15.61 One question that frequently arose in submissions and consultations related to how specific consent needs to be. In particular, concerns were raised about whether researchers should be able to obtain consent to the future unspecified use of genetic samples or information and, if so, subject to what processes or safeguards.
The National Statement, the Privacy Act and specific consent
15.62 Under the National Statement, obtaining consent should involve:
(a) the provision to participants, at their level of comprehension, of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results); and
(b) the exercise of a voluntary choice to participate.
15.63 This guidance appears to be consistent with the meaning of consent as it is used in the Privacy Act. The Guidelines on Privacy in the Private Health Sector state that there are three key elements involved in seeking consent to use health information in particular ways: consent must be provided voluntarily, the individual must be adequately informed, and the individual must have capacity to understand, provide and communicate his or her consent.
15.64 The National Statement provides that consent to the collection of human tissue for research purposes should be specific to the purpose for which the tissue is to be used. Where it is proposed that human tissue samples previously collected and stored with consent for research be used for a different research purpose, separate consent for the different research should be obtained.
15.65 The provisions relating to the use of genetic material and information more clearly anticipate that researchers may seek consent to ‘as yet unspecified future research’. Paragraph 16.10(j) of the National Statement provides that when consent is being sought for prospective collection of genetic material and information, individuals should be informed
about any intention to store their genetic material and information for as yet unspecified future research in accordance with paragraphs 16.12 and 16.16 below. If consent is given, the duration of storage should be specified. If consent for future research use is refused, the genetic material and information should be disposed of at the end of the research, once the sample storage and record keeping requirements of good research practice have been met.
15.66 The NHMRC Human Research Ethics Handbook notes, in its commentary on paragraph 16.10(j) of the National Statement, that while consent should normally be specific,
the nature of genetic research may make it difficult to be specific at the time of collection. It is appropriate to ask potential research participants to consent to storage of genetic material for unspecified future use, on the basis that consent will be sought at the time a specific research project is identified.
15.67 According to this interpretation of the National Statement, while researchers may ask participants to consent to the storage of genetic material, further consent to the use of that material in future research will normally need to be sought.
De-identification and specific consent
15.68 The following discussion about obtaining consent to unspecified future use of genetic samples or information is premised on the information or samples remaining identified or potentially identifiable. If information or samples are stored in de-identified form so that that no link can be made between the information or samples and the individuals to whom they relate, the ethical and privacy interests of those individuals are reduced, though not necessarily eliminated.
Interpretation of consent requirements
15.69 Many submissions, notably from medical researchers and research organisations, expressed concerns that too strict an interpretation of specific consent requirements would handicap the conduct of genetic research. The Human Genetics Society of Australasia (HGSA) expressed concerns that privacy legislation
gives primacy to privacy (and the consent requirements) making it increasingly difficult to use stored samples, even in de-identified form. It is the experience of the membership of the HGSA that the community is supportive of research, in general and when asked personally to participate. Current privacy legislation, and the application of that legislation, constrains that community support by setting in place requirements that are likely to lead to the situation in which specific current consent is the only acceptable mechanism for using a stored tissue sample for research – it would be unfortunate if that proves to be the case.
15.70 Dr Joe Sambrook from the PMCI submitted that the requirements of genetic research cannot be served by ‘restricting the use of patient material or information to a single specified project or a specific time-span’.
Instead consent should be obtained in a general fashion to enable tissue to be used for both present and future research purposes, even though those purposes may not be precisely defined.
15.71 The Victorian Department of Human Services Genetics Advisory Committee considered that specific consent should not be necessary for de-identified research. It should be sufficient for ‘generic consent’ for de-identified research to be obtained to enable tissue to be used for both present and future research purposes, even though those purposes may not be precisely defined.
We believe that the standard of ‘general’ consent for use in research, combined with the waiver system (described in 15.8 of the National Statement) and review of the use of tissue in specific research projects by a HREC, constitute a model that best protects both the interests of patients and the research community.
