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AHRQ Evidence-based Practice Center Policy on Financial and Nonfinancial
Interests
Background and Purpose of Policy To maintain public confidence in the scientific integrity and credibility of work produced by the EPC Program, it is essential that all aspects of the process and methodological approach on which the Evidence- based Practice Centers evidence reports rests are clear and respected. To ensure the credibility of evidence reviews and additional reports put forth on behalf of the EPC, objectivity must be maintained and the risk of bias reduced in the framing of questions and application of methods. Bias threatens the validity of clear and cogent findings and jeopardizes the public's trust in science and reporting.
While it is impossible to eliminate the potential for bias completely, policies and procedures can reduce the risk for bias and improve credibility and trust in the final product. Since its inception, the EPC Program has had an established policy for reducing the risk of bias from financial and non-financial interests. The Institute of Medicine defines conflict of interest (COI) as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”^1. While COI is not an exact proxy for potential for bias, it is a concrete measure that can be identified or declared. While both financial and non-financial interests may influence the judgment of an individual synthesizing the evidence on a particular subject matter, use of financial COI as a proxy and measure of bias is a more established and accepted practice than collection of non-financial COI.
This document updates the previous policy and is intended for EPC reference and use. All individuals participating in a review (including the EPC Core Team, EPC Key Informants, EPC Technical Expert Panel members, EPC Invited Peer Reviewers, and Partners) should complete the Disclosure Form for COI in Appendix A.
The previous disclosure form, in use since the inception of the program, required individuals to self-report and perceived COI as mandated by federal regulations described in Title 45 Code of Federal Regulations (CFR), Part 94. However, open response resulted in high variability with both over- and under-reporting at times. In 2009, the International Committee of Medical Journal Editors (ICMJE) developed a COI reporting form for authors submitting manuscripts. The ICMJE form provided specific examples for which individuals needed to report any relevant financial interests, rather than leaving it open-ended for individual interpretation. Appendix A adapts this form for prospective use in conducting EPC projects, rather than for retrospective COI evaluation in a manuscript submission.
Both the previous form and the ICMJE form request disclosure of other non-financial COI, but provide little specific guidance and generally leave it up to individual judgment. Likewise, the Institute of Medicine (IOM) Standards of Systematic Reviews (2011) further emphasized the importance of non financial COI, but also provided little guidance on how to identify non-financial COE that pose the greatest risk of bias.
The EPC Program assembled a workgroup in 2012 to develop an approach to identifying and managing non-financial COI. Although still in progress at the time of this update, the Disclosure Form (Appendix A) incorporates and adapts the work group's specific questions to help individuals identify non-financial COI. It is important to note continued debate over whether non-financial COI, such as professional interests, relationships, and activities, automatically increase the risk of bias and whether the benefits of increased expertise or increased partnership by an organization that the individual represents may offset some of these risks.
Definitions of Varying Roles : Different roles of individuals participating in the EPC report may necessitate different management of COI based on level of responsibility in making judgments and conclusions in the project. However, all must disclose COI related to the subject matter, including (as relevant): a) EPC Core Team (including the EPC Director and Lead Investigator) b) EPC Key Informants c) EPC Technical Expert Panel d) EPC Invited Peer Reviewers e) Partner for EPC report
EPC Core Team: The EPC core team includes anyone who participates meaningfully in any of the key steps of the systematic review process such as: a) Design and execution of the literature search strategy b) Decisions on the final inclusion and exclusion criteria c) Decisions on which studies shall be included or excluded from the evidence report or other product (screening of abstracts and full-text studies) d) Abstraction of information from eligible studies e) Analyses of the evidence f) Grading or rating the quality of studies and body of evidence f) Writing or editing any portion of the evidence report or other product g) Administrative or logistical tasks
Decisions about who comprises the Core Team for COI purposes should be made based on the participation in one or more tasks as listed above. It is recognized that Core Team members may include different sorts of individuals for different projects or different EPCs including faculty, staff, students, fellows, librarians, and editors. This would also include any subcontractors participating in the conduct of the EPC project.
EPC Director: The EPC Director is Principal Investigator for EPC-related work and is responsible for identifying and assembling the EPC Core Team. In many cases, the EPC Director may designate one person as the Lead Investigator and delegate some responsibilities as described below or may assume these responsibilities him/ herself. The EPC Director maintains responsibility for collecting and assessing COI disclosures for the EPC Core Team members. Although the logistics of gathering COI disclosure forms may be delegated to a project manager, the EPC Director is responsible for evaluating any disclosed COI and developing a management plan.
