Compliance and Transparency
GEM Biosolutions upholds rigorous ethical principles and adheres to all applicable local, regional, and international regulations governing human biospecimen collection and use. All samples are obtained under approved informed consent processes and in alignment with globally recognized ethical standards. Our worldwide network of biorepositories and clinical sites operates under strict regulatory oversight to ensure full compliance at every stage.
Our Ethical and Regulatory Commitment
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Compliance with major regulations, including HIPAA, PIPEDA, GDPR, and applicable country-specific laws
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Biospecimen collections conducted under IRB, Ethics Committee or Health Ministerial approved informed consent
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Alignment with the Helsinki Declaration and internationally accepted guidelines for research involving human subjects
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Partnerships with accredited biorepositories and clinical sites worldwide, each compliant with local and regional biobanking and pre-clinical research regulations
Documentation Available Upon Request
Copies of Ethics Committee or Health Ministry approvals from partnered providers
Informed Consent Form (ICF) templates used for the approved collection
Provider certifications confirming regulatory and ethical compliance
De-identified medical or pathology reports, when relevant and permitted