15.72 Other groups considered that current guidelines relating to consent were inadequate to protect the interests of those whose genetic material or information may be used for research. The Genetic Support Council WA stated that where future research purposes are contemplated but not known at the time consent is given, further written consent from the individual should be required. The AIS Support Group asked:
Can a person who has no real understanding of the potential ultimate uses of genetic information, truly give informed consent for the taking of a tissue sample for research purposes? Should express consent be obtained each and every time a researcher seeks to use a tissue sample for research? If consent is obtained in an environment where it is felt that adequate understanding of the nature of research exists, is such consent perpetual?
15.73 The AIS Support Group observed that the complexities of the issues involved require ‘at least a reasonable base level of specific medical or scientific knowledge’ and that to ask a person to give consent to the use of their tissue samples for research purposes without this knowledge ‘challenges the very concept of informed consent’.
15.74 Some submissions emphasised the importance of distinguishing between concepts of consent in the clinical and research settings. The best known legal test for determining what information doctors should give patients before a medical procedure was established in Rogers v Whitaker.Doctors have an obligation to inform patients about the material risks of a proposed procedure. A risk is considered material if the patient would be likely to attach significance to it.
15.75 Such a test may be appropriate where research involves clinical intervention, but is not necessarily an appropriate guide to how much information should be provided by researchers to research participants about the proposed use of genetic samples or information in medical research.
Defining the research purpose
15.76 Concerns about the practical implications of specific consent requirements were emphasised by individuals and organisations involved in large scale medical research projects using major collections of genetic samples for multiple research projects. For example, the Queensland Institute of Medical Research (QIMR) noted that its studies depend upon
our ability to correlate different measures on the same people over long periods of time. To require that we go back to subjects every time we want to do a different assay on their blood, or type a different gene, would impose an unsustainable burden. Were this to be mandated, it would close us down. We trust that decisions on these issues will continue to be left to the discretion of local [HRECs]. We believe that this system is currently working well for both subjects and researchers.
15.77 The PMCI supported the existing principles relating to consent contained in the National Statement but warned that these principles should not be interpreted
to mean that either retrospective or prospective consent is required for use of genetic information or human tissue in a specific study (as opposed to purpose) that was not contemplated at the time that the consent was originally obtained. This interpretation, analogous to that operative in the clinical setting, is not appropriate in the research setting and would seriously impede the research endeavour. Therefore, the only modification that need be made to the current principles, as delineated, is a clear distinction between the application of the informed consent requirement in the clinical setting and the research setting.
15.78 Similar points were made in other submissions and in consultations with researchers. The view was put that it should be sufficient, for example, to obtain consent to a broad research purpose, such as ‘biochemical and genetic studies in cancer’—without the need to specify exactly what sorts of analysis might be performed on genetic material. The emergence of new genetic research technologies, such as micro-array technology, may mean that researchers wish to re-test samples and this should not necessitate fresh consent, if it is for the same broad research purpose.
15.79 The National Statement refers to a requirement that consent to the use of human tissue samples be specific to the ‘purpose’ for which the tissue is to be used and that where previously collected samples are to be used for a different ‘research purpose’ further consent should generally be obtained.
15.80 While it has been suggested that the parameters of this provision might be clarified, the Inquiry does not believe that any change is necessary. It seems sufficiently clear that a distinction may be made between a broad research purpose and the particular study or research techniques that may be used in the pursuit of that purpose.
Consent to unspecified future research
15.81 It is common practice for researchers to seek consent from donors for their tissue to be used in a particular experiment and then stored for possible later inclusion in other experiments, the details and potential implications of which are unspecified. This practice has been criticised as inappropriate because, as a matter of principle, valid consent cannot be provided in the absence of full and complete disclosure of the uses to which the tissue is to be put.
