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Use of tissue and informed consent – guidance

Mandatory tests

When possible, uses of tissue (as with all aspects of study participation) should be optional to ensure participants are able to access the benefits of study participation without unnecessary burden.

When proposed use of tissue is required for the primary purpose of the study it can be a mandatory part of study participation.

When proposed use of tissue is not required for the primary purpose of the study it must be optional.

Mandatory use of tissue can be specific or broad, meaning that not all tests that will be conducted need to be known at the time of consent, but all mandatory use of tissue must be required to answer the primary study questions.

Distinct information and consent

When an aspect of a study is optional the information and consent for this must be distinct to ensure it is clear to participants what is required for study participation and what is optional.

Information on optional aspects of study participation can be contained in the main Participant Information Sheet and Consent Form document but should not be in the main body text of the main Participant Information Sheet or Consent Form.

When a participant reads an information sheet the information they encounter should encounter follow the following pattern:

  • information about the main study
  • consent form for the main study
  • information about optional aspect of the study
  • consent form for optional aspect of the study.

This helps to ensure clarity for participants about what is required to be in the study and what is optional.

Type of consent Requirements

Defined, specific

  • Required for the primary purpose of the study.
  • All uses explained.
  • Actual tests detailed.
  • All storage plans and duration, and destruction detailed.

Defined (specific) consent for the use of tissue can be mandatory.

All information can be in the body of the main Participant Information Sheet and Consent Form.

Defined, broad

  • Required for the primary purpose of the study.
  • General area of use explained, eg, biomarker.
  • Not all tests known at time of consent.
  • Duration of storage clear.

Defined (broad) consent for the use of tissue can be mandatory.

All information can be in the body of the main Participant Information Sheet and Consent Form.

Extended consent

  • Tests are additional to those required for the main study, eg, sub-study.
  • Tissue may be already collected for main study, or additional tissue may be collected.
  • Duration of storage may be unknown.

Extended consent for the use of tissue must be optional as it is not required for the primary purposes of the main study.

Information on extended consent must not be contained in the body of the main Participant Information Sheet, although it may be in the same document following the main study Consent Form.

A distinct consent form is required for extended consent.

As much information as possible about the intended uses of the tissue should be given.

Information that is the same as the main Participant Information Sheet does not need to be repeated (eg, if already collected tissue is to be used the risks of blood draws do not need to be repeated). 

Future Unspecified Use of Tissue

  • Tissue storage beyond duration of the study.
  • Tissue testing not specified.

Future Unspecified Use of Tissue must be fully distinct and optional from any mandatory aspects of study participation.

Information on Future Unspecified/undefined Use of Tissue must not be contained in the body of the main Participant Information Sheet, it may be in the same document following the main study Consent Form.

A distinct consent form is required for Future Unspecified Use of Tissue.

As much information as possible about the intended uses of the tissue should be given, detailed information on what must be included can be found at Future unspecified use of human tissue – guidance.