Ethics Practices & Transparency
At TriMetis Life Sciences, informed consent is the ethical foundation of the use of biospecimens in research. We implement stringent protocols to guarantee donor comprehension of specimen usage and ongoing permission. Respect and transparency for patient donors, acquisition service providers, and research users are central pillars of our consent process.
Informed Consent Protocols Ensure Donor Rights
Per all protocols, any specimens collected for human subject research require documented informed consent where applicable. Our partners’ protocols must also have applicable IRB approval and consent procedures per our standard Material Transfer Agreements. For more info on our MTA, see section 4 (iii) under 'Representations and Warranties'.
For remnant clinical biospecimens, we follow 45 CFR 46.104(d)(4) allowing certain research uses without consent. Alternatively, we obtain proper waivers or consent based on the specific sourcing institution’s requirements. Researchers can specify their preferred consent parameters when procuring samples through our services.
Fortifying Data Security in Biospecimen Research
Robust security precautions protect the integrity and confidentiality of sensitive data and specimens. Following cybersecurity best practices, we implement encryption, stringent access controls, continuous monitoring, auditing and more to prevent unauthorized access. Our systems are thoughtfully designed to enable effective de-identified research while safeguarding critical information.
Unwavering Adherence to All Legal and Regulatory Standards
Compliance with legal frameworks including HIPAA and 45 CFR 46 exemption 4 guides all aspects of our work. We rigorously ensure protocols satisfy every applicable regulation related to the ethical collection and research use of biospecimens. Our diligent compliance efforts span from initial protocol design through ongoing monitoring once research is underway.
Integrity Ingrained in Our Culture
Integrity and ethics are deeply ingrained in our organizational culture. Our code of conduct mandates alignment with core moral values in every business decision. Additionally, bona fide compliance teams help us thoughtfully navigate challenges in ways that uphold principles of integrity. This unwavering ethical foundation strengthens trust with our partners.
The Gold Standard in Biospecimen Research Ethics
Our expertise in conducting ethical and legally compliant biospecimen research is unmatched. When you choose TriMetis as a research partner, you can be fully confident that our practices uphold the highest standards. Contact us today to learn more about our capabilities and commitment.
Our rigorous informed consent protocols, industry-leading data security, unwavering legal and regulatory compliance, and a deeply ingrained culture of ethics and integrity demonstrate our commitment to being the gold standard for ethical biospecimen research. When partnering with us, you can trust your research meets the highest ethical principles. At TriMetis Life Sciences, we don’t promise quality, we prove it.
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