C1 Consent is obtained in accordance with the requirements of the Human Tissue Act 2004 and as set out in the code of practice
22. Two major shortfalls were found against the standard C1.
23. In one case, our audit findings showed there was a lack of assurance that the consent process had been followed in accordance with local procedures. There was ambiguity surrounding the physical completion of consent forms, which made it unclear whether a participant had provided their consent for research. Following the site visit inspection, and working with the HTA, an investigation was undertaken by the establishment and the small number of samples associated with ambiguous consent were disposed of and consent was re-sought from with the donors. A number of remedial actions were taken by the establishment to prevent any similar issues arising in the future.
24. In a separate case, researchers had an inconsistent approach to seeking consent due to the absence of a documented consent procedure. Establishments that have multiple research groups working under the governance of a HTA licence should follow consistent procedures to eliminate the risk of obtaining invalid consent. A documented procedure can be used to reinforce to staff seeking consent which aspects must be discussed with the donor for consent to be informed and valid.
25. The HT Act 2004 does not specify the format in which consent is given or documented. However, it is usual practice for consent forms to be completed by donors for research purposes. There may be occasions where oral consent may be sought and, where this is the case, the person who obtains the consent should document it in the participant’s file or medical case notes. On one inspection, it was found that there was a reliance on staff to provide the assurance that consent was in place, which often but not consistently, was backed up with a consent form. A robust consent process reduces the risk of human tissue being stored without consent.
26. The consent requirements of the HT Act 2004 do not apply to imported material. However, as good practice, licensed establishments importing human tissue from outside England, Wales and Northern Ireland should have in place, agreements that describe the consent arrangements for material that is supplied for research use. This is particularly important when individual consent forms are not provided to licensed establishments. A minor shortfall was identified at a licensed establishment that was importing human tissue without having an agreement in place to confirm that only material which had consent for storage and use for research was supplied.
27. A licensed establishment was given a minor shortfall against standard C1 because agreements with a third party tissue provider did not refer to the legal requirements for consent under the HT Act 2004 for human tissue to be stored after the completion of the clinical trial or the expiry of NHS Research Ethics Committee (NHS REC) approval.