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OU HTA Standard Operating Procedures

***THE NDMRB SOPs ARE UNDER REVIEW AND ARE COMING SOON! - PLEASE CONTACT THE PERSON DESIGNATED WITH ANY QUESTIONS REGARDING HTA***

OVERARCHING CORE UNIVERSITY SOPs are now published on the quality management system - iPasspost. For access to iPassport contact the Human Tissue Governance team.

All of the overarching SOPs listed above must be signed off in staff training forms. The HTA training and quiz must be undertaken and successfully completed prior to working with any human tissue. A link to this training can be found here.

General guidance and advice about the HTA and storing samples under the licence can be found on the Research Services website here.

NDMRB-RA-120 Human Tissue Act (HTA) in the NDMRB ***COMING SOON***

Samples that come to the NDMRB must be given (if they do not already have) a unique ID, which will be used to track the samples from the moment they arrive to the moment they are used/disposed of.

It must be made clear what will happen to the samples when the study is complete - consent must be checked as to whether samples can be kept and stored for future study or if they must be destroyed once the study is complete. If a member of staff leaves and there are human tissue samples stored here, that member of staff must ensure they are either disposed of or transferred to an appropriate custodian. Should this situation arise it must be clearly documented when the samples were disposed of or who the new custodian of the samples is.

All samples which are HTA relevant must be declared and suitable sample logs must be maintained.

It is useful for the PD in the NDMRB to have on file a copy of:

  • The project outline.
  • Any ethical approval (local or international).
  • Material Transfer Agreements (MTAs) - further information about MTAs can be sought from Research Services.
  • A blank example of the consent form used to collect the samples.
  • A copy of the annual samples log.
Example sample log for samples in the NDMRB.

The procedure for dealing with a freezer or cryostore breakdown can be found in NDMRB-SOP-031 NDMRB Liquid Nitrogen and -80 freezer emergency procedures and protocol. If material covered by the NDMRB HTA licence is moved into another location all storage details must be amended in the relevant material log. HTA material may only be stored in locations that have the relevant licence.

For blood letting in the NDMRB guidance can be found in NDMRB-SOP-016. When taking blood from healthy volunteers in the NDMRB the consent form and information sheet must be provided to each volunteer at each collection.

All staff and students working with Relevant Human Material falling under licensable activities must have read the SOP above and signed their training record before work with human tissue starts.

  • HTA Individual Training Record ***COMING SOON***

Training Records will be held by the NDMRB PD.