Ethics

Responsible Research

Asterand upholds the fundamental bioethics principles of autonomy, privacy, safety and informed consent. We support legal and ethical efforts to promote voluntary donation of surplus human tissues and clinical information for research use. In general, the tissue Asterand recieves is Surplus surgical tissue that would otherwise be discarded following surgery performed for medical treatment.

Asterand maintains a global network of collaborators who conduct subject recruitment, informed consent and scientific activities. We ensure that all of our activities, and those of our collaborators, are conducted in accordance with applicable laws, regulations, and ordinances. Asterand 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.

Informed Consent
Please click here to obtain an example of Asterand's standard template informed consent template form for the collection of surplus surgical tissues and associated clinical information. All informed consent form templates are subject to review and approval 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 may be unavailable. For example, Asterand has worked with hospitals to recover pathology specimens and data no longer needed for diagnostic purposes. In such circumstances, Asterand obtains a waiver of informed consent from an institutional review board to enable the research use of the tissues and clinical information.

Privacy
Asterand 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. In addition, Asterand 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 related to research involving genetic information.

Although we are not a covered entity, Asterand 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 clinical data.

United Kingdom Human Tissue Authority License
Asterand 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. Asterand maintains a designated individual to oversee full compliance with all United Kingdom Human Tissue Authority Codes of Practice and directives.

Client Participation
Asterand 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 ethics@asterand.com.