gms | German Medical Science

Background: Clinical guidelines are used in health landscapes with legal frameworks. Some guideline topics have specific legal requirements. In such cases, there is potential for conflicts between evidence and law; direct (e.g., where evidence suggests recommendations in direct contradiction to law) or indirect (e.g. where evidence and/or legal requirements are uncertain or are open to interpretation). Depending on conflict type and potential impact, different solutions/approaches may be used.

Objectives: To describe processes of legal implications during guideline development, problems encountered and possible solutions.

Methods: We were commissioned to develop national guidelines on improving donor identification and donation consent rates. Significant legal aspects and challenges needed consideration from the outset.

Results: Recommendations cover early potential donor identification of, optimising consent, maintaining health of potentially suitable organs whilst the patient is still alive, prior to seeking consent. Different legal interpretations around handling of body parts arose between the responsible transplantation authority and advising lawyers.. Prior to publication, medical-legal opinion was sought and recommendations amended. However, lawyers and clinicians on the guideline development group (GDG) still did not agree. The GDG met with lawyers and agreed recommendations which accurately represented the law and were clinically precise. Further advice was sought from an academic lawyer.

Discussion: Conflicts between evidence and law are complex and have significant implications for development processes and outcome.

Implications for guideline developers/users: Potential conflicts between evidence and law should be identified early. Approaches to resolution should be planned, involving experts in evidence and guideline processes, and legal experts.