Chapter 3.2: Human biospecimens in laboratory based research. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction - Chapter 3.2

'Human biospecimens' is a broad term that, for the purposes of this chapter, refers to any biological material obtained from a person including tissue, blood, urine and sputum; it also includes any derivative of these, such as cell lines. It does not include non-human biological material such as micro-organisms that live on or in a person.

Research involving human biospecimens often involves special ethical consideration because of:

• the way that human biospecimens are obtained
• the information that may be derived from human biospecimens and the implications of that information for the individual donor, their relatives and their community
• the significance that may be attached to the human biospecimens by individual donors and/or communities.

Chapter 3.2 should be read in conjunction with Chapter 3.1 and other parts of the National Statement.

Researchers and institutions must also meet any relevant legislative requirements that relate to the collection, retention, use and disposal of human biospecimens, including the general prohibition on trade in human tissue.

Specific considerations for human embryos, gametes and fetal tissue

Specific requirements for research involving fetal tissue are detailed in Chapter 4.1: Women who are pregnant and the human fetus.

Research involving human embryos and gametes, including the derivation of human embryonic stem cell lines, is separately governed by the Research Involving Human Embryos Act 2002 (Cth) and the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2017) (ART guidelines), issued by the NHMRC. Research involving the derivation of embryonic stem cell lines or other products from a human embryo must be considered by a Human Research Ethics Committee (HREC) as part of a licence application to the Embryo Research Licensing Committee (see Part C of the ART guidelines). The legislation and ART guidelines do not regulate the use of these products after they have been derived.

Once human biospecimens have been derived from human embryos, gametes or fetuses, the requirements of this chapter apply for any subsequent use in research.

Conscientious objection

Those who conscientiously object to being involved in conducting research using human biospecimens derived from human embryos, gametes, fetuses or embryonic or fetal tissue should not be obligated to participate, nor should they be put at a disadvantage because of their objection.

Element 1: Research scope, aims, themes, questions and methods

Ethical considerations related to laboratory based research involving human biospecimens vary according to whether the biospecimens are being collected prospectively for the research or whether the biospecimens to be used in the research are stored biospecimens that have been previously collected for research or non‑research purposes.

Prospective collection of human biospecimens for research

3.2.1 For human biospecimens collected for research purposes (including biobanks), there should be ethics review and approval by an HREC of the proposed consent, collection, processing, storage and distribution or disposal.

Use of stored human biospecimens for research

3.2.2 In determining the level of ethics review appropriate for the research involving the use of human biospecimens, the responsible institution and researcher should consider:

1. (a) whether the research involves any risks to the donors, their relatives or their community that are more serious than discomfort (see Chapter 2.1: Risk and Benefit)
2. (b) whether the research may give rise to information that may be important for the health of the donors, their relatives or their community where the identity of the donors will be known to, or can reasonably be ascertained by, those conducting the research or with access to health or research data or information related to donors.

3.2.3 If the research involves only the use of stored biospecimens and involves no more than low risk, then the provisions of paragraphs 5.1.18 – 5.1.21 for non-HREC levels of review may apply.

Element 2: Recruitment

Sources of human biospecimens include voluntary donation, material taken for clinical purposes, and material collected post-mortem (after death).

Human biospecimens are commonly collected, stored and distributed by researchers, biobanks, clinical pathology services, health care providers, research institutes and commercial entities, such as pharmaceutical and biotechnology companies.

For the purposes of this chapter, the concept of 'recruitment ' includes the acquisition or collection of human biospecimens.

Prospective collection of human biospecimens for research

3.2.4 Those proposing to collect human biospecimens for research should:

1. (a) ensure that the burdens of the biospecimen collection on the donor(s) are justified by the potential benefits of the proposed research
2. (b) ensure that those involved in the collection of the biospecimens are suitably qualified or experienced, and follow current best practice
3. (c) ensure that suitable provisions, including financial and governance arrangements, have been made for the intended processing, storage, distribution and/or use, and disposal of the biospecimens.