EPC Lead Investigator: If the EPC Director chooses, he or she may assign a separate Lead Investigator for a particular project. Either the EPC Director or the designated Lead Investigator leads the Core Team and is the primary person responsible for the overall design, conduct, or reporting of the systematic review. This person is responsible for collecting and assessing COI disclosures for Key Informants or Technical Expert Panel members. Although the logistics of gathering the COI disclosure forms may be delegated to a project manager, the Lead Investigator is responsible for evaluating any disclosed COI and developing a management plan. This role may be filled by or shared with the EPC Director.
the EPC project. When listing competing interests, individuals should err on the side of being liberal in the disclosure.
According to Title 45 CFR Part 94, financial interests include anything of monetary value that when aggregated exceeds the minimum threshold value as described above or represents more than a five percent (5%) ownership interest in any single entity.
What financial interests not to disclose: Financial interests that do not need to be disclosed include:
· Ownership interests in an institution if the institution is an applicant under the Small Business Innovation Research (SBIR) program; · Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; · Income from service on advisory committees or review panels for public or nonprofit entities; · Equity interest that represents less than a five percent ownership interest in any single entity, and when aggregated with all other financial interests does not exceed $5,000 (or $1,000 for EPC Core Team members) in value.
Disclosing Non-financial Interests The Disclosure Form and instructions in Appendix A identifies nine specific questions related to non- financial interests that individuals must answer. The questions are geared to identify entrenched opinions that may not be open to alternative conclusions given adequate evidence to the contrary and interests or institutional relationships that are not direct financial COI but may influence or bias the individual.
Management of COI : Management of Financial COI The EPC Core Team is ultimately responsible for making final judgments, decisions, and assessments and writing the report, and thus must pass a higher standard. EPC Core Team members must not have related financial COI which cumulatively total greater than $1,000. Depending on the nature of the financial COI, in some cases these conflicts may be managed by divestment (e.g., selling stock holdings).
In general, Key Informants, TEP members, Invited Peer Reviewers, and Partners should not have financial COI related to the EPC project cumulatively totaling more than $5,000. However there may be extenuating circumstances in which a field has a limited number of experts. In these special circumstances, the EPC and the AHRQ official will ensure that the panel is balanced with individuals of differing opinions to ensure that not only one perspective is unfairly weighted. They may consider not only the nature of the COI but also the timing (whether present in the past 12 months or anticipated in the next 12 months). Other input from individuals with COI may be obtained through specified public comment periods.
Management of Non-financial COI The Disclosure form asks specific questions in an attempt to identify entrenched opinions or other influences that are not directly related to financial COI. However, because current understanding is limited about how to use proxy questions to identify individuals at highest risk of bias without inappropriately excluding individuals with particularly relevant expertise, many situations of identified non-financial COI will need to be handled on a case-by-case basis until the field is further developed.
In general, the EPC and AHRQ need to consider whether the systematic review topic is the subject of advocacy or policy change, has inter-specialty variations, or is an area with a limited pool of experts. The existence of advocacy, policy change, or inter-specialty variations may affect the likelihood that institutional relationships or professional affiliations would increase the risk of bias and thus may be considered a higher risk for non-financial COI.
Individuals with COI may be either restricted from participating in the review altogether or limited in their participation to certain aspects of the review. For example, individuals with a specific COI (e.g., authorship of a particular study) should not be involved in judgment or decision-making regarding any question that includes that particular study. Alternatively, individuals with a particularly entrenched opinion based on previously published opinion pieces may better serve as TEP members rather than on the EPC Core Team. For institutional conflicts, the EPC and AHRQ may choose to institute and implement a clear COI management policy and procedures. In fields with a limited pool of experts, the EPC and AHRQ may elect to balance COI across all involved individuals (as in the cases of professional interests or advocacy).
Responsibilities : Responsibilities of the EPC Prior to starting the project, the EPC Director and/or designated project manager will obtain a completed Disclosure Form from each potential member of the Core Team. The EPC Director will submit these forms to AHRQ along with justification of any issues presented therein prior to starting a project.
The Lead Investigator (or appropriate designee) will collect and review completed Disclosure Forms from Key Informants and TEP members. The Lead Investigator should provide justification to AHRQ for participation for inclusion of individuals with COI. Note that Key Informants and TEP members must be approved by AHRQ via an email confirmation before any individual can participate.
The EPC should update Disclosure Forms for any individual whose involvement in the projects extends beyond 12 months. The EPC should maintain the Disclosure Forms for 6 years past delivery of the final report.
