15. Biobanks

Introduction

A biobank is a collection of human tissue samples stored for potential use in research beyond the life of a specific study.

To be a biobank, a tissue collection must contain both:

  • human biological materials, with or without genetic information generated from their analysis; and
  • associated demographic and health information.

Some common features of biobanks are as follows.

  • They are ongoing and open-ended, which allows for unspecified future research and the donation of tissue that is stored for definite or indefinite periods
  • They need tissue and data to remain potentially re-identifiable, even if they are coded, because researchers may need to link tissue and associated data to other sources of health information for studies in the future, or to follow up information added over time
  • They focus on the common good, with a greater concern for future public benefit than individual benefit for participants themselves. Currently, many studies that make use of biobanks offer no direct or immediate benefit to individual donors.

In te ao Māori, the donation of a bio sample is a “tākoha”. The gift of the donation refers to the responsibility to look after the taonga. Kawa (principles) should be considered at every decision-making point to ensure that responsibility towards tikanga (custom) is being met during at all points during each step involving the donation

In most situations, the custodian of human tissue will be the individual researcher or agency who collected the information, or an intermediary such as a tissue warehouse that manages tissue coming from a number of sources. In some cases, it may be necessary for a biobank to have an independent custodian. For example, when a biobank stores coded tissue, it may appoint a custodian independent of both the tissue collectors and the researchers to maintain the tissue in coded form while enabling individual participants to access their own identified results or tissue.

General considerations

15.1 Researchers obtaining tissue samples for a biobank should collect and store tissue and make it accessible in such a way future research can make use of it.

15.2 Researchers should record restrictions on the use of participants’ tissue and make them known to other researchers who wish to access the biobank for their own studies.

15.3 Researchers and custodians of biobanks should observe confidentiality agreements with participant about stored tissue. Custodians should take every precaution to prevent the tissue from becoming available for uses to which participants did not consent.

15.4 Researchers and custodians of biobanks must ensure that the biobank is used responsibly and respectfully, and that the privacy of participants is safeguarded.

15.5 Researchers and custodians of biobanks should consider denying or restricting access to some or all of the biobank samples for uses that could harm participants.

15.6 Researchers must justify any collection, use or retention of tissue beyond what they require for a particular study, and must gain separate consent for such activities, or in limited circumstances seek a waiver.

15.7 When a biobank is closed, researchers should appropriately transfer or dispose of the biological material and data.

Informed consent

15.8 When seeking participants’ consent for storing tissue in a biobank, researchers should provide information on:

  • the purpose of the biobank
  • governance arrangements, including the rules of access to the biobank, how they will protect privacy and confidentiality of participants, commercial use and benefit sharing, intellectual property issues and the transfer of tissue or material to other institutions or countries
  • the risks and burdens associated with collecting, storing and using tissue
  • the nature of the tissue they will collect
  • the form (i.e. identifiable, re-identifiable or non-identifiable) in which they will store the tissue
  • whether the researcher and/or custodian of the biobank will seek specific or broad unspecified consent for future research or approval from an ethics committee for use of identified or potentially identifiable tissue for research
  • the procedures for returning results, including incidental findings
  • what will occur if the biobank management changes.

15.9 Researchers must inform participants that if the tissue is made non-identifiable, they may not be able to know what is done with their tissue, and in this situation they will not have the option of withdrawing their consent. Researchers should be aware of the following aspects in regard to unspecified consent.

  • A participant’s unspecified consent may sometimes need to include permission to enter tissue into a biobank.
  • When researchers seek unspecified consent, they should clearly explain its terms and wide-ranging implications to potential participants. When participants give such consent, researchers should clearly record its terms.
  • If a later research proposal relies on existing unspecified consent, it should describe the terms of that unspecified consent.
  • Research will sometimes need tissue additional to that covered by a participant’s original or unspecified consent. In this case, they must seek consent to access the additional tissue.

15.10 Researchers’ use of biobanks must comply with conditions that the providers of the tissue have specified.

Limitations of consent

In the context of biobanks, due to the prevalence of future unspecified research, consent does not protect all the interests of participants. Neither does it set aside the moral duty of care that researchers who can access a biobank owe to participants.

15.11 Researchers need to establish a coherent set of measures for protecting the interests of participants in addition to consent procedures, such as removing identifiers on data and adhering to the forms of governance that guide the conduct of professionals in the public interest.

15.12 Researchers should establish these measures in relation to underlying moral norms and values, and in relation to an agreed understanding of the hazards, benefits and uncertainties of tissue use in the context of particular tissue initiatives.

