Chapter 2.2: General requirements for consent. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 2.2

Respect for human beings involves giving due scope to people's capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by participants – commonly known as 'the requirement for consent '. This requirement has the following conditions: consent should be a voluntary choice, and should be based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.

What is needed to satisfy these conditions depends on the nature of the project, and may be affected by the requirements of the codes, laws, ethics and cultural sensitivities of the community in which the research is to be conducted.

Variations of these conditions may be ethically justified for some research. Respect for human beings must, however, always be shown in any alternative arrangements for deciding whether potential participants are to enter the research.

It should be noted that a person's consent to participate in research may not be sufficient to justify his or her participation.

This chapter provides guidelines on the requirement for consent. Chapter 2.3: Qualifying or waiving conditions for consent then discusses and provides guidelines on conditions under which the requirement may be qualified or waived.

Guidelines – Chapter 2.2

2.2.1 The guiding principle for researchers is that a person's decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it. For qualifications of this principle, see Chapter 2.3: Qualifying or waiving conditions for consent.

2.2.2 Participation that is voluntary and based on sufficient information requires an adequate understanding of the purpose, methods, demands, risks and potential benefits of the research.

2.2.3 This information must be presented in ways suitable to each participant (see paragraph 5.2.17).

2.2.4 The process of communicating information to participants and seeking their consent should not be merely a matter of satisfying a formal requirement. The aim is mutual understanding between researchers and participants. This aim requires an opportunity for participants to ask questions and to discuss the information and their decision with others if they wish.

2.2.5 Consent may be expressed orally, in writing or by some other means (for example, return of a survey, or conduct implying consent), depending on:

1. (a) the nature, complexity and level of risk of the research
2. (b) the participant's personal and cultural circumstances.

2.2.6 Information on the following matters should also be communicated to participants. Except where the information in specific sub-paragraphs below is also deemed necessary for a person's voluntary decision to participate, it should be kept distinct from the information described in paragraphs 2.2.1 and 2.2.2:

1. (a) any alternatives to participation
2. (b) how the research will be monitored
3. (c) provision of services to participants adversely affected by the research
4. (d) contact details of a person to receive complaints
5. (e) contact details of the researchers
6. (f) how privacy and confidentiality will be protected
7. (g) the participant's right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data
8. (h) the amounts and sources of funding for the research
9. (i) financial or other relevant declarations of interests of researchers, sponsors or institutions
10. (j) any payments to participants
11. (k) the likelihood and form of dissemination of the research results, including publication
12. (l) any expected benefits to the wider community
13. (m) any other relevant information, including research-specific information required under other chapters of this National Statement.

2.2.7 Whether or not participants will be identified, research should be designed so that each participant's voluntary decision to participate will be clearly established.

Renegotiating consent

2.2.8 In some research, consent may need to be renegotiated or confirmed from time to time, especially where projects are complex or long-running, or participants are vulnerable. Research participants should be told if there are changes to the terms to which they originally agreed, and given the opportunity to continue their participation or withdraw (see paragraphs 5.2.17 and 5.2.19).

Coercion and pressure

2.2.9 No person should be subject to coercion or pressure in deciding whether to participate. Even where there is no overt coercion or pressure, consent might reflect deference to the researcher's perceived position of power, or to someone else's wishes. Here as always, a person should be included as a participant only if his or her consent is voluntary.

Reimbursing participants

2.2.10 It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.

2.2.11 Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted.

Where others need to be involved in participation decisions

2.2.12 Where a potential participant lacks the capacity to consent, a person or appropriate statutory body exercising lawful authority for the potential participant should be provided with relevant information and decide whether he or she will participate. That decision must not be contrary to the person's best interests. Researchers should bear in mind that the capacity to consent may fluctuate, and even without that capacity people may have some understanding of the research and the benefits and burdens of their participation. For implications of these factors, see Chapter 4.2: Children and young people, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, and Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness.

2.2.13 Within some communities, decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families or community elders. Researchers need to engage with all properly interested parties in planning the research.

Consent to future use of data and tissue in research

2.2.14 Consent may be:

1. 1. (a)'specific ': limited to the specific project under consideration
   2. (b) 'extended ': given for the use of data or tissue in future research projects that are:
      1. (i) an extension of, or closely related to, the original project
      2. (ii) in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research)
   3. (c) 'unspecified ': given for the use of data or tissue in any future research. The necessarily limited information and understanding about research for which extended or unspecified consent is given can still be sufficient and adequate for the purpose of consent (see paragraph 2.2.2).

2.2.15 Extended or unspecified consent may sometimes need to include permission to enter the original data or tissue into a databank or tissuebank (see paragraph 3.2.9).

2.2.16 When unspecified consent is sought, its terms and wide-ranging implications should be clearly explained to potential participants. When such consent is given, its terms should be clearly recorded.

2.2.17 Subsequent reliance, in a research proposal, on existing unspecified consent should describe the terms of that unspecified consent.

2.2.18 Data or tissue additional to those covered by the original extended or unspecified consent will sometimes be needed for research. Consent for access to such additional data or tissue must be sought from potential participants unless the need for this consent is waived by an ethical review body.

Declining to consent and withdrawing consent

2.2.19 People who elect not to participate in a research project need not give any reason for their decision. Researchers should do what they can to see that people who decline to participate will suffer no disadvantage as a result of their decision.

2.2.20 Participants are entitled to withdraw from the research at any stage. Before consenting to involvement in the research, participants should be informed about any consequences of such withdrawal.

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.