A comprehensive, ongoing process that involves providing potential and enrolled research participants with adequate information about a clinical trial’s purpose, procedures, risks, and benefits, informed consent helps individuals make sure they fully understand the implications when deciding whether they want to participate. 

Informed consent is more than just obtaining a patient’s signature on a document; it’s a continuous process that involves answering participants’ questions and providing information as the study progresses or as the subject or situation requires. Nurses have a responsibility to facilitate informed consent and ensure that participants fully comprehend the trial information and their role as clinical trial participants. 

The U.S. Food and Drug Administration has an overview of the basic elements of informed consent.  

Protecting Patients’ Rights 

Informed consent respects and upholds clinical trial participants’ rights to:  

  • Receive detailed information about the trial, including its purpose, procedures, risks, and benefits, in a language that they can understand  
  • Ask questions if they do not understand something 
  • Withdraw from the trial at any time without facing any consequences 

However, researchers conducting an extensive systematic review and meta-analysis spanning studies published over three decades found that only 52.1%–75.8% of participants in clinical trials understood different components of informed consent—and those numbers didn’t budge at all in the 30-year time span. Specifically, approximately: 

  • 75% understood the nature of study, potential benefits, and that they had the freedom to withdraw at any time. 
  • 65%–70% understood the study’s purpose, potential risks, and side effects; confidentiality; availability of alternative treatment if they withdraw; and treatments being compared. 
  • 50% understood the concepts of placebo and randomization. 

As oncology nurses, we have a duty to provide comprehensive education to people with cancer. When their cancer treatment is part of a clinical trial, our patient education duties include providing clinical trial information and decision-making support throughout their participation.  

According to the Health Insurance Portability and Accountability Act (HIPAA), participants also have the right to privacy and confidentiality and access to medical care. As nurses, it is our responsibility to maintain the highest standards of our patient’s privacy throughout the clinical trial and to advocate for their well-being to ensure that they receive the care and support that they need. 

Defining Participants’ Responsibilities 

After they agree to participate in a clinical trial, patients have responsibilities such as attending scheduled visits, adhering to the clinical trial protocol, complying with their medication schedule, and reporting adverse events. Nurses should inform patients about their responsibilities during the informed consent process and emphasize the importance of meeting the requirements during their participation. 

Informed consent is an essential component of clinical trials. As nurses, we play an important role in explaining the process, providing information, and advocating for the well-being of those who choose to participate. By keeping patients well-informed and supported throughout a clinical trial, we can help them make informed decisions about their participation. 

Implications for Oncology Nurses: Case Study 

Using Jane, a newly diagnosed patient with cancer, as an example, here’s one way oncology nurses can include informed consent as an ongoing process throughout a patient’s participation in a clinical trial.  

Jane is enrolled in a phase II oncology clinical trial during her clinic visit. At this visit, the oncology nurse and physician conduct a thorough informed consent by explaining the elements included in the document. At each of Jane’s future return visits during the trial, the oncology nurse assesses gaps in Jane’s understanding of the trial, addresses her questions, any emerging safety concerns, and updates her about modifications to the trial protocol and relevant protocol findings.   

During cycle 3, Jane’s creatinine clearance level is less than 50 ml/min. According to the clinical trial protocol, that level requires a dose reduction of the investigational product. The oncology nurse ensures Jane’s comprehension about the need for a dose reduction and her willingness to continue participating in the trial. 

Six months into the trial, the data and safety monitoring board identifies a new potential side effect based on interim results analysis which warrants an update to the informed consent. The nurse collaborates with the physician to discuss the updated side effects with Jane, answers any questions she has, and assists in reconsenting her with the most updated informed consent document. During the reconsent process, the nurse conducts intermittent comprehension assessments to ensure that Jane understands the updated information. 

By diligently continuing to ensure Jane fully understands the study and her rights and responsibilities at every visit throughout the trial, the oncology nurse is providing comprehensive informed consent for her as a participant.