Responsibilities of AHRQ: AHRQ will review the Disclosure Forms for EPC Core Team members, Key Informants, TEP members, Invited Peer Reviewers, and Partners. AHRQ will consider whether any COI can be avoided without a damaging loss of expert review prior to disqualifying any proposed Key Informant, TEP member, and Invited Peer Reviewer from participating in the review. Any concerns about potential COI by AHRQ will be discussed with the EPC Director (for EPC Core Team members), or the Lead Investigator (for Key Informants or TEP members).
To ensure the transparency and credibility of the EPC program, AHRQ reserves the right to require that an individual with a COI not participate in the collection or analysis of date or in the writing or review of report findings or associated translation products. The affected EPC will be given an opportunity to substitute another investigator in a revised proposal.
Appendix A: Disclosure Form for Conflicts of Interest
Disclosure Form for Conflicts of Interest
Section 1. Identifying Information
- Project Title:
- Your proposed role in the EPC Project.
EPC Core Team - if checked, summarize your role in the EPC Core Team: Conceptualizing the protocol of the evidence report or other project
Abstraction of information from eligible studies
Decisions on which studies shall be included or excluded from the EPC project (screening of abstracts and full-text studies)
Design and execution of the literature search strategy
Administrative or logistical tasks
Grading or rating the quality of studies and body of evidence Writing or editing any portion of the evidence report or other product Key Informant Technical Expert Panel (TEP) member Invited Peer Reviewer
Decisions on the final inclusion and exclusion criteria
Analysis of the evidence
Partner of EPC Report
Financial activities related to the EPC Project
Type of Relationship No
- Board Membership
- Expert Advisor
- Consultancy
- Officer
- Trustee
- Director
- Employment/ Business
Income or Assets for You
Income or Assets for your Institution on Your Behalf
Your Spouse/ Children's Income or Assets
Name of Equity and description of activity (please add separate sheet if necessary)
Amount or Value
Is the cumulative amount for Financial Activities, including the “Look ahead 12 months”, greater than $1000 for EPC team members, or greater than $5,000 for Partners, Key Informants, Technical Experts, or Invited Peer Reviewers? No Yes
If "no" you are not required to disclose these sources in the section "Financial Activities related to the EPC Project." Please proceed to "Non-Financial Activities related to the EPC Project."
Financial activities related to the EPC Project
Type of Relationship No
Patents (planned, pending or issued)
Royalties
Payment for development of educational presentations
Income or Assets for You
Income or Assets for your Institution on Your Behalf
Your Spouse/ Children's Income or Assets
Name of Equity and description of activity (if faxing or scanning the form please add separate sheet if necessary)
Amount or Value
- Grants/contracts
- Payment for manuscript preparation
- Payment for lectures including service on speakers bureas
- Expert Testimony
Section 3. Non-financial activities related to the EPC Project Please answer questions to the best of your ability. The questions ask about personal beliefs, previously published opinions, institutional relationships, advocacy or policy positions, or clinical specialty practice that may relate to the topic of the EPC project. If the answer is yes for any question, please include details or references that may be helpful in evaluating the potential influence of each relationship or personal belief. A “yes” answer will not necessarily disqualify you from participating in the project.
Non-Financial activities related to the Project Type of Relationship No Yes If yes, explain
- Do you have strongly held beliefs related to the topic area that would make it difficult for you to work on this EPC Project in an unbiased manner?
- To the best of your knowledge, could your institution benefit or be harmed based on whether this review finds benefit, harm, or no difference in outcomes?
- Have you ever authored, coauthored, or publicly provided an opinion related to the topic area of this EPC Project?
- Would the support you would receive from your primary mentor, institution, or other entities change if your work generated a strong reaction from peers outside your institution?
- To the best of your knowledge, do you work for, or are you a member of an organization with a stated position (e.g., position statement, blog, editorial, legislature or legal testimony, or related document) related to the topic area of this EPC project?
- Are you involved in formulating/voting for positions in any organization with a stated position related to the topic area of this EPC Project?
- Could findings of this EPC Project conflict with policies you have promoted or are obliged to follow?
- Do you have a primary clinical specialty or subspecialty?
- Do you prescribe or otherwise recommend the test or treatment to be examined in this review?
- Have you authored or coauthored a publication related to the topic area of this EPC project?
Section 4. Certification
- I certify that the information above is true and complete.
- I agree to update and resubmit this form within 7 days of entering into any new financial relationships related to this EPC project. I acknowledge this may affect my role in the project.
Signature
Print Name
Date
September 2018