Governance

15.13 Researchers or custodians of biobanks must provide additional safeguards in terms of appropriate governance and strict storage arrangements when they are keeping tissue for future unspecified use or for use in other studies.

15.14 In this case, governance arrangements should cover:

  • the purpose of the biobank
  • how the biobank will be used
  • the form (i.e. identifiable, re-identifiable or non-identifiable) in which the tissue will be stored
  • the rules of access to the biobank
  • how researchers or custodians will protect privacy and confidentiality of participants
  • procedures for returning results, including incidental findings
  • commercial use and benefit sharing, intellectual property issues and transfer of tissue or material to other institutions or countries
  • measures to make all aspects of the biobank’s operation transparent
  • ways in which researchers will be accountable for complying with requirements addressing access, use and privacy.

15.15 Researchers or custodians of biobanks must involve a range of people with relevant interests when they are developing governance arrangements, in the ongoing management of the biobank and in the periodic review of governance arrangements.

15.16 In developing governance arrangements, researchers or custodians of biobanks should:

  • identify potentially relevant values and interests
  • take special care to identify people whose interests may be especially at risk, and interests that arise from diverse values
  • identify existing privacy norms in relation to contemplated uses

15.16.a When people with relevant interests participate in the design and governance of biobanks, researchers can identify relevant privacy norms and develop governance measures (e.g. design of consent and authorisation measures) in relation to these norms.

Transparency

15.17 Participants have the right to request and receive information from biobanks about their stored tissue and how it is being used.

15.18 Participants have the right to request that researchers correct mistakes or omissions about their health data.

15.19 Certain information held by biobanks should be publicly available. This includes information on:

  • who may have access to tissue and other information, and for what purpose
  • tissue-sharing agreements
  • if relevant, the results of independent audits of compliance.

15.20 Researchers or custodians of biobanks must keep an auditable record of all researchers who receive access to the biobank, and the purposes of that access.

15.21 Researchers or custodians of biobanks must report any privacy breach affecting a participant to that participant.

Public interests and privacy interests

The public has an interest in the responsible use of tissue to improve the health and wellbeing of individuals, groups and all New Zealanders. Research using biobanks may lead to improvements in health care and service delivery, better targeting of services and greater understanding of risk factors.

Participants have an interest in controlling access to and disclosure of information relating to themselves, where that information is held in circumstances that they regard as confidential. They also have an interest in limiting the power of researchers or custodians to interfere with their individual privacy in the public interest; for example, using their tissue for research and publishing the results in an identifiable way.

Misuse of tissue can harm individuals, groups and communities. Such harm may include loss of privacy, stigmatisation, discrimination or financial loss.

15.22 The broader public interest may come into conflict with individual privacy. Researchers or custodians of biobanks should seek to avoid potential conflicts and violations rather than addressing them retrospectively.

Using identifiable tissue for accurate linkage

15.23 It may be permissible for a researcher to use identifiable tissue to ensure a linkage is accurate, even if participants have not given their consent for the use of the identifiable tissue. In this case, researchers must assure participants that they will not disclose their identity for purposes beyond this use. When linkage is complete, researchers must remove identifiers from tissue unless participants have consented to its use in an identifiable form.

15.24 Where researchers seek access to biobanks that another organisation holds, it may be preferable for the biobank custodian to carry out the linkage and remove identifiers before providing the linked tissue to the researchers.

Transferring existing samples of tissue when a donor is deceased

15.25 If tissue is to be stored or used for a purpose other than research (e.g. continued storage in a biobank, unrelated to a particular research project), researchers or custodians must meet the informed consent conditions set out in section 31 of the Human Tissue Act 2008:

  1. This section applies to informed consent to collection or use, for any purpose that is not anatomical examination, public display, or both, of human tissue that is, or is collected from, a body.
  2. Informed consent to which this section applies may only be given by the following people in the following circumstances:
    1. the individual whose body is the tissue, or from whose body the tissue concerned is collected, and before his or her death:
    2. that individual’s nominee or nominees, on behalf of that individual and after his or her death, if–
      1. no consent has been given under paragraph (a); and
      2. no informed objection has been raised by that individual:
    3. a member of that individual’s immediate family and on its behalf after that individual’s death, if–
      1. no consent has been given under paragraph (b); and
      2. no informed objection has been raised by that individual’s nominee or nominees:
    4. a close available relative of that individual after his or her death, if–
      1. no consent has been given under paragraph (c); and
      2. no informed objection has been raised on behalf of that individual’s immediate family.