Policy: Collection, storage and disposal of human tissue in research
To set out the University’s requirements for ethical approval of research studies involving the use of human tissue, including the requirement for donor consent for the use of that tissue.
The University requirements for ethical approval of research studies involving the use of human tissue, including the requirement for donor consent for the use of that tissue.
This document describes the University's requirements for ethical approval of research studies involving the use of human tissue, including the requirement for donor consent for the use of that tissue.
ANU Human Research Ethics Committee approval of the use of human tissue may relate to, but is not limited to:
- anatomical dissection
- tissue discarded after surgery
- tissue removed at autopsy
- tissue collected for ‘one-off' research projects
- tissue stored in ‘tissue banks'
- tissue transferred to and from the ANU
- imported tissue
This policy is based on the principles described more fully in the following documents.
This contains preliminary information, donation of tissue by living persons, donation of tissue after death, post-mortem examination, donation for anatomical purposes, schools of anatomy, prohibition of trading in tissue, definition of death, and miscellaneous details.
The 2007 National Statement consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is used to inform the design, ethical review and conduct of human research. The National Statement sets national standards for use by any individual, institution or organisation conducting human research and its purpose is to promote ethically good research. Chapter 3.4 details principles relative to the use of human tissue for research purposes.
On 1 August 2001, Australian Health Ministers directed the Australian Health Ministers' Advisory Council (AHMAC) to establish a subcommittee to continue the work completed by the Australian Health Ethics Committee (AHEC) on organs retained at autopsy. Advice for informing and involving families has been developed.
- ANU Medical School Anatomy Laboratory Manual (2007)
The Manual details body donation program, documentation, standard operating procedures, dissection process, student access, disposal of remains, and work safety
This document contains details of guidelines for submitting research proposals to the ACT Health Ethics Committee.
Human tissue samples and the National Statement
- The National Statement on Conduct in Human Research (2007) states that institutions should develop a policy for the collection, storage and disposal of human tissue in research. This policy should cover:
- what information needs to be recorded about the source, nature and reason for collection of the tissue;
- requirements about participant consent including circumstances where waiver of consent may be justified;
- privacy of samples and information;
- access to samples and information;
- disposal of samples;
- socio-cultural considerations bearing on these issues.
- This policy should conform to relevant legislation and be consistent with the National Statement.
- Researchers should demonstrate that tissues will be collected, stored, used and disposed of in accordance with this policy.
- The use of human tissue in research at the University must be carried out in accordance with the Human Research Ethics Committee requirements outlined in this document.
- Donor consent for the use of tissue is generally required, but the requirement may be waived by the Ethics Committee in appropriate circumstances.
Information re. source, nature, and reason for collection of the tissue
- Where a proposed research project carried out at the ANU, or controlled primarily by ANU staff involves any use of human tissue, it must be reviewed by the ANU HREC before the research can commence. This includes instances where tissue is taken for normal diagnostic or therapeutic purposes and is used for research or teaching purposes as well as tissue samples obtained solely for the purpose of research or teaching. The ACT HEC guidelines detailed below are relevant to situations where ethics approval may be exempt, and it is considered that the ANU HREC would also allow exemption where these situations apply. The HREC should receive a detailed scientific protocol and documentation of the source of the tissue, nature, and reason for collection of the tissue in addition to other information requested by the HREC. Within the protocol, the location of appropriate documentation should be clearly stated.
- Much use of human tissue by ANU personnel will need approval by the ACT Human Ethics Committee. The ACT HEC guidelines state the following in regard to the need for ethics approval and where ethics approval may be exempt:
- "Ethics approval should be considered for any study which involves humans (clients/patients, staff, volunteers). Such studies may take many forms and be of either a quantitative or qualitative nature. Please consider the following information when determining if a detailed application to the ACTHEC is necessary.
- Samples used for research procedures in laboratories will be exempt from the need for Ethics approval in the following situations:
- The use of stored specimens for the purposes of quality control of routine diagnostic analytical procedures.
- The use of stored specimens as a source of biological materials to be used as components of diagnostic analytical procedures (eg protein standards, antibodies, hormone-free serum, conditioned media).Investigators should note that at the point when/if a commercial application is first conceived the procedure may no longer be exempt and discussion with the ACTHEC is advised.
- The use for quality control or the development of analytical methods of the excess portion of diagnostic patient specimens, even where the likelihood of such use was known at the time of sampling."
- In terms of tissue collection the ACT Transplantation and Anatomy Act 1978 legislates for donation of tissue by living persons, effects of consents and authorities, revocation of consent or agreement, donations of tissue after death, donations for anatomical purposes, and regulation for schools of anatomy.
Information and consent
- Participants should receive clear information about whether their tissue 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 tissue was 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 procedure 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.
- Consent for the use of tissue may be specific, extended or unspecified, oral or written. The use of written, signed consent is strongly encouraged and in most cases will be necessary for compliance with ethical requirements. When consent is specified in a document signed by the donor as given for the use of human tissue in specific research only, that tissue should not be used for any other purpose without the express written and signed consent of the tissue donor unless an HREC or other review body has waived the requirement to seek further consent. The use of tissue for any other purpose constitutes a variation to the approved ethics protocol and as such the variation will need to be submitted to the HREC.
