Conflicts of interest
What must be declared, by whom, at what threshold, and what a declaration does and does not entail.
§1Who declares
Every person contributing to an Institute document declares, and every declaration is published in full. That includes trustees, committee members, secretariat staff, external reviewers, specialist advisers and every respondent to a public comment period.
A declaration of no interest is itself a declaration and is recorded as one. A blank field is not a declaration and is not accepted.
§2What is declarable
- Employment, consultancy or advisory relationship with a manufacturer, marketing-authorisation holder, supplier or laboratory named in or bearing on the document.
- Research funding, whether restricted or unrestricted, received personally or by the respondent's department.
- Honoraria, travel support and speaking fees.
- Direct shareholdings above the materiality threshold, and any direct holding in a named company regardless of size.
- Patents and patent applications bearing on the subject matter.
- Trusteeship or office in an organisation receiving funding from an interested party.
- Non-financial interests, including having published a review reaching a different conclusion from the draft, and having used a compound in the class under assessment.
§3Lived experience
Personal use of a compound in the class under assessment is declarable. The requirement was contested during the founding consultation on the ground that it would deter exactly the respondents least represented in the trial literature. The requirement was retained — a declaration not required of everyone is not a declaration system — and the policy was amended to state in terms, on the submission form and on every published submission, that a lived-experience declaration is an interest and not a disqualification.
§4Industry submissions
A submission made by an employee of a marketing-authorisation holder, or on behalf of one, is identified as an industry submission on the face of the published submission. That was adopted unanimously at consultation. Industry submissions are answered on the same terms as any other and are frequently accepted where they correct a fact; the Institute records that corrections of fact from a manufacturer are among the most reliable it receives, because the manufacturer holds the underlying record.
§5Recusal
A committee member with a declared interest in a compound, manufacturer or supplier under assessment recuses from the ratification of documents concerning it. Recusals are recorded and the affected document records that one occurred.