Human biospecimens obtained after death for research

3.2.5 Any wish expressed by a person about the use of their biospecimens postmortem should be respected. If no such wish is discovered, researchers seeking to obtain human biospecimens post-mortem should obtain consent from the person(s) authorised by relevant legislation.

Use of human biospecimens collected for clinical purposes

3.2.6 Where human biospecimens were obtained for clinical purposes and have been retained by an accredited clinical pathology service, the biospecimens may be used for research purposes if:

1. (a) the identity of the donor is not necessary for the activity, or
2. (b) where the identity of the donor is required for the purposes of the research, a waiver of consent (see paragraph 3.2.14) has been obtained.

Importation and exportation of human biospecimens for research

3.2.7 Where it is intended that human biospecimens will be, or where the biospecimens have been imported from another country for use in research in Australia, researchers must establish whether these human biospecimens were obtained in a manner consistent with the requirements of this chapter and relevant Australian legislation.

3.2.8 Where it cannot be established that the human biospecimens described in paragraph 3.2.7 were obtained in a manner consistent with the requirements described in this chapter and relevant Australian legislation, the biospecimens should not be used for research in Australia.

3.2.9 Human biospecimens obtained for research in Australia may be sent overseas for research in accordance with institutional policy, if:

1. (a) evidence of ethics approval by an appropriate ethics review body for importation of the biospecimens is submitted, or
2. (b) the exportation of the biospecimens is consistent with the original consent and ethics approval is provided by an HREC.

Transition provisions for existing biospecimens

3.2.10 Where biospecimens were obtained domestically or via importation prior to December 2013, the biospecimens may continue to be used in Australia for approved research provided that the researcher's institution ensures that:

1. (a) there is sufficient evidence that the samples were obtained in a manner consistent with any prior guidelines and/or the accepted ethical practice at the time of collection
2. (b) the proposed research for which the biospecimens will be used is within the scope of the consent provided by the donor(s).

Element 3: Consent

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:

1. (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
2. (b) how their biospecimens will be stored, used and disposed of, including any processes to be adopted to respect their personal or cultural sensitivities
3. (c) the extent to which their biospecimens will be reasonably identifiable, and how their privacy and confidentiality will be protected
4. (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
5. (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)
6. (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)
7. (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)
8. (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
9. (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)
10. (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 (for example, 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:

1. (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
2. (b) whether there is a known or likely reason for thinking that the donor(s) would not have consented if they had been asked.

Element 5: Communication of research findings or results to participants

3.2.15 Where proposed research involving the use of human biospecimens may reveal information that may be important for the health of the donor(s), their relatives or their community, whether anticipated or incidental to the scope of the research, researchers should prepare an ethically defensible plan to describe the management of any proposed disclosure or non-disclosure of that information. This plan must be approved by an HREC and, in reviewing this plan, the HREC should consider:

1. (a) the circumstances in which the biospecimens were obtained, including the type of consent provided (see paragraph 2.2.14) and the manner in which the consent was obtained
2. (b) the likelihood of the research generating information that may be important for the health of the donor(s), their relatives or their community
3. (c) whether a recognised intervention exists that can benefit or reduce the risk of harm to the donor(s), their relatives or their community from any health impact revealed by this information
4. (d) the resource requirements and infrastructure in place to support the return of information of the kind referred to in (b) and (c) in an ethically appropriate manner
5. (e) whether participants will be given a choice to receive such information
6. (f) whether there is a pathway to identify and re-contact the donor(s), their relatives or their community, taking into account the relationship between the researchers and the donor(s), if any
7. (g) the potential for sampling or coding errors that may compromise the certainty that the biospecimens came from a particular donor
8. (h) whether the findings of specific tests being undertaken as part of the research have been produced or validated in an accredited laboratory
9. (i) who will take responsibility for any subsequent care requirements.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.