Stakeholder Recommendations on Shaping Human Biospecimen Banking Governance in Pakistan

Area of Science:

• Biomedical research infrastructure
• Biospecimen banking and biorepository science
• Pathology and molecular pathology

Background:

• Standardized biospecimen banking is crucial for biomedical research and population health.
• Biobanking in low- and middle-income countries (LMICs) is often fragmented and poorly governed, reducing scientific value and public trust.
• Pakistan faces challenges in biospecimen banking, including fragmentation and governance gaps.

Purpose of the Study:

• To identify drivers of biospecimen banking fragmentation and governance gaps in Pakistan.
• To explore contextually appropriate harmonization opportunities for biospecimen banking in Pakistan.
• To propose a sustainable model for improving biospecimen banking infrastructure and practice in LMICs.

Main Methods:

• Insights gathered from a stakeholder dialogue at a national pathology conference in Pakistan.
• Participants included national and international biobankers, clinicians, laboratory directors, bioethicists, and researchers.
• Key themes identified through synthesis of participant inputs and discourse analysis.

Main Results:

• Biospecimen banking is often not recognized as core health research infrastructure, leading to reliance on short-term funding and siloed collections.
• Significant gaps exist in regulatory oversight, ethics, quality standards, and data governance.
• A network-based, practitioner-led governance model is proposed as a pragmatic first step toward harmonization and capacity building.

Conclusions:

• A practitioner-led network, potentially incubated within the Association of Molecular Pathology of Pakistan, offers a viable interim solution for harmonization.
• This model addresses resource and governance constraints in LMICs, with potential for future transition to a dedicated biobanking organization.
• Stepwise standardization and practitioner coordination are key elements applicable to other LMIC settings facing similar challenges.