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Risk Assessment and Adverse Event Reporting

Risk Assessment

In order to comply with HTA Standards, risk assessments should be carried out for all procedures relating to the storage, use, transportation and disposal of human tissue. Risks to the tissue, in addition to the handlers, should be assessed. Risk assessments must be reviewed regularly and kept locally by the researcher, with copies sent to the relevant PD.

Things to consider when completing a risk assessment for the tissue include package failure, delay or loss in transit, malfunction of storage facilities, traceability, unauthorised access to tissue samples, incorrect procedures being carried out, untrained personnel handling the tissue and any other hazards that result in tissue loss. A copy of the University’s HTA Risk Assessment form and Guidance can be downloaded from the Resource section at the top right of this page.

For further information see Cardiff University HTA Standard Operating Procedure for Risk Management and Contingency Planning located on the Information for Researchers page on the left. 

 

Adverse Event Reporting

The HTA also requires that a local reporting system is in place to record adverse events. A form has been developed, based on the OSHEU form for accident reporting, for use by researchers storing and using human tissue. The form should be used for reporting any event that resulted in damage to or loss of tissue; ‘near miss’ events should also be reported where there was the potential for human tissue to be lost or damaged.

A copy of the University’s HTA Adverse Event Reporting form can be downloaded from the Resource section at the top right of this page. The form should be completed and returned to the HTA Compliance Team and School PD.

For further information see Cardiff University HTA Standard Operating Procedure for Adverse Event Reporting located on the Information for Researchers page on the left.