Conflict of Interest Disclosure for Evidence-based Practice Center (EPC) Projects, Study Guides, Projects, Research of Medicine

Download Conflict of Interest Disclosure for Evidence-based Practice Center (EPC) Projects and more Study Guides, Projects, Research Medicine in PDF only on Docsity! 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. 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. References 1. Institute of Medicine. (2010). Committee on Conflict of Interest in Medical Research, Education, and Practice, edited by Bernard Lo and Marilyn J. Field. 2. “Responsible Prospective Contractors” Title 45 Code of Federal Regulations, Pt. 94 October 1, 2017. Available at: U.S. Government Printing Office. http://www.gpo.gov/fdsys/. Accessed April 2018. 3. “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest” Available at: International Committee of Medical Journal Editors. http://www.icmje.org/ethical_4conflicts.html. Accessed July 2012. 4. Institute of Medicine. (2011). Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academies Press. Available at: Institute of Medicine. http:// www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Finding-What-Works-in- Health-Care-Standards-for-Systematic-Reviews/Standards%20for%20Systematic%20Review% 202010%20Insert.pdf. Accessed July 2012. Appendix A: Disclosure Form for Conflicts of Interest Financial activities related to the EPC Project Type of Relationship No 1. Board Membership 3. Expert Advisor 2. Consultancy 4. Officer 5. Trustee 6. Director 7. 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? Yes No 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 12. Patents (planned, pending or issued) 13. Royalties 14. 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 9. Grants/contracts 11. Payment for manuscript preparation 10. Payment for lectures including service on speakers bureas 8. Expert Testimony Will you have ongoing financial relationships related to this project in the future? Do you anticipate new financial relationships related to this project in the future? Look Ahead 12 Months If yes, describe type of relationship and durationYesNo Amount or Value 16. Travel/ accommodations/ meeting expenses unrelated to activities listed above 17. Other (err on the side of full disclosure) Financial activities related to the EPC Project Type of Relationship No 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 15. Stock/stock options