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      Equipment is appropriate for use, maintained, validated and where appropriate monitored                                           

 HTA standard

 Examples of best practice standards

 a)    There is suitable training and support of staff involved in seeking consent, which addresses the requirements of the HT Act and the HTA’s Codes of Practice.

  • Individuals obtaining consent for the use and storage of relevant material for research should seek Good Clinical Practice, HTA and informed consent training.

 b)    Records demonstrate up-to-date staff training.

  • Documentation of informed consent and HTA training, ideally in a dedicated HTA file and in staff personal development records.
  • Maintain training records for staff, including completed training, competencies, and records of reading SOPs and risk assessments

  • Update training when there are changes in legislation, new policies, different research activities, or a significant amount of time has passed since research activities were last conducted.

 c)    Competency is assessed and maintained.

  • Conduct formal competency assessments based on the consent SOP to prove competence.
  • Consent-seekers should stay informed about current standards by referring to published guidance and relevant policies.

   

 

 

 

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