Researchers working with biological samples taken from both animals and humans need to know that the material they are working with has been obtained legally, ethically and with due consideration for the wellbeing, privacy and dignity of the donor.
The acquisition of clinical samples from both humans and animals is regulated by legislation and approved guidelines. Although the legislation covering the use of animals in biomedical research varies from country to country the appointment of a local animal ethics committee (AEC) is the first step to making contact with the appropriate licensing authority. In the UK, further information about the use of animals in biomedical research can be found in the Animals (Scientific Procedures) Act 1986 and from the MRC.
In the UK, the acquisition of human clinical samples is now legislated under the Human Tissue Act (2004). Any sample acquired from a human donor must have been collected with the informed consent of the donor or the donor’s relatives.
Informed consent describes a process for enabling individuals to make voluntary decisions about participating in research with an understanding of the purpose, procedures, risks, benefits, and alternatives. Informed consent is premised on well-established ethical principles, including respect for persons, beneficence, and justice. Following from these principles, key aspects of informed consent include the provision of information about the research that a reasonable person would want to know, in a manner and language understandable to the person, and under conditions that are free from coercion or undue influence1.
Historically it was not always the case, in some instances clinical samples were taken from patients without a full explanation of what may happen to the sample once removed from the patient. The most famous and widely publicised case being that of the HeLa cell line.
Because of the tremendous public interest generated by the story of Henrietta Lacks, there have been significant steps made to improve how clinicians ask for and obtain informed consent. The family and descendants of Henrietta Lacks are only now regaining some control over who has access to the HeLa genome data first published by German scientists in 2013.
ECACC sources the cell lines for its catalogue from research organisations and individuals from around the world. As such we are not involved in obtaining informed consent; confirmation that this was obtained would only be available from the originators, and the level of consent required may vary depending on the requirements of country of origin of the cell line.
Since the introduction of the various pieces of legislation ECACC requires all researchers who wish to deposit human cell lines or clinical samples into our collection to show that the samples were obtained with informed consent.
All documentation associated with these samples is securely held here at ECACC in accordance with the UK Data Protection Act 1998 and 2003. ECACC is licensed under section 16 of the Human Tissue Act 2004 for the following activities:
ECACC is also licensed under regulation 7 and schedule 1 of the Human Tissue (Quality & Safety for Human Application) Regulations 2007. Our licence number is 12114.
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