15.82 However, there was also broad consensus within the medical research community about the need for procedures under which prospective research participants may provide consent for unspecified future research—provided that such research is approved by an HREC (which might, in some circumstances require researchers to obtain renewed consent from the donors).
15.83 Suggestions for appropriate procedures often focussed on the idea of ‘tick a box’ consent options. That is, prospective research participants could elect from a graduated set of consent options so that, for example, in addition to the participant being asked to consent to participation in a specified research study, the following options might be presented:
May be stored for future research related to this study (including DNA studies) but only if my consent is obtained at the time for this future research and the research is approved by a Human Research Ethics Committee (HREC) Yes/No
May be stored for future research related to this study (including DNA studies) without my further consent being required, provided the research is approved by an HREC Yes/No
May be stored for future research unrelated to this study (including DNA studies) but only if my consent is obtained at the time for this future research and the research is approved by an HREC Yes/No
May be stored for future research unrelated to this study (including DNA studies) without my further consent being required and, provided that the research is approved by an HREC, and may be used
- in de-identified form (anonymous) Yes/No
- in potentially identifiable form (coded) Yes/No
- in identifiable form. Yes/No.
15.84 Saunders and Komesaroff noted that an approach presently followed by a few HRECs is for individuals to be given the opportunity to choose whether their samples are to be destroyed after the specified experiment has been completed, to be kept and preserved for possible uses approved by an ethics committee, or to be kept and preserved for possible use subject to subsequent renewed individual consent.
15.85 This sort of consent process was seen as having significant advantages for research and, at the same time, respecting the wishes of many donors of human tissue. The QIMR stated that in future studies it envisaged using consent forms with tick boxes to indicate consent to restricted or more general use of samples.
The suggestion that subjects cannot give informed consent to future uses that have not even been invented yet seems to us to ignore the obvious point that the subjects who tick this box are overwhelmingly altruistic in the matter of medical research, and that an [HREC] is perfectly able to make a judgement on whether a future use is reasonable or not without going back to the subject.
15.86 The advantages of obtaining consent for unspecified future research are significant for the organisations conducting genetic research. However, some research organisations expressed concern that presenting a wide range of consent options to prospective research participants may present practical difficulties, both at the point of obtaining consent and in the subsequent handling of samples and information.
15.87 In consultations, medical researchers emphasised the need to balance the potential information needs of prospective research participants with consent forms that are readable and understandable to them. For example, the PMCI Tissue Bank Manager stated that:
In my experience of consenting patients, the length and complexity of the consent document can be quite daunting for the prospective donor. There is a fine balance that must be struck between presenting the individual with all the relevant details, thus obtaining truly informed consent, and effectively ‘confounding’ the donor with detail such that they consent on the basis that they trust the Tissue Bank official or they ‘like the look of you’. This is not informed consent.
15.88 In relation to research practice, the QIMR, in commenting on the model consent form discussed above, stated that
it would be possible to have a huge number of variations on the consent form and administration or keeping track of who agreed to what would be very difficult.
15.89 Similarly, the PMCI Tissue Bank stated that the consent options proposed by the model consent form
do not accurately reflect the nature of consent sought for a large prospective tissue collection such as ours, where all donors are asked to consent for broad research purposes. Within a collection of tissues, having mixed levels of consent places many restrictions on the use of that group of tissues. Each sample must be carefully tracked to ensure the use is in compliance with the wishes of the donor. Administration of the collection becomes increasingly complex and the number of samples available within any disease cohort is potentially reduced.
15.90 In the course of the Inquiry, a number of useful models for obtaining consent to unspecified future research were highlighted—in particular those used in relation to the operation of human genetic research databases. These models are discussed in Chapter 18.
Reform of specific consent requirements
15.91 The National Statement anticipates that researchers may seek consent to storage of genetic material for unspecified future research on the basis that consent to its use will be sought at the time a specific research project is identified.
