Participant consent in clinical trials
Securing participant consent is a legal necessity in the ethical conduct of research. Participant consent ensures that a participant's rights and well-being are prioritised, allowing them to confidently know that their contributions are valued and respected.
In this blog, we will explore the different forms of consent, consider why consent matters and what information a participant needs to know before they consent to being part of a study.
What is participant consent in a clinical trial?
Participant consent in a clinical trial is where individuals voluntarily agree to participate after being informed about the purpose, procedures, potential risks, and benefits of the trial. This consent is an essential ethical requirement in research involving human participants. It ensures that participants understand what they are agreeing to and that they have the autonomy to make informed decisions about their involvement.
What is informed consent in clinical trials?
Informed consent is a process whereby individuals are provided with comprehensive information about a research study and voluntarily agree to participate in a trial based on their understanding of that information.
Key elements of informed consent include:
- Information disclosure: Participants are provided with detailed information about the purpose of the study, its procedures, potential risks and benefits, alternative treatments or procedures, and any foreseeable consequences of participation.
- Understanding: Participants must understand the information provided to them. Information is typically presented in a language and format that the participant can easily understand, but it may also require the use of other strategies, such as visual aids or interpreters, to enhance participants' understanding, especially if they have limited literacy or language barriers.
- Voluntary participation: Participants must enter into the trial voluntarily, without coercion or undue influence. They should feel free to ask questions, seek clarification, and make decisions about participation without pressure from others.
- Capacity to consent: Participants must have the cognitive ability to understand the information provided and make an informed decision. In cases where participants may lack decision-making capacity (e.g. due to cognitive impairment or where children are involved), additional safeguards may be necessary to protect their rights.
- Documentation: After understanding the information provided, participants typically provide their consent by signing the informed consent form. This document serves as evidence that the participant agreed to participate after being adequately informed.
- Continued consent: Consent is an ongoing process throughout the trial. Participants should be kept informed about any significant changes to the study protocol or new information that may affect their decision to continue participating.
- Confidentiality and privacy: Participants have the right to expect that their personal information will be kept confidential and their privacy will be protected throughout the trial.
- Right to withdraw: Participants have the right to withdraw from the study at any time, for any reason, without facing negative consequences.
Types of informed consent
The main types of informed consent used in clinical trials in Australia include:
Written informed consent
This is the most common form of informed consent used in clinical trials. Participants are provided with a written document, known as an informed consent form, which contains detailed information about the study, including its purpose, procedures, potential risks and benefits, confidentiality measures, and their rights as participants. Participants are required to sign the form to indicate their understanding and voluntary agreement to participate.
Verbal informed consent
In some cases, particularly for low-risk studies or when participants have limited literacy or language barriers, verbal informed consent may be obtained. Researchers verbally provide participants with the necessary information about the study and document their consent in written records. However, verbal consent is usually supplemented with written materials whenever possible.
Assent
Assent may be obtained from individuals who may not have the legal capacity to provide informed consent, such as children or individuals with cognitive impairments. While assent does not replace parental or guardian consent, it involves explaining the study in a manner appropriate to the individual's age and cognitive abilities and seeking their agreement to participate. A person should be given the opportunity to choose a support person, such as a carer, to be part of discussions.
‘Opt-out’ or passive consent
The 'opt-out' approach involves providing potential participants with written information about the research and their potential involvement and presumes their participation unless they actively decline to take part. This approach is only appropriate if people can make an informed decision about participation.
Potential participants must be able to read and understand the information provided to them and be able to decline participation. The approach might be appropriate if you are running a large-scale, low-risk project and it is not feasible to get written informed consent from each person. You must get permission from the Human Research Ethics Committee (HREC) to use this approach. Before using this approach, researchers should first consider:
- if the opt-out approach is permitted under State and Commonwealth law and their institutional policy
- the nature of the research and whether using the opt-out approach is clearly warranted (for example, the risk of not seeking express consent is outweighed by the public benefit or interest of the research)
- if researchers have the necessary experience to manage an opt-out approach
- that data obtained through the opt-out approach is de-identified prior to publication.
