Advice on consent forms

16.51 The Inquiry considers that information and advice for human genetic research should include guidance on the drafting of consent forms. Guidance is required on the following matters:

• The use of a graduated set of consent options, from consent to specific research, to related research, or to unspecified future research (as approved by an HREC). Issues concerning consent to the use of genetic samples and information in human genetic research—including issues relating to obtaining consent to as yet unspecified future research are discussed in Chapter 15 above.^[57]

• Disclosure by researchers, to research participants, of information about actual or anticipated commercial arrangements connected with human genetic research proposals, as discussed above.

• Clarification of ownership or property interests in any genetic samples, or the information derived from such samples. Issues relating to property in genetic samples are discussed in Chapter 20.

16.52 There was wide support in the submissions for the development of guidelines for preparing consent forms for human genetic research.^[58] Some reservations were expressed about the uncertainty of the ownership issue^[59] and others identified the need for constant communication between governing bodies and researchers^[60] and the need for flexibility.^[61]

16.53 There is a range of other matters that might usefully be included in guidance on the drafting of consent forms. These include

• Model statements about how the privacy of research participants is to be protected—that is, through coding or de-identification of genetic samples or information. Saunders and Komesaroff submitted that the implications of decisions about coding or de-identification should be more fully presented to prospective research participants, when their consent is being sought.^[62]
• Model statements about whether, and if so how, consent to participation may be withdrawn. The National Statement provides that a participant must be free at any time to withdraw consent to further involvement in research and the consequences of withdrawal must be explained when obtaining consent.^[63]Saunders and Komesaroff stated that, in human genetic research, ‘withdrawal may affect not only the research participant but also her or his blood relations’. They also noted that it is often the case that ‘to avoid critical biases in statistical analysis withdrawal of a subject enrolled in a research project does not lead to retrospective withdrawal of the data relating to him or her’.^[64] The Department of Health Western Australia recommended that guidance is needed for the rare situations in which the design of the research project precludes the withdrawal of consent.^[65] These sorts of matters may need to be made clearer to prospective research participants on consent forms.
• Who should consent to the access to tumour blocks where the donor of the tissue has died and where access is sought for use in research of relevance to other family members.