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We inspect establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 at least every two years.
We continue to engage with and involve both professionals and the public on our work, and provide timely advice and guidance on areas that affect them.
Research establishments reported that they comply with the HTA’s licensing standards on consent.
The data we received in relation to governance and quality systems was positive. 98% of establishments reported having documented policies and procedures in place for all licensable activities.
20. Overall, establishments in the research sector were found to be compliant with the HTA’s licensing standards, with no shortfalls being identified in more than half of inspections. The following sections highlight the key areas against our standards which were identified as requiring further...
Research establishments reported that they meet the HTA standards on consent, confirming that consent is obtained in accordance with the HT Act and the HTA’s codes of practice. This is consistent with our inspection findings.
This publication has reviewed and analysed data collected from licensed establishments through the biennial compliance submissions, incident reports and inspections during the year to 31 March 2018, the first year following the introduction of the new HTA standards for the PM sector.
Who can consent to cord blood donation? In all cases, consent for cord blood collection must come from the mother.