15.92 The Inquiry understands that the National Statement is currently being interpreted, by at least some HRECs, to permit researchers and research organisations to obtain consent for unspecified future research, as approved by an HREC, and without the need for later, specific, consent.
15.93 This interpretation has met with concern in some quarters, as an unjustified erosion of the protection provided by requirements for specific consent to participation in research. Others have expressed the view that procedures to obtain ‘broad and durable’ consent should be facilitated and that the National Statement may not sufficiently mandate such processes.
15.94 At the centre of this debate are differing views about the application of the concept of consent where people cannot be informed in any detail about the nature of the research. It has been suggested that the language of consent should, in some contexts, be augmented by the concept of ‘donation’ or ‘gifting’: it should be recognised that individuals may choose to ‘gift’ samples for research purposes—for example by leaving their body to science or donating blood to the Red Cross.
15.95 In respect of the last example, Sister Regis Mary Dunne observed that donors to the Red Cross are informed that their blood may be used for transfusion, for the extraction of blood products, or for research.
They do not know, nor have the need to know where their blood has gone. However, the documentation is such that individual identity is protected, yet donors could be contacted again if necessary. Such an Australian system already in place could provide a model for the use in research of altruistically donated blood, and tissue surplus to diagnostic purposes. The initial donation could be accepted with the guarantee that all research will be done only after Ethics Committee approval.
15.96 As discussed above, some Australian human genetic research databases currently obtain consent to unspecified future research and their ability to continue doing so is important to the effective operation of the databases. The PMCI observed:
The HREC and the tissue bank act together as the gatekeeper of the samples. Patients consent to the use of the material as controlled by the HREC, which, in turn, can respond to changing expectations and increased information over time. Patients may always elect to have their samples removed from the bank at any time.
15.97 DP 66 noted that there was much support from medical researchers and others for procedures allowing researchers to obtain consent for unspecified future research, subject to future approval by an HREC. In particular, those involved in the development and ongoing operation of Australian human genetic research databases submitted that the use of tissue banks—with a structure of broad patient consent for research on prospectively collected samples and controlled access to samples through HRECs—is the best way to protect the privacy of patients as well as facilitating research.
15.98 In DP 66, the Inquiry proposed that the National Statement should provide guidelines dealing specifically with obtaining consent to unspecified future research. This proposal attracted considerable support in submissions. The Department of Health Western Australia stated that:
The proposal that guidelines should be developed is supported, as the issue of unspecified future research raises many complex issues. … Further, it is recommended that in these guidelines references to ‘consent’ be replaced with the phrase ‘permitting access’ which may or may not refer to consent.
15.99 The HGSA expressed strong support for guidelines allowing researchers to obtain consent to unspecified future research.
The near future will bring an opportunity to undertake ‘parallel processing’ of vast amounts of genetic information. This will be of little use if completely anonymous but may help establish genotype-phenotype correlations if coded or identified. Consent forms should, where appropriate, recognise this and, respecting an individual’s right to limit or de-limit use of their genetic material, invite a range of consent options…
15.100 Similar views were expressed by the Australian Biospecimen Network, who emphasised the importance of medical research carried out on archival materials and associated health information.
Given that human tissue taken during routine surgery will almost certainly be used for research and teaching, prospective consent should be considered a routine part of consent to elective surgery. This consent should be broad and open … delegating responsibility to HRECs to regulate appropriate usage. To consider a system of requiring re-consent would not only be impractical but could also be considered a re-invasion of privacy of an individual since the person would have to be recontacted.
15.101 The OFPC also supported the Inquiry’s proposal and observed that individuals’ consent for the storage of their tissue for future research should be obtained and that guidelines relating to such consent
could promote good privacy practices by encouraging researchers to devise practical measures to inform, and in appropriate cases to keep informed, the altruistic donors of their samples and their information.
