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NIH Clinical Research Trials and You

Talking to Your Patient About a Clinical Trial: Using an Informed Consent Self-Evaluation Checklist

Talking with prospective participants about enrollment in a clinical trial is not always easy and there are few evidence-based strategies to help us.

Fortunately, an NCI-funded research team (Eric Kodish, MD, PI)* has pioneered an approach in pediatric oncology that can be applied to a broader range of populations and disease areas.

Their research provides practical advice for improving these conversations. It stresses the importance of a sequenced approach: a patient’s understanding of the disease, followed by discussion of current standard treatment, and finally the possibility of a clinical trial.

All of these steps have been incorporated into the following modified checklist that supports understanding and encourages questions.

Communication Techniques

When speaking with potential participants, consider the following:

  • Provide an empowering environment by inviting the prospective participant to select who will attend this discussion.
  • Increase your prospective participant’s ability to focus on the discussion by holding the meeting in a private location without interruptions.
  • Communicate respect and the importance of this meeting by acknowledging trauma of diagnosis (if appropriate) and empathizing with emotional reactions.
  • Simplify information by avoiding medical jargon and a laundry list of medications and side effects. Summarize often, and repeat important points.
  • Provide a pen and paper to take notes and write down questions, invite them to make comments or ask questions at any time, and encourage them to share their thoughts and feelings. Tell them that all questions are good questions.
  • Stress the importance of information-seeking and elicit questions in an open-ended manner. (“What questions do you have?”)
  • Avoid interrupting.
  • Check that questions were answered to your patients’ satisfaction.
  • Talk about how disease treatments have improved over time due to clinical research and participation of patients in clinical trials.
  • Avoid pushing the recommendation of clinical trial, but if asked, respond accordingly.

Improving Disclosure to Increase Potential Participant Understanding

When speaking with potential participants, consider the following:

  • Follow the sequence of 1) explain disease, 2) describe current best proven treatment, and 3) present option of the clinical trial. Assure that the potential participant has good comprehension of each step before moving to the next one.
  • Break the informed consent conference into two separate meetings if your patient would prefer this or if you think two sessions would help enhance understanding.
  • Use the consent document as a communication tool by providing copies, encouraging reading, and referring to sections of the document during the conference.
  • Discuss treatment options outside of the clinical trial and explain how the study differs from current standard treatment.
  • Explain at least three times that trial participation is voluntary.
  • Explain the right to withdraw at any time.
  • For randomized trials, use examples to clarify the randomization process and avoid potentially misleading descriptions (for instance, a computer randomly assigns alternative treatments).
  • Use a diagram to show differences among the randomization groups of the trial.
  • Discuss any potential conflict of interest you may have as an investigator.
  • Be prepared to give an answer if the prospective participant asks if you personally would enroll in the trial, or if you would advise one of your family members to enroll.


*Eder M, Yamokoski A, Wittmann P, Kodish E. Improving informed consent: Suggestions from parents of children with leukemia. Pediatrics 2007;119;e849-e859

DOI: 10.1542/peds.2006-2208Yap T, Yamokoski A, Noll R, Drotar D, Zyzanski S, Kodish E, A physician-directed intervention: Teaching and measuring better informed consent. Academic Med. Vol. 84, No 84, Aug. 2009

This page last reviewed on January 11, 2011

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