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Please note:

The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.

15. Use of Human Tissue Samples

Samples of tissue, including blood and other body fluids, are collected from persons in hospitals and other health care institutions in a variety of circumstances. Samples collected for diagnostic purposes in the course of treatment may also be used for teaching or quality assurance activities and for research. Directors of Pathology have traditionally exercised, and should continue to exercise, discretion in the use of clinical samples in the interpretation and development of laboratory procedures. After the original purpose for which samples were collected has been achieved, the residual tissue may be discarded. Hospitals and pathology laboratories are required by law to retain archival samples for diagnostic or forensic purposes. Accordingly, most hospitals have collections of stored samples, the use of which in research may lead to important advances in the understanding and treatment of disease.

The principles of ethical conduct and review described in 1. 'Principles of ethical conduct', and 2. 'Human Research Ethics Committees' of this Statement should govern all such research.

This Statement refers to such tissue samples as are referred to above but excludes fetal tissue, reproductive tissue and tissue from autopsy to which additional guidelines or legislation may apply.

Where human tissue is to be used in any research, researchers and Human Research Ethics Committees (HRECs) need to be satisfied that the research proposal conforms to the guidelines below. The additional ethical issues that arise in genetic research that uses human tissue need to be addressed in conformity with 16. 'Human Genetic Research'.

Appendix 3 to the National Statement defines 'human tissue' as including the substance, structure, and texture of which the human body or any part or organ of it is composed that is removed or separated from living human beings. This also includes blood, blood components and waste products.

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Respect for persons

NS 15.1

The fundamental ethical principle to be observed in the use of human tissue samples for research is respect for the person and this is reflected in:

  1. the provision to the donor of full information about the purposes of the sampling, and/or the plan of the research proposal;

    2.

  2. consent by the donor to the use of the sample;

  3. the professional removal of samples to be used;

  4. provision for appropriate and secure storage of tissue samples;

  5. provision and maintenance of appropriate and secure systems to ensure confidentiality and privacy in the recording, storage and release of data; and

  6. accountability in the care and usage of such samples.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

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NS 15.2

It is important for institutions or organisations in conjunction with their HRECs to determine when consent should be sought for the use of tissue in research or when a waiver of the requirement for consent may be considered.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

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Institutional responsibility

NS 15.3

Institutions or organisations at which research involving the use of human tissue samples is conducted, should develop policies about the conduct and ethical approval of such research which conform to relevant legislation and are consistent with this Statement. Those polices need to provide guidance to researchers and HRECs in relation to soliciting or accepting voluntary donations of, and specifying conditions for, the use of human tissue samples in research. In their development, relevant considerations include:

  1. the source, nature and cultural or religious sensitivity of the sample;

  2. the original reason for its collection; and

  3. the purpose of the research.

    4.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

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Where consent would be required

NS 15.4

Where human tissue samples are collected for purposes including research, consent for their use in research is generally required.

Except where the requirement for consent is waived by a Human Research Ethics Committee (HREC) under Paragraph 15.8, persons who have tissue removed from them should be given the opportunity to agree or object to their tissue being used in research, or even to opt for its disposal.

For more information on statutory provisions relating to donation, see the Research Ethics Collection page E89 and the Research Law Collection page L35 .

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NS 15.5

Consent should:

  1. be voluntary; and

  2. be specific to the purpose for which the tissue is to be used; and

  3. follow the provision of full information about the project, including advice as to whether, after completion of the research for which consent is given, tissue samples are to be stored.

15.5(b)

This is an important element of the way that consent in this type of research is expressed. HRECs need to be satisfied that there is sufficient detail about the purpose of the research for which the tissue is sought.

15.5(c)

HRECs should be satisfied that those responsible for obtaining consent provide potential donors, or authorised third parties, with full information about:

  • the purpose(s) of the research;
  • the type and amount of tissue to be taken, as well as the (bodily) location that the tissue is to be taken from;
  • the manner in which tissue will be taken and the safety and invasiveness of acquisition;
  • the duration and conditions of preservation of the tissue;
  • the potential uses for the tissue, including any commercial uses;
  • the safeguards in place to ensure protection of the donor's, and the donor's family's, privacy and confidentiality;
  • identifying information to be attached to the tissue and whether it will render the donor of the tissue potentially identifiable;
  • how use of the tissue could affect the donor's privacy; and
  • what will happen to any remaining tissue when the research has been completed.

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NS 15.6

Where it is proposed that human tissue samples previously collected and stored with consent for research be used for a research purpose different from that of the previously approved research, consent for the use of the tissue samples in the new research should generally be obtained. An HREC may waive the requirement for consent in conformity with paragraph 15.8.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

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NS 15.7

Where it is proposed to use tissue samples which have been:

  • obtained for or held in storage following, or in association with, clinical investigations;

  • held in archives or banks; or

  • removed in the course of a clinical procedure and not required for any clinical purpose, in research that may be lead to harm, benefit or injustice to a donor of such tissue, consent of those donors should normally be obtained.

    •

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

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Where the requirement for consent could be waived

NS 15.8

An HREC may sometimes waive, with or without conditions, the requirement for consent. In determining whether consent may be waived or waived subject to conditions, an HREC may take into account:

  • the nature of any existing consent relating to the collection and storage of the sample;

  • the justification presented for seeking waiver of consent including the extent to which it is impossible or difficult or intrusive to obtain specific consent;

  • the proposed arrangements to protect privacy including the extent to which it is possible to de-identify the sample;

  • the extent to which the proposed research poses a risk to the privacy or wellbeing of the individual;

  • whether the research proposal is an extension of, or closely related to, a previously approved research project;

  • the possibility of commercial exploitation of derivatives of the sample; and

  • relevant statutory provisions.

    •

For an extended discussion of the matters listed in this paragraph, see the Research Ethics Collection, ' Human tissue, research involving ', page E89.

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Confidentiality

NS 15.9

Wherever human tissue samples or related information are gathered in the course of a professional relationship, professional confidentiality must be observed. Identification of samples must be limited to the minimum necessary to achieve the stated objectives of the study. If the study may produce information relevant to the health and well being of the person from which it was derived, the HREC may require procedures to allow participants to be identified to facilitate appropriate follow-up.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Points to consider NS 15.1­15.9

  • Does the research have a therapeutic intention that justifies collecting tissue in a way that may otherwise be considered lacking in respect for the integrity of the human body, living or dead?
  • Is the tissue 'previously collected' or is it to be collected for the purposes of the proposed research?
  • Is the consent of individual providers required? What arrangements are proposed for obtaining consent? Are they appropriate in the circumstances of the tissue collection and the proposed research?
  • If the tissue for research is identifiable or potentially traceable to the tissue donor, has the researcher provided protocols for ensuring that the privacy and confidentiality of tissue providers will be protected?
  • Does the research have the potential to reveal information about future health risks for the tissue donor or her or his family? Has the researcher provided a protocol for informing tissue providers and/or their families of research results?

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