11. What is Informed Consent?
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Values Underpinning Research
The National Statement on Ethical Conduct on Human Research outlines the values and
principles of ethical conduct in the research setting. The four principles upon which our
ethical guidance is founded are respect for human beings, research merit and integrity,
justice and beneficence.
Here we will deal with respect for human beings as this is a central tenet in informed
consent for research. The principle for respect recognises that each human being has
value in themselves and that this value must inform all interactions between people.
Respect
The principle of respect recognises the value of human autonomy. By autonomy, we
mean the capacity that an individual has to determine their own life and make their own
decisions. Respect also obligates society to protect people with limited, diminished or
no autonomy. It assumes that wherever possible these groups will be empowered and
protected and that they will be helped where it would be wrong of us not to help them.
The Requirement for Consent
In research, this means that people who participate in research do so as a result of their
own choice. This is the requirement for consent. In facilitating a person’s right to
choose, we are recognising their autonomy. It is ethically and legally required to obtain
consent for participation in research.
What is Informed Consent?
In obtaining consent we must inform potential participants, providing them with enough
information to make a decision, to understand the proposed research and the
implications participating in that research has for them personally. Their consent must
be voluntary, there can be no coercion of people to participate in research, only then can
consent be considered informed consent. How these conditions are satisfied will
depend on the project being discussed and will be affected by laws, codes, ethics and
cultural sensitivities of the community the research is occurring in.
Informed Consent Guidelines
Obtaining consent is not just a matter of satisfying formal, ethical and legal
requirements. Guidelines recommend that in order to make an informed and voluntary
choice, people need to understand the purpose, methods, demands, risks and potential
benefits of the research they are considering participating in. This information needs to
be conveyed to people in a way that is suitable for them and that will help them develop
an adequate understanding. What is an adequate understanding is an issue open to
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interpretation and, to some extent, is likely to be dependent on the individual’s personal
preference for information and involvement in decision-making.
Informed Consent Guidelines 2
It is important to understand informed consent as a process rather than a document. The
aim of the consent process is really to develop a mutual understanding between
participants and the researcher or researchers. In order to achieve that understanding,
individual participants need to be given the opportunity to ask questions, often on more
than one occasion, and from more than one person. They also need the opportunity to
discuss the information and decisions with others, such as their family, friends, their
general practitioner or others, if they wish to.
How is Consent Expressed?
You will often hear the term “written informed consent” implying that consent is always
written down somewhere. Our guidelines require only that it be expressed, that it is
explicitly expressed in some form. So consent can be expressed in writing, by signing a
consent form, orally, at which time the researcher documents consent, or by an action of
the participant that implied consent, for example, returning a survey or other behaviour.
How consent is documented is really dependent on the nature of the research, how
complex it is and the risks associated with it. It is also dependent on an individual
participant’s personal circumstances. In cancer clinical trials, consent is almost always
obtained in written form, so participants sign a written document detailing what they are
consenting to.
Consent
Consent for research is not a one-off event but rather an ongoing process. It requires
ongoing communication between researchers and participants for the duration of the
study. As medical research is dynamic field, new data may emerge during the lifespan
of a single trial. This could be evidence of better outcomes with an existing or new
treatment, evidence of harm from the treatment under investigation or similar.
Particularly in these circumstances participants need to be informed and consider
whether they are happy to continue this process. There are some good examples of how
our Australian Cancer Cooperative Trials Groups have handled new data relevant to
ongoing trials. If you look elsewhere on the website, you will see information about
trials of Tamoxifen to prevent breast cancer and how the Australian/New Zealand
Breast Cancer Trials Group managed early release data from another trial. Some
participants’ circumstances may change and they need to reconsider what participation
in the trial means to them. Remember that participants have the right to withdraw from
a study at any time during the trial. Informing and obtaining consent from research
participants is a complex process but one that is vital to the value and integrity of
research. It is a process that should not be underestimated.
What are the four values underpinning research?
What is the principle most important in guiding research?
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What do people need to understand to make an informed and voluntary decision?
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