The National Statement and consent

15.5 Consent is a basic principle of ethical research. The National Statement states that the consent of participants in research must be obtained, except in some types of research using de-identified data^[3] and in specified circumstances approved by an HREC.^[4] Consent must be based on information about the purpose, methods, demands, risks, discomforts and outcomes of the research and it must be voluntary and not impaired by any coercion, inducement or influence. It must be given by the participant, where competent, or by a person acting with lawful authority on behalf of a participant who lacks competence.^[5] A person must be able to refuse to participate without giving reasons^[6] or to withdraw consent to further involvement in research.^[7] The circumstances in which consent may be waived in research using genetic samples or information are discussed in more detail below.

Consent and epidemiological research

15.6 The National Statement provides that the consent of participants should generally be obtained for the use of identified or potentially identifiable data for epidemiological research.^[8] An HREC may approve access to identified or potentially identifiable data without consent where the HREC is satisfied that obtaining consent is likely to cause unnecessary anxiety to those whose consent would be sought or would prejudice the scientific value of the research and there will be no disadvantage to the participants. An alternate ground for approving such access is that it is impossible to obtain consent in practice, due to the quantity, age or accessibility of the records. Access to data without consent, on either ground, may be approved only where the HREC determines that the public interest in the research outweighs to a substantial degree the public interest in privacy.^[9]

Consent and the use of human tissue samples

15.7 The National Statement provides that consent should generally be required for collection of human tissue for research purposes.^[10] Consent should be voluntary, specific to the purpose for which the tissue is to be used and follow the provision of full information about the research, including advice as to whether any remaining tissue samples are to be stored following completion of the research.^[11]

15.8 It is important to distinguish between two situations in which stored human tissue is used for research.

• Tissue samples may be collected primarily for use in research and stored in collections maintained by researchers and research organisations. Chapter 18 considers the issues related to human genetic research databases^[12] (often referred to as ‘tissue banks’).

• Tissue samples may be collected primarily for therapeutic and diagnostic purposes and stored in collections maintained by hospitals or pathology laboratories, and then used in research. These human tissue collections are discussed in Chapter 19.

15.9 The National Statement provides that 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.^[13] It also states that consent should be obtained for the use of human tissue samples that have been collected and stored after clinical procedures or held in ‘archives or banks’, in any research which may lead to harm or injustice or be of benefit to the donor.^[14] An HREC may waive the requirement for individual consent to the use of human tissue samples in research in restricted circumstances after taking into account certain matters.^[15]

Consent and the use of genetic material or genetic information

15.10 The National Statement separately provides that consent should generally be required for the use of stored genetic material or genetic information.^[16] Those from whom consent is sought must be informed about a range of prescribed matters, including whether it is intended to store their genetic material and information for as yet unspecified future research;^[17] whether their genetic material is to be disposed of on completion of research;^[18] and that participants may withdraw from the research and either request disposal of their genetic material and information or that it be retained in de-identified form.^[19]

15.11 When human genetic research reveals information important to the future health of an identified or potentially identifiable participant or his or her offspring, the research protocol must provide for the same consent, counselling and confidentiality protection as would apply in a clinical setting.^[20] If participants are asked to consent to the use of their genetic material or information in future research, information and counselling about possible consequences should be provided.^[21] The National Statement notes that in general, genetic material and information will be used for future research in de-identified form and feedback will not be possible.^[22]

15.12 An HREC may waive the requirement for consent to participation in human genetic research.In reaching that decision, the HREC may consider factors that mirror those applicable to waiving consent to the use of human tissue samples.^[23]

15.13 In addition, the National Statement anticipates that institutions or organisations may wish to conduct research on genetic material and information collected for non-research purposes. It states that such institutions or organisations should develop and disseminate a general policy that informs patients that such material and information may be used for future research following HREC approval, and give patients an opportunity to opt out of participation in such research.^[24]