Scholarlink

Background <p>The International Hemoglobinopathy Research Network (INHERENT) focuses on studying genetic modifiers through large, multi-ethnic genome-wide association studies involving paediatric and adult patients with haemoglobinopathies. The growing integration of genetics and genomics into global healthcare has highlighted the need for standardized policies on biospecimen and data handling. This study describes the necessary ethical and regulatory framework for conducting multinational, researcher-driven genetic studies on humans.</p> Methods <p>Key areas related to the INHERENT study were identified through collaborative research. A review of the grey literature was performed, consulting official sources. An online survey was conducted to identify the local rules.</p> Results <p>Despite the availability of 33 international documents applicable to the three key areas of our investigation, i.e. personal data processing, clinical research and biospecimen management, there is no unique reference for genetic studies without investigational drugs, i.e. outside the scope of good clinical practice. Specific laws and guidelines/recommendations governing the processing of personal data and privacy have been released in most of the 32 surveyed countries. As an example, discordances were found regarding the requirement to get approval from the ethics committees.</p> Conclusions <p>Such heterogeneity challenges the scientific community in conducting these genetic studies. This study calls for further efforts to harmonize international standards for genetic research.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Ethical and regulatory requirements for conducting researcher-driven large-scale multinational genetic haematological studies: the INHERENT experience

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年8月5日

查看全文
  • Antonella Didio,
  • Viviana Giannuzzi,
  • Natasha Archer,
  • Esther Gani,
  • Sabina Sblano,
  • Emmanuel Peprah,
  • Petros Kountouris,
  • Fedele Bonifazi

摘要

Background

The International Hemoglobinopathy Research Network (INHERENT) focuses on studying genetic modifiers through large, multi-ethnic genome-wide association studies involving paediatric and adult patients with haemoglobinopathies. The growing integration of genetics and genomics into global healthcare has highlighted the need for standardized policies on biospecimen and data handling. This study describes the necessary ethical and regulatory framework for conducting multinational, researcher-driven genetic studies on humans.

Methods

Key areas related to the INHERENT study were identified through collaborative research. A review of the grey literature was performed, consulting official sources. An online survey was conducted to identify the local rules.

Results

Despite the availability of 33 international documents applicable to the three key areas of our investigation, i.e. personal data processing, clinical research and biospecimen management, there is no unique reference for genetic studies without investigational drugs, i.e. outside the scope of good clinical practice. Specific laws and guidelines/recommendations governing the processing of personal data and privacy have been released in most of the 32 surveyed countries. As an example, discordances were found regarding the requirement to get approval from the ethics committees.

Conclusions

Such heterogeneity challenges the scientific community in conducting these genetic studies. This study calls for further efforts to harmonize international standards for genetic research.