- Waiver of consent might be approved in the following circumstances:
- Applications for approval of research projects in which non-consented tissue held by ANU researchers will be used must include a request for waiver of the consent requirement addressing the relevant factors identified in 2.3.6 of the National Statement on Ethical Conduct in Human Research (2007). The Committee will then assess the merits of each request.
- Applications for approval of research projects in which non-consented tissue will be used where the tissue is held external to the ANU must include a request for waiver of the consent requirement addressing the relevant factors identified in 2.3.6 of the National Statement. Such applications must also include as much information as possible regarding the source of the tissue, the consent policies of the facility where the tissue is stored/archived, the nature of the consent obtained at collection, and, if applicable, evidence of approval of the consent process provided by another HREC, or, a statement as to why this information cannot be provided.
- The Ethics Committee may also request further information from researchers proposing to use non-consented tissue in order to comply with ANU or national standards. The Committee will then assess the merits of each application on a case-by-case basis.
- The Commonwealth Privacy Act (1988) 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 should observe any confidentiality agreement about stored data with the participant, and custodians should 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 should be disclosed to treating clinicians only in accordance with the consent given for the research.
Privacy of samples and information
- 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.
With advances in genetic knowledge and data linkage, and the proliferation of tissue banks of identified material, human tissue samples should always be regarded as, in principle, re-identifiable.
- 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
- Researchers' use of data from databanks must comply with conditions specified by the providers of the data; 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.
- 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.
- In most situations, the custodian of data will be the individual researcher or agency who 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.
- 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 tissue samples
- Disposal of tissues and cadaveric remains must be done in accordance with the ACT Transplantation and Anatomy Act (1978) and the ANU Medical School Anatomy Laboratory Manual. 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
- Due consideration must be given to possible socio-cultural consequences of research using human tissues. Issues of religious and cultural sensitivity to the collection, storage and use of particular human tissue samples should be considered. Under some circumstances tissue samples may belong to a group who are more readily identifiable and may subsequently be at some risk of discriminatory treatment.
- 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.
- Where tissue is imported from another country for use in Australia, researchers should try to establish whether there are ethical and professional policies in that country, or the relevant institution, governing the collection of tissue for use in research.
- Where such a policy exists, and reasonable enquiry reveals no reason to believe the collection of the tissue contravened it, the Human Research Ethics Committee (HREC) may consider waiving consent for the use of this tissue.
- Where it cannot be established that a policy exists, or where it exists but enquiry reveals reason to believe the tissue was not collected in accordance with it, the tissue should not be used in research in Australia.
- For research with tissues 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 Tissue Samples and Other Considerations.
Application to use tissue stored in tissue banks
- Specific issues to consider when applying for ethics committee approval include:
- the original reason for which the tissue is collected that is, whether it is donated for the purpose of research or removed as part of a medical procedure performed for a therapeutic purpose.
- whether the proposed use of the samples is different from the original purpose of collection of the stored human tissue samples,
- the terms upon which consent was obtained at the time of collection and whether the current proposed use differs from the consented use.
- the research use to which the tissue will be put that is, whether this will be epidemiological, non-identifying use, or identifying use, given that the results of such research 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 may be potential commercial applications for research outcomes and whether the donor, or an authorised third party, has been informed of those applications as well as any potential conflicts of interest and understands and approves of the research and its objectives.
- whether the donor has been informed of his or her capacity to have the sample and associated data removed from the research project.
Tissue from external tissue banks and material transfer agreements
- Where tissue to be used in an ANU research project is to be obtained from an external tissue bank and is to be transferred to the control of ANU, the transfer of tissue shall be subject to a Materials Transfer Agreement (MTA). The MTA must document the formal transfer of authority from the external institution to ANU with respect to management of the tissue.
- 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 tissue after separation from the woman.
- In particular, attention is drawn to section 4.1.11: "Those conducting research involving the human foetusex utero or foetal tissue, after termination of pregnancy, should have no involvement in the clinical care of the woman from whom the foetus or foetal tissue was derived, and no financial or legal relationships with those who are so involved. Such research should be conducted in a location that maintains a separation of the woman's clinical care from research".
- The question sometimes arises concerning the need for application of this policy to tissue of some antiquity. If tissue would be identified by a "living person" or a "living collectivity" as being culturally or biologically connected to them, then the human tissue policy should be followed insofar as it is practical and reasonable to do so.
Human research ethics review at ANU
All information relative to human research ethical review at ANU, including contact details, can be found at: https://services.anu.edu.au/research-support/ethics-integrity.
|Printable version (PDF)|
|Title||Collection, storage and disposal of human tissue in research|
|Purpose||To set out the University’s requirements for ethical approval of research studies involving the use of human tissue, including the requirement for donor consent for the use of that tissue.|
|Topic/ SubTopic||Research - Integrity & Ethics|
|Effective Date||1 Apr 2009|
|Review Date||24 Mar 2011|
|Responsible Officer||Director, Research Services|
|Contact Area||Research Services|
Transplantation and Anatomy Act 1978