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Assessing conflicts of interest when selecting scientific advisers

Scientific experience alone does not establish that an adviser can assess a particular trial decision independently.

Representative research photograph: Assessing conflicts of interest when selecting scientific advisers
Photo: Horadrim · License: CC BY-SA 4.0 · Cropped and resized.
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Scientific experience alone does not establish that an adviser can assess a particular trial decision independently. Financial relationships, prior product work or commercial roles may affect interpretation of their advice. Sponsors should assess conflicts in the context of the assigned task rather than merely collecting a disclosure form.

Decision framework

Define the decision or output the adviser will influence first. Appropriate governance owners should examine how disclosed relationships connect to that work. Possible responses include safeguards, recusal or another expert. Absence of relationships does not automatically demonstrate superior expertise, just as disclosure alone does not remove the potential conflict.

Worked example

For example, an expert is asked to evaluate a bid from a provider they previously advised. The sponsor records the relationship and reviews the assessment arrangement. The expert might help explain technical requirements while others perform commercial comparison. The response is justified by the role and potential influence rather than an invented universal prohibition.

Implementation checks

  • Assess how each disclosed relationship could affect a particular decision, using the actual assigned task as the context.
  • Identify who will implement any safeguard and where the assessment and its rationale will be recorded.
  • Provide an update route that triggers reassessment when the adviser's responsibilities or relevant relationships change.

Acceptance and boundaries

Accept the arrangement when expert contributions and managed limitations can both be explained. Do not distribute personal relationship details to unnecessarily broad groups; balance assessment visibility with confidentiality. Independent committee roles and local obligations require separate consideration through their appropriate authorised processes where applicable.

Frequently asked questions

Is obtaining a disclosure form sufficient?
No. Assess relevance to the task and the practical measures used to manage the concern.
Does every financial relationship require the same response?
No. Consider its nature, the role and possible influence on the decision together.

Sources

  1. EMA — ICH E6 good clinical practice
  2. WHO — Guidance for best practices for clinical trials