What is informed consent, and why is it important for clinical trial participants?

 In medical research, especially in medical trials like those carried out by NZCR, it’s important that people fully understand what a clinical trial involves, as well as the risks and benefits. This ensures participants can make an informed decision about whether they would like to take part or not.  

“Informed consent” is a fundamental ethical principle and legal requirement not only in clinical studies, but in the medical field in general.  So, before someone joins one of the Christchurch or Auckland clinical trials, NZCR must give potential participants all the details about the study. This information ensures participants have a comprehensive understanding of what the clinical trial is about.  If the clinical trial participant understands everything and are comfortable, they will be asked to sign an information and consent form to show that they’re participating of their own free will.   

The key components of informed consent include: 

 1.  Information Disclosure:

NZCR clinical teams must provide potential participants with detailed information about the clinical research, including:  

• The clinical study’s purpose: Potential participants are informed about the clinical trial’s overall goals, such as what the study aims to explore or achieve. This includes details on the specific condition or disease being studied. 
• The potential risks and benefits: Potential side effects or adverse reactions that could occur during the trial are explained, including any steps we take to mitigate side effects. The potential benefits of the treatment or medical intervention are also outlined. 
• The procedures involved: The participant is given a comprehensive understanding of the tests, treatments, medications, or procedures they will undergo during the clinical research, including how often and for how long these procedures will occur. 
• Voluntary Participation: It is made clear that participation in the trial is entirely their choice. Potential participants can withdraw from the trial at any time, for any reason, without their medical care being affected. 
• Confidentiality and Data Protection: Explanation about how participant’s data will be collected, stored, and used ensures their confidentiality and privacy.  
• Alternatives to participation: Information about alternative treatments or studies that might be available as an option for participants is given when relevant. 

2.  Understanding:

Potential participants must have the capacity to understand the information NZCR provides. This means the information should be presented in a clear and comprehensible manner, taking into consideration the participant’s level of health and language literacy. For studies that include specific ethnicities, NZCR will also provide a native speaker of that language. 

3.  Willingness:

Participants should choose whether to participate, without undue influence, coercion, or pressure. They can withdraw from the study at any time without suffering any negative consequences. 

4.  Competence:

The individual providing consent should be legally and mentally competent to make the decision. In the case of individuals with impaired decision-making capacity, a legally authorised representative may provide consent. 

Informed consent is important for several reasons in medical trials: 

1.  Protection of Participants:

Informed consent is a critical mechanism for safeguarding the rights, safety, and welfare of clinical trial participants. It allows individuals to make informed decisions about the potential risks and benefits of participating in clinical research.  

2.  Ethical Considerations:

It ensures that individuals have the right to make decisions about their own bodies and healthcare.  

3.  Transparency and Accountability:

Informed consent documentation provides transparency in the research process, demonstrating that researchers have followed ethical and legal guidelines. It also ensures accountability of NZCR, its researchers, and its Sponsors.  

4.  Scientific Validity:

Informed participants are more likely to remain engaged in the study, follow the protocol, and provide accurate data, which contributes to the scientific validity of the trial.  

5.  Legal Requirements:

It is a legal requirement for NZCR to obtain proper informed consent from all participants before conducting clinical studies.  Failure to do so can lead to legal and ethical violations. 

6.  Public Trust:

Ensuring that clinical trial participants provide informed consent helps build and maintain public trust in the medical and research communities. 

At NZCR, creating an environment where participants are informed, supported, respected, and valued is crucial. We want all our participants to have a clear understanding of what their involvement would entail, and ensure they feel comfortable making a decision that aligns with their own values and preferences. Providing clear and transparent information while addressing their concerns or questions is one of the core values that underpin NZCR’s purpose.