Procedure: Collection, storage and disposal of human biospecimens in research

Purpose

This procedure describes the University’s Human research Ethics Committee’s requirements for University staff, students, emeriti and visitors seeking ethical approval to use human biospecimens in research projects.

Definitions

Human biospecimen: the term as defined in the National Statement, refers to any biological material obtained from a human including biospecimens, blood, urine, sputum and any derivative from these, such as cell lines. It does not include non-human biological material such as micro-organisms that live on or in a person.

Procedure

1. This procedure covers:

1. what information needs to be recorded about the source, nature and reason for collection of the human biospecimens;
2. requirements about participant consent including circumstances where waiver of consent may be justified;
3. confidentiality of samples and information;
4. access to samples and information;
5. disposal of samples; and
6. socio-cultural considerations bearing on these issues.

2. This procedure is consistent with the National Statement. researchers must demonstrate that human biospecimens will be collected, stored, used and disposed of in accordance with:

• the Policy: Collection, Storage and Disposal of human biospecimens in research;
• this procedure;
• all relevant legislation and regulations;
• NHMRC statement; and
• University Human Research Ethics Committee (HREC) approvals and any ACT Health Human Ethics Approval

3. researchers in any doubt should consult the Research Services Division for guidance.

Information re. source, nature, and reason for collection of the human biospecimens

4. Where a proposed research project, carried out at the University, or controlled primarily by University staff, involves any use of human biospecimens, it must be reviewed and approved by the HREC before the research can commence. This includes instances where human biospecimens are taken for normal diagnostic or therapeutic purposes and are used for research or teaching purposes or samples obtained solely for the purpose of research or teaching. The HREC must receive a detailed scientific protocol and documentation of the source of the human biospecimens, nature, and reason for collection of the human biospecimens in addition to other relevant information requested by the HREC. Within the protocol, the location of appropriate documentation must be clearly stated.
5. Use of human biospecimens by University staff often requires approval by the ACT Human Ethics Committee.
6. In terms of human biospecimen collection, the Transplantation and Anatomy Act 1978 (ACT) legislates for donation of biospecimens by living persons, effects of consents and authorities, revocation of consent or agreement, donations of biospecimens after death, donations for anatomical purposes, and regulation for schools of anatomy.

Information and consent

7. Participants must receive clear information about whether their biospecimen samples will be identified, and if so, how. If the research is likely to produce information relevant to the health and wellbeing of the person from whom the biospecimens were derived, procedures to allow participants to be identified for appropriate follow-up should, wherever possible, be included in the research proposal. In this situation, ethics applications should include a statement concerning procedures should there be a change in diagnosis as a result of review. The statement could include details of additional diagnostic procedures and also the procedure for reporting information to relevant health professionals, particularly clinicians and pathologists.
8. Consent for the use of biospecimens may be specific, extended or unspecified, written or in exceptional circumstances oral. In exceptional circumstances a waiver of consent may be approved. Consent processes and documentation are subject to the approval of the HREC and must comply with relevant regulations. The use of human biospecimens for any purpose other than specified in the ethics approval constitutes a variation to the approved ethics protocol and, as such, the variation will need to be submitted to the HREC for review and approval. The HREC then assesses each application on a case-by-case basis.

Confidentiality

9. The Privacy Act 1988 (C’th) specifies obligations and responsibilities in relation to privacy, especially as it relates to the collection, use, storage and dissemination of personal information. Researchers and custodians of a databank must observe any confidentiality agreement with the participant about stored data, and custodians must take every precaution to prevent the data becoming available for uses to which participants did not consent. It is the duty of the custodian to ensure that the data are used responsibly and respectfully, and that the privacy of participants is safeguarded. Researchers must ensure the confidentiality and privacy of stored genetic information or research results relating to identified or re-identifiable participants. Such information or research results must be disclosed to treating clinicians only in accordance with the consent given for the research.

Privacy of samples and information

10. Subject to HREC consent data may be collected, stored or disclosed in three mutually exclusive forms:

• individually identifiable data, where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual's name, image, date of birth or address;
• re-identifiable data, from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets;
• non-identifiable data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non- identifiable data is that which can be linked with other data so it can be known that they are about the same data subject, although the person's identity remains unknown.

11. With advances in genetic knowledge and data linkage, and the proliferation of biospecimen banks of identified material, human biospecimen samples should always be regarded as, in principle, re-identifiable.
12. The increased ability to link data has greatly enhanced the contribution that collections of data can make to research, as it enables researchers to match individuals in different data sets without being able to identify the person. These data may or may not have originally been obtained for research purposes.

