| Reviewer | Employment | Research Grant | Other Research Support | Speakers' Bureau/ Honoraria | Expert Witness | Ownership Interest | Consultant/ Advisory Board | Other |
|---|---|---|---|---|---|---|---|---|
| Jason Acworth | University of Queensland, Children's Health Clinical Unit (Australia) | None | None | None | None | None | None | None |
| Jana Djakow | Masaryk University (Czech Republic) | None | None | None | None | None | None | None |
| Jesse Hackell | Committee on Practice & Ambulatory Medicine | None | None | None | None | None | None | None |
| Tomitra Latimer | Lurie Children's Hospital | None | None | None | None | None | None | None |
| Joshua Nagler | Division of Emergency Medicine, Boston Children's Hospital | None | None | None | None | None | None | None |
| Mohsen Saidinejad | Harbor Medical Center UCLA | None | None | None | None | None | None | None |
| Linda Siegel | Cohen Children's Medical Center | None | None | None | None | None | None | None |
| Sarah Tabbutt | University of California San Francisco | None | None | None | None | None | None | None |
This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be “significant” if (a) the person receives $5,000 or more during any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $5,000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
*Modest.
†Significant.
The following definitions describe the categories or types of relationships used for RWI reporting, clarifying expectations for disclosure and general determinations for relevance.
| Reporting Category | Definition |
|---|---|
| Consultant | Relationships for which honoraria are allocated or received from private sector payers, pharmaceutical, device, or other mission-related companies, gifts, or other consideration, or “in kind” compensation, including fees donated to nonprofit organizations, whether for consulting, lecturing, traveling, service on advisory boards, or similar activities in the reporting period (12 months prior to the date of the kick-off meeting). This includes consulting or advisory activities for Federal, state,or local government agenciessuch as Centers for Medicare & Medicaid Services (CMS) or the FDA. Since the Federal government maintains procedures to assure freedom from bias, consulting for its agencies is generally not classified as relevant to AHA/ACC document development. |
| Speaker or Member of Speakers Bureau | Honoraria or fees received directly from industry for lecturing. Compensation received through contracts with industry or other entities for membership on or participation in speakers bureaus (both domestic and international). Honoraria or fees received from an accredited continuing medical education (CME) program organized through certified educational organizations need not be disclosed. Food and beverage payments related to a single instance with a single company for ≤$250.00 is not considered a relevant RWI. Additionally, it will not be considered a relevant RWI if the total payments for food and beverage received from all relevant companies do not exceed $1000.00 during the reporting timeframe (see section 2.1.1). |
| Ownership/ Partnership/ Principal | Stock holdings*, stock options*, ownership, partnership, membership, or other equity positions, regardless of the form of the entity, or options or rights to acquire such positions, rights, and/or royalties in patents or other intellectual property. Ownership of interests in diversified mutual funds is excluded from this designation and need not be reported. |
| Personal Research | Roles as principal investigator (PI), co-PI, or investigator at a local, national or international level, steering committee member or consultant for grants pending, awarded or received (including commercially funded, NIH, or other Federal agency-funded, and university-managed grants and data monitoring committee [DMC; DSMB], clinical event adjudication committee [CEAC; CEC] activities, and other operational activities related to research). This category includes receipt of drugs, supplies, equipment, or other support when the individual has direct decision-making responsibility for allocated resources or proceeds. This type of relationship should be reported by the individual even when funds are budgeted to an institution. For investigators, sub-investigators†, or co-investigators† (as defined below), affirmative responses to any question in the definition indicate responsibility to report. Research activity funded by the NIH or other Federal agency should be reported but is generally not classified as relevant to AHA/ACC document development. |
| Employment or Salary Support | Full or partial employment or grant support of salary, position, or program; may also include pension or benefits received from prior employment. |
| Institutional or Organizational (including but not limited to research) | This category refers to relationships between industry and an institution or organization with which the individual is affiliated when the individual is involved in the relationship. The individual should report RWI when funds provided to an academic institution or organization are designated for the use of the individual, rather than awarded or paid directly to the individual. For example, an individual participating as a co-investigator or subsidiary investigator in a study for which another individual is designated as the grant awardee or funded PI is an example of this type of relationship, which should be disclosed. When industry funds an institution for other purposes (e.g., to support a program or fellowship), the determining consideration is whether the reporting individual has decision-making responsibility over the funds. Examples of RWI that should be reported include (1) serving as an investigator, sub-investigator†, or co-investigator† (as defined below) when the individual engages in or oversees recruitment of subjects to participate in a clinical trial; (2) a Department Chair or Division Chief with fiscal authority or decision-making responsibility over funds received from extramural sources for research, fellowships, educational conferences, institutional supplies, etc.; (3) funds provided by a commercial entity to an institution with which the individual has a professional or personal affiliation (e.g., faculty of a medical school) when the funds provide full or partial salary support of the individual or staff under the direction of the individual. These relationships may be considered relevant to the writing effort (see Section 2.1.5), whereas research or clinical funding obtained from Federal sources (e.g., grant support from NIH or other government agency) is not considered relevant, even when the government has received support from industry for the project. Other relationships that should be reported include leadership or governance responsibilities or roles (e.g., officer, director, trustee or other fiduciary role, editor.) in professional or nonprofit organizations, whether or not remunerated, that may involve interests potentially competitive with the AHA or AHA or cooperative or competitive with entities having business interests in the guideline topic. |
| Expert Witness | Legal proceedings in which the individual served as a consultant, expert or deposed witness, whether compensated or uncompensated, should be disclosed, reporting the year of involvement, alignment with the plaintiff or defendant,and the topic of the case/testimony, whether or not the matter proceeded to trial. Disclosure should be consistent with applicable legal requirements and restrictions, such as HIPAA or confidentiality agreements. |
*Divesting publicly traded stock or stock options nullifies the specific relationship, and in such cases the 12-month rule does not apply.
†Sub-investigators or co-investigators are defined here as individuals who have signed FDA Form 1572 or an Investigator Agreement in roles other than primary or co-author of data analyses, abstracts, or manuscripts, who do not have oversight of the research, report data, or receive compensation from the sponsor (including direct salary support or salary support for staff, shared staff, or overhead charges), and do not receive funds for travel or accommodation to attend investigator meetings hosted by the sponsor.
Sub-investigators or co-investigators should answer 3 questions: (1) Have you signed an FDA Form 1572 or an Investigator Agreement? (2) Do you have oversight of the research or data reporting? (3) Did you receive funds or compensation to attend investigator meetings? If the answer to any of these is affirmative, the relationship should be disclosed under the personal research category; if all answers are negative, the relationship should be disclosed under the institutional category.
Clinical trial enrollers who have signed an FDA Form 1572 but only apply study inclusion or exclusion criteria to enroll clinical patients in studies are not considered to have a relevant relationship with the study sponsor.
Membership on Data Monitoring Committees (DMCs), Data Safety Monitoring Boards (DSMBs), Clinical Event Adjudication Committees (CEACs), or Endpoint Committees (CECs), whether commercially funded or government- or university-managed, are not classified as relevant relationships when the committee is independent of industry influence, as recommended by the FDA. The AHA/ACC recognizes that the main responsibility of the DMC is to assure the safety of trial participants and the scientific integrity of the study in the interest of advancing clinical research. DMC membership should be reported on the member’s comprehensive disclosure. The oversight Joint Committee will review the DMC Charter to assure compliance with FDA regulations regarding independence from influence by a commercial sponsor, in which case the relationship will not be considered relevant to the document under development.
2.1.3. Writing Committee