The following financial disclosure guidelines have been developed by the NIDDK to promote fair, open, and unfettered discussion of important conflict of interest concerns that often emerge during the design and conduct of multicenter clinical trials. The aim is to help multicenter study groups ensure that the scientific design, conduct, and reporting of the study are not biased by financial influences. These guidelines do not supersede Institutional requirements developed to comply with Public Health Service (PHS) regulations on Financial Conflict of Interest reporting (Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought; 42 C.F.R. Part 50, Subpart F). Further information about these PHS regulations, including a set of FAQs, can be found on the NIH Office of Extramural Research (OER) Financial Conflict of Interest page.
Who should disclose?
Principal Investigators of multicenter clinical trials and other active participants in study design and conduct, such as committee members, subcontractors, or other regular attendees at Steering Committee meetings, should fully disclose all commercial or professional ties that might pose a real or perceived conflict of interest. In addition, disclosures should include information from their spouses, domestic partners and/or dependent children.
NIH staff are required to make full financial disclosure to the NIH. Thus, additional full disclosure by NIH staff need not be required. However, NIH scientific staff who serve as voting members of the study group should indicate to the oversight body a 'yes/no' as to whether a potential financial conflict exists and should provide additional information if a conflict exists.
What should be disclosed?
At a minimum, disclosure should reflect remuneration during the previous year and ownership interests held as of the reporting date that may be related to products, services, or interventions considered for use in the trial or that may be significantly affected by the trial. Commercial ties requiring disclosure include, but are not restricted to, any pharmaceutical, behavior modification, medical or surgical device/equipment and/or technology company. Although the study group should determine what to report, examples of categories that might be included are:
- equity holdings (excluding mutual funds or blind trusts),
- research contracts or grants from a commercial entity,
- intellectual property rights (patents, royalties, etc.),
- fees for speeches, lectures, and/or presentations, if received directly from industry or a company acting on behalf of an industrial sponsor,
- consulting fees,
- other honoraria (either direct or donated),
- travel or meeting expenses (if received directly from industry or a company acting on behalf of an industrial sponsor),
- other forms of compensation (salaries, pension plans, equipment, property), if received directly from industry or company acting on behalf of an industrial sponsor
- arrangements for future employment
- memberships on Boards of Directors or Advisory Committees
In addition, provision should be made for disclosure of any non-commercial potential conflicts that may have financial implications (for example, professional collaborations that may impact on academic promotion).
Each study should have a form which captures the disclosures in each category. Studies may wish to include a “de minimus” standard to exclude interests that are considered negligible. Current federal regulations (42 C.F.R. Part 50, Subpart F) require reporting of financial interests exceeding $5,000. A sample form (DOCX, 31 KB) is provided as a reference.
How should disclosure be overseen?
Each study should specify a process for oversight of conflict disclosures. This includes indicating who will make final decisions (typically the Steering Committee) and specifying an oversight body, such as the study Executive Committee or specifically designated Ethics Committee, to review the reports and make recommendations. At a minimum, annual documentation should be required for all principal investigators and any other individuals who are active participants in study design functions or central decision-making activities. Annual disclosures should be reviewed by the appropriate study oversight group. Those required to disclose interests by the study group should affirm their intent to abide by the study financial disclosure policy for the upcoming year by filling out a disclosure form and transmitting it to the coordinating center.
Disclosures should be reported by the oversight group to the entire study group in some appropriate summary manner, for instance, as a 'yes/no' for each disclosure category and investigator.
Verbal disclosure also should occur during the course of committee meetings as study issues relating to specific commercial products or other conflicts are discussed and voted upon. Committee chairs should regularly ask members if real or potential conflicts exist and remind them of the need to disclose such conflicts to the committee. Committee chairs should be informed of any relevant action (e.g., to require that an individual be recused from voting) taken by the oversight committee on any committee member's real or apparent conflict of interest.
The degree and manner of disclosure chosen by the study should reflect a balance of the need to respect confidentiality of investigators' financial information and the potential for full disclosure to reduce real or perceived conflicts of interest. This balance may vary between studies.
What Actions Should be Taken if Conflicts are Identified?
The appropriate committee should be charged with making recommendations to limit the potential impact of real or apparent conflicts. Recommendations could include recusal from certain decisions, suspension of voting rights on issues affected by the potential conflict, external monitoring by independent reviewers (protocol review committee, DSMB, or other body), removal from committee chairmanships, divestiture of specific assets, or severance of relationships that generate a serious conflict potential. In cases of failure to fully and truthfully comply with study policies, study investigators may be removed from participation in any central study activities.
A process for collecting, archiving and disposing of completed conflict of interest forms should be specified. For instance, forms might be collected through the publication date of the primary study results manuscript, stored in a secure manner by the Coordinating Center, and destroyed after the close of the study on a date determined by the Steering Committee. Materials should be considered confidential and not to be released to any individual or group outside the study.
To assist investigators, an example clinical trial conflict of interest policy template (DOCX, 23 KB) is provided. The template can be customized and used as needed by each individual study group. There is no requirement to use this document and investigators are free to develop and use their own materials.
Morin, K., Rakatansky, H.R., et al. Managing Conflicts of Interest in the Conduct of Clinical Trials. JAMA 2002; 78-84.
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