Overview of Informed Consent

Informed consent is the process through which a potential subject is informed about a clinical research study and volunteers to participate. This typically entails a discussion with a member of the clinical research team or study doctor, documented on an Informed Consent Form (ICF) and concludes when the subject completes the study. It is important that informed consent is obtained from every subject prior to any clinical trial tests or procedures.

In order to obtain informed consent from a subject they will need to be informed on many aspects of the study and their participation; including:

• That the trial involves research
• The purpose of the trial
• Trial treatments, procedures and expected duration of participation
• Foreseeable risks and benefits of participating in the trial
• Alternatives to participation
• Their rights as a subject

Let’s take a birds eye view of the informed consent process. Hover your cursor over the text in the graphic below to reveal a detail descriptor of each step in the process.

Conducting the Informed Consent Discussion

The principal investigator (PI)  is responsible for all conduct of a clinical trial at a site. Including ensuring that all subjects have provided informed consent prior to participating in the study. As with many aspects of running a clinical trial, the PI may choose to delegate this to another member of his team, such as a trained clinical research coordinator.

Before any trial related procedures are performed, including tests to determine eligibility, every subject must provide their written informed consent. Every clinical study will outline a specific set of criteria which subjects must meet to be enrolled in the study, these are called the inclusion andexclusion criteria, or selection criteria.   Sometimes patients will need to undergo a series of tests to determine their eligibility to participate in the study, a process sometimes called screening. In these instances, the subject will still need to provide informed consent before they are subject to the screening assessments.

Once a patient has been identified as eligible for a study, it is time to present the study and begin the informed consent discussion. Some important tips and talking points to consider when approaching a patient initially:

• Introduce yourself and state your position and affiliation with the hospital / physician etc
  • “ Hello, my name is James and I am a clinical research coordinator working with Dr. Smith”
• Let them know why you are approaching them
  • “ Dr. Smith is participating in a clinical trial on hypertension and has asked me to speak with you about potentially participating”
• Often subject’s will not be familiar with the world of clinical research, medical terminology etc.Let the subject know that their participation in the study is completely voluntary and their refusal to participate will not impact the care they receive
  • Be sure to fully explain all terminology and concepts unique to clinical research
• Ask the subject if they would like to hear more information on the trial

Now it’s time to introduce the patient to the study, including all risks and benefits and what exactly it will entail. All of the required information is contained in the informed consent form, so sometimes this is a helpful guide for the discussion. Provide the patient with a copy of the ICF so that they may follow along, make notes and ask questions.

Once you have reviewed the ICF with the subject, they must be provided with an opportunity to ask any questions they may have. You may not be able to answer all their questions, defer to theprincipal investigator if you are unsure. The subject may want to take some time to consider their participation in the study and take the ICF home to discuss with family, friends and trusted advisors. This is strongly encouraged. Enrolling a subject in a clinical study is a big undertaking, and it is in everyone’s best interest to ensure that the subject is fully informed.

Once the potential subject has had ample opportunity to ask any questions and consider participation they should be offered the opportunity to speak with the PI, if not already present, to discuss the impact on their care.

Remember that informed consent does not end when the subject agrees to participate and signs theinformed consent form. There is a reason we call it the informed consent discussion. Informed consent should be maintained continually throughout the subject’s participation in the study. Take the opportunity at each study visit to discuss any recent developments in the study (especially those which may increase risk to the subject) and continually assess the subject’s understanding of andcompliance to the study.

Informed Consent Best Practices

• Emphasize the patients role in this process, it is their decision whether or not to consent.
• Present the information at a level which is appropiate to the patient. Constantly assess and guage your delivery
  • Dont present the study to a well seasoned nurse in the same manner you would present to a medically niave patient.
  • Cover all of the same topics and points though in an appropiate manner
• Use the “teach back” method where by you have patients repeat back information as it was presented to them
• Assess comprehension of the subject through post discussion questions. Reinforce concepts which the patient was not clear on.
  • How often will you be presenting for study visits?
  • What are the common adverse effects of the investigational product?
• Have the principal investigator, or a sub-investigator, present for at least a portion of the initial informed consent discussion
  • Patient’s will be able to discuss care options and ask any medical questions to someone they trust
• Encourage the patient to discuss their participation with family and friends and allow them to call you with questionsEncourage the subject to take the informed consent form home and write any questions or clarifications down facilitate your next discussion
  • This will assist in greatly boosting your subject retention rate if the support of the patient’s family and friends is on your site
• Do not use buzzwords such as “side effects” “Guinea pig”

Stay tuned for our next post on proper documentation of the informed consent discussion; both on the informed consent form and in the subject’s source records.

Check out Advantage Clinical’s Clinical Research Coordinator Training Programwhich trains study coordinators on topics such as this and more! A full on-boarding and skills improvement course for your clinical research staff.