The information provided below is considered as WVU guidance and does not constitute NIH policy.
Guidance
This guidance is provided to assist researchers with the disclosure of relationships (financial and other) with commercial entities to manage potential or perceived conflicts of interest relating to the research project.
Purpose
The purpose of this guidance is to manage potential bias or the appearance of bias related to commercial entities (such as pharmaceutical, biotechnology, and medical device manufacturers) whose products or services may be used, tested and/or affected by or whose products or services might be affected by the results of the research project.
Participant Obligations
It is the obligation of all participants to understand and comply with the policies of their individual institution and its Institutional Review Board (IRB).
- All Study research personnel should be in full compliance with all relevant DHHS, NIH, FDA and IRB DOI policies as well as all individual institutional DOI policies.
- Under the DHHS “final rule” (PDF) (see Subpart F) a duality for the purposes of The Study consists of any qualifying (see below) financial affiliation or equity holding in a private entity where that entity could reasonably be interpreted to be affected by the results of The Study.
- Any such duality that is reported to the individual’s Institution must also be reported to The Study.
- The participant’s individual Institution then determines whether a declared duality requires management and the steps to be taken to mitigate the appearance of a duality. The management plan should also be reported to The Study that in turn may take additional steps to manage the duality.
- Regardless of the individual’s Institutional requirements, each participant must also disclose any DOI that satisfies the criteria for a significant financial interest as specified by The Study.
Who Should Complete a DOI Disclosure Form?
All individuals who are participating in the conduct of The Study in any capacity (e.g., Principal Investigators, Co-Investigators, Study Coordinators, study staff, consultants, etc.) should complete a DOI Disclosure Form.
Study Duration
This guidance applies for the duration of The Study activity, the preceding 12 months prior to completing the Disclosure Form, and until all major primary outcome publications are completed.
Disclosures
All activities that would qualify as a duality according to the individual’s Institution requirements should be reported to the Institution and also to The Study. In addition, regardless of the Institution’s requirements, all relationships with commercial entities whose products/services are being used/tested or are in direct competition with those being used/tested should be disclosed to The Study.
- Ownership of stock, equity, or other financial interest in a company/entity which has products that might be used in or benefit from or be harmed by the results of The Study.
- Employment, office or directorship in any company/entity involved or potentially involved with The Study.
- Personal compensation from any company/entity involved or potentially involved with The Study.
Consulting/advisory arrangements with any company/entity involved or potentially involved with The Study, including service on:
- Data and Safety Monitoring Boards
- External Evaluation Committees
- Advisory Board
Involvement with grants, contracts, research, training or other support (restricted or unrestricted) from any company/entity involved or potentially involved with The Study.
- Travel grants to attend educational symposia provided by any company/entity involved or potentially involved with The Study. This includes serving in one of the aforementioned consulting/advisory arrangements.
- Intellectual property rights (i.e. copyright, patent, trademark) related to the activities of The Study.
- Relationship with a company/entity that may affect academic advancement or status, such as sponsorship of an endowed chair or establishment of a fund for use by The Study investigator.
All of the above applies to companies/entities being studied as well as those in direct competition with the companies/entities being studied as defined above.
DOI Disclosure Procedures
DOI Disclosure Forms should be completed when first engaged in The Study and updated on no less than an annual basis. New conflicts should be reported as soon as they are identified by submitting a new DOI form.
Individuals meeting the qualifications for completion of a DOI Disclosure Form should specify their level of interest in combination with the levels of interest of their spouse and children:
- (A) No financial interest or equity.
- (B) Financial interest in any publicly traded entity with a value > $5,000 including the value of equity interest.
- (C) Financial interest > $5,000 in a commercial entity that is NOT publicly
traded OR ANY equity interest in such an entity.
- If an individual and/or the individual’s and/or dependent children own stock in a publicly traded company, and the individual and/or the spouse and/or dependent children have received payments from the company (e.g. as a consultant), and the total value of the income received and equity interest exceeds $5000, then this would be declared as a duality of interest under (B).
- If an individual owns equity in a company that is not publicly traded that is worth $50, regardless of any other financial interest (e.g. income) then this would be declared under (C).
- If an individual secures a $6,000 speaking fee from Pharmaceutical Company Y, whether publicly traded or not, the speaking fee is greater than $5,000 and therefore would be declared as (B or C).
- DOI forms for all participants in The Study should be maintained by The Study Coordinating Center. DOI forms will not be maintained at NIDDK.
Review Procedures
- DOI forms will be reviewed by NIDDK and a committee appointed by the Executive Committee. A review group independent of the Executive Committee will review the executive committee members’ DOI forms.
- DOIs that are relevant should be reported prior to each study meeting of The Study Group.
- Change in DOI status should be reported as soon as identified.
Management Options
In addition to the steps instituted by an individual’s Institution to manage a reported duality, one or more approaches to the management of DOIs may be exercised at the discretion of The Study. This will be decided on an individual basis according to the policies and procedures of The Study.
- Public disclosure of relevant significant financial interests including disclosure to the Steering Committee. In some cases, disclosure alone may be sufficient and no further action is needed. Disclosure should be noted in meeting minutes and may be required in Study publications.
- Disqualification from participation in an activity that would potentially be affected by the DOI (e.g., authorship on a paper or voting on any issue related to a company/entity with which they have a relationship).
- Divestiture of significant financial interests to the extent that the financial relationship falls above the stated threshold for DOI.
- Severance of the relationships/activities that create actual or potential DOI.