Return of results: towards a lexicon?

Area of Science:

• Biobanking and Biomedical Research Ethics
• Genomic Data Management
• Research Governance

Background:

• The return of research results from biobanks is ethically and legally complex for both population and clinical studies.
• Existing uncertainty surrounds the definition and practical application of
• return of results
• in biobanking.
• Population biobanks are frequently not distinguished from disease-specific biobanks, complicating policy development.

Purpose of the Study:

• To demystify the terminology associated with the return of results in biobanking.
• To analyze international and national normative guidance on returning results.
• To propose a unified meaning and a simplified lexicon for key terms.

Main Methods:

• Lexical analysis of key terms: results, return, clinical significance, and utility.
• Review of international and national normative guidance documents.
• Comparative analysis of ethical and legal frameworks governing biobanking.

Main Results:

• Identified ambiguity and varied interpretations of
• return of results
• across different biobanking contexts.
• Highlighted inconsistencies in normative guidance regarding result dissemination.
• Established a clearer understanding of the terms 'results', 'return', 'clinical significance', and 'utility'.

Conclusions:

• A simplified lexicon and concordance of meaning are proposed to address the ethical and legal complexities of returning results.
• Standardized terminology will aid in developing consistent policies for biobanking research.
• Clarifying these terms is crucial for responsible biobanking practices and participant engagement.