15.102 Other submissions expressed reservations about facilitating the obtaining of consent to unspecified future research, as compared to specific consent. The Law Institute of Victoria stated that
it is ‘fundamental to the concept of informed consent’ that researchers, researchers, research organisations and HRECs be required to take reasonable steps to obtain specific consent at the time a future research project is identified. The fact that research techniques are changing at a rapid rate simply reinforces the argument that specific consent should, where possible, be obtained.
15.103 The Queensland Government cautioned that the development of guidelines dealing specifically with obtaining consent to unspecified future research may raise strong views from the public, particularly in circumstances where it is proposed that specific, informed consent not be required. It suggested that:
An analysis of community views in respect of consent to unspecified future research is needed to ensure confidence in research in Australia is maintained and individuals feel comfortable allowing their samples to be used. Such analysis could be undertaken by the proposed HGCA.
15.104 The Inquiry has concluded that the National Statement needs to deal more clearly with the issue of consent to future research. The Inquiry recommends that the NHMRC, as part of its review of the National Statement in the 2003–2005 triennium, should amend the National Statement to provide clear guidance about obtaining consent to unspecified future human genetic research.
15.105 In Chapter 18, the Inquiry recommends that the NHMRC should include specific guidance in the National Statement on obtaining consent to unspecified future research in relation to the operation of human genetic research databases. However, the Inquiry does not believe that the use of consent to unspecified future research should be limited to registered human genetic research databases. Other researchers may also wish to use this mechanism, with the approval of their HRECs, although it may be expected that consent to unspecified future research will most commonly be sought in the context of the operation of standing research databases.
Recommendation 15–4 The NHMRC, as part of its review of the National Statement in the 2003–2005 triennium, should amend the National Statement to provide clear guidance to researchers about obtaining consent to unspecified future human genetic research.
 For example, Department of Human Services Victoria Genetics Advisory Committee, Submission G089, 24 January 2002; Queensland Institute of Medical Research, Submission G036, 14 January 2002; Peter MacCallum Cancer Institute, Submission G070, 20 December 2001; Peter MacCallum Cancer Institute, Submission G071, 7 January 2002; Genetic Support Council WA, Submission G112, 13 March 2002; M Dunne, Submission G041, 17 December 2001; N Zeps, Submission G047, 14 January 2002.
 For example, Queensland Institute of Medical Research, Consultation, Brisbane, 13 December 2001; Children’s Cancer Research Institute, Consultation, Perth, 4 December 2001; Peter MacCallum Cancer Institute, Consultation, Melbourne, 15 March 2002; L Skene, Consultation, Melbourne, 15 March 2002.
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [1.7].
 Office of the Federal Privacy Commissioner, Guidelines on Privacy in the Private Health Sector (2001), OFPC, Sydney, xii. The definition of ‘consent’ under the Privacy Act includes ‘express or implied’ consent: Privacy Act 1988 (Cth)s6.
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [15.5(b)].
 Ibid [15.6].
 Ibid [16.10(j)].
 National Health and Medical Research Council, Human Research Ethics Handbook (2002), NHMRC, Canberra [C105].
 Human Genetics Society of Australasia, Submission G050, 14 January 2002.
 Peter MacCallum Cancer Institute, Submission G104, 20 February 2002.
 Department of Human Services Victoria Genetics Advisory Committee, Submission G089, 24 January 2002.
 Genetic Support Council WA, Submission G112, 13 March 2002.
 Androgen Insensitivity Syndrome Support Group Australia, Submission G106, 26 February 2002.
 Peter MacCallum Cancer Institute, Submission G028, 20 December 2001; L Skene, Consultation, Melbourne, 15 March 2002.
Rogers v Whitaker (1992) 175 CLR 479.
 Ibid, 634.
 L Skene, Consultation, Melbourne, 15 March 2002.
 Queensland Institute of Medical Research, Submission G036, 14 January 2002.
 Peter MacCallum Cancer Institute, Submission G028, 20 December 2001.
