Risk Assessment for Activity Regulated Under the Human Tissue Act: A Single Institution Experience.

Risk assessment represents one of the requirements for all activities involving human tissues within the premises. Although a variety of procedures are available to prepare risk assessments in general, there are no published examples of risks associated with the use of human samples in research. To cover this gap and to give an overview of the evaluation performed in our institution, we summarized the potential risks for the use of human samples in research identified in the projects under the remit of the UCL/UCLH Biobank. The procedures of acquisition, transportation, storage, use, and disposal of human samples, and security of the premises were analyzed. From our experience, there are governance-related risks associated with the process of consenting the patients, with the donor confidentiality, with mislabeling of samples and with the ethical approval associated with the project, and they generally do not compromise the integrity of the samples. On the other hand, samples' integrity is more at risk during collection, storage, transport, and use of the sample. Adequate training and having appropriate standard procedures in place and available for all staff seem to be the most effective control measures to prevent any issue. In addition, appropriate equipment maintenance, contingency plans, and strict regulation and monitoring of the facility security should always be in place. In summary, an appropriate evaluation of the risks associated with the use of human samples in research is one of the requirements for the use of human samples in research and it is fundamental for the protection of staff, students, the institution itself, and the patients. Supporting biobanking, implementing a culture of biosafety in the life sciences, and raising awareness in the scientific and regulatory communities are key ways to anticipate future problems associated with biological and governance risks.