Sharing Clinical Trial Data

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    • #7897
      LRobison
      Participant

      Hi all,

      I have a question for those of you who have a data sharing statement for your trials that indicates deidentified data will be shared for future research.

      Please can you advise if your patient information sheet informs patients that data sharing will happen to their deidentified data, rather than give patients the option of opting out of data sharing?

      Many thanks.

      Laura

       

    • #8015
      praxisaus
      Moderator

      Hi Laura,

      Long answer – but the necessary requirements for consent to future use are well articulated in the National Statement. In essence, participants should be given the opportunity to consent – or not consent, or withdraw consent – to the use of their data or specimens for all future purposes.   If you do not wish to give them this option then you’ll need to justify this to your HREC.  I do hope that helps. A good case example is the famous Henrietta Lacks and HeLa cell line story. It is one of many cases in history that we have learned from.

      Chat to your HREC.
      <h4 id=”toc__790″>Element 3: Consent</h4>
      Prospective collection of human biospecimens for research

      3.2.11 Those involved in the collection of human biospecimens specifically for research should obtain and record the consent of donor(s) in order to meet the requirements of Chapter 2.2.

      3.2.12 Before potential participants consent to donation of their biospecimens, they should be given sufficient information about:

      (a) the research for which their biospecimens are to be used and, where extended or unspecified consent is sought, sufficient information to meet the requirements of paragraphs 2.2.1 and 2.2.16;
      (b) how their biospecimens will be stored, used and disposed of, including any processes to be adopted to respect their personal or cultural sensitivities;
      (c) the extent to which their biospecimens will be reasonably identifiable, and how their privacy and confidentiality will be protected;
      (d) whether or not research using their biospecimens is likely to provide information that may be important to their health or to the health of their relatives or their community;
      (e) if information of the kind referred to in (d) is likely to be revealed, whether or not they will have the choice to receive this information, and how this will be managed
      (see paragraph 3.2.14);
      (f) if information of the kind referred to in (d) is likely to be revealed, whether or not they will have the choice for it to be provided to their relatives or their community;
      and how this will be managed (see paragraph 3.2.14);
      (g) whether their biospecimens and associated data may be distributed to other researchers, including those outside Australia (see paragraphs 3.2.7 – 3.2.9);
      (h) their right to withdraw consent for the continued use of their biospecimens or associated data in research (see paragraph 2.2.6(g)), and any limitations that may be
      relevant to their withdrawal of consent; for example, as a consequence of the removal of identifiers, or the prior distribution and/or use of their biospecimens;
      (i) any relevant financial or personal interests that those engaged in the collection, processing, storage and distribution and use of their biospecimens may have (see Chapter 5.4); and
      (j) any potential for commercial application of any outcomes of the research involving their biospecimens, how this will be managed and to whom the benefits, if any, will be distributed.

      Use of stored human biospecimens for research

      3.2.13 Reviewers of proposed research involving the use of human biospecimens must consider the circumstances in which the biospecimens were obtained and any
      known limitations the donor(s) placed on their use during the consent process.

      3.2.14 Where it is contemplated that proposed research will involve the use of human biospecimens that have been obtained without specific consent for their use in research (e.g. where biospecimens were collected for clinical investigation), or where the proposed research is not consistent with the scope of the original consent, the biospecimens may be used only if an HREC is satisfied that the conditions for waiver of consent are met (see Chapter 2.3). In particular, reviewers should consider:

      (a) whether there is a pathway to identify and re-contact the donor(s) in order to seek their informed consent to the use of their biospecimens in research; and
      (b) whether there is a known or likely reason for thinking that the donor(s) would not have consented if they had been asked.

       

    • #8169
      stellabrown
      Participant

      Thanks for sharing the informative blog.

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