National Statement on Ethical
Conduct in Research Involving Humans
Part 15 - Use of Human Tissue Samples
Respect for persons
Institutional responsibility
Where consent would be required
Where the requirement for consent could be waived
Confidentiality
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.Footnote 7
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.
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:
(a) the provision to the donor of full information about the purposes of the sampling, and/or the plan of the research proposal;
(b) consent by the donor to the use of the sample;
(c) the professional removal of samples to be used;
(d) provision for appropriate and secure storage of tissue samples;
(e) provision and maintenance of appropriate and secure systems to ensure confidentiality and privacy in the recording, storage and release of data; and
(f) accountability in the care and usage of such samples.
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.
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:
(a) the source, nature and cultural or religious sensitivity of the sample;
(b) the original reason for its collection; and
(c) the purpose of the research.
Where consent would be required
15.4 Where human tissue samples are collected for purposes including research, consent for their use in research is generally required.
15.5 Consent should:
(a) be voluntary; and
(b) be specific to the purpose for which the tissue is to be used; and
(c) 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.
15.6 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.
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.
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 well being 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.
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.
Footnote
7 For guidelines on fetal tissue see Supplementary Note 5 The human fetus and the use of human fetal tissue (1983).
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]