Consent arrangements: Generic or project-specific consent

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Introduction

When preparing materials to support the consent process for the collection of new data and/or tissues, the type of consent to be sought should be clearly thought through i.e. will consent be specific to the project itself, or more generic for storage and future use. If the latter, how much information can be provided about future research to help potential participants make an informed decision.

For data or tissue banks, where the purpose is to collect information and/or human tissue samples for access by the research community (collaborators or unknown third parties), generic consent for storage and future use is obviously a necessity, otherwise the bank would not be able to function. Such banks should be designed to hold identifiable data (if needed) but only to release pseudonymised/linked anonymised data to third party researchers (unless further consent is sought).

For both data and tissues, the research participant may place certain restrictions on the use of their data and/or tissues, for example use only in certain disease areas (tiered consent). The custodian of the data/tissues should either have systems in place to honour these wishes, or be explicit to research participants that there are no mechanisms to manage such specific requests.  The MRC supports the use of broad and enduring generic consent for medical research, with tiered consent only used in exceptional circumstances.

Consent is a fundamental principle of the human tissue legislation. Within law, consent for research use of tissue can be broad in both scope and time. By routinely asking for generic consent participants are made aware that research may be undertaken using their samples, they understand what this might mean for them and are given the opportunity to donate samples to ongoing future research or not, as they wish.

One way of managing the possibility of obtaining generic consent when collecting data or tissue samples for discrete projects, would be to provide two options:

  1. Consent for the specific project only; or
  2. Consent for the specific project and for storage and future use of tissue samples and/or data (where for future use of data this is likely to be with specific caveats).

This approach obviously requires careful management to ensure that participants’ wishes are honoured.

As a minimum, the following should be provided if planning to ask for generic consent:

  • As much information as possible about future projects, e.g. the types of diseases to be researched, and how in lay terms. Including details of any proposed linkages to other datasets or tissue collections.
  • If identifiable information or samples will be stored and used in future research
    • exactly what the dataset will contain
    • how privacy will be maintained
    • who will have access and the extent of the access
    • whether and how the participant will be contacted again
    • that the participant can withdraw at any time (not possible for irreversibly anonymised data/tissues)
  • If data/tissue samples will be shared with collaborators and/or unknown third parties, and where (i.e. within UK and/or abroad). Whether these will be commercial partners.
  • Specific mention of any genetic analyses, or screening for diseases.
  • How any clinically significant information will be dealt with i.e. will it be fed back to the patient or their clinician.
  • Whether all projects using the data and/or tissues will or will not be reviewed by a research ethics committee, to safeguard the interests of participants.

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