Waiver of informed consent
In certain circumstances, such as emergency situations or when obtaining consent would be impractical or compromise the integrity of the study, researchers may seek a waiver of informed consent from an HREC. However, strict criteria must be met to justify such waivers, and alternative safeguards for participants' rights and welfare must be in place.
Tiered consent
In studies involving multiple components or levels of participation, researchers may use tiered consent approaches. Participants can choose the level of involvement they are comfortable with, and consent forms are tailored accordingly.
The use of informed consent in clinical trials in Australia is governed by the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research, along with other relevant regulations and guidelines. Researchers conducting clinical trials in Australia must adhere to these standards to ensure that participants' rights, autonomy, and well-being are protected throughout the research process.
Each state and territory in Australia has guardianship and/or medical treatment legislation about capacity and consent. It is the responsibility of all healthcare providers to know and understand their legal obligations in whichever state or territory they are conducting research.
Why participant consent matters
Obtaining participant consent is a legal, ethical, and professional obligation for all healthcare providers involved in clinical trials. It is critical to supporting person-centred care and safeguarding the rights, autonomy, and well-being of participants in clinical research. Good clinical practice involves ensuring that informed consent is validly obtained and appropriately timed.
What participants should know before giving consent
Researchers must provide prospective participants with comprehensive written information about the study that should include:
- the purpose of the study
- if it is a clinical trial, and what phase it is in
- who can participate in the study
- who is running the study (organisation/s and researcher/s)
- who has approved the research
- who is funding the study
- how the study will be run
- what their participation will involve, including how long they will need to be involved
- how the study will be monitored
- whether they will need to have tests, scans or other procedures
- If and where they need to go for appointments, treatments or meetings
- whether researchers will require access to their medical records
- whether they will be reimbursed for any expenses related to the study (e.g. travel costs)
- information about possible side effects or other risks
- information about possible benefits
- any restrictions on things they cannot do while participating
- who to contact for more information about the study, or if they have a problem or wish to make a complaint during the study
- information about their rights, including data privacy, consent and withdrawal.
What is a Participant Information and Consent Form?
A Participant Information and Consent Form (PICF) is a written document provided to prospective participants before they participate in a research study or clinical trial. The PICF is a crucial component of the informed consent process as it ensures that participants have the necessary information to make autonomous decisions about their involvement and helps protect their rights and well-being throughout the study.
The PICF has several purposes:
- Information provision: The PICF provides detailed information about the study, including its purpose, procedures, potential risks and benefits, confidentiality measures, and the rights and responsibilities of participants.
- Informed consent: By reading the PICF, participants gain an understanding of what their participation in the study entails. After reviewing the information provided, participants have the opportunity to ask questions and clarify any concerns before deciding whether to consent to participation.
- Consent documentation: After reviewing the PICF and having their questions answered, participants can indicate their informed consent by signing the PICF. This signed document serves as evidence that the participant agreed to participate voluntarily after being adequately informed about the study.
FAQs about clinical trial consent
Informed consent is a voluntary agreement by an individual to participate in a clinical trial after being provided with comprehensive information about the study. The process of seeking informed consent is crucial for ensuring that participants understand the purpose, procedures, risks, and benefits of the trial before making a decision to participate.
The PICF should contain detailed information about the study, including its purpose, procedures, potential risks and benefits, confidentiality measures, and participants' rights and responsibilities. It should be written in clear and understandable language.
Yes, participants have the right to withdraw from a clinical trial at any time and for any reason without facing negative consequences. They should be informed about this right during the consent process.
In most cases, adult participants provide their own consent to participate. For minors or individuals who lack decision-making capacity, consent may be obtained from a legally authorised representative, such as a parent or guardian.
Participants should be informed about the procedures for reporting adverse events or side effects during the trial. They should also be reassured that appropriate medical care will be provided if they experience any unexpected health issues related to their participation in the trial.
Participants should be informed about the measures taken to protect their privacy and confidentiality, including how their personal information will be collected, stored and used. Researchers should adhere to strict confidentiality protocols and comply with relevant privacy laws and guidelines.
The ethical conduct of clinical trials in Australia is overseen by Human Research Ethics Committees (HRECs). These committees review research proposals to ensure that they meet ethical standards and regulatory requirements.