Access to samples and information

13. Researchers' use of data from databanks must comply with conditions specified by the providers/custodians of the data, including, in particular, any conditions on the identifiability of the data. Where research involves linkage of data sets, approval may be given to the use of identifiable data to ensure that the linkage is accurate, even if consent has not been given for the use of identifiable data in research. Once linkage has been completed, identifiers should be removed from the data to be used in the research unless consent has been given for its identifiable use. It is the duty of the custodian to ensure that the data are used responsibly and respectfully, and that the privacy of participants is safeguarded.
14. Whenever research using re-identifiable data reveals information that bears on the wellbeing of participants, researchers have an obligation to consider how to make that information available to the participants. Where individual notification is warranted, the custodian of the data will need to take all reasonable steps to re-identify those data.
15. In most situations, the custodian of data will be the individual researcher or agency that collected the information, or an intermediary such as a data warehouse that manages data coming from a number of sources. In some cases, an independent custodian may be necessary. For example, when coded data are stored in a databank, a custodian independent of both the data collectors and the researchers may be appointed, to maintain the data in coded form while enabling individual participants to access their own identified results or data.
16. Some uses of data in a databank may be detrimental to people to whom the data relate. Researchers and/or custodians should consider denying or restricting access to some or all of the data for those uses.

Disposal of biospecimens samples

17. Disposal of biospecimens and cadaveric remains must be done in accordance with the Transplantation and Anatomy Act 1978 (ACT) and any health and safety requirements. Guidelines for handling and disposing of organs and body parts relative to autopsy are well defined in the National Code of Ethical Autopsy Practice. Socio-cultural considerations bearing on these issues
18. Due consideration must be given to possible socio-cultural consequences of research using human biospecimens. Issues of religious and cultural sensitivity to the collection, storage and use of particular human biospecimen samples should be considered. Under some circumstances human biospecimen samples may belong to a group who are more readily identifiable and may subsequently be at some risk of discriminatory treatment.
19. The rarity of some genetic disorders might allow certain families or individuals to be identified by other researchers and in some cases by members of the community, even if information is given to others in non-identifiable form. For this reason, where genetic data are stored, confidentiality might sometimes require restrictions on the release of data for research use.

Other considerations

Imported human biospecimens

20. Where biospecimens are imported from another country for use in Australia, researchers must seek to establish whether there are ethical and professional policies in that country, or the relevant institution, governing the collection of human biospecimens for use in research.

• Where such a policy/regulation exists, and a reasonable enquiry reveals no reason to believe the collection of the human biospecimens contravened it, the HREC may consider waiving consent for the use of these human biospecimens.
• Where it cannot be established that a policy/regulation exists, or where it exists but enquiry reveals reason to believe the human biospecimens were not collected in accordance with it, the human biospecimens should not be used for research in Australia.
• For research with human biospecimens that were in collections either imported or existing overseas before the release of the National Statement, the HREC may consider waiving consent without reference to Human biospecimen Samples and Other Considerations.

Application to use human biospecimens stored in biospecimen banks

21. Specific issues to consider when applying for HREC approval include:

• the original reason for which the human biospecimens are collected; that is, whether they were donated for the purpose of research or removed as part of a medical procedure performed for a therapeutic purpose;
• whether the proposed use and consent of the samples is different from the original purpose of collection of the stored human biospecimen samples;
• the research use of the human biospecimens, and whether it is epidemiological, non-identifying, or identifying, given that the results may have consequences for the donor or the donor's family.
• whether information of clinical importance to the health of the donor or the donor's family may be discovered and if so how that information may be communicated with particular regard to confidentiality requirements.
• whether there are commercial applications for the research outcomes and whether the donor, or an authorised third party, has been informed of those applications and any relevant potential conflicts of interest and understands and approves of such further use.
• whether the donor has been informed of his or her capacity to have the sample and associated data removed from the research project.

22. Applications to use human biospecimens within the National Centre for Indigenous Genomics collection (NCIG) requires a separate application process outlined in the documentation available on request from NCIG.

Human biospecimens from external biospecimen banks and Material Transfer Agreements

23. Where human biospecimens to be used in a University research project are obtained from an external Human Biobank and are transferred to the control of University, the transfer of human biospecimens is subject to a Materials Transfer Agreement (MTA). The MTA must document the formal transfer of authority from the external institution to the University with respect to management of the human biospecimens.

Foetal biospecimens

24. Chapter 4.1 of the National Statement is pertinent to woman who are pregnant and the human foetus. The chapter provided ethical guidelines for the ethical conduct of research involving women who are pregnant, the human foetus ex-utero, and human foetal biospecimens after separation from the woman.
25. Research involving human embryos and gametes, including the derivation of human embryonic stem cell lines, is separately governed by the Research involving Human Embryos and the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2007) (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 the 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.
26. Once human biospecimens have been derived from human embryos, gametes or foetuses, the requirements of this procedure apply for any subsequent use in research.

Old biospecimens

27. The question sometimes arises concerning the need for application of this policy to human biospecimens of some antiquity. If human biospecimens is identified by a "living person" or a "living collectivity" as being culturally or biologically connected to them, then the human biospecimens policy and its procedure should be followed insofar as it is practical and reasonable to do so.

Human research Ethics Review at the University

28. All information relative to human research ethical review at the University, including contact details, can be found at: https://services.anu.edu.au/-support/ethics-integrity.