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European Biopharmaceutical Review

Consent and Biospecimen Collection in Human Research

Regulations governing the protection of human research subjects are based on the ethical principles identified in the Belmont Report: “respect for persons, beneficence, and justice” and in the Nuremberg Code and the Declaration of Helsinki (1-3). Guidelines established by the Council for the International Organization of Medical Sciences, the Nuffield Council on Bioethics, and Good Clinical Practice also contributed (4-6). The application of these principles in the use of human biospecimens in research is enforced by legal and ethical regulations, the most important of which relates to permission. This may come directly from the donor or be granted by others with authorisation to protect the interests of biospecimen donors.

Legal and ethical oversight is country/region-specific. In the UK, consent or authorisation is required for the collection of biospecimens for research from both living and deceased donors, with a similar situation existing in other European countries. However, in the UK, whether or not a research study also requires ethical approval by an independent ethics committee (IEC) can be determined via an online tool provided by the Health Research Authority (7). In the US, institutional review boards (IRBs) are responsible for the regulatory oversight of research involving human subjects, with the Office of Human Research Protection (OHRP) 45 CFR Part 46 regulations governing IRBs and their operation (8). In other countries, the ministries of health (MOH) or their equivalent may be responsible or may transfer the responsibility to authorised IECs.

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Dr Tony Brown is Senior Director of Scientific and Corporate Development at BioIVT. Kelly Sapsford is General Manager for the UK and Europe at BioIVT.
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