Asterand Bioscience upholds the fundamental bioethics principles of autonomy, privacy, safety and informed consent. Further, we support legal and
ethical efforts to promote voluntary donation of surplus human tissues and clinical information for research. The tissue Asterand Bioscience receives is generally surplus tissue that would otherwise be discarded following medical surgery.
Asterand Bioscience maintains a global network of collaborators who conduct subject recruitment, informed consent and scientific activities. All of our activities, and those of our collaborators, are conducted in accordance with applicable laws, regulations, and ordinances. Asterand Bioscience confirms that the following activities have been completed by our collaborators (as necessary): institutional and independent review board approval, privacy officer authorization, government licenses, or industry accreditations. We continually monitor our practices to conform to evolving external scientific, legal and ethical requirements.
The Department of Health and Human Services regulations for the protection of human subjects (45 CFR §46.116 and §46.117) and Good Clinical Practice (GLP), (ICH E6) require that informed consent will be sought from each prospective subject or the subject’s legally authorized representative and will be appropriately documented in writing. Furthermore, we have various forms of informed consent that are utilized for the collection of various biospecimens in different disease areas. These forms, along with their corresponding protocols, are reviewed and approved by appropriate regulatory and ethics authorities. Special situations may exist where the informed consent of the subject (or the subject’s legal representative) to participate in research is unavailable. For example, Asterand Bioscience has worked with hospitals to recover pathology specimens and data no longer needed for diagnostic purposes. In such circumstances, Asterand Bioscience obtains a waiver of informed consent from an institutional review board to enable the research.
For a more in depth review of Asterand Bioscience’s Ethics and Regulatory process, please read Bioethics at Asterand Bioscience.
Asterand Bioscience values the security of confidential medical information. We require identifying information about the subject to be removed at the source of collection; this information is not transferred to our clients. Additionally, Asterand Bioscience promotes the responsible use of genetic information obtained through research. We continually revise our consent processes to ensure that subjects are aware of the risks of research involving genetic information.
Although we are not a covered entity, Asterand Bioscience also assists its collaborators in obtaining Patient Authorizations that comply with the U.S. Health Insurance Portability & Accountability Act (HIPAA). The levels of security applied to patient health information allow our customers to have confidence in Asterand Bioscience clinical data.
Asterand Bioscience is licensed by the United Kingdom Human Tissue Authority to store human organs, tissues, and cells for research purposes other than for a specific ethically-approved research project. We maintain a designated professional to oversee full compliance with all United Kingdom Human Tissue Authority Codes of Practice and directives.
Asterand Bioscience works closely with our clients to ensure that our practices are consistent with their internal policies and standards. Please direct inquiries about bioethics issues to firstname.lastname@example.org.
Asterand Bioscience is accredited by the College of American Pathologists (CAP) and ISO 9001. Alongside our GLP monitoring, we operate a Good Clinical Laboratory Practice (GCLP) laboratory for clinical assay services.