally of lesser concern. Any honoraria should be paid by the sponsoring society and not by a commercial enterprise. All lectures must be reported and evaluated, whether or not an honorarium was paid and by whom it was paid.


• Invited lectures delivered at not-for-profit institutions (eg, medical schools, hospitals) are conflicts of interest that generally are of lesser concern. Any honoraria should be paid by the sponsoring institution. If the honoraria payments are made to an individual rather than to an institution, details about the arrangements, topics, etc, are critical for final determination.


• If an individual is directly paid for giving a talk or expert testimony in a lawsuit, the details regarding the topics and funders are relevant to assessing the COI.

Does support for research activities constitute a conflict of interest?
Support for research activities should be disclosed.

What about being paid to sit on steering committees of industry-funded studies?
Sitting on steering committees or advisory committees, or acting as a consultant for industry, is considered on a case-by-case basis. It is most problematic if a person’s conflict relates to marketing or postmarketing surveillance activities for a commercial product.

In the past 36 months, I have given lectures for which I received payment from a commercial enterprise. Will this disqualify me?
Such activities may disqualify you depending on the facts surrounding the lectures and the payments. However, it is possible that you may be approved if you refrain from similar activities during your participation with the guidelines.

How are “manageable” conflicts managed?
If a person’s COIs are deemed to be manageable, he/she will be assigned, when possible, to chapters or topics that do not implicate or in any way relate to those COIs. Alternatively, select individuals, often the chapter editor and/or HSP liaison, will be assigned to oversee the work of that individual to look for any imbalances that may appear in the manuscripts. The methodologists and others also will oversee the work of all authors. During the review process, all chapters are reviewed for any possible biases.

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