For all clinical trials involving human beings, informed consent is mandatory however, in certain conditions the IRB might waive the informed consent. The Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA) are two major roles in clinical research that deal with consent forms. In this article I will discuss the CRC responsibility in obtaining the consent to the patient.
In clinical trials although the PI explains the study and answers patient questions but, the CRC is the one who needs to provide necessary information to patients when obtaining informed consent. The following are the most important factors that the CRC should consider when obtaining the consent to the patient
Provide realistic expectations
For some studies the overall goal of the intervention is to improve the quality of life. For example, in most of the oncology clinical studies the overall survival is the ultimate goal. So, it is critical to ensure that the patient has a realist view/expectation.
Emphasize on voluntary choice
Taking part in any clinical trial is voluntary. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. The patient should fully understand that they have the right to leave the study at any time, for any reason.
Discuss the proposed treatment and the potential risks
Every single procedure and intervention may have some risks. Detailed explanation of the study to the patient and its potential risks is required. If the patient has a sufficient understanding of the associated risks, he/she will keep the study staff and PI updated about any adverse event.
Provide enough time for decision-making
Providing the patient adequate time to read the lengthy consent form is also essential. After verbally explaining the consent to the patient, the PI and CRC should provide adequate opportunity for the patient to consider all options. Usually the coordinator will follow-up with the patient after few days and can provide more information if the patient has any questions.
After the patient has verbally agreed to sign the consent, the CRC needs to provide the proper documents and ask the patient to sign the consent. Depending on the consent, there are sometimes different sections that require signature, printed name and date. Being fully aware of the content and making sure that the patient is signing the assigned sections are the CRC responsibility. Giving a copy of all pages of the consent is also required. Overall, the patient should feel comfortable to exchange information and ask questions anytime during the process.
In the next part I will explain about how the CRA reviews the consent forms.