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Consent is obtained in accordance with the requirements of the Human Tissue Act 2004 (HT Act) and the HTA's Code of Practice
HTA standard
Examples of best practice standards
a) Consent procedures are documented and these, along with any associated documents, comply with the HT Act and the HTA’s Codes of Practice.
Make the intended storage and analysis of DNA clear to donors in the consent form and participant information sheets.
HRA provides template consent forms and participant information sheets.
b) Consent forms are available to those using or releasing relevant material for a scheduled purpose.
Keep track of signed consent forms and make sure they are accessible for internal or HTA inspection.
If samples and consent forms arrive separately, regularly check consent forms to ensure consent has been given.
If consent forms are kept by another party and not transferred with the relevant material, the following assurances should be documented between the parties.
Confirmation that appropriate consent is in place, including a copy of the blank consent form and a Material Transfer Agreement (MTA).
Assurance that consent forms won't be destroyed while St. George's, University of London (SGUL) holds the relevant material.
Notify St. George 's, University of London (PI’s or Responsible persons) if consent is withdrawn so that relevant material can be disposed of.
Ensure that consent forms (paper or electronic) will be available during an HTA inspection.
c) Where applicable, there are agreements with other parties to ensure that consent is obtained in accordance with the requirements of the HT Act and the HTA’s Codes of Practice.
External parties should confirm consent through a Material Transfer Agreement (MTA) (refer to the MTA form).
Documentation where consent forms are kept and how consent is verified.
d) Written information is provided to those from whom consent is sought, which reflects the requirements of the HT Act and the HTA’s Codes of Practice.
Those writing participant information sheets must be trained in the HT Act requirements.
e) Language translations are available when appropriate.
Translation into other languages should be available if requested.
f) Information is available in formats appropriate to the situation.
Where appropriate, use visual, audible, or novel means of providing information during the consent process where this may enhance participant understanding.
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