 Queensland Institute of Medical Research, Submission G036, 14 January 2002; Queensland Institute of Medical Research, Consultation, Brisbane, 13 December 2001; Peter MacCallum Cancer Institute, Consultation, Melbourne, 15 March 2002.
 Peter MacCallum Cancer Institute, Consultation, Melbourne, 15 March 2002.
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [15.5(b)].
 Ibid [15.6].
 Peter MacCallum Cancer Institute, Submission G028, 20 December 2001; Peter MacCallum Cancer Institute, Consultation, Melbourne, 15 March 2002.
 N Saunders and P Komesaroff, Submission G084, 9 January 2002.
 B Uren, undated pro forma consent form: Consent for Collection, Storage and Testing of Human Tissue for Research.
 N Saunders and P Komesaroff, Submission G084, 9 January 2002.
 Queensland Institute of Medical Research, Submission G036, 14 January 2002.
 See Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney [12.105]–[12.106].
 Peter MacCallum Cancer Institute Tissue Bank, Submission G263, 20 December 2002.
 Written comments provided at Queensland Institute of Medical Research, Consultation, Brisbane, 13 December 2001.
 Peter MacCallum Cancer Institute Tissue Bank, Submission G263, 20 December 2002. This problem was also highlighted in a recent report for the Nuffield Trust, who stated that ‘Informatics experts say that in large computerised systems it is very difficult to lock-in various patient reservations as to purposes as data are split, merged, transformed, transferred, and otherwise manipulated’: W Lowrance, Learning from Experience: Privacy and the Secondary Use of Data in Health Research (2002), The Nuffield Trust, London, 20.
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [16.10(j)]; National Health and Medical Research Council, Human Research Ethics Handbook (2002), NHMRC, Canberra, C105. In its general provisions dealing with privacy the National Statement also states that the consent of participants should be obtained for the use of the personal information where the information is to be held on registers for use by researchers in future research projects: National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [18.4].
 M Dunne, Submission G041, 17 December 2001.
 Peter MacCallum Cancer Institute, Submission G071, 7 January 2002.
 Ibid; N Zeps, Submission G047, 14 January 2002.
 Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney, Proposal 12–2.
 Children’s Hospital at Westmead Tumour Bank, Submission G276, 17 December 2002; Department of Human Services South Australia, Submission G288, 23 December 2002; Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002; Children’s Cancer Institute Australia, Submission G221, 29 November 2002; Genetic Support Council WA, Submission G243, 19 December 2002; Centre for Law and Genetics, Submission G255, 21 December 2002; Department of Health Western Australia, Submission G271, 23 December 2002; Human Genetics Society of Australasia, Submission G267, 20 December 2002; Australian Biospecimen Network, Submission G238, 19 December 2002; NSW Health Department, Submission G303, 13 January 2003; Office of the Federal Privacy Commissioner, Submission G294, 6 January 2003; Association of Genetic Support of Australasia, Submission G284, 25 December 2002; Commonwealth Department of Health and Ageing, Submission G313, 6 February 2003; Medicines Australia, Submission G302, 12 February 2003.
 Department of Health Western Australia, Submission G271, 23 December 2002.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002.
 Australian Biospecimen Network, Submission G238, 19 December 2002.
 Office of the Federal Privacy Commissioner, Submission G294, 6 January 2003. One model is the Tumour Bank Newsletter published by the Children’s Hospital at Westmead Tumour Bank: Children’s Hospital at Westmead Tumour Bank, Submission G276, 17 December 2002.
 Law Institute of Victoria, Submission G275, 19 December 2002; Centre for Genetics Education, Submission G232, 18 December 2002.
 Law Institute of Victoria, Submission G275, 19 December 2002.
 Queensland Government, Submission G274, 18 December 2002.
 The HGSA agreed, emphasising that ‘information from quite small studies may contribute to much larger enterprises’: Human Genetics Society of Australasia, Submission G267, 20 December 2002.