Chapter 2.3: Qualifying or waiving conditions for consent. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 2.3

Consent to participate in research must be voluntary and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.

'Limited disclosure ' to participants of the aims and/or methods of research may sometimes be justifiable. This is because in some human research (for example, in the study of behaviour), the aims of the research cannot be achieved if those aims and/or the research method are fully disclosed to participants.

Research involving limited disclosure covers a spectrum, from simply not fully disclosing or describing the aims or methods of observational research in public contexts, all the way to actively concealing information and planning deception of participants. Examples along the spectrum include: observation in public spaces of everyday behaviour; covert observation, for example of the hand-washing behaviour of hospital employees; undisclosed role-playing by a researcher to investigate participants' responses; telling participants the aim of the research is one thing when it is in fact quite different.

Depending upon the circumstances of an individual project it may be justifiable to employ an opt-out approach or a waiver of the requirement for consent, rather than seeking explicit consent.

A single research project may involve discrete elements or participant groups where different recruitment approaches can be used. For example, a project may involve some elements or participant groups where explicit consent must be sought and other elements where an opt-out approach may be considered or where a waiver of the consent requirement may be applied.

The opt-out approach is a method used in the recruitment of participants into research where information is provided to the potential participant regarding the research and their involvement and where their participation is presumed unless they take action to decline to participate.

While an opt-out approach makes it possible for people to make an informed choice about their participation, this choice can only be made if participants receive and read the information provided, and they understand that they are able to act on this information in order to decline to participate.

Importantly, the opt-out approach is unlikely to constitute consent when applying commonwealth privacy legislation to the handling of sensitive information, including health information. Therefore, where it is impracticable to obtain an individual's explicit consent to the use of their information and the purpose of the research cannot be served by using non-identifiable information, researchers must comply with the Guidelines under Section 95 of the Privacy Act 1988 (s95 guidelines) or the Guidelines approved under Section 95A of the Privacy Act 1988 (s95A guidelines) (as applicable) to ensure that their handling of personal information does not breach the Privacy Act 1988. Where researchers need approval to use an opt-out approach for research to which the s95 or 95A guidelines apply, only an HREC may grant this approval. Other review bodies may approve an opt-out approach for other research.

The Australian Privacy Principles Guidelines contain further information about consent and the handling of personal information.

When neither explicit consent nor an opt-out approach are appropriate, the requirement for consent may sometimes be justifiably waived. When an HREC or, where appropriate, another review body grants a waiver of consent for research conducted prospectively or retrospectively, research participants will characteristically not know that they, or perhaps their tissue or data, are involved in the research.

Guidelines – Chapter 2.3

Limited disclosure

2.3.1 Where limited disclosure does not involve active concealment or planned deception, ethical review bodies may approve research provided researchers can demonstrate that:

a) there are no suitable alternatives involving fuller disclosure by which the aims of the research can be achieved b) the potential benefits of the research are sufficient to justify both the limited disclosure to participants and any risk to the community's trust in research and researchers c) the research involves no more than low risk to participants (see paragraph 2.1.6, page 18), and the limited disclosure is unlikely to affect participants adversely d) the precise extent of the limited disclosure is defined e) whenever possible and appropriate, after their participation has ended, participants will be: (i) provided with information about the aims of the research and an explanation of why the omission or alteration was necessary (ii) offered the opportunity to withdraw any data or tissue provided by them.

2.3.2 Where limited disclosure involves active concealment or explicit deception, and the research does not aim to expose illegal activity, researchers should in addition demonstrate that:

a) participants will not be exposed to an increased risk of harm as a result of the concealment or deception b) a full explanation, both of the real aims and/or methods of the research, and also of why the concealment or deception was necessary, will subsequently be made available to participants c) there is no known or likely reason for thinking that participants would not have consented if they had been fully aware of what the research involved.

2.3.3 Where research involving limited disclosure aims to expose illegal activity (see paragraph 4.6.1, page 67), the adverse effects on those whose illegal activity is exposed must be justified by the value of the exposure.

2.3.4 Only a Human Research Ethics Committee (HREC) can review and approve research that:

a) involves active concealment or planned deception or b) aims to expose illegal activity.

Opt-out approach

2.3.5 An opt-out approach to participant recruitment to research may be appropriate when it is feasible to contact some or all of the participants, but where the project is of such scale and significance that using explicit consent is neither practical nor feasible.

2.3.6 Before approving the use of an opt-out approach for research, an HREC or, where appropriate, another review body must be satisfied that:

a) involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants b) the public interest in the proposed activity substantially outweighs the public interest in the protection of privacy c) the research activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation d) reasonable attempts are made to provide all prospective participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and the procedure to decline participation or withdraw from the research e) a reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate is provided before the research begins f) a mechanism is provided for prospective participants to obtain further information and decline to participate g) the data collected will be managed and maintained in accordance with relevant security standards h) there is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data i) the opt-out approach is not prohibited by State, federal, or international law.

2.3.7 For guidance on the use of an opt-out approach in activities other than research, such as quality assurance and evaluation, refer to Ethical Considerations in Quality Assurance and Evaluation Activities, 2014.

2.3.8 When considering the provision of information to prospective participants and the mechanism by which individuals can decline participation, the ethical review body should consider the sensitivity and the risks, the potential participant pool, the context in which the research and opt-out approach will occur, and whether withdrawal from participation is feasible once identifiers have been removed from data.

Waiver

2.3.9 Only an HREC may grant waiver of consent for research using personal information in medical research, or personal health information. Other review bodies may grant waiver of consent for other research.

2.3.10 Before deciding to waive the requirement for consent (other than in the case of research aiming to expose illegal activity), an HREC or other review body must be satisfied that:

a) involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants b) the benefits from the research justify any risks of harm associated with not seeking consent c) it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records) d) there is no known or likely reason for thinking that participants would not have consented if they had been asked e) there is sufficient protection of their privacy f) there is an adequate plan to protect the confidentiality of data g) in case the results have significance for the participants' welfare there is, where practicable, a plan for making information arising from the research available to them (for example, via a disease-specific website or regional news media) h) the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled i) the waiver is not prohibited by State, federal, or international law.

2.3.11 Before deciding to waive the requirement for consent in the case of research aiming to expose illegal activity, an HREC must be satisfied that:

a) the value of exposing the illegal activity justifies the adverse effects on the people exposed (see paragraph 4.6.1, page 67) b) there is sufficient protection of their privacy c) there is sufficient protection of the confidentiality of data d) the waiver is not otherwise prohibited by State, federal, or international law.

2.3.12 Given the importance of maintaining public confidence in the research process, it is the responsibility of each institution to make publicly accessible (for example in annual reports) summary descriptions of all its research projects for which consent has been waived under paragraphs 2.3.10 and 2.3.11. Waiver decisions under paragraph 2.3.11 should not be made publicly accessible until